COVID-19 Updates

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

From Northwell Health, Lake Success, NY.

Objective: Northwell Health, New York’s largest health care organization, rapidly adopted technology solutions to support patient and family communication during the COVID-19 pandemic.

Methods: This case series outlines the pragmatic, interdisciplinary approach Northwell underwent to rapidly implement patient virtual visitation processes during the peak of the initial crisis.

Results: Implementation of large-scale virtual visitation required leadership, technology, and dedicated, empathetic frontline professionals. Patient and family feedback uncovered varied feelings and perspectives, from confusion to gratitude.

Conclusion: Subsequent efforts to obtain direct patient and family perspectives and insights helped Northwell identify areas of strength and ongoing performance improvement.

Keywords: virtual visitation; COVID-19; technology; communication; patient experience.

The power of human connection has become increasingly apparent throughout the COVID-19 pandemic and subsequent recovery phases. Due to the need for social distancing, people worldwide have turned to virtual means of communication, staying in touch with family, friends, and colleagues via digital technology platforms. On March 18, 2020, the New York State Department of Health (NYSDOH) issued a health advisory, suspending all hospital visitation.¹ As a result, hospitals rapidly transformed existing in-person visitation practices to meet large-scale virtual programming needs.

Family members often take on various roles—such as advocate, emotional support person, and postdischarge caregiver—for an ill or injured loved one.² The Institute for Patient- and Family-Centered Care, a nonprofit organization founded in 1992, has been leading a cultural transformation where families are valued as care partners, as opposed to “visitors.”³ Although widely adopted and well-received in specialized units, such as neonatal intensive care units,⁴ virtual visitation had not been widely implemented across adult care settings. The NYSDOH guidance therefore required organizational leadership, innovation, flexibility, and systems ingenuity to meet the evolving needs of patients, families, and health care professionals. An overarching goal was ensuring patients and families were afforded opportunities to stay connected throughout hospitalization.

Reflecting the impact of COVID-19 surges, hospital environments became increasingly depersonalized, with health care providers wearing extensive personal protective equipment (PPE) and taking remarkable measures to socially distance and minimize exposure. Patients’ room doors were kept primarily closed, while codes and alerts blared in the halls overhead. The lack of families and visitors became increasingly obvious, aiding feelings of isolation and confinement. With fear of nosocomial transmission, impactful modalities (such as sitting at the bedside) and empathetic, therapeutic touch were no longer taking place.

With those scenarios—common to so many health care systems during the pandemic—as a backdrop, comes our experience. Northwell Health is the largest health care system in New York State, geographically spread throughout New York City’s 5 boroughs, Westchester County, and Long Island. With 23 hospitals, approximately 820 medical practices, and over 72 000 employees, Northwell has cared for more than 100 000 COVID-positive patients to date. This case series outlines a pragmatic approach to implementing virtual visitation during the initial peak and obtaining patient and family perspectives to help inform performance improvement and future programming.

Methods

Implementing virtual visitation

Through swift and focused multidisciplinary collaboration, numerous Northwell teams came together to implement large-scale virtual visitation across the organization during the first wave of the COVID crisis. The initial priority involved securing devices that could support patient-family communication. Prior to COVID, each facility had only a handful of tablets that were used primarily during leadership rounding, so once visitation was restricted, we needed a large quantity of devices within a matter of days. Through diligent work from System Procurement and internal Foundation, Northwell was able to acquire nearly 900 devices, including iPads, PadInMotion tablets, and Samsung tablets.

Typically, the benefits of using wireless tablets within a health care setting include long battery life, powerful data processing, advanced operating systems, large screens, and easy end-user navigation.⁴ During COVID-19 and its associated isolation precautions, tablets offered a lifeline for effective and socially distant communication. With new devices in hand, the system Office of the Chief Information Officer (OCIO) and site-based Information Technology (IT) teams were engaged. They worked tirelessly to streamline connectivity, download necessary apps, test devices on approved WiFi networks, and troubleshoot issues. Once set up, devices were strategically deployed across all Northwell hospitals and post-acute rehabilitation facilities.

Frontline teams quickly realized that a model similar to mobile proning teams, who focus solely on turning and positioning COVID patients to promote optimal respiratory ventilation,⁵ was needed to support virtual visitation. During the initial COVID wave, elective surgeries were not permissible, as per the NYSDOH. As a result, large numbers of clinical and nonclinical ambulatory surgery employees were redeployed throughout the organization, with many assigned and dedicated to facilitating newly created virtual visitation processes. These employees were primarily responsible for creating unit-based schedules, coordinating logistics, navigating devices on behalf of patients, being present during video calls, and sanitizing the devices between uses. Finally, if necessary, virtual interpretation services were used to overcome language barriers between staff and patients.

What began as an ad hoc function quickly became a valued and meaningful role. Utilizing triage mentality, virtual visitation was first offered during unit-based rounding protocols to those patients with the highest acuity and need to connect with family. We had no formal script; instead, unit-based leaders and frontline team members had open dialogues with patients and families to gauge their interest in virtual visitation. That included patients with an active end-of-life care plan, critically ill patients within intensive care units, and those soon to be intubated or recently extubated. Utilization also occurred within specialty areas such as labor and delivery, pediatrics, inpatient psychiatry, medical units, and long-term rehab facilities. Frontline teams appreciated the supplementary support so they could prioritize ongoing physical assessments and medical interventions. Donned in PPE, virtual visitation team members often served as physical extensions of the patient’s loved ones—holding their hand, offering prayers, and, at times, bearing witness to a last breath. In reflecting on that time, this role required absolute professionalism, empathy, and compassion.

In summer 2020, although demand for virtual visitation was still at an all-time high when ambulatory surgery was reinstated, redeployed staff returned to their responsibilities. To fill this void without interruption to patients and their families, site leaders quickly pivoted and refined processes and protocols utilizing Patient & Customer Experience and Hospitality department team members. Throughout spring 2021, the NYSDOH offered guidance to open in-person visitation, and the institution’s Clinical Advisory Group has been taking a pragmatic approach to doing that in a measured and safe manner across care settings.

Listening to the ‘voice’ of patients and families

Our institution’s mission is grounded in providing “quality service and patient-centered care.” Honoring those tenets, during the initial COVID wave, the system “Voice of the Customer End User Device Workgroup” was created with system and site-based interdisciplinary representation. Despite challenging and unprecedented times, conscious attention and effort was undertaken to assess the use and impact of virtual devices. One of the major work streams was to capture and examine patient and family thoughts, feedback, and the overall experience as it relates to virtual visitation.

The system Office of Patient & Customer Experience (OPCE), led by Sven Gierlinger, SVP Chief Experience Officer, reached out to our colleagues at Press Ganey to add a custom question to patient experience surveys. Beginning on December 1, 2020, discharged inpatients were asked to rate the “Degree to which you were able to stay connected with your family/caregiver during your stay.” Potential answers include the Likert scale responses of Always, Usually, Sometimes, and Never, with “Always” representing the Top Box score. The OPCE team believes these quantitative insights are important to track and trend, particularly since in-person and virtual visitation remain in constant flux.

In an effort to obtain additional, focused, qualitative feedback, OPCE partnered with our institution’s Digital Patient Experience (dPX) colleagues. The approach consisted of voluntary, semistructured, interview-type conversations with patients and family members who engaged in virtual visitation multiple times while the patient was hospitalized. OPCE contacted site-based Patient Experience leads, also known as Culture Leaders, at 3 hospitals, asking them to identify potential participants. This convenience sample excluded instances where the patient passed away during and/or immediately following hospitalization.

The OPCE team phoned potential interview candidates to make a personalized connection, explain the purpose of the interviews, and schedule them, if interested. For consistency, the same Digital Customer Experience Researcher on the dPX team facilitated all sessions, which were 30-minute, semiscripted interviews conducted virtually via Microsoft Teams. The tone was intentionally conversational so that patients and family members would feel comfortable delving into themes that were most impactful during their experience. After some initial ice breakers, such as “What were some of your feelings about being a patient/having a loved one in the hospital during the early days of the COVID-19 pandemic?” we moved on to some more pragmatic, implementation questions and rating scales. These included questions such as “How did you first learn about the option for virtual visitation? Was it something you inquired about or did someone offer it to you? How was it explained to you?” Patients were also asked, on a scale of 1 (easy) to 5 (difficult), to rate their experience with the technology aspect when connecting with their loved ones. They also provided verbal consent to be recorded and were given a $15 gift card upon completion of the interview.

Transcriptions were generated by uploading the interview recordings to a platform called UserTesting. In addition to these transcriptions, this platform also allowed for a keyword mapping tool that organized high-level themes and adjectives into groupings along a sentiment axis from negative to neutral to positive. Transcripts were then read carefully and annotated by the Digital Customer Experience Researcher, which allowed for strengthening of some of the automated themes as well as the emergence of new, more nuanced themes. These themes were organized into those that we could address with design and/or procedure updates (actionable insights), those that came up most frequently overall (frequency), and those that came up across our 3 interview sessions (commonality).

This feedback, along with the responses to the new Press Ganey question, was presented to the system Voice of the Customer End User Device Workgroup. The results led to robust discussion and brainstorming regarding how to improve the process to be more patient-centered. Findings were also shared with our hospital-based Culture Leaders. As many of their local strategic plans focused on patient-family communication, this information was helpful to them in considering plans for expansion and/or sustaining virtual visitation efforts. The process map in the Figure outlines key milestones within this feedback loop.

Outcomes

During the height of the initial COVID-19 crisis, virtual visitation was a new and ever-evolving process. Amidst the chaos, mechanisms to capture the quantity and quality of virtual visits were not in place. Based on informal observation, a majority of patients utilized personal devices to connect with loved ones, and staff even offered their own cellular devices to facilitate timely patient-family communication. The technology primarily used included FaceTime, Zoom, and EZCall, as there was much public awareness and comfort with those platforms.

In the first quarter of 2021, our institution overall performed at a Top Box score of 60.2 for our ability to assist patients with staying connected to their family/caregiver during their inpatient visit. With more than 6700 returned surveys during that time period, our hospitals earned Top Box scores ranging between 48.0 and 75.3. At this time, obtaining a national benchmark ranking is not possible, because the question regarding connectedness is unique to Northwell inpatient settings. As other health care organizations adopt this customized question, further peer-to-peer measurements can be established.

Regarding virtual interviews, 25 patients were initially contacted to determine their interest in participating. Of that sample, 17 patients were engaged over the phone, representing a reach rate of 68%. Overall, 10 interviews were scheduled; 7 patients did not show up, resulting in 3 completed interviews. During follow-up, “no-show” participants either gave no response or stated they had a conflict at their originally scheduled time but were not interested in rescheduling due to personal circumstances. Through such conversations, ongoing health complications were found to be a reoccurring barrier to participation.

Each of the participating patients had experienced being placed on a ventilator. They described their hospitalization as a time of “confusion and despair” in the first days after extubation. After we reviewed interview recordings, a reoccurring theme across all interviews was the feeling of gratitude. Patients expressed deep and heartfelt appreciation for being given the opportunity to connect as a family. One patient described virtual visitation sessions as her “only tether to reality when nothing else made sense.”

Interestingly enough, none of the participants knew that virtual visitation was an option and/or thought to inquire about it before a hospital staff member offered to set up a session. Patients recounted how they were weak and physically unable to connect to the sessions without significant assistance. They reported examples of not having the physical strength to hold up the tablet or needing a staff member to facilitate the conversation because the patient could not speak loudly enough and/or they were having difficulty hearing over background medical equipment noises. Participants also described times when a nurse or social worker would stand and hold the tablet for 20 to 30 minutes at a time, further describing mixed feelings of gratitude, guilt for “taking up their time,” and a desire for more privacy to have those precious conversations.

Discussion

Our institution encountered various barriers when establishing, implementing, and sustaining virtual visitation. The acquisition and bulk purchasing of devices, so that each hospital unit and department had adequate par levels during a high-demand time frame, was an initial challenge. Ensuring appropriate safeguards, software programming, and access to WiFi required ingenuity from IT teams. Leaders sought to advocate for the importance of prioritizing virtual visitation alongside clinical interventions. For team members, education was needed to build awareness, learn how to navigate technology, and troubleshoot, in real-time, issues such as poor connectivity. However, despite these organizational struggles, the hospital’s frontline professionals fully recognized and understood the humanistic value of connecting ill patients with their loved ones. Harnessing their teamwork, empathy, and innovative spirits, they forged through such difficulties to create meaningful interactions.

Although virtual visitation occurred prior to the COVID-19 pandemic, particularly in subspecialty areas such as neonatal intensive care units,⁶ it was not commonplace in most adult inpatient care settings. However, now that virtual means to communication are widely accepted and preferred, our hospital anticipates these offerings will become a broad patient expectation and, therefore, part of standard hospital care and operations. Health care leaders and interdisciplinary teams must therefore prioritize virtual visitation protocols, efforts, and future programming. It is no longer an exception to the rule, but rather a critical approach when ensuring quality communication between patients, families, and care teams.

We strive to continually improve by including user feedback as part of an interactive design process. For a broader, more permanent installation of virtual visitation, health care organizations must proactively promote this capability as a valued option. Considering health literacy and comfort with technology, functionality, and logistics must be carefully explained to patients and their families. This may require additional staff training so that they are knowledgeable, comfortable with, and able to troubleshoot questions/concerns in real time. There needs to be an adequate number of mobile devices available at a unit or departmental level to meet short-term and long-term demands. Additionally, now that we have emerged from our initial crisis-based mentality, it is time to consider alternatives to alleviate the need for staff assistance, such as mounts to hold devices and enabling voice controls.

Conclusion

As an organization grounded in the spirit of innovation, Northwell has been able to quickly pivot, adopting virtual visitation to address emerging and complex communication needs. Taking a best practice established during a crisis period and engraining it into sustainable organizational culture and operations requires visionary leadership, strong teamwork, and an unbridled commitment to patient and family centeredness. Despite unprecedented challenges, our commitment to listening to the “voice” of patients and families never wavered. Using their insights and feedback as critical components to the decision-making process, there is much work ahead within the realm of virtual visitation.

Acknowledgements: The authors would like to acknowledge the Northwell Health providers, frontline health care professionals, and team members who worked tirelessly to care for its community during initial COVID-19 waves and every day thereafter. Heartfelt gratitude to Northwell’s senior leaders for the visionary leadership; the OCIO and hospital-based IT teams for their swift collaboration; and dedicated Culture Leaders, Patient Experience team members, and redeployed staff for their unbridled passion for caring for patients and families. Special thanks to Agnes Barden, DNP, RN, CPXP, Joseph Narvaez, MBA, and Natalie Bashkin, MBA, from the system Office of Patient & Customer Experience, and Carolyne Burgess, MPH, from the Digital Patient Experience teams, for their participation, leadership, and syngeristic partnerships.

Corresponding Author: Nicole Giammarinaro, MSN, RN, CPXP, Director, Patient & Customer Experience, Northwell Health, 2000 Marcus Ave, Lake Success, NY 11042; [email protected].

Financial disclosures: Sven Gierlinger serves on the Speakers Bureau for Northwell Health and as an Executive Board Member for The Beryl Institute.

From Northwell Health, Lake Success, NY.

Objective: Northwell Health, New York’s largest health care organization, rapidly adopted technology solutions to support patient and family communication during the COVID-19 pandemic.

Methods: This case series outlines the pragmatic, interdisciplinary approach Northwell underwent to rapidly implement patient virtual visitation processes during the peak of the initial crisis.

Results: Implementation of large-scale virtual visitation required leadership, technology, and dedicated, empathetic frontline professionals. Patient and family feedback uncovered varied feelings and perspectives, from confusion to gratitude.

Conclusion: Subsequent efforts to obtain direct patient and family perspectives and insights helped Northwell identify areas of strength and ongoing performance improvement.

Keywords: virtual visitation; COVID-19; technology; communication; patient experience.

The power of human connection has become increasingly apparent throughout the COVID-19 pandemic and subsequent recovery phases. Due to the need for social distancing, people worldwide have turned to virtual means of communication, staying in touch with family, friends, and colleagues via digital technology platforms. On March 18, 2020, the New York State Department of Health (NYSDOH) issued a health advisory, suspending all hospital visitation.¹ As a result, hospitals rapidly transformed existing in-person visitation practices to meet large-scale virtual programming needs.

Family members often take on various roles—such as advocate, emotional support person, and postdischarge caregiver—for an ill or injured loved one.² The Institute for Patient- and Family-Centered Care, a nonprofit organization founded in 1992, has been leading a cultural transformation where families are valued as care partners, as opposed to “visitors.”³ Although widely adopted and well-received in specialized units, such as neonatal intensive care units,⁴ virtual visitation had not been widely implemented across adult care settings. The NYSDOH guidance therefore required organizational leadership, innovation, flexibility, and systems ingenuity to meet the evolving needs of patients, families, and health care professionals. An overarching goal was ensuring patients and families were afforded opportunities to stay connected throughout hospitalization.

Reflecting the impact of COVID-19 surges, hospital environments became increasingly depersonalized, with health care providers wearing extensive personal protective equipment (PPE) and taking remarkable measures to socially distance and minimize exposure. Patients’ room doors were kept primarily closed, while codes and alerts blared in the halls overhead. The lack of families and visitors became increasingly obvious, aiding feelings of isolation and confinement. With fear of nosocomial transmission, impactful modalities (such as sitting at the bedside) and empathetic, therapeutic touch were no longer taking place.

With those scenarios—common to so many health care systems during the pandemic—as a backdrop, comes our experience. Northwell Health is the largest health care system in New York State, geographically spread throughout New York City’s 5 boroughs, Westchester County, and Long Island. With 23 hospitals, approximately 820 medical practices, and over 72 000 employees, Northwell has cared for more than 100 000 COVID-positive patients to date. This case series outlines a pragmatic approach to implementing virtual visitation during the initial peak and obtaining patient and family perspectives to help inform performance improvement and future programming.

Methods

Implementing virtual visitation

Through swift and focused multidisciplinary collaboration, numerous Northwell teams came together to implement large-scale virtual visitation across the organization during the first wave of the COVID crisis. The initial priority involved securing devices that could support patient-family communication. Prior to COVID, each facility had only a handful of tablets that were used primarily during leadership rounding, so once visitation was restricted, we needed a large quantity of devices within a matter of days. Through diligent work from System Procurement and internal Foundation, Northwell was able to acquire nearly 900 devices, including iPads, PadInMotion tablets, and Samsung tablets.

Typically, the benefits of using wireless tablets within a health care setting include long battery life, powerful data processing, advanced operating systems, large screens, and easy end-user navigation.⁴ During COVID-19 and its associated isolation precautions, tablets offered a lifeline for effective and socially distant communication. With new devices in hand, the system Office of the Chief Information Officer (OCIO) and site-based Information Technology (IT) teams were engaged. They worked tirelessly to streamline connectivity, download necessary apps, test devices on approved WiFi networks, and troubleshoot issues. Once set up, devices were strategically deployed across all Northwell hospitals and post-acute rehabilitation facilities.

Frontline teams quickly realized that a model similar to mobile proning teams, who focus solely on turning and positioning COVID patients to promote optimal respiratory ventilation,⁵ was needed to support virtual visitation. During the initial COVID wave, elective surgeries were not permissible, as per the NYSDOH. As a result, large numbers of clinical and nonclinical ambulatory surgery employees were redeployed throughout the organization, with many assigned and dedicated to facilitating newly created virtual visitation processes. These employees were primarily responsible for creating unit-based schedules, coordinating logistics, navigating devices on behalf of patients, being present during video calls, and sanitizing the devices between uses. Finally, if necessary, virtual interpretation services were used to overcome language barriers between staff and patients.

What began as an ad hoc function quickly became a valued and meaningful role. Utilizing triage mentality, virtual visitation was first offered during unit-based rounding protocols to those patients with the highest acuity and need to connect with family. We had no formal script; instead, unit-based leaders and frontline team members had open dialogues with patients and families to gauge their interest in virtual visitation. That included patients with an active end-of-life care plan, critically ill patients within intensive care units, and those soon to be intubated or recently extubated. Utilization also occurred within specialty areas such as labor and delivery, pediatrics, inpatient psychiatry, medical units, and long-term rehab facilities. Frontline teams appreciated the supplementary support so they could prioritize ongoing physical assessments and medical interventions. Donned in PPE, virtual visitation team members often served as physical extensions of the patient’s loved ones—holding their hand, offering prayers, and, at times, bearing witness to a last breath. In reflecting on that time, this role required absolute professionalism, empathy, and compassion.

In summer 2020, although demand for virtual visitation was still at an all-time high when ambulatory surgery was reinstated, redeployed staff returned to their responsibilities. To fill this void without interruption to patients and their families, site leaders quickly pivoted and refined processes and protocols utilizing Patient & Customer Experience and Hospitality department team members. Throughout spring 2021, the NYSDOH offered guidance to open in-person visitation, and the institution’s Clinical Advisory Group has been taking a pragmatic approach to doing that in a measured and safe manner across care settings.

Listening to the ‘voice’ of patients and families

Our institution’s mission is grounded in providing “quality service and patient-centered care.” Honoring those tenets, during the initial COVID wave, the system “Voice of the Customer End User Device Workgroup” was created with system and site-based interdisciplinary representation. Despite challenging and unprecedented times, conscious attention and effort was undertaken to assess the use and impact of virtual devices. One of the major work streams was to capture and examine patient and family thoughts, feedback, and the overall experience as it relates to virtual visitation.

The system Office of Patient & Customer Experience (OPCE), led by Sven Gierlinger, SVP Chief Experience Officer, reached out to our colleagues at Press Ganey to add a custom question to patient experience surveys. Beginning on December 1, 2020, discharged inpatients were asked to rate the “Degree to which you were able to stay connected with your family/caregiver during your stay.” Potential answers include the Likert scale responses of Always, Usually, Sometimes, and Never, with “Always” representing the Top Box score. The OPCE team believes these quantitative insights are important to track and trend, particularly since in-person and virtual visitation remain in constant flux.

In an effort to obtain additional, focused, qualitative feedback, OPCE partnered with our institution’s Digital Patient Experience (dPX) colleagues. The approach consisted of voluntary, semistructured, interview-type conversations with patients and family members who engaged in virtual visitation multiple times while the patient was hospitalized. OPCE contacted site-based Patient Experience leads, also known as Culture Leaders, at 3 hospitals, asking them to identify potential participants. This convenience sample excluded instances where the patient passed away during and/or immediately following hospitalization.

The OPCE team phoned potential interview candidates to make a personalized connection, explain the purpose of the interviews, and schedule them, if interested. For consistency, the same Digital Customer Experience Researcher on the dPX team facilitated all sessions, which were 30-minute, semiscripted interviews conducted virtually via Microsoft Teams. The tone was intentionally conversational so that patients and family members would feel comfortable delving into themes that were most impactful during their experience. After some initial ice breakers, such as “What were some of your feelings about being a patient/having a loved one in the hospital during the early days of the COVID-19 pandemic?” we moved on to some more pragmatic, implementation questions and rating scales. These included questions such as “How did you first learn about the option for virtual visitation? Was it something you inquired about or did someone offer it to you? How was it explained to you?” Patients were also asked, on a scale of 1 (easy) to 5 (difficult), to rate their experience with the technology aspect when connecting with their loved ones. They also provided verbal consent to be recorded and were given a $15 gift card upon completion of the interview.

Transcriptions were generated by uploading the interview recordings to a platform called UserTesting. In addition to these transcriptions, this platform also allowed for a keyword mapping tool that organized high-level themes and adjectives into groupings along a sentiment axis from negative to neutral to positive. Transcripts were then read carefully and annotated by the Digital Customer Experience Researcher, which allowed for strengthening of some of the automated themes as well as the emergence of new, more nuanced themes. These themes were organized into those that we could address with design and/or procedure updates (actionable insights), those that came up most frequently overall (frequency), and those that came up across our 3 interview sessions (commonality).

This feedback, along with the responses to the new Press Ganey question, was presented to the system Voice of the Customer End User Device Workgroup. The results led to robust discussion and brainstorming regarding how to improve the process to be more patient-centered. Findings were also shared with our hospital-based Culture Leaders. As many of their local strategic plans focused on patient-family communication, this information was helpful to them in considering plans for expansion and/or sustaining virtual visitation efforts. The process map in the Figure outlines key milestones within this feedback loop.

Outcomes

During the height of the initial COVID-19 crisis, virtual visitation was a new and ever-evolving process. Amidst the chaos, mechanisms to capture the quantity and quality of virtual visits were not in place. Based on informal observation, a majority of patients utilized personal devices to connect with loved ones, and staff even offered their own cellular devices to facilitate timely patient-family communication. The technology primarily used included FaceTime, Zoom, and EZCall, as there was much public awareness and comfort with those platforms.

In the first quarter of 2021, our institution overall performed at a Top Box score of 60.2 for our ability to assist patients with staying connected to their family/caregiver during their inpatient visit. With more than 6700 returned surveys during that time period, our hospitals earned Top Box scores ranging between 48.0 and 75.3. At this time, obtaining a national benchmark ranking is not possible, because the question regarding connectedness is unique to Northwell inpatient settings. As other health care organizations adopt this customized question, further peer-to-peer measurements can be established.

Regarding virtual interviews, 25 patients were initially contacted to determine their interest in participating. Of that sample, 17 patients were engaged over the phone, representing a reach rate of 68%. Overall, 10 interviews were scheduled; 7 patients did not show up, resulting in 3 completed interviews. During follow-up, “no-show” participants either gave no response or stated they had a conflict at their originally scheduled time but were not interested in rescheduling due to personal circumstances. Through such conversations, ongoing health complications were found to be a reoccurring barrier to participation.

Each of the participating patients had experienced being placed on a ventilator. They described their hospitalization as a time of “confusion and despair” in the first days after extubation. After we reviewed interview recordings, a reoccurring theme across all interviews was the feeling of gratitude. Patients expressed deep and heartfelt appreciation for being given the opportunity to connect as a family. One patient described virtual visitation sessions as her “only tether to reality when nothing else made sense.”

Interestingly enough, none of the participants knew that virtual visitation was an option and/or thought to inquire about it before a hospital staff member offered to set up a session. Patients recounted how they were weak and physically unable to connect to the sessions without significant assistance. They reported examples of not having the physical strength to hold up the tablet or needing a staff member to facilitate the conversation because the patient could not speak loudly enough and/or they were having difficulty hearing over background medical equipment noises. Participants also described times when a nurse or social worker would stand and hold the tablet for 20 to 30 minutes at a time, further describing mixed feelings of gratitude, guilt for “taking up their time,” and a desire for more privacy to have those precious conversations.

Discussion

Our institution encountered various barriers when establishing, implementing, and sustaining virtual visitation. The acquisition and bulk purchasing of devices, so that each hospital unit and department had adequate par levels during a high-demand time frame, was an initial challenge. Ensuring appropriate safeguards, software programming, and access to WiFi required ingenuity from IT teams. Leaders sought to advocate for the importance of prioritizing virtual visitation alongside clinical interventions. For team members, education was needed to build awareness, learn how to navigate technology, and troubleshoot, in real-time, issues such as poor connectivity. However, despite these organizational struggles, the hospital’s frontline professionals fully recognized and understood the humanistic value of connecting ill patients with their loved ones. Harnessing their teamwork, empathy, and innovative spirits, they forged through such difficulties to create meaningful interactions.

Although virtual visitation occurred prior to the COVID-19 pandemic, particularly in subspecialty areas such as neonatal intensive care units,⁶ it was not commonplace in most adult inpatient care settings. However, now that virtual means to communication are widely accepted and preferred, our hospital anticipates these offerings will become a broad patient expectation and, therefore, part of standard hospital care and operations. Health care leaders and interdisciplinary teams must therefore prioritize virtual visitation protocols, efforts, and future programming. It is no longer an exception to the rule, but rather a critical approach when ensuring quality communication between patients, families, and care teams.

We strive to continually improve by including user feedback as part of an interactive design process. For a broader, more permanent installation of virtual visitation, health care organizations must proactively promote this capability as a valued option. Considering health literacy and comfort with technology, functionality, and logistics must be carefully explained to patients and their families. This may require additional staff training so that they are knowledgeable, comfortable with, and able to troubleshoot questions/concerns in real time. There needs to be an adequate number of mobile devices available at a unit or departmental level to meet short-term and long-term demands. Additionally, now that we have emerged from our initial crisis-based mentality, it is time to consider alternatives to alleviate the need for staff assistance, such as mounts to hold devices and enabling voice controls.

Conclusion

As an organization grounded in the spirit of innovation, Northwell has been able to quickly pivot, adopting virtual visitation to address emerging and complex communication needs. Taking a best practice established during a crisis period and engraining it into sustainable organizational culture and operations requires visionary leadership, strong teamwork, and an unbridled commitment to patient and family centeredness. Despite unprecedented challenges, our commitment to listening to the “voice” of patients and families never wavered. Using their insights and feedback as critical components to the decision-making process, there is much work ahead within the realm of virtual visitation.

Acknowledgements: The authors would like to acknowledge the Northwell Health providers, frontline health care professionals, and team members who worked tirelessly to care for its community during initial COVID-19 waves and every day thereafter. Heartfelt gratitude to Northwell’s senior leaders for the visionary leadership; the OCIO and hospital-based IT teams for their swift collaboration; and dedicated Culture Leaders, Patient Experience team members, and redeployed staff for their unbridled passion for caring for patients and families. Special thanks to Agnes Barden, DNP, RN, CPXP, Joseph Narvaez, MBA, and Natalie Bashkin, MBA, from the system Office of Patient & Customer Experience, and Carolyne Burgess, MPH, from the Digital Patient Experience teams, for their participation, leadership, and syngeristic partnerships.

Corresponding Author: Nicole Giammarinaro, MSN, RN, CPXP, Director, Patient & Customer Experience, Northwell Health, 2000 Marcus Ave, Lake Success, NY 11042; [email protected].

Financial disclosures: Sven Gierlinger serves on the Speakers Bureau for Northwell Health and as an Executive Board Member for The Beryl Institute.

From Northwell Health, Lake Success, NY.

Objective: Northwell Health, New York’s largest health care organization, rapidly adopted technology solutions to support patient and family communication during the COVID-19 pandemic.

Methods: This case series outlines the pragmatic, interdisciplinary approach Northwell underwent to rapidly implement patient virtual visitation processes during the peak of the initial crisis.

Results: Implementation of large-scale virtual visitation required leadership, technology, and dedicated, empathetic frontline professionals. Patient and family feedback uncovered varied feelings and perspectives, from confusion to gratitude.

Conclusion: Subsequent efforts to obtain direct patient and family perspectives and insights helped Northwell identify areas of strength and ongoing performance improvement.

Keywords: virtual visitation; COVID-19; technology; communication; patient experience.

The power of human connection has become increasingly apparent throughout the COVID-19 pandemic and subsequent recovery phases. Due to the need for social distancing, people worldwide have turned to virtual means of communication, staying in touch with family, friends, and colleagues via digital technology platforms. On March 18, 2020, the New York State Department of Health (NYSDOH) issued a health advisory, suspending all hospital visitation.¹ As a result, hospitals rapidly transformed existing in-person visitation practices to meet large-scale virtual programming needs.

Family members often take on various roles—such as advocate, emotional support person, and postdischarge caregiver—for an ill or injured loved one.² The Institute for Patient- and Family-Centered Care, a nonprofit organization founded in 1992, has been leading a cultural transformation where families are valued as care partners, as opposed to “visitors.”³ Although widely adopted and well-received in specialized units, such as neonatal intensive care units,⁴ virtual visitation had not been widely implemented across adult care settings. The NYSDOH guidance therefore required organizational leadership, innovation, flexibility, and systems ingenuity to meet the evolving needs of patients, families, and health care professionals. An overarching goal was ensuring patients and families were afforded opportunities to stay connected throughout hospitalization.

Reflecting the impact of COVID-19 surges, hospital environments became increasingly depersonalized, with health care providers wearing extensive personal protective equipment (PPE) and taking remarkable measures to socially distance and minimize exposure. Patients’ room doors were kept primarily closed, while codes and alerts blared in the halls overhead. The lack of families and visitors became increasingly obvious, aiding feelings of isolation and confinement. With fear of nosocomial transmission, impactful modalities (such as sitting at the bedside) and empathetic, therapeutic touch were no longer taking place.

With those scenarios—common to so many health care systems during the pandemic—as a backdrop, comes our experience. Northwell Health is the largest health care system in New York State, geographically spread throughout New York City’s 5 boroughs, Westchester County, and Long Island. With 23 hospitals, approximately 820 medical practices, and over 72 000 employees, Northwell has cared for more than 100 000 COVID-positive patients to date. This case series outlines a pragmatic approach to implementing virtual visitation during the initial peak and obtaining patient and family perspectives to help inform performance improvement and future programming.

Methods

Implementing virtual visitation

Through swift and focused multidisciplinary collaboration, numerous Northwell teams came together to implement large-scale virtual visitation across the organization during the first wave of the COVID crisis. The initial priority involved securing devices that could support patient-family communication. Prior to COVID, each facility had only a handful of tablets that were used primarily during leadership rounding, so once visitation was restricted, we needed a large quantity of devices within a matter of days. Through diligent work from System Procurement and internal Foundation, Northwell was able to acquire nearly 900 devices, including iPads, PadInMotion tablets, and Samsung tablets.

Typically, the benefits of using wireless tablets within a health care setting include long battery life, powerful data processing, advanced operating systems, large screens, and easy end-user navigation.⁴ During COVID-19 and its associated isolation precautions, tablets offered a lifeline for effective and socially distant communication. With new devices in hand, the system Office of the Chief Information Officer (OCIO) and site-based Information Technology (IT) teams were engaged. They worked tirelessly to streamline connectivity, download necessary apps, test devices on approved WiFi networks, and troubleshoot issues. Once set up, devices were strategically deployed across all Northwell hospitals and post-acute rehabilitation facilities.

Frontline teams quickly realized that a model similar to mobile proning teams, who focus solely on turning and positioning COVID patients to promote optimal respiratory ventilation,⁵ was needed to support virtual visitation. During the initial COVID wave, elective surgeries were not permissible, as per the NYSDOH. As a result, large numbers of clinical and nonclinical ambulatory surgery employees were redeployed throughout the organization, with many assigned and dedicated to facilitating newly created virtual visitation processes. These employees were primarily responsible for creating unit-based schedules, coordinating logistics, navigating devices on behalf of patients, being present during video calls, and sanitizing the devices between uses. Finally, if necessary, virtual interpretation services were used to overcome language barriers between staff and patients.

What began as an ad hoc function quickly became a valued and meaningful role. Utilizing triage mentality, virtual visitation was first offered during unit-based rounding protocols to those patients with the highest acuity and need to connect with family. We had no formal script; instead, unit-based leaders and frontline team members had open dialogues with patients and families to gauge their interest in virtual visitation. That included patients with an active end-of-life care plan, critically ill patients within intensive care units, and those soon to be intubated or recently extubated. Utilization also occurred within specialty areas such as labor and delivery, pediatrics, inpatient psychiatry, medical units, and long-term rehab facilities. Frontline teams appreciated the supplementary support so they could prioritize ongoing physical assessments and medical interventions. Donned in PPE, virtual visitation team members often served as physical extensions of the patient’s loved ones—holding their hand, offering prayers, and, at times, bearing witness to a last breath. In reflecting on that time, this role required absolute professionalism, empathy, and compassion.

In summer 2020, although demand for virtual visitation was still at an all-time high when ambulatory surgery was reinstated, redeployed staff returned to their responsibilities. To fill this void without interruption to patients and their families, site leaders quickly pivoted and refined processes and protocols utilizing Patient & Customer Experience and Hospitality department team members. Throughout spring 2021, the NYSDOH offered guidance to open in-person visitation, and the institution’s Clinical Advisory Group has been taking a pragmatic approach to doing that in a measured and safe manner across care settings.

Listening to the ‘voice’ of patients and families

Our institution’s mission is grounded in providing “quality service and patient-centered care.” Honoring those tenets, during the initial COVID wave, the system “Voice of the Customer End User Device Workgroup” was created with system and site-based interdisciplinary representation. Despite challenging and unprecedented times, conscious attention and effort was undertaken to assess the use and impact of virtual devices. One of the major work streams was to capture and examine patient and family thoughts, feedback, and the overall experience as it relates to virtual visitation.

The system Office of Patient & Customer Experience (OPCE), led by Sven Gierlinger, SVP Chief Experience Officer, reached out to our colleagues at Press Ganey to add a custom question to patient experience surveys. Beginning on December 1, 2020, discharged inpatients were asked to rate the “Degree to which you were able to stay connected with your family/caregiver during your stay.” Potential answers include the Likert scale responses of Always, Usually, Sometimes, and Never, with “Always” representing the Top Box score. The OPCE team believes these quantitative insights are important to track and trend, particularly since in-person and virtual visitation remain in constant flux.

In an effort to obtain additional, focused, qualitative feedback, OPCE partnered with our institution’s Digital Patient Experience (dPX) colleagues. The approach consisted of voluntary, semistructured, interview-type conversations with patients and family members who engaged in virtual visitation multiple times while the patient was hospitalized. OPCE contacted site-based Patient Experience leads, also known as Culture Leaders, at 3 hospitals, asking them to identify potential participants. This convenience sample excluded instances where the patient passed away during and/or immediately following hospitalization.

The OPCE team phoned potential interview candidates to make a personalized connection, explain the purpose of the interviews, and schedule them, if interested. For consistency, the same Digital Customer Experience Researcher on the dPX team facilitated all sessions, which were 30-minute, semiscripted interviews conducted virtually via Microsoft Teams. The tone was intentionally conversational so that patients and family members would feel comfortable delving into themes that were most impactful during their experience. After some initial ice breakers, such as “What were some of your feelings about being a patient/having a loved one in the hospital during the early days of the COVID-19 pandemic?” we moved on to some more pragmatic, implementation questions and rating scales. These included questions such as “How did you first learn about the option for virtual visitation? Was it something you inquired about or did someone offer it to you? How was it explained to you?” Patients were also asked, on a scale of 1 (easy) to 5 (difficult), to rate their experience with the technology aspect when connecting with their loved ones. They also provided verbal consent to be recorded and were given a $15 gift card upon completion of the interview.

Transcriptions were generated by uploading the interview recordings to a platform called UserTesting. In addition to these transcriptions, this platform also allowed for a keyword mapping tool that organized high-level themes and adjectives into groupings along a sentiment axis from negative to neutral to positive. Transcripts were then read carefully and annotated by the Digital Customer Experience Researcher, which allowed for strengthening of some of the automated themes as well as the emergence of new, more nuanced themes. These themes were organized into those that we could address with design and/or procedure updates (actionable insights), those that came up most frequently overall (frequency), and those that came up across our 3 interview sessions (commonality).

This feedback, along with the responses to the new Press Ganey question, was presented to the system Voice of the Customer End User Device Workgroup. The results led to robust discussion and brainstorming regarding how to improve the process to be more patient-centered. Findings were also shared with our hospital-based Culture Leaders. As many of their local strategic plans focused on patient-family communication, this information was helpful to them in considering plans for expansion and/or sustaining virtual visitation efforts. The process map in the Figure outlines key milestones within this feedback loop.

Outcomes

During the height of the initial COVID-19 crisis, virtual visitation was a new and ever-evolving process. Amidst the chaos, mechanisms to capture the quantity and quality of virtual visits were not in place. Based on informal observation, a majority of patients utilized personal devices to connect with loved ones, and staff even offered their own cellular devices to facilitate timely patient-family communication. The technology primarily used included FaceTime, Zoom, and EZCall, as there was much public awareness and comfort with those platforms.

In the first quarter of 2021, our institution overall performed at a Top Box score of 60.2 for our ability to assist patients with staying connected to their family/caregiver during their inpatient visit. With more than 6700 returned surveys during that time period, our hospitals earned Top Box scores ranging between 48.0 and 75.3. At this time, obtaining a national benchmark ranking is not possible, because the question regarding connectedness is unique to Northwell inpatient settings. As other health care organizations adopt this customized question, further peer-to-peer measurements can be established.

Regarding virtual interviews, 25 patients were initially contacted to determine their interest in participating. Of that sample, 17 patients were engaged over the phone, representing a reach rate of 68%. Overall, 10 interviews were scheduled; 7 patients did not show up, resulting in 3 completed interviews. During follow-up, “no-show” participants either gave no response or stated they had a conflict at their originally scheduled time but were not interested in rescheduling due to personal circumstances. Through such conversations, ongoing health complications were found to be a reoccurring barrier to participation.

Each of the participating patients had experienced being placed on a ventilator. They described their hospitalization as a time of “confusion and despair” in the first days after extubation. After we reviewed interview recordings, a reoccurring theme across all interviews was the feeling of gratitude. Patients expressed deep and heartfelt appreciation for being given the opportunity to connect as a family. One patient described virtual visitation sessions as her “only tether to reality when nothing else made sense.”

Interestingly enough, none of the participants knew that virtual visitation was an option and/or thought to inquire about it before a hospital staff member offered to set up a session. Patients recounted how they were weak and physically unable to connect to the sessions without significant assistance. They reported examples of not having the physical strength to hold up the tablet or needing a staff member to facilitate the conversation because the patient could not speak loudly enough and/or they were having difficulty hearing over background medical equipment noises. Participants also described times when a nurse or social worker would stand and hold the tablet for 20 to 30 minutes at a time, further describing mixed feelings of gratitude, guilt for “taking up their time,” and a desire for more privacy to have those precious conversations.

Discussion

Our institution encountered various barriers when establishing, implementing, and sustaining virtual visitation. The acquisition and bulk purchasing of devices, so that each hospital unit and department had adequate par levels during a high-demand time frame, was an initial challenge. Ensuring appropriate safeguards, software programming, and access to WiFi required ingenuity from IT teams. Leaders sought to advocate for the importance of prioritizing virtual visitation alongside clinical interventions. For team members, education was needed to build awareness, learn how to navigate technology, and troubleshoot, in real-time, issues such as poor connectivity. However, despite these organizational struggles, the hospital’s frontline professionals fully recognized and understood the humanistic value of connecting ill patients with their loved ones. Harnessing their teamwork, empathy, and innovative spirits, they forged through such difficulties to create meaningful interactions.

Although virtual visitation occurred prior to the COVID-19 pandemic, particularly in subspecialty areas such as neonatal intensive care units,⁶ it was not commonplace in most adult inpatient care settings. However, now that virtual means to communication are widely accepted and preferred, our hospital anticipates these offerings will become a broad patient expectation and, therefore, part of standard hospital care and operations. Health care leaders and interdisciplinary teams must therefore prioritize virtual visitation protocols, efforts, and future programming. It is no longer an exception to the rule, but rather a critical approach when ensuring quality communication between patients, families, and care teams.

We strive to continually improve by including user feedback as part of an interactive design process. For a broader, more permanent installation of virtual visitation, health care organizations must proactively promote this capability as a valued option. Considering health literacy and comfort with technology, functionality, and logistics must be carefully explained to patients and their families. This may require additional staff training so that they are knowledgeable, comfortable with, and able to troubleshoot questions/concerns in real time. There needs to be an adequate number of mobile devices available at a unit or departmental level to meet short-term and long-term demands. Additionally, now that we have emerged from our initial crisis-based mentality, it is time to consider alternatives to alleviate the need for staff assistance, such as mounts to hold devices and enabling voice controls.

Conclusion

As an organization grounded in the spirit of innovation, Northwell has been able to quickly pivot, adopting virtual visitation to address emerging and complex communication needs. Taking a best practice established during a crisis period and engraining it into sustainable organizational culture and operations requires visionary leadership, strong teamwork, and an unbridled commitment to patient and family centeredness. Despite unprecedented challenges, our commitment to listening to the “voice” of patients and families never wavered. Using their insights and feedback as critical components to the decision-making process, there is much work ahead within the realm of virtual visitation.

Acknowledgements: The authors would like to acknowledge the Northwell Health providers, frontline health care professionals, and team members who worked tirelessly to care for its community during initial COVID-19 waves and every day thereafter. Heartfelt gratitude to Northwell’s senior leaders for the visionary leadership; the OCIO and hospital-based IT teams for their swift collaboration; and dedicated Culture Leaders, Patient Experience team members, and redeployed staff for their unbridled passion for caring for patients and families. Special thanks to Agnes Barden, DNP, RN, CPXP, Joseph Narvaez, MBA, and Natalie Bashkin, MBA, from the system Office of Patient & Customer Experience, and Carolyne Burgess, MPH, from the Digital Patient Experience teams, for their participation, leadership, and syngeristic partnerships.

Corresponding Author: Nicole Giammarinaro, MSN, RN, CPXP, Director, Patient & Customer Experience, Northwell Health, 2000 Marcus Ave, Lake Success, NY 11042; [email protected].

Financial disclosures: Sven Gierlinger serves on the Speakers Bureau for Northwell Health and as an Executive Board Member for The Beryl Institute.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; [email protected].

Financial disclosures: None.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; [email protected].

Financial disclosures: None.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; [email protected].

Financial disclosures: None.

While sick at home with a 26-day symptomatic course of COVID-19 in March 2020, I watched the surge unfold in my state and the hospital where I work as an inpatient adult medicine physician. Although the preponderance of my professional life is dedicated to leading teams in implementing delivery system transformation, the hat I wore in that moment involved living through and keeping up with the changes around me. Once I recovered and returned to the arena as a COVID doctor, I adapted to and made changes during constant shifts in how we provided care.

Looking back on those months during the worst of the COVID-19 hospital surge in my region, I reflect on the factors that helped me, as a frontline and shift-work clinician, adapt to and make those changes. In reflecting on the elements that were meaningful to me during the crisis, I recognize a set of change-enabling factors that have broad relevance for those of us who work to improve outcomes for patients and populations.

Confidence engendered by liberating data

In the early days of the surge, there was much uncertainty, and unfortunately, some seriously imperfect messaging. Trust was broken or badly bruised for many frontline clinicians. I share this painful phase not to criticize, but rather reflect on what mattered to me during that crisis of confidence. It was data. Raw, unadjusted, best-available data. Produced and pushed out. Available, trended over time, telling the story of where we are, now. Counts of tests, beds, and ventilators. The consistent, transparent availability of relevant and straightforward data provided an active antidote to a sense of uncertainty during a crisis of confidence.

Personal practice change stimulated by relevance and urgency

For half a decade, I have been encouraging interdisciplinary inpatient teams to identify and actively engage the family and/or care partner as a member of the care team. Despite even the American Association of Retired Persons mobilizing an impressive regulatory approach in 32 states to require that family and/or care partners are included as such, the practice change efforts continued on a slow and steady path. Why? We just didn’t believe it was of urgent, relevant, mission-critical importance to our daily practice to do so. That all changed in March 2020.

Without needing to be told, educated, or incentivized, my first night as a COVID doctor found me calling every single patient’s family upon admission, regardless of what time it was. It was critical to review the diagnosis, transparently discuss the uncertainty regarding the upcoming hours and days, review the potential contingencies, and ask, right there and then, whether intubation is consistent with goals of care. It was that urgent and relevant. Without exception, families were grateful for the effort and candor.

The significance of this practice—undoubtedly adopted by every inpatient provider who has worked a COVID surge—is rooted in decades of academic deliberation on which is the “right” doctor to have these discussions. None of that mattered. Historical opinions changed due to what was urgent and relevant given the situation at hand and the job we had to do. Imagine, for example, what we could do and how we could change if we now consider it urgent and relevant to identify and mobilize enhanced services and supports to patients who experience inequities because we believe it to be mission-critical to the job we show up to do every day.

Change fostered by a creative problem-solving ecosystem

Embracing personal practice change was made easier and implicitly affirmed by the creative problem solving that occurred everywhere. Tents, drive-throughs, and even college field houses were now settings of care. Primary care physicians, cardiologists, and gastrointestinal (GI) and postanesthesia care nurses staffed the COVID floors. Rolling stands held iPads so staff could communicate with patients without entering the room. This creative ecosystem fostered individual practice change. No debates were needed to recognize that standard processes were inadequate. No single role or service of any discipline was singularly asked to change to meet the needs of the moment. Because of this ecosystem of creative, active change, there was a much greater flexibility among individuals, role types, departments, and disciplines to change. This is particularly poignant to me in light of the work I lead to improve care for patients who experience systemic inequities in our health care system. When we ask a single role type or discipline to change, it can be met with resistance; far more success is achieved when we engage an interdisciplinary and interdepartmental approach to change. When surrounded by others making change, it makes us more willing to change, too.

It is so often invoked that health care is a team sport. In practicality, while we may aspire to work as a team, health care delivery is still all too often comprised of a set of individual actors with individualized responsibilities trying to communicate the best they can with each other.

What I experienced during the surge at my hospital was the very best version of teamwork I have ever been a part of in health care: empathetic, mutually interdependent strangers coming together during daily changes in staffing, processes, and resources. I will never forget nights walking into the pediatric floor or day surgery recovery area—now repurposed as a COVID unit—to entirely new faces comprised of GI suite nurses, outpatient doctors, and moonlighting intensivists.

We were all new to each other, all new to working in this setting, and all new to whatever the newest changes of the day brought. I will never forget how we greeted each other and introduced ourselves. We asked each other where we were “from,” and held a genuine appreciation to each other for being there. Imagine how this impacted how we worked together. Looking back on those night shifts, I remember us as a truly interdependent team. I will endeavor to bring that sense of mutual regard and interdependency into my work to foster effective interdisciplinary and cross-continuum teamwork.

Takeaways

As a student and practitioner of delivery system transformation, I am often in conversations about imperfect data, incomplete evidence, and role-specific and organizational resistance to change. As an acute care provider during the COVID-19 hospital surge in my region, the experiences I had as a participant in the COVID-related delivery system change will stay with me as I lead value-based delivery system change. What worked in an infectious disease crisis holds great relevance to our pressing, urgent, relevant work to create a more person-centered, equitable, and value-based delivery system.

I am confident that if those of us seeking to improve outcomes use visible and accessible data to engender confidence, clearly link practice change to the relevant and urgent issue at hand, promote broadly visible creative problem solving to foster an ecosystem of change, and cultivate empathy and mutual interdependence to promote the teamwork we aspire to have, that we will foster meaningful progress in our efforts to improve care for patients and populations.

Corresponding author: Amy Boutwell, MD, MPP, President, Collaborative Healthcare Strategies, Lexington, MA; [email protected].

Financial disclosures: None.

While sick at home with a 26-day symptomatic course of COVID-19 in March 2020, I watched the surge unfold in my state and the hospital where I work as an inpatient adult medicine physician. Although the preponderance of my professional life is dedicated to leading teams in implementing delivery system transformation, the hat I wore in that moment involved living through and keeping up with the changes around me. Once I recovered and returned to the arena as a COVID doctor, I adapted to and made changes during constant shifts in how we provided care.

Looking back on those months during the worst of the COVID-19 hospital surge in my region, I reflect on the factors that helped me, as a frontline and shift-work clinician, adapt to and make those changes. In reflecting on the elements that were meaningful to me during the crisis, I recognize a set of change-enabling factors that have broad relevance for those of us who work to improve outcomes for patients and populations.

Confidence engendered by liberating data

In the early days of the surge, there was much uncertainty, and unfortunately, some seriously imperfect messaging. Trust was broken or badly bruised for many frontline clinicians. I share this painful phase not to criticize, but rather reflect on what mattered to me during that crisis of confidence. It was data. Raw, unadjusted, best-available data. Produced and pushed out. Available, trended over time, telling the story of where we are, now. Counts of tests, beds, and ventilators. The consistent, transparent availability of relevant and straightforward data provided an active antidote to a sense of uncertainty during a crisis of confidence.

Personal practice change stimulated by relevance and urgency

For half a decade, I have been encouraging interdisciplinary inpatient teams to identify and actively engage the family and/or care partner as a member of the care team. Despite even the American Association of Retired Persons mobilizing an impressive regulatory approach in 32 states to require that family and/or care partners are included as such, the practice change efforts continued on a slow and steady path. Why? We just didn’t believe it was of urgent, relevant, mission-critical importance to our daily practice to do so. That all changed in March 2020.

Without needing to be told, educated, or incentivized, my first night as a COVID doctor found me calling every single patient’s family upon admission, regardless of what time it was. It was critical to review the diagnosis, transparently discuss the uncertainty regarding the upcoming hours and days, review the potential contingencies, and ask, right there and then, whether intubation is consistent with goals of care. It was that urgent and relevant. Without exception, families were grateful for the effort and candor.

The significance of this practice—undoubtedly adopted by every inpatient provider who has worked a COVID surge—is rooted in decades of academic deliberation on which is the “right” doctor to have these discussions. None of that mattered. Historical opinions changed due to what was urgent and relevant given the situation at hand and the job we had to do. Imagine, for example, what we could do and how we could change if we now consider it urgent and relevant to identify and mobilize enhanced services and supports to patients who experience inequities because we believe it to be mission-critical to the job we show up to do every day.

Change fostered by a creative problem-solving ecosystem

Embracing personal practice change was made easier and implicitly affirmed by the creative problem solving that occurred everywhere. Tents, drive-throughs, and even college field houses were now settings of care. Primary care physicians, cardiologists, and gastrointestinal (GI) and postanesthesia care nurses staffed the COVID floors. Rolling stands held iPads so staff could communicate with patients without entering the room. This creative ecosystem fostered individual practice change. No debates were needed to recognize that standard processes were inadequate. No single role or service of any discipline was singularly asked to change to meet the needs of the moment. Because of this ecosystem of creative, active change, there was a much greater flexibility among individuals, role types, departments, and disciplines to change. This is particularly poignant to me in light of the work I lead to improve care for patients who experience systemic inequities in our health care system. When we ask a single role type or discipline to change, it can be met with resistance; far more success is achieved when we engage an interdisciplinary and interdepartmental approach to change. When surrounded by others making change, it makes us more willing to change, too.

It is so often invoked that health care is a team sport. In practicality, while we may aspire to work as a team, health care delivery is still all too often comprised of a set of individual actors with individualized responsibilities trying to communicate the best they can with each other.

What I experienced during the surge at my hospital was the very best version of teamwork I have ever been a part of in health care: empathetic, mutually interdependent strangers coming together during daily changes in staffing, processes, and resources. I will never forget nights walking into the pediatric floor or day surgery recovery area—now repurposed as a COVID unit—to entirely new faces comprised of GI suite nurses, outpatient doctors, and moonlighting intensivists.

We were all new to each other, all new to working in this setting, and all new to whatever the newest changes of the day brought. I will never forget how we greeted each other and introduced ourselves. We asked each other where we were “from,” and held a genuine appreciation to each other for being there. Imagine how this impacted how we worked together. Looking back on those night shifts, I remember us as a truly interdependent team. I will endeavor to bring that sense of mutual regard and interdependency into my work to foster effective interdisciplinary and cross-continuum teamwork.

Takeaways

As a student and practitioner of delivery system transformation, I am often in conversations about imperfect data, incomplete evidence, and role-specific and organizational resistance to change. As an acute care provider during the COVID-19 hospital surge in my region, the experiences I had as a participant in the COVID-related delivery system change will stay with me as I lead value-based delivery system change. What worked in an infectious disease crisis holds great relevance to our pressing, urgent, relevant work to create a more person-centered, equitable, and value-based delivery system.

I am confident that if those of us seeking to improve outcomes use visible and accessible data to engender confidence, clearly link practice change to the relevant and urgent issue at hand, promote broadly visible creative problem solving to foster an ecosystem of change, and cultivate empathy and mutual interdependence to promote the teamwork we aspire to have, that we will foster meaningful progress in our efforts to improve care for patients and populations.

Corresponding author: Amy Boutwell, MD, MPP, President, Collaborative Healthcare Strategies, Lexington, MA; [email protected].

Financial disclosures: None.

While sick at home with a 26-day symptomatic course of COVID-19 in March 2020, I watched the surge unfold in my state and the hospital where I work as an inpatient adult medicine physician. Although the preponderance of my professional life is dedicated to leading teams in implementing delivery system transformation, the hat I wore in that moment involved living through and keeping up with the changes around me. Once I recovered and returned to the arena as a COVID doctor, I adapted to and made changes during constant shifts in how we provided care.

Looking back on those months during the worst of the COVID-19 hospital surge in my region, I reflect on the factors that helped me, as a frontline and shift-work clinician, adapt to and make those changes. In reflecting on the elements that were meaningful to me during the crisis, I recognize a set of change-enabling factors that have broad relevance for those of us who work to improve outcomes for patients and populations.

Confidence engendered by liberating data

In the early days of the surge, there was much uncertainty, and unfortunately, some seriously imperfect messaging. Trust was broken or badly bruised for many frontline clinicians. I share this painful phase not to criticize, but rather reflect on what mattered to me during that crisis of confidence. It was data. Raw, unadjusted, best-available data. Produced and pushed out. Available, trended over time, telling the story of where we are, now. Counts of tests, beds, and ventilators. The consistent, transparent availability of relevant and straightforward data provided an active antidote to a sense of uncertainty during a crisis of confidence.

Personal practice change stimulated by relevance and urgency

For half a decade, I have been encouraging interdisciplinary inpatient teams to identify and actively engage the family and/or care partner as a member of the care team. Despite even the American Association of Retired Persons mobilizing an impressive regulatory approach in 32 states to require that family and/or care partners are included as such, the practice change efforts continued on a slow and steady path. Why? We just didn’t believe it was of urgent, relevant, mission-critical importance to our daily practice to do so. That all changed in March 2020.

Without needing to be told, educated, or incentivized, my first night as a COVID doctor found me calling every single patient’s family upon admission, regardless of what time it was. It was critical to review the diagnosis, transparently discuss the uncertainty regarding the upcoming hours and days, review the potential contingencies, and ask, right there and then, whether intubation is consistent with goals of care. It was that urgent and relevant. Without exception, families were grateful for the effort and candor.

The significance of this practice—undoubtedly adopted by every inpatient provider who has worked a COVID surge—is rooted in decades of academic deliberation on which is the “right” doctor to have these discussions. None of that mattered. Historical opinions changed due to what was urgent and relevant given the situation at hand and the job we had to do. Imagine, for example, what we could do and how we could change if we now consider it urgent and relevant to identify and mobilize enhanced services and supports to patients who experience inequities because we believe it to be mission-critical to the job we show up to do every day.

Change fostered by a creative problem-solving ecosystem

Embracing personal practice change was made easier and implicitly affirmed by the creative problem solving that occurred everywhere. Tents, drive-throughs, and even college field houses were now settings of care. Primary care physicians, cardiologists, and gastrointestinal (GI) and postanesthesia care nurses staffed the COVID floors. Rolling stands held iPads so staff could communicate with patients without entering the room. This creative ecosystem fostered individual practice change. No debates were needed to recognize that standard processes were inadequate. No single role or service of any discipline was singularly asked to change to meet the needs of the moment. Because of this ecosystem of creative, active change, there was a much greater flexibility among individuals, role types, departments, and disciplines to change. This is particularly poignant to me in light of the work I lead to improve care for patients who experience systemic inequities in our health care system. When we ask a single role type or discipline to change, it can be met with resistance; far more success is achieved when we engage an interdisciplinary and interdepartmental approach to change. When surrounded by others making change, it makes us more willing to change, too.

It is so often invoked that health care is a team sport. In practicality, while we may aspire to work as a team, health care delivery is still all too often comprised of a set of individual actors with individualized responsibilities trying to communicate the best they can with each other.

What I experienced during the surge at my hospital was the very best version of teamwork I have ever been a part of in health care: empathetic, mutually interdependent strangers coming together during daily changes in staffing, processes, and resources. I will never forget nights walking into the pediatric floor or day surgery recovery area—now repurposed as a COVID unit—to entirely new faces comprised of GI suite nurses, outpatient doctors, and moonlighting intensivists.

We were all new to each other, all new to working in this setting, and all new to whatever the newest changes of the day brought. I will never forget how we greeted each other and introduced ourselves. We asked each other where we were “from,” and held a genuine appreciation to each other for being there. Imagine how this impacted how we worked together. Looking back on those night shifts, I remember us as a truly interdependent team. I will endeavor to bring that sense of mutual regard and interdependency into my work to foster effective interdisciplinary and cross-continuum teamwork.

Takeaways

As a student and practitioner of delivery system transformation, I am often in conversations about imperfect data, incomplete evidence, and role-specific and organizational resistance to change. As an acute care provider during the COVID-19 hospital surge in my region, the experiences I had as a participant in the COVID-related delivery system change will stay with me as I lead value-based delivery system change. What worked in an infectious disease crisis holds great relevance to our pressing, urgent, relevant work to create a more person-centered, equitable, and value-based delivery system.

I am confident that if those of us seeking to improve outcomes use visible and accessible data to engender confidence, clearly link practice change to the relevant and urgent issue at hand, promote broadly visible creative problem solving to foster an ecosystem of change, and cultivate empathy and mutual interdependence to promote the teamwork we aspire to have, that we will foster meaningful progress in our efforts to improve care for patients and populations.

Corresponding author: Amy Boutwell, MD, MPP, President, Collaborative Healthcare Strategies, Lexington, MA; [email protected].

Financial disclosures: None.

Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.

“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.

The study was published online in the journal Brain.
 

No uptick in pandemic cases

Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.

To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.

The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.

Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”

Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.

The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.

Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.

All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.

All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).

The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days. 
 

More research needed

The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”

Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”

“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2. 

“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.

The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.

A version of this article first appeared on Medscape.com.

Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.

“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.

The study was published online in the journal Brain.
 

No uptick in pandemic cases

Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.

To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.

The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.

Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”

Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.

The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.

Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.

All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.

All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).

The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days. 
 

More research needed

The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”

Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”

“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2. 

“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.

The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.

A version of this article first appeared on Medscape.com.

Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.

“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.

The study was published online in the journal Brain.
 

No uptick in pandemic cases

Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.

To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.

The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.

Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”

Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.

The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.

Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.

All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.

All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).

The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days. 
 

More research needed

The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”

Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”

“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2. 

“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.

The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.

A version of this article first appeared on Medscape.com.

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

[email protected]

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

[email protected]

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

[email protected]

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

A version of this article first appeared on WebMD.com.

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

A version of this article first appeared on WebMD.com.

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

A version of this article first appeared on WebMD.com.

More than one in six cancer patients experience long-term sequelae following SARS-CoV-2 infection, placing them at increased risk of discontinuing their cancer treatment or dying, according to European registry data.

Given the “high lethality” of COVID-19 in cancer patients and the risk for long-term complications following infection in the general population, Alessio Cortellini, MD, a consultant medical oncologist at Hammersmith Hospital and Imperial College London, and colleagues wanted to explore the “prevalence and clinical significance of COVID-19 sequelae in cancer patients and their oncological continuity of care.”

Dr. Cortellini presented the OnCovid registry research on Sept. 21 at the 2021 European Society for Medical Oncology Congress. He reported that overall, the data suggest that post–COVID-19 complications may “impair” patients’ cancer survival as well as their cancer care.

The OnCovid registry data showed that the 15% of cancer patients who had long-term COVID-19 complications were 76% more likely to die than those without sequelae. Cancer patients with COVID-19 sequelae were significantly more likely to permanently stop taking their systemic anticancer therapy, and they were more than 3.5 times more likely to die than those who continued their treatment as planned. In terms of long-term complications, almost half of patients experienced dyspnea, and two-fifths reported chronic fatigue.

“This data confirms the need to continue to prioritize cancer patients,” Antonio Passaro, MD, PhD, division of thoracic oncology, European Institute of Oncology IRCCS, Milan, commented in a press release. “In the fight against the pandemic, it is of the utmost importance that we do not neglect to study and understand the curves of cancer incidence and mortality.”

Invited to discuss the results, Anne-Marie C. Dingemans, MD, PhD, a pulmonologist and professor of thoracic oncology at Erasmus Medical Center, Rotterdam, the Netherlands, said COVID-19 remains a “very important” issue for cancer patients.

Interestingly, Dr. Dingemans noted that COVID-19 sequelae in patients with cancer appear to occur slightly less frequently, compared with estimates in the general population – which range from 13% to 60% – though patients with cancer tend to have more respiratory problems.

However, Dr. Dingemans added, the difficulty with comparing sequelae rates between cancer patients and the general population is that cancer patients “probably already have a lot of symptoms” associated with long COVID, such as dyspnea and fatigue, and may not be aware that they are experiencing COVID sequelae.
 

The registry results

To investigate the long-term impact of COVID-19 on survival and continuity of care, the team examined data from the OnCovid registry, which was established at the beginning of the pandemic to study consecutive patients aged 18 years and older with confirmed SARS-CoV-2 infection and a history of solid or hematologic malignancies.

At the data cutoff on March 1, 2021, the registry included 35 institutions in six European countries. The institutions collected information on patient demographics and comorbidities, cancer history, anticancer therapy, COVID-19 investigations, and COVID-19–specific therapies.

For the current analysis, the team included 1,557 of 2,634 patients who had undergone a clinical reassessment after recovering from COVID-19. Information sufficient to conduct multivariate analysis was available for 840 of these patients.

About half of the patients were younger than 60 years, and just over half were women. The most common cancer diagnoses were breast cancer (23.4%), gastrointestinal tumors (16.5%), gynecologic/genitourinary tumors (19.3%), and hematologic cancers (14.1%), with even distribution between local/locoregional and advanced disease.

The median interval between COVID-19 recovery and reassessment was 44 days, and the mean post–COVID-19 follow-up period was 128 days.

About 15% of patients experienced at least one long-term sequela from COVID-19. The most common were dyspnea/shortness of breath (49.6%), fatigue (41.0%), chronic cough (33.8%), and other respiratory complications (10.7%).

Dr. Cortellini noted that cancer patients who experienced sequelae were more likely to be male, aged 65 years or older, to have at least two comorbidities, and to have a history of smoking. In addition, cancer patients who experienced long-term complications were significantly more likely to have had COVID-19 complications, to have required COVID-19 therapy, and to have been hospitalized for the disease.

Factoring in gender, age, comorbidity burden, primary tumor, stage, receipt of anticancer and anti–COVID-19 therapy, COVID-19 complications, and hospitalization, the team found that COVID-19 sequelae were independently associated with an increased risk for death (hazard ratio, 1.76).

Further analysis of patterns of systemic anticancer therapy in 471 patients revealed that 14.8% of COVID-19 survivors permanently discontinued therapy and that a dose or regimen adjustment occurred for 37.8%.

Patients who permanently discontinued anticancer therapy were more likely to be former or current smokers, to have had COVID-19 complications or been hospitalized for COVID-19, and to have had COVID-19 sequelae at reassessment. The investigators found no association between permanent discontinuation of therapy and cancer disease stage.

Dr. Cortellini and colleagues reported that permanent cessation of systemic anticancer therapy was associated with an increased risk for death. A change in dose or regimen did not affect survival.

The most common reason for stopping therapy permanently was deterioration of the patient’s performance status (61.3%), followed by disease progression (29.0%). Dose or regimen adjustments typically occurred to avoid immune suppression (50.0%), hospitalization (25.8%), and intravenous drug administration (19.1%).

Dr. Cortellini concluded his presentation by highlighting the importance of increasing awareness of long COVID in patients with cancer as well as early treatment of COVID-19 sequelae to improve patient outcomes.

The study was funded by the Imperial College Biomedical Research Center. Dr. Cortellini has relationships with MSD, Bristol-Myers Squibb, Roche, Novartis, AstraZeneca, Astellas, and Sun Pharma. Dr. Dingemans has relationships with Roche, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Jansen, Chiesi, Amgen, Pfizer, Bayer, Takeda, Pharmamar, and Sanofi.

A version of this article first appeared on Medscape.com.

More than one in six cancer patients experience long-term sequelae following SARS-CoV-2 infection, placing them at increased risk of discontinuing their cancer treatment or dying, according to European registry data.

Given the “high lethality” of COVID-19 in cancer patients and the risk for long-term complications following infection in the general population, Alessio Cortellini, MD, a consultant medical oncologist at Hammersmith Hospital and Imperial College London, and colleagues wanted to explore the “prevalence and clinical significance of COVID-19 sequelae in cancer patients and their oncological continuity of care.”

Dr. Cortellini presented the OnCovid registry research on Sept. 21 at the 2021 European Society for Medical Oncology Congress. He reported that overall, the data suggest that post–COVID-19 complications may “impair” patients’ cancer survival as well as their cancer care.

The OnCovid registry data showed that the 15% of cancer patients who had long-term COVID-19 complications were 76% more likely to die than those without sequelae. Cancer patients with COVID-19 sequelae were significantly more likely to permanently stop taking their systemic anticancer therapy, and they were more than 3.5 times more likely to die than those who continued their treatment as planned. In terms of long-term complications, almost half of patients experienced dyspnea, and two-fifths reported chronic fatigue.

“This data confirms the need to continue to prioritize cancer patients,” Antonio Passaro, MD, PhD, division of thoracic oncology, European Institute of Oncology IRCCS, Milan, commented in a press release. “In the fight against the pandemic, it is of the utmost importance that we do not neglect to study and understand the curves of cancer incidence and mortality.”

Invited to discuss the results, Anne-Marie C. Dingemans, MD, PhD, a pulmonologist and professor of thoracic oncology at Erasmus Medical Center, Rotterdam, the Netherlands, said COVID-19 remains a “very important” issue for cancer patients.

Interestingly, Dr. Dingemans noted that COVID-19 sequelae in patients with cancer appear to occur slightly less frequently, compared with estimates in the general population – which range from 13% to 60% – though patients with cancer tend to have more respiratory problems.

However, Dr. Dingemans added, the difficulty with comparing sequelae rates between cancer patients and the general population is that cancer patients “probably already have a lot of symptoms” associated with long COVID, such as dyspnea and fatigue, and may not be aware that they are experiencing COVID sequelae.
 

The registry results

To investigate the long-term impact of COVID-19 on survival and continuity of care, the team examined data from the OnCovid registry, which was established at the beginning of the pandemic to study consecutive patients aged 18 years and older with confirmed SARS-CoV-2 infection and a history of solid or hematologic malignancies.

At the data cutoff on March 1, 2021, the registry included 35 institutions in six European countries. The institutions collected information on patient demographics and comorbidities, cancer history, anticancer therapy, COVID-19 investigations, and COVID-19–specific therapies.

For the current analysis, the team included 1,557 of 2,634 patients who had undergone a clinical reassessment after recovering from COVID-19. Information sufficient to conduct multivariate analysis was available for 840 of these patients.

About half of the patients were younger than 60 years, and just over half were women. The most common cancer diagnoses were breast cancer (23.4%), gastrointestinal tumors (16.5%), gynecologic/genitourinary tumors (19.3%), and hematologic cancers (14.1%), with even distribution between local/locoregional and advanced disease.

The median interval between COVID-19 recovery and reassessment was 44 days, and the mean post–COVID-19 follow-up period was 128 days.

About 15% of patients experienced at least one long-term sequela from COVID-19. The most common were dyspnea/shortness of breath (49.6%), fatigue (41.0%), chronic cough (33.8%), and other respiratory complications (10.7%).

Dr. Cortellini noted that cancer patients who experienced sequelae were more likely to be male, aged 65 years or older, to have at least two comorbidities, and to have a history of smoking. In addition, cancer patients who experienced long-term complications were significantly more likely to have had COVID-19 complications, to have required COVID-19 therapy, and to have been hospitalized for the disease.

Factoring in gender, age, comorbidity burden, primary tumor, stage, receipt of anticancer and anti–COVID-19 therapy, COVID-19 complications, and hospitalization, the team found that COVID-19 sequelae were independently associated with an increased risk for death (hazard ratio, 1.76).

Further analysis of patterns of systemic anticancer therapy in 471 patients revealed that 14.8% of COVID-19 survivors permanently discontinued therapy and that a dose or regimen adjustment occurred for 37.8%.

Patients who permanently discontinued anticancer therapy were more likely to be former or current smokers, to have had COVID-19 complications or been hospitalized for COVID-19, and to have had COVID-19 sequelae at reassessment. The investigators found no association between permanent discontinuation of therapy and cancer disease stage.

Dr. Cortellini and colleagues reported that permanent cessation of systemic anticancer therapy was associated with an increased risk for death. A change in dose or regimen did not affect survival.

The most common reason for stopping therapy permanently was deterioration of the patient’s performance status (61.3%), followed by disease progression (29.0%). Dose or regimen adjustments typically occurred to avoid immune suppression (50.0%), hospitalization (25.8%), and intravenous drug administration (19.1%).

Dr. Cortellini concluded his presentation by highlighting the importance of increasing awareness of long COVID in patients with cancer as well as early treatment of COVID-19 sequelae to improve patient outcomes.

The study was funded by the Imperial College Biomedical Research Center. Dr. Cortellini has relationships with MSD, Bristol-Myers Squibb, Roche, Novartis, AstraZeneca, Astellas, and Sun Pharma. Dr. Dingemans has relationships with Roche, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Jansen, Chiesi, Amgen, Pfizer, Bayer, Takeda, Pharmamar, and Sanofi.

A version of this article first appeared on Medscape.com.

More than one in six cancer patients experience long-term sequelae following SARS-CoV-2 infection, placing them at increased risk of discontinuing their cancer treatment or dying, according to European registry data.

Given the “high lethality” of COVID-19 in cancer patients and the risk for long-term complications following infection in the general population, Alessio Cortellini, MD, a consultant medical oncologist at Hammersmith Hospital and Imperial College London, and colleagues wanted to explore the “prevalence and clinical significance of COVID-19 sequelae in cancer patients and their oncological continuity of care.”

Dr. Cortellini presented the OnCovid registry research on Sept. 21 at the 2021 European Society for Medical Oncology Congress. He reported that overall, the data suggest that post–COVID-19 complications may “impair” patients’ cancer survival as well as their cancer care.

The OnCovid registry data showed that the 15% of cancer patients who had long-term COVID-19 complications were 76% more likely to die than those without sequelae. Cancer patients with COVID-19 sequelae were significantly more likely to permanently stop taking their systemic anticancer therapy, and they were more than 3.5 times more likely to die than those who continued their treatment as planned. In terms of long-term complications, almost half of patients experienced dyspnea, and two-fifths reported chronic fatigue.

“This data confirms the need to continue to prioritize cancer patients,” Antonio Passaro, MD, PhD, division of thoracic oncology, European Institute of Oncology IRCCS, Milan, commented in a press release. “In the fight against the pandemic, it is of the utmost importance that we do not neglect to study and understand the curves of cancer incidence and mortality.”

Invited to discuss the results, Anne-Marie C. Dingemans, MD, PhD, a pulmonologist and professor of thoracic oncology at Erasmus Medical Center, Rotterdam, the Netherlands, said COVID-19 remains a “very important” issue for cancer patients.

Interestingly, Dr. Dingemans noted that COVID-19 sequelae in patients with cancer appear to occur slightly less frequently, compared with estimates in the general population – which range from 13% to 60% – though patients with cancer tend to have more respiratory problems.

However, Dr. Dingemans added, the difficulty with comparing sequelae rates between cancer patients and the general population is that cancer patients “probably already have a lot of symptoms” associated with long COVID, such as dyspnea and fatigue, and may not be aware that they are experiencing COVID sequelae.
 

The registry results

To investigate the long-term impact of COVID-19 on survival and continuity of care, the team examined data from the OnCovid registry, which was established at the beginning of the pandemic to study consecutive patients aged 18 years and older with confirmed SARS-CoV-2 infection and a history of solid or hematologic malignancies.

At the data cutoff on March 1, 2021, the registry included 35 institutions in six European countries. The institutions collected information on patient demographics and comorbidities, cancer history, anticancer therapy, COVID-19 investigations, and COVID-19–specific therapies.

For the current analysis, the team included 1,557 of 2,634 patients who had undergone a clinical reassessment after recovering from COVID-19. Information sufficient to conduct multivariate analysis was available for 840 of these patients.

About half of the patients were younger than 60 years, and just over half were women. The most common cancer diagnoses were breast cancer (23.4%), gastrointestinal tumors (16.5%), gynecologic/genitourinary tumors (19.3%), and hematologic cancers (14.1%), with even distribution between local/locoregional and advanced disease.

The median interval between COVID-19 recovery and reassessment was 44 days, and the mean post–COVID-19 follow-up period was 128 days.

About 15% of patients experienced at least one long-term sequela from COVID-19. The most common were dyspnea/shortness of breath (49.6%), fatigue (41.0%), chronic cough (33.8%), and other respiratory complications (10.7%).

Dr. Cortellini noted that cancer patients who experienced sequelae were more likely to be male, aged 65 years or older, to have at least two comorbidities, and to have a history of smoking. In addition, cancer patients who experienced long-term complications were significantly more likely to have had COVID-19 complications, to have required COVID-19 therapy, and to have been hospitalized for the disease.

Factoring in gender, age, comorbidity burden, primary tumor, stage, receipt of anticancer and anti–COVID-19 therapy, COVID-19 complications, and hospitalization, the team found that COVID-19 sequelae were independently associated with an increased risk for death (hazard ratio, 1.76).

Further analysis of patterns of systemic anticancer therapy in 471 patients revealed that 14.8% of COVID-19 survivors permanently discontinued therapy and that a dose or regimen adjustment occurred for 37.8%.

Patients who permanently discontinued anticancer therapy were more likely to be former or current smokers, to have had COVID-19 complications or been hospitalized for COVID-19, and to have had COVID-19 sequelae at reassessment. The investigators found no association between permanent discontinuation of therapy and cancer disease stage.

Dr. Cortellini and colleagues reported that permanent cessation of systemic anticancer therapy was associated with an increased risk for death. A change in dose or regimen did not affect survival.

The most common reason for stopping therapy permanently was deterioration of the patient’s performance status (61.3%), followed by disease progression (29.0%). Dose or regimen adjustments typically occurred to avoid immune suppression (50.0%), hospitalization (25.8%), and intravenous drug administration (19.1%).

Dr. Cortellini concluded his presentation by highlighting the importance of increasing awareness of long COVID in patients with cancer as well as early treatment of COVID-19 sequelae to improve patient outcomes.

The study was funded by the Imperial College Biomedical Research Center. Dr. Cortellini has relationships with MSD, Bristol-Myers Squibb, Roche, Novartis, AstraZeneca, Astellas, and Sun Pharma. Dr. Dingemans has relationships with Roche, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Jansen, Chiesi, Amgen, Pfizer, Bayer, Takeda, Pharmamar, and Sanofi.

A version of this article first appeared on Medscape.com.

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

A version of this article first appeared on Medscape.com.

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

A version of this article first appeared on Medscape.com.

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

A version of this article first appeared on Medscape.com.

Social distancing and the shutdown of services like physical and occupational therapy because of COVID-19 have had a profound impact on the mental health of people with Parkinson’s disease, a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.

Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.

“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.

“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.

Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.

The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.

The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
 

Vulnerable subgroups

“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.

“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”

When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.

The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.

The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”

Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.

“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.

“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.

What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”

Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.

Social distancing and the shutdown of services like physical and occupational therapy because of COVID-19 have had a profound impact on the mental health of people with Parkinson’s disease, a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.

Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.

“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.

“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.

Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.

The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.

The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
 

Vulnerable subgroups

“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.

“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”

When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.

The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.

The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”

Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.

“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.

“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.

What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”

Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.

Social distancing and the shutdown of services like physical and occupational therapy because of COVID-19 have had a profound impact on the mental health of people with Parkinson’s disease, a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.

Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.

“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.

“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.

Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.

The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.

The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
 

Vulnerable subgroups

“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.

“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”

When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.

The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.

The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”

Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.

“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.

“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.

What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”

Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.