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Masks don’t affect oxygen saturation in people with asthma
Wearing a mask to protect against transmission of COVID-19 does not decrease oxygen saturation, according to a new study.
Oxygen saturation did not decline in more than 200 mask-wearing individuals attending an asthma and allergy clinic, regardless of the type of mask they were wearing and how long they had been wearing the mask.
The study was presented in a late breaking poster session by Marisa Hodges, MD, University of Michigan, Ann Arbor, at the virtual annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“In patients with or without asthma, wearing a mask does not decrease your oxygen level,” coauthor Alan P. Baptist, MD, MPH, director of the University of Michigan Comprehensive Asthma Program, said in an interview.
“Some of my asthma patients had called me requesting an exemption from wearing a mask because they feared that their oxygen intake may be affected, and that got me thinking,” said Malika Gupta, MD, assistant professor, division of allergy and immunology, University of Michigan, Ann Arbor, and the study’s lead investigator.
“We say masks are safe, but I couldn’t find any data to support that statement, and we wanted to provide them with evidence, so they could feel comfortable about wearing their masks,” Dr. Gupta added.
The study collected 223 surveys from adult and pediatric patients presenting to the University of Michigan Medicine Allergy Clinic between Sept. 10 and Oct. 23, 2020.
The patients were asked whether they had a diagnosis of asthma, their degree of perceived control if they did have asthma, the type of mask they were wearing, and how long they had been wearing it.
Investigators obtained resting pulse oximetry readings to measure oxygen saturation (SpO2) from all study participants.
Forty percent of the participants were male, 46% reported having asthma, and 27% were age 19 years or younger.
Overall, the mean SpO2 was 98% (range, 93%-100%) in both asthma and nonasthma groups.
The study also looked at SpO2 with 3 different types of masks: fabric, surgical, and N95.
The mean SpO2 for a fabric mask was 98% (119 patients), for a surgical mask it was also 98% (83 patients), and for the N95 mask it was 99% (3 patients).
Similar results were found with duration of mask use, with the mean SpO2 98% in those wearing a mask for 1 hour or less and 99% in those wearing a mask for 1 hour or longer.
People with asthma who reported they were well controlled showed similar mean SpO2 levels (98%) compared with those who reported they were not well controlled (96.5%)
“No effect on oxygen saturation was noted in any patients, whether they had asthma or not, whether it was well controlled or not, and this was also true regardless of what masks they wore and how long they wore the masks for. So our data reinforce that wearing a mask, whether it be a surgical mask, cloth mask, or N95, is completely safe,” Dr. Baptist said.
“We know wearing a mask is an essential step we can all take to reduce the spread of COVID-19, and we hope these data will give peace of mind to individuals who fear that wearing a mask will adversely affect their oxygen levels,” Dr. Gupta added.
Leonard B. Bacharier, MD, professor of pediatrics and director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn., agreed with the investigators’ conclusions.
“The authors found no differences in oxygen saturations between asthmatic and nonasthmatic patients, nor was there a difference based upon mask use or type,” Dr. Bacharier, who was not part of the study, said in an interview.
“These findings provide reassurance that patients, including those with stable asthma, do not experience impaired oxygenation while wearing a mask.”
Dr. Hodges, Dr. Baptist, and Dr. Bacharier have disclosed no relevant financial relationships.
This article was updated 3/11/21.
A version of this article first appeared on Medscape.com.
Wearing a mask to protect against transmission of COVID-19 does not decrease oxygen saturation, according to a new study.
Oxygen saturation did not decline in more than 200 mask-wearing individuals attending an asthma and allergy clinic, regardless of the type of mask they were wearing and how long they had been wearing the mask.
The study was presented in a late breaking poster session by Marisa Hodges, MD, University of Michigan, Ann Arbor, at the virtual annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“In patients with or without asthma, wearing a mask does not decrease your oxygen level,” coauthor Alan P. Baptist, MD, MPH, director of the University of Michigan Comprehensive Asthma Program, said in an interview.
“Some of my asthma patients had called me requesting an exemption from wearing a mask because they feared that their oxygen intake may be affected, and that got me thinking,” said Malika Gupta, MD, assistant professor, division of allergy and immunology, University of Michigan, Ann Arbor, and the study’s lead investigator.
“We say masks are safe, but I couldn’t find any data to support that statement, and we wanted to provide them with evidence, so they could feel comfortable about wearing their masks,” Dr. Gupta added.
The study collected 223 surveys from adult and pediatric patients presenting to the University of Michigan Medicine Allergy Clinic between Sept. 10 and Oct. 23, 2020.
The patients were asked whether they had a diagnosis of asthma, their degree of perceived control if they did have asthma, the type of mask they were wearing, and how long they had been wearing it.
Investigators obtained resting pulse oximetry readings to measure oxygen saturation (SpO2) from all study participants.
Forty percent of the participants were male, 46% reported having asthma, and 27% were age 19 years or younger.
Overall, the mean SpO2 was 98% (range, 93%-100%) in both asthma and nonasthma groups.
The study also looked at SpO2 with 3 different types of masks: fabric, surgical, and N95.
The mean SpO2 for a fabric mask was 98% (119 patients), for a surgical mask it was also 98% (83 patients), and for the N95 mask it was 99% (3 patients).
Similar results were found with duration of mask use, with the mean SpO2 98% in those wearing a mask for 1 hour or less and 99% in those wearing a mask for 1 hour or longer.
People with asthma who reported they were well controlled showed similar mean SpO2 levels (98%) compared with those who reported they were not well controlled (96.5%)
“No effect on oxygen saturation was noted in any patients, whether they had asthma or not, whether it was well controlled or not, and this was also true regardless of what masks they wore and how long they wore the masks for. So our data reinforce that wearing a mask, whether it be a surgical mask, cloth mask, or N95, is completely safe,” Dr. Baptist said.
“We know wearing a mask is an essential step we can all take to reduce the spread of COVID-19, and we hope these data will give peace of mind to individuals who fear that wearing a mask will adversely affect their oxygen levels,” Dr. Gupta added.
Leonard B. Bacharier, MD, professor of pediatrics and director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn., agreed with the investigators’ conclusions.
“The authors found no differences in oxygen saturations between asthmatic and nonasthmatic patients, nor was there a difference based upon mask use or type,” Dr. Bacharier, who was not part of the study, said in an interview.
“These findings provide reassurance that patients, including those with stable asthma, do not experience impaired oxygenation while wearing a mask.”
Dr. Hodges, Dr. Baptist, and Dr. Bacharier have disclosed no relevant financial relationships.
This article was updated 3/11/21.
A version of this article first appeared on Medscape.com.
Wearing a mask to protect against transmission of COVID-19 does not decrease oxygen saturation, according to a new study.
Oxygen saturation did not decline in more than 200 mask-wearing individuals attending an asthma and allergy clinic, regardless of the type of mask they were wearing and how long they had been wearing the mask.
The study was presented in a late breaking poster session by Marisa Hodges, MD, University of Michigan, Ann Arbor, at the virtual annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“In patients with or without asthma, wearing a mask does not decrease your oxygen level,” coauthor Alan P. Baptist, MD, MPH, director of the University of Michigan Comprehensive Asthma Program, said in an interview.
“Some of my asthma patients had called me requesting an exemption from wearing a mask because they feared that their oxygen intake may be affected, and that got me thinking,” said Malika Gupta, MD, assistant professor, division of allergy and immunology, University of Michigan, Ann Arbor, and the study’s lead investigator.
“We say masks are safe, but I couldn’t find any data to support that statement, and we wanted to provide them with evidence, so they could feel comfortable about wearing their masks,” Dr. Gupta added.
The study collected 223 surveys from adult and pediatric patients presenting to the University of Michigan Medicine Allergy Clinic between Sept. 10 and Oct. 23, 2020.
The patients were asked whether they had a diagnosis of asthma, their degree of perceived control if they did have asthma, the type of mask they were wearing, and how long they had been wearing it.
Investigators obtained resting pulse oximetry readings to measure oxygen saturation (SpO2) from all study participants.
Forty percent of the participants were male, 46% reported having asthma, and 27% were age 19 years or younger.
Overall, the mean SpO2 was 98% (range, 93%-100%) in both asthma and nonasthma groups.
The study also looked at SpO2 with 3 different types of masks: fabric, surgical, and N95.
The mean SpO2 for a fabric mask was 98% (119 patients), for a surgical mask it was also 98% (83 patients), and for the N95 mask it was 99% (3 patients).
Similar results were found with duration of mask use, with the mean SpO2 98% in those wearing a mask for 1 hour or less and 99% in those wearing a mask for 1 hour or longer.
People with asthma who reported they were well controlled showed similar mean SpO2 levels (98%) compared with those who reported they were not well controlled (96.5%)
“No effect on oxygen saturation was noted in any patients, whether they had asthma or not, whether it was well controlled or not, and this was also true regardless of what masks they wore and how long they wore the masks for. So our data reinforce that wearing a mask, whether it be a surgical mask, cloth mask, or N95, is completely safe,” Dr. Baptist said.
“We know wearing a mask is an essential step we can all take to reduce the spread of COVID-19, and we hope these data will give peace of mind to individuals who fear that wearing a mask will adversely affect their oxygen levels,” Dr. Gupta added.
Leonard B. Bacharier, MD, professor of pediatrics and director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn., agreed with the investigators’ conclusions.
“The authors found no differences in oxygen saturations between asthmatic and nonasthmatic patients, nor was there a difference based upon mask use or type,” Dr. Bacharier, who was not part of the study, said in an interview.
“These findings provide reassurance that patients, including those with stable asthma, do not experience impaired oxygenation while wearing a mask.”
Dr. Hodges, Dr. Baptist, and Dr. Bacharier have disclosed no relevant financial relationships.
This article was updated 3/11/21.
A version of this article first appeared on Medscape.com.
FROM AAAAI
FDA grants emergency use authorization to Johnson & Johnson COVID-19 vaccine
And then there were three.
More vaccine availability at a time of high demand and limited supply could help officials vaccinate more Americans, more quickly. In addition, the J&J vaccine offers one-dose convenience and storage at conventional refrigeration temperatures.
Initial reactions to the EUA for the J&J vaccine have been positive.
“The advantages of having a third vaccine, especially one that is a single shot and can be stored without special refrigeration requirements, will be a major contribution in getting the general public vaccinated sooner, both in the U.S. and around the world,” Phyllis Tien, MD, professor of medicine in the division of infectious diseases at the University of California, San Francisco, told Medscape Medical News.
“It’s great news. We have yet a third vaccine that is highly effective at preventing COVID, and even more effective at preventing severe COVID,” said Paul Goepfert, MD. It’s a “tremendous boon for our country and other countries as well.”
“This vaccine has also been shown to be effective against the B.1.351 strain that was first described in South Africa,” added Dr. Goepfert, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama at Birmingham.
The EUA “is indeed exciting news,” Colleen Kraft, MD, associate chief medical officer at Emory University Hospital and associate professor at Emory University School of Medicine in Atlanta, said during a February 25 media briefing.
One recent concern centers on people aged 60 years and older. Documents the FDA released earlier this week suggest a lower efficacy, 42%, for the J&J immunization among people in this age group with certain relevant comorbidities. In contrast, without underlying conditions like heart disease or diabetes, efficacy in this cohort was 72%.
The more the merrier
The scope and urgency of the COVID-19 pandemic necessitates as many protective measures as possible, said Raj Shah, MD, geriatrician, and associate professor of family medicine and codirector of the Center for Community Health Equity at Rush University in Chicago.
“Trying to vaccinate as many individuals living in the United States to prevent the spread of COVID is such a big project that no one company or one vaccine was going to be able to ramp up fast enough on its own,” Dr. Shah told Medscape Medical News.“This has been the hope for us,” he added, “to get to multiple vaccines with slightly different properties that will provide more options.”
Experience with the J&J vaccine so far suggests reactions are less severe. “The nice thing about the Johnson and Johnson [vaccine] is that it definitely has less side effects,” Dr. Kraft said.
On the other hand, low-grade fever, chills, or fatigue after vaccination can be considered a positive because they can reflect how well the immune system is responding, she added.
One and done?
Single-dose administration could be more than a convenience — it could also help clinicians vaccinate members of underserved communities and rural locations, where returning for a second dose could be more difficult for some people.
“In a controlled setting, in a clinical trial, we do a lot to make sure people get all the treatment they need,” Dr. Shah said. “We’re not seeing it right now, but we’re always worried when we have more than one dose that has to be administered, that some people will drop off and not come back for the second vaccine.”
This group could include the needle-phobic, he added. “For them, having it done once alleviates a lot of the anxiety.”
Looking beyond the numbers
The phase 3 ENSEMBLE study of the J&J vaccine revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among U.S. participants. In contrast, researchers reported 94% to 95% efficacy for the Pfizer/BioNTech and Moderna vaccines.
However, experts agreed that focusing solely on these numbers can miss more important points. For example, no participants who received the J&J vaccine in the phase 3 trial died from COVID-19-related illness. There were five such deaths in the placebo cohort.
“One of the things that these vaccines do very well is they minimize severe disease,” Dr. Kraft said. “As somebody that has spent an inordinate time in the hospital taking care of patients with severe disease from COVID, this is very much a welcome addition to our armamentarium to fight this virus.”
“If you can give something that prevents people from dying, that is a true path to normalcy,” Dr. Goepfert added.
More work to do
“The demand is strong from all groups right now. We just have to work on getting more vaccines out there,” Dr. Shah said.
“We are at a point in this country where we are getting better with the distribution of the vaccine,” he added, “but we are nowhere close to achieving that distribution of vaccines to get to everybody.”
Dr. Goepfert, Dr. Shah, and Dr. Kraft disclosed no relevant financial relationships. Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the San Francisco VA Health Care System.
A version of this article first appeared on Medscape.com.
And then there were three.
More vaccine availability at a time of high demand and limited supply could help officials vaccinate more Americans, more quickly. In addition, the J&J vaccine offers one-dose convenience and storage at conventional refrigeration temperatures.
Initial reactions to the EUA for the J&J vaccine have been positive.
“The advantages of having a third vaccine, especially one that is a single shot and can be stored without special refrigeration requirements, will be a major contribution in getting the general public vaccinated sooner, both in the U.S. and around the world,” Phyllis Tien, MD, professor of medicine in the division of infectious diseases at the University of California, San Francisco, told Medscape Medical News.
“It’s great news. We have yet a third vaccine that is highly effective at preventing COVID, and even more effective at preventing severe COVID,” said Paul Goepfert, MD. It’s a “tremendous boon for our country and other countries as well.”
“This vaccine has also been shown to be effective against the B.1.351 strain that was first described in South Africa,” added Dr. Goepfert, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama at Birmingham.
The EUA “is indeed exciting news,” Colleen Kraft, MD, associate chief medical officer at Emory University Hospital and associate professor at Emory University School of Medicine in Atlanta, said during a February 25 media briefing.
One recent concern centers on people aged 60 years and older. Documents the FDA released earlier this week suggest a lower efficacy, 42%, for the J&J immunization among people in this age group with certain relevant comorbidities. In contrast, without underlying conditions like heart disease or diabetes, efficacy in this cohort was 72%.
The more the merrier
The scope and urgency of the COVID-19 pandemic necessitates as many protective measures as possible, said Raj Shah, MD, geriatrician, and associate professor of family medicine and codirector of the Center for Community Health Equity at Rush University in Chicago.
“Trying to vaccinate as many individuals living in the United States to prevent the spread of COVID is such a big project that no one company or one vaccine was going to be able to ramp up fast enough on its own,” Dr. Shah told Medscape Medical News.“This has been the hope for us,” he added, “to get to multiple vaccines with slightly different properties that will provide more options.”
Experience with the J&J vaccine so far suggests reactions are less severe. “The nice thing about the Johnson and Johnson [vaccine] is that it definitely has less side effects,” Dr. Kraft said.
On the other hand, low-grade fever, chills, or fatigue after vaccination can be considered a positive because they can reflect how well the immune system is responding, she added.
One and done?
Single-dose administration could be more than a convenience — it could also help clinicians vaccinate members of underserved communities and rural locations, where returning for a second dose could be more difficult for some people.
“In a controlled setting, in a clinical trial, we do a lot to make sure people get all the treatment they need,” Dr. Shah said. “We’re not seeing it right now, but we’re always worried when we have more than one dose that has to be administered, that some people will drop off and not come back for the second vaccine.”
This group could include the needle-phobic, he added. “For them, having it done once alleviates a lot of the anxiety.”
Looking beyond the numbers
The phase 3 ENSEMBLE study of the J&J vaccine revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among U.S. participants. In contrast, researchers reported 94% to 95% efficacy for the Pfizer/BioNTech and Moderna vaccines.
However, experts agreed that focusing solely on these numbers can miss more important points. For example, no participants who received the J&J vaccine in the phase 3 trial died from COVID-19-related illness. There were five such deaths in the placebo cohort.
“One of the things that these vaccines do very well is they minimize severe disease,” Dr. Kraft said. “As somebody that has spent an inordinate time in the hospital taking care of patients with severe disease from COVID, this is very much a welcome addition to our armamentarium to fight this virus.”
“If you can give something that prevents people from dying, that is a true path to normalcy,” Dr. Goepfert added.
More work to do
“The demand is strong from all groups right now. We just have to work on getting more vaccines out there,” Dr. Shah said.
“We are at a point in this country where we are getting better with the distribution of the vaccine,” he added, “but we are nowhere close to achieving that distribution of vaccines to get to everybody.”
Dr. Goepfert, Dr. Shah, and Dr. Kraft disclosed no relevant financial relationships. Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the San Francisco VA Health Care System.
A version of this article first appeared on Medscape.com.
And then there were three.
More vaccine availability at a time of high demand and limited supply could help officials vaccinate more Americans, more quickly. In addition, the J&J vaccine offers one-dose convenience and storage at conventional refrigeration temperatures.
Initial reactions to the EUA for the J&J vaccine have been positive.
“The advantages of having a third vaccine, especially one that is a single shot and can be stored without special refrigeration requirements, will be a major contribution in getting the general public vaccinated sooner, both in the U.S. and around the world,” Phyllis Tien, MD, professor of medicine in the division of infectious diseases at the University of California, San Francisco, told Medscape Medical News.
“It’s great news. We have yet a third vaccine that is highly effective at preventing COVID, and even more effective at preventing severe COVID,” said Paul Goepfert, MD. It’s a “tremendous boon for our country and other countries as well.”
“This vaccine has also been shown to be effective against the B.1.351 strain that was first described in South Africa,” added Dr. Goepfert, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama at Birmingham.
The EUA “is indeed exciting news,” Colleen Kraft, MD, associate chief medical officer at Emory University Hospital and associate professor at Emory University School of Medicine in Atlanta, said during a February 25 media briefing.
One recent concern centers on people aged 60 years and older. Documents the FDA released earlier this week suggest a lower efficacy, 42%, for the J&J immunization among people in this age group with certain relevant comorbidities. In contrast, without underlying conditions like heart disease or diabetes, efficacy in this cohort was 72%.
The more the merrier
The scope and urgency of the COVID-19 pandemic necessitates as many protective measures as possible, said Raj Shah, MD, geriatrician, and associate professor of family medicine and codirector of the Center for Community Health Equity at Rush University in Chicago.
“Trying to vaccinate as many individuals living in the United States to prevent the spread of COVID is such a big project that no one company or one vaccine was going to be able to ramp up fast enough on its own,” Dr. Shah told Medscape Medical News.“This has been the hope for us,” he added, “to get to multiple vaccines with slightly different properties that will provide more options.”
Experience with the J&J vaccine so far suggests reactions are less severe. “The nice thing about the Johnson and Johnson [vaccine] is that it definitely has less side effects,” Dr. Kraft said.
On the other hand, low-grade fever, chills, or fatigue after vaccination can be considered a positive because they can reflect how well the immune system is responding, she added.
One and done?
Single-dose administration could be more than a convenience — it could also help clinicians vaccinate members of underserved communities and rural locations, where returning for a second dose could be more difficult for some people.
“In a controlled setting, in a clinical trial, we do a lot to make sure people get all the treatment they need,” Dr. Shah said. “We’re not seeing it right now, but we’re always worried when we have more than one dose that has to be administered, that some people will drop off and not come back for the second vaccine.”
This group could include the needle-phobic, he added. “For them, having it done once alleviates a lot of the anxiety.”
Looking beyond the numbers
The phase 3 ENSEMBLE study of the J&J vaccine revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among U.S. participants. In contrast, researchers reported 94% to 95% efficacy for the Pfizer/BioNTech and Moderna vaccines.
However, experts agreed that focusing solely on these numbers can miss more important points. For example, no participants who received the J&J vaccine in the phase 3 trial died from COVID-19-related illness. There were five such deaths in the placebo cohort.
“One of the things that these vaccines do very well is they minimize severe disease,” Dr. Kraft said. “As somebody that has spent an inordinate time in the hospital taking care of patients with severe disease from COVID, this is very much a welcome addition to our armamentarium to fight this virus.”
“If you can give something that prevents people from dying, that is a true path to normalcy,” Dr. Goepfert added.
More work to do
“The demand is strong from all groups right now. We just have to work on getting more vaccines out there,” Dr. Shah said.
“We are at a point in this country where we are getting better with the distribution of the vaccine,” he added, “but we are nowhere close to achieving that distribution of vaccines to get to everybody.”
Dr. Goepfert, Dr. Shah, and Dr. Kraft disclosed no relevant financial relationships. Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the San Francisco VA Health Care System.
A version of this article first appeared on Medscape.com.
J&J COVID-19 vaccine wins unanimous backing of FDA panel
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.
Johnson & Johnson’s vaccine can be stored for at least 3 months at normal refrigerator temperatures of 2°C to 8°C (36°F to 46°F). Its shipping and storage fits into the existing medical supply infrastructure, the company said in its briefing materials for the FDA advisory committee meeting. In contrast, Pfizer’s vaccine is stored in ultracold freezers at temperatures between -80°C and -60°C (-112°F and -76°F), according to the Centers for Disease Control and Prevention. Moderna’s vaccine may be stored in a freezer between -25°C and -15°C (-13°F and 5°F).
But FDA advisers focused more in their deliberations on concerns about Janssen’s vaccine, including emerging reports of allergic reactions.
The advisers also discussed how patients might respond to the widely reported gap between Johnson & Johnson’s topline efficacy rates compared with rivals. The company’s initial unveiling last month of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe COVID-19 28 days postvaccination first reported at about 66% globally. By contrast, results for the Pfizer and Moderna vaccines suggest they have efficacy rates of 95% and 94%.
But in concluding, the advisers spoke of the Janssen vaccine as a much-needed tool to address the COVID-19 pandemic. The death toll in the United States attributed to the virus has reached 501,414, according to the World Health Organization.
“Despite the concerns that were raised during the discussion. I think what we have to keep in mind is that we’re still in the midst of this deadly pandemic,” said FDA adviser Archana Chatterjee, MD, PhD, from Rosalind Franklin University. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
The FDA is not bound to accept the recommendations of its advisers, but it often does so.
Anaphylaxis case
FDA advisers raised only a few questions for Johnson & Johnson and FDA staff ahead of their vote. The committee’s deliberations were less contentious and heated than had been during its December reviews of the Pfizer and Moderna vaccines. In those meetings, the panel voted 17-4, with one abstention, in favor of Pfizer’s vaccine and 20-0, with one abstention, on the Moderna vaccine.
“We are very comfortable now with the procedure, as well as the vaccines,” said Arnold Monto, MD, after the Feb. 26 vote on the Janssen vaccine. Dr. Monto, from the University of Michigan School of Public Health in Ann Arbor, has served as the chairman of the FDA panel through its review of all three COVID-19 vaccines.
Among the issues noted in the deliberations was the emergence of a concern about anaphylaxis with the vaccine.
This serious allergic reaction has been seen in people who have taken the Pfizer and Moderna vaccines. Before the week of the panel meeting, though, there had not been reports of anaphylaxis with the Johnson & Johnson vaccine, said Macaya Douoguih, MD, MPH, head of clinical development and medical affairs for Janssen/ Johnson & Johnson’s vaccines division.
However, on February 24, Johnson & Johnson received preliminary reports about two cases of severe allergic reaction from an open-label study in South Africa, with one of these being anaphylaxis, Dr. Douoguih said. The company will continue to closely monitor for these events as outlined in their pharmacovigilance plan, Dr. Douoguih said.
Federal health officials have sought to make clinicians aware of the rare risk for anaphylaxis with COVID vaccines, while reminding the public that this reaction can be managed.
The FDA had Tom Shimabukuro, MD, MPH, MBA, from the CDC, give an update on postmarketing surveillance for the Pfizer and Moderna vaccines as part of the review of the Johnson & Johnson application. Dr. Shimabukuro and CDC colleagues published a report in JAMA on February 14 that looked at an anaphylaxis case reported connected with COVID vaccines between December 14, 2020, and January 18, 2021.
The CDC identified 66 case reports received that met Brighton Collaboration case definition criteria for anaphylaxis (levels 1, 2, or 3): 47 following Pfizer/BioNTech vaccine, for a reporting rate of 4.7 cases/million doses administered, and 19 following Moderna vaccine, for a reporting rate of 2.5 cases/million doses administered, Dr. Shimabukuro and CDC colleagues wrote.
The CDC has published materials to help clinicians prepare for the possibility of this rare event, Dr. Shimabukuro told the FDA advisers.
“The take-home message here is that these are rare events and anaphylaxis, although clinically serious, is treatable,” Dr. Shimabukuro said.
At the conclusion of the meeting, FDA panelist Patrick Moore, MD, MPH, from the University of Pittsburgh in Pennsylvania, stressed the need to convey to the public that the COVID vaccines appear so far to be safe. Many people earlier had doubts about how the FDA could both safely and quickly review the applications for EUAs for these products.
“As of February 26, things are looking good. That could change tomorrow,” Dr. Moore said. But “this whole EUA process does seem to have worked, despite my own personal concerns about it.”
No second-class vaccines
The Johnson & Johnson vaccine, known as Ad26.COV2.S, is composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector. It’s intended to encode a stabilized form of SARS-CoV-2 spike (S) protein. The Pfizer and Moderna vaccines use a different mechanism. They rely on mRNA.
The FDA advisers also discussed how patients might respond to the widely reported gap between Janssen’s topline efficacy rates compared with rivals. They urged against people parsing study details too finely and seeking to pick and choose their shots.
“It’s important that people do not think that one vaccine is better than another,” said FDA adviser H. Cody Meissner, MD, from Tufts University School of Medicine in Boston.
Dr. Monto agreed, noting that many people in the United States are still waiting for their turn to get COVID vaccines because of the limited early supply.
Trying to game the system to get one vaccine instead of another would not be wise. “In this environment, whatever you can get, get,” Dr. Monto said.
During an open public hearing, Sarah Christopherson, policy advocacy director of the National Women’s Health Network, said that press reports are fueling a damaging impression in the public that there are “first and second-class” vaccines.
“That has the potential to exacerbate existing mistrust” in vaccines, she said. “Public health authorities must address these perceptions head on.”
She urged against attempts to compare the Janssen vaccine to others, noting the potential effects of emerging variants of the virus.
“It’s difficult to make an apples-to-apples comparison between vaccines,” she said.
Johnson & Johnson’s efficacy results, which are lower than those of the mRNA vaccines, may be a reflection of the ways in which SARS-Co-V-2 is mutating and thus becoming more of a threat, according to the company. A key study of the new vaccine, involving about 44,000 people, coincided with the emergence of new SARS-CoV-2 variants, which were emerging in some of the countries where the pivotal COV3001 study was being conducted, the company said.
At least 14 days after vaccination, the Johnson & Johnson COVID vaccine efficacy (95% confidence interval) was 72.0% (58.2, 81.7) in the United States, 68.1% (48.8, 80.7) in Brazil, and 64.0% (41.2, 78.7) in South Africa.
Weakened standards?
Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.
They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.
“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.
“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Dr. Doshi said.
Dr. Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.
The FDA’s June 2020 guidance on the development of COVID vaccines had asked drugmakers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Dr. Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”
“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Dr. Doshi said.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Dr. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Dr. Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.
“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Dr. Zuckerman said.
A version of this article first appeared on Medscape.com.
FDA approves first targeted treatment for rare DMD mutation
, the agency has announced.
This particular mutation of the DMD gene “is amenable to exon 45 skipping,” the FDA noted in a press release. The agency added that this is its first approval of a targeted treatment for patients with the mutation.
“Developing drugs designed for patients with specific mutations is a critical part of personalized medicine,” Eric Bastings, MD, deputy director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said in a statement.
The approval was based on results from a 43-person randomized controlled trial. Patients who received casimersen had a greater increase in production of the muscle-fiber protein dystrophin compared with their counterparts who received placebo.
Approved – with cautions
The FDA noted that DMD prevalence worldwide is about 1 in 3,600 boys – although it can also affect girls in rare cases. Symptoms of the disorder are commonly first observed around age 3 years but worsen steadily over time. DMD gene mutations lead to a decrease in dystrophin.
As reported by Medscape Medical News in August, the FDA approved viltolarsen (Viltepso, NS Pharma) for the treatment of DMD in patients with a confirmed mutation amenable to exon 53 skipping, following approval of golodirsen injection (Vyondys 53, Sarepta Therapeutics) for the same indication in December 2019.
The DMD gene mutation that is amenable to exon 45 skipping is present in about 8% of patients with DMD.
The trial that carried weight with the FDA included 43 male participants with DMD aged 7-20 years. All were confirmed to have the exon 45-skipping gene mutation and all were randomly assigned 2:1 to received IV casimersen 30 mg/kg or matching placebo.
Results showed that, between baseline and 48 weeks post treatment, the casimersen group showed a significantly higher increase in levels of dystrophin protein than in the placebo group.
Upper respiratory tract infections, fever, joint and throat pain, headache, and cough were the most common adverse events experienced by the active-treatment group.
Although the clinical studies assessing casimersen did not show any reports of kidney toxicity, the adverse event was observed in some nonclinical studies. Therefore, clinicians should monitor kidney function in any patient receiving this treatment, the FDA recommended.
Overall, “the FDA has concluded that the data submitted by the applicant demonstrated an increase in dystrophin production that is reasonably likely to predict clinical benefit” in this patient population, the agency said in its press release.
However, it noted that definitive clinical benefits such as improved motor function were not “established.”
“In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease, and the lack of [other] available therapy,” the agency said.
It added that the manufacturer is currently conducting a multicenter study focused on the safety and efficacy of the drug in ambulatory patients with DMD.
The FDA approved casimersen using its Accelerated Approval pathway, granted Fast Track and Priority Review designations to its applications, and gave the treatment Orphan Drug designation.
A version of this article first appeared on Medscape.com.
, the agency has announced.
This particular mutation of the DMD gene “is amenable to exon 45 skipping,” the FDA noted in a press release. The agency added that this is its first approval of a targeted treatment for patients with the mutation.
“Developing drugs designed for patients with specific mutations is a critical part of personalized medicine,” Eric Bastings, MD, deputy director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said in a statement.
The approval was based on results from a 43-person randomized controlled trial. Patients who received casimersen had a greater increase in production of the muscle-fiber protein dystrophin compared with their counterparts who received placebo.
Approved – with cautions
The FDA noted that DMD prevalence worldwide is about 1 in 3,600 boys – although it can also affect girls in rare cases. Symptoms of the disorder are commonly first observed around age 3 years but worsen steadily over time. DMD gene mutations lead to a decrease in dystrophin.
As reported by Medscape Medical News in August, the FDA approved viltolarsen (Viltepso, NS Pharma) for the treatment of DMD in patients with a confirmed mutation amenable to exon 53 skipping, following approval of golodirsen injection (Vyondys 53, Sarepta Therapeutics) for the same indication in December 2019.
The DMD gene mutation that is amenable to exon 45 skipping is present in about 8% of patients with DMD.
The trial that carried weight with the FDA included 43 male participants with DMD aged 7-20 years. All were confirmed to have the exon 45-skipping gene mutation and all were randomly assigned 2:1 to received IV casimersen 30 mg/kg or matching placebo.
Results showed that, between baseline and 48 weeks post treatment, the casimersen group showed a significantly higher increase in levels of dystrophin protein than in the placebo group.
Upper respiratory tract infections, fever, joint and throat pain, headache, and cough were the most common adverse events experienced by the active-treatment group.
Although the clinical studies assessing casimersen did not show any reports of kidney toxicity, the adverse event was observed in some nonclinical studies. Therefore, clinicians should monitor kidney function in any patient receiving this treatment, the FDA recommended.
Overall, “the FDA has concluded that the data submitted by the applicant demonstrated an increase in dystrophin production that is reasonably likely to predict clinical benefit” in this patient population, the agency said in its press release.
However, it noted that definitive clinical benefits such as improved motor function were not “established.”
“In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease, and the lack of [other] available therapy,” the agency said.
It added that the manufacturer is currently conducting a multicenter study focused on the safety and efficacy of the drug in ambulatory patients with DMD.
The FDA approved casimersen using its Accelerated Approval pathway, granted Fast Track and Priority Review designations to its applications, and gave the treatment Orphan Drug designation.
A version of this article first appeared on Medscape.com.
, the agency has announced.
This particular mutation of the DMD gene “is amenable to exon 45 skipping,” the FDA noted in a press release. The agency added that this is its first approval of a targeted treatment for patients with the mutation.
“Developing drugs designed for patients with specific mutations is a critical part of personalized medicine,” Eric Bastings, MD, deputy director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said in a statement.
The approval was based on results from a 43-person randomized controlled trial. Patients who received casimersen had a greater increase in production of the muscle-fiber protein dystrophin compared with their counterparts who received placebo.
Approved – with cautions
The FDA noted that DMD prevalence worldwide is about 1 in 3,600 boys – although it can also affect girls in rare cases. Symptoms of the disorder are commonly first observed around age 3 years but worsen steadily over time. DMD gene mutations lead to a decrease in dystrophin.
As reported by Medscape Medical News in August, the FDA approved viltolarsen (Viltepso, NS Pharma) for the treatment of DMD in patients with a confirmed mutation amenable to exon 53 skipping, following approval of golodirsen injection (Vyondys 53, Sarepta Therapeutics) for the same indication in December 2019.
The DMD gene mutation that is amenable to exon 45 skipping is present in about 8% of patients with DMD.
The trial that carried weight with the FDA included 43 male participants with DMD aged 7-20 years. All were confirmed to have the exon 45-skipping gene mutation and all were randomly assigned 2:1 to received IV casimersen 30 mg/kg or matching placebo.
Results showed that, between baseline and 48 weeks post treatment, the casimersen group showed a significantly higher increase in levels of dystrophin protein than in the placebo group.
Upper respiratory tract infections, fever, joint and throat pain, headache, and cough were the most common adverse events experienced by the active-treatment group.
Although the clinical studies assessing casimersen did not show any reports of kidney toxicity, the adverse event was observed in some nonclinical studies. Therefore, clinicians should monitor kidney function in any patient receiving this treatment, the FDA recommended.
Overall, “the FDA has concluded that the data submitted by the applicant demonstrated an increase in dystrophin production that is reasonably likely to predict clinical benefit” in this patient population, the agency said in its press release.
However, it noted that definitive clinical benefits such as improved motor function were not “established.”
“In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease, and the lack of [other] available therapy,” the agency said.
It added that the manufacturer is currently conducting a multicenter study focused on the safety and efficacy of the drug in ambulatory patients with DMD.
The FDA approved casimersen using its Accelerated Approval pathway, granted Fast Track and Priority Review designations to its applications, and gave the treatment Orphan Drug designation.
A version of this article first appeared on Medscape.com.
Data on atopic dermatitis risk factors are accumulating
, according to Zelma Chiesa Fuxench, MD.
This gene codes for profilaggrin, a protein, which is then cleaved to form filaggrin, which helps to organize the cytoskeleton of the skin and is an important structural component of the skin. The understanding is that patients who have filaggrin mutations tend to have earlier onset and more persistent disease, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said during the Revolutionizing Atopic Dermatitis virtual symposium.
“Prior studies have shown that mutations in the FLG gene can confer a risk of developed AD that is two- to sevenfold with variants R501X and the 22804del4 frequently described. It is important to note that most of these findings have been described primarily in populations of European descent, with other variants being found in populations of African nation descent, and seem to be more prevalent in populations with early onset disease.”
Environmental factors
Other AD-related risk factors that have been previously described in the literature include environmental factors such as climate, diet, breastfeeding, obesity, pollution, tobacco smoke, pet ownership, and microbiome or gut microflora. “The list of culprits is ever increasing,” she said. “However, it’s important to recognize that data to support some of these associations are lacking, and oftentimes, a lot of the results are contradictory.”
As part of the International Study of Asthma and Allergies in Childhood, researchers evaluated the association between climate factors with the 12-month period prevalence rates of symptoms of atopic eczema in children. They found that patients who lived at higher latitudes and those who lived in areas where there were lower mean outdoor temperatures tended to have a higher prevalence of eczema symptoms. Worldwide, they found that symptoms of eczema were also prevalent in areas where there was lower indoor humidity.
“The authors concluded that they can’t really demonstrate a cause and effect, and that while latitude and temperature changes appear to affect the prevalence of eczema, they may do so indirectly, perhaps to changes in behavior and differences in sun exposure,” said Dr. Chiesa Fuxench, who was not involved with the study. “For example, we know that vitamin D is a protective risk factor for AD. Low vitamin D has been associated with more severe disease in some studies. We also know that UV exposure leads to the conversion of filaggrin degradation products such as trans-urocanic acid into cis-urocanic acid, which has been demonstrated to have immunosuppressive effects.”
A systematic review and meta-analysis of nine articles found small associations, which were significant, between being born in the winter (odds ratio, 1.15) and fall (OR, 1.16) and the risk of developing AD, compared with being born in the spring and summer. However, an analysis of satellite-derived data on air temperature across the United States from 1993 to 2011 found that as ambient air temperature increases, so did the risk for an ambulatory visit for AD to physicians from the National Ambulatory Medical Care Survey.
In all areas but the south, the largest number of AD visits occur in the spring. In the south, more AD visits occur in the summer. “This raises the point that we don’t really know everything when it comes to the influence of temperature and climate change on AD,” Dr. Chiesa Fuxench said.
Several maternal and neonatal risk factors for AD have been described in the literature, including the effect of prenatal exposure to antibiotics. In one large analysis, investigators assessed the association among 18-month-old children in the Danish National Birth Cohort, which included 62,560 mother-child pairs. They found that prenatal antibiotic use was associated with an increased odds of AD among children born to atopic mothers but only when used during all three trimesters (adjusted OR, 1.45). When they further stratified these analyses by type of birth (vaginal versus C-section), the association persisted in both groups, but was stronger among those delivered by C-section.
Probiotics
The role of probiotics to reduce the risk for AD has also been investigated. “We do know that probiotics could potentially be helpful, and it is often a readily available intervention,” Dr. Chiesa Fuxench said. “But the question still is how and when to supplement.”
In a systematic review and meta-analysis, researchers examined supplementation with probiotics given to breastfeeding mothers, pregnant mothers, or directly given to infants, and the risk of developing AD up to 18 months of age. They found that overall, probiotic exposure resulted in decreased risk of developing AD. In stratified analyses, the strongest association was observed for those who received probiotics during their pregnancy, during breastfeeding, and as an infant, which conferred about a 25% reduced risk.
Antibiotic exposure
What about early-life exposure to antibiotics on one’s risk for developing AD? A meta-analysis of 22 studies found that children who had been exposed to antibiotics during the first 2 years of life had an increased risk of eczema (OR, 1.26), compared with children who had not been exposed during the same period of time. “Interesting hypotheses can be generated from this study,” she said. “Perhaps future steps should focus on the impact of antibiotic exposure, the gut microbiome, and maternal risk factors for AD.”
In a separate study that supported these findings, researchers evaluated the association between the use of acid-suppressive medications and antibiotics during infancy and the development of allergic disease in early childhood. They found that exposure to either of these medications during the first six months of infancy resulted in a mild increased risk of developing AD, and concluded that they should be used during infancy only in situations of clear clinical benefit. “We should be good stewards of antibiotic use, in particular due to concern for antibiotic resistance in the population overall,” Dr. Chiesa Fuxench said.
Prevention strategies
Several AD prevention strategies have also been described in the medical literature, including the use of daily emollients during infancy. In a multicenter trial carried out in the United Kingdom, researchers tested whether daily use of emollient in the first year of life could prevent eczema in high-risk children, which was defined as having at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma. The primary outcome was eczema at age 2 years. The researchers found no evidence to suggest that daily emollient use during the first year of life prevents eczema.
Another study, the PreventADALL trial of 2,397 infants, consisted of four treatment arms: a control group advised to follow national guidelines on infant nutrition; a skin intervention group that was asked to use skin emollients, a food intervention group with early introduction of peanut, cow’s milk, wheat, and egg, and a combined skin and food intervention. The investigators found no difference in the risk reduction of developing AD among patients who were treated with skin emollients or early complementary feeding, and concluded that these types of interventions should not be considered as interventions to prevent AD in this cohort of patients.
However, Dr. Chiesa Fuxench emphasized that emollients and moisturizers are an important part of the treatment regimen for AD patients. A Cochrane systematic review of nearly 80 randomized, controlled trials evaluating the use of emollients in eczema found that most moisturizers showed some beneficial effects in addition to active treatment, including prolonging the time to flare, reducing the number of flares, and reducing the amount of topical corticosteroids used.
For treatment, Dr. Chiesa Fuxench recommends a proactive approach focused on short-term induction therapy with intensive topical anti-inflammatories until the affected area is almost healed, followed by maintenance therapy that involves use of a long-term, low- to mid-potency steroid or a topical calcineurin inhibitor to previously affected areas. “These interventions have been shown to decrease the risk of recurrence and can shorten the treatment duration in the event of a flare,” she said.
She also favors a time-contingent approach to treating patients with AD. “As physicians, we tend to do our visits more as symptom contingent, which means when a patient is flaring. This reinforces the view that this is a difficult disease to treat, and that there is no hope,” she pointed out. But for chronic diseases, she added, “a time-contingent approach with appointments at set intervals leads to a different perception. It can result in better compliance, because skin care might be performed more regularly. It’s analogous to when you know you’re going to see the dentist so you floss more regularly the week before your appointment. There also seems to be less pressure on physicians and patients because you are seeing each other more frequently; you can talk more openly about what’s working and what’s not.”
Dr. Chiesa Fuxench reported having no disclosures relevant to her presentation.
, according to Zelma Chiesa Fuxench, MD.
This gene codes for profilaggrin, a protein, which is then cleaved to form filaggrin, which helps to organize the cytoskeleton of the skin and is an important structural component of the skin. The understanding is that patients who have filaggrin mutations tend to have earlier onset and more persistent disease, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said during the Revolutionizing Atopic Dermatitis virtual symposium.
“Prior studies have shown that mutations in the FLG gene can confer a risk of developed AD that is two- to sevenfold with variants R501X and the 22804del4 frequently described. It is important to note that most of these findings have been described primarily in populations of European descent, with other variants being found in populations of African nation descent, and seem to be more prevalent in populations with early onset disease.”
Environmental factors
Other AD-related risk factors that have been previously described in the literature include environmental factors such as climate, diet, breastfeeding, obesity, pollution, tobacco smoke, pet ownership, and microbiome or gut microflora. “The list of culprits is ever increasing,” she said. “However, it’s important to recognize that data to support some of these associations are lacking, and oftentimes, a lot of the results are contradictory.”
As part of the International Study of Asthma and Allergies in Childhood, researchers evaluated the association between climate factors with the 12-month period prevalence rates of symptoms of atopic eczema in children. They found that patients who lived at higher latitudes and those who lived in areas where there were lower mean outdoor temperatures tended to have a higher prevalence of eczema symptoms. Worldwide, they found that symptoms of eczema were also prevalent in areas where there was lower indoor humidity.
“The authors concluded that they can’t really demonstrate a cause and effect, and that while latitude and temperature changes appear to affect the prevalence of eczema, they may do so indirectly, perhaps to changes in behavior and differences in sun exposure,” said Dr. Chiesa Fuxench, who was not involved with the study. “For example, we know that vitamin D is a protective risk factor for AD. Low vitamin D has been associated with more severe disease in some studies. We also know that UV exposure leads to the conversion of filaggrin degradation products such as trans-urocanic acid into cis-urocanic acid, which has been demonstrated to have immunosuppressive effects.”
A systematic review and meta-analysis of nine articles found small associations, which were significant, between being born in the winter (odds ratio, 1.15) and fall (OR, 1.16) and the risk of developing AD, compared with being born in the spring and summer. However, an analysis of satellite-derived data on air temperature across the United States from 1993 to 2011 found that as ambient air temperature increases, so did the risk for an ambulatory visit for AD to physicians from the National Ambulatory Medical Care Survey.
In all areas but the south, the largest number of AD visits occur in the spring. In the south, more AD visits occur in the summer. “This raises the point that we don’t really know everything when it comes to the influence of temperature and climate change on AD,” Dr. Chiesa Fuxench said.
Several maternal and neonatal risk factors for AD have been described in the literature, including the effect of prenatal exposure to antibiotics. In one large analysis, investigators assessed the association among 18-month-old children in the Danish National Birth Cohort, which included 62,560 mother-child pairs. They found that prenatal antibiotic use was associated with an increased odds of AD among children born to atopic mothers but only when used during all three trimesters (adjusted OR, 1.45). When they further stratified these analyses by type of birth (vaginal versus C-section), the association persisted in both groups, but was stronger among those delivered by C-section.
Probiotics
The role of probiotics to reduce the risk for AD has also been investigated. “We do know that probiotics could potentially be helpful, and it is often a readily available intervention,” Dr. Chiesa Fuxench said. “But the question still is how and when to supplement.”
In a systematic review and meta-analysis, researchers examined supplementation with probiotics given to breastfeeding mothers, pregnant mothers, or directly given to infants, and the risk of developing AD up to 18 months of age. They found that overall, probiotic exposure resulted in decreased risk of developing AD. In stratified analyses, the strongest association was observed for those who received probiotics during their pregnancy, during breastfeeding, and as an infant, which conferred about a 25% reduced risk.
Antibiotic exposure
What about early-life exposure to antibiotics on one’s risk for developing AD? A meta-analysis of 22 studies found that children who had been exposed to antibiotics during the first 2 years of life had an increased risk of eczema (OR, 1.26), compared with children who had not been exposed during the same period of time. “Interesting hypotheses can be generated from this study,” she said. “Perhaps future steps should focus on the impact of antibiotic exposure, the gut microbiome, and maternal risk factors for AD.”
In a separate study that supported these findings, researchers evaluated the association between the use of acid-suppressive medications and antibiotics during infancy and the development of allergic disease in early childhood. They found that exposure to either of these medications during the first six months of infancy resulted in a mild increased risk of developing AD, and concluded that they should be used during infancy only in situations of clear clinical benefit. “We should be good stewards of antibiotic use, in particular due to concern for antibiotic resistance in the population overall,” Dr. Chiesa Fuxench said.
Prevention strategies
Several AD prevention strategies have also been described in the medical literature, including the use of daily emollients during infancy. In a multicenter trial carried out in the United Kingdom, researchers tested whether daily use of emollient in the first year of life could prevent eczema in high-risk children, which was defined as having at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma. The primary outcome was eczema at age 2 years. The researchers found no evidence to suggest that daily emollient use during the first year of life prevents eczema.
Another study, the PreventADALL trial of 2,397 infants, consisted of four treatment arms: a control group advised to follow national guidelines on infant nutrition; a skin intervention group that was asked to use skin emollients, a food intervention group with early introduction of peanut, cow’s milk, wheat, and egg, and a combined skin and food intervention. The investigators found no difference in the risk reduction of developing AD among patients who were treated with skin emollients or early complementary feeding, and concluded that these types of interventions should not be considered as interventions to prevent AD in this cohort of patients.
However, Dr. Chiesa Fuxench emphasized that emollients and moisturizers are an important part of the treatment regimen for AD patients. A Cochrane systematic review of nearly 80 randomized, controlled trials evaluating the use of emollients in eczema found that most moisturizers showed some beneficial effects in addition to active treatment, including prolonging the time to flare, reducing the number of flares, and reducing the amount of topical corticosteroids used.
For treatment, Dr. Chiesa Fuxench recommends a proactive approach focused on short-term induction therapy with intensive topical anti-inflammatories until the affected area is almost healed, followed by maintenance therapy that involves use of a long-term, low- to mid-potency steroid or a topical calcineurin inhibitor to previously affected areas. “These interventions have been shown to decrease the risk of recurrence and can shorten the treatment duration in the event of a flare,” she said.
She also favors a time-contingent approach to treating patients with AD. “As physicians, we tend to do our visits more as symptom contingent, which means when a patient is flaring. This reinforces the view that this is a difficult disease to treat, and that there is no hope,” she pointed out. But for chronic diseases, she added, “a time-contingent approach with appointments at set intervals leads to a different perception. It can result in better compliance, because skin care might be performed more regularly. It’s analogous to when you know you’re going to see the dentist so you floss more regularly the week before your appointment. There also seems to be less pressure on physicians and patients because you are seeing each other more frequently; you can talk more openly about what’s working and what’s not.”
Dr. Chiesa Fuxench reported having no disclosures relevant to her presentation.
, according to Zelma Chiesa Fuxench, MD.
This gene codes for profilaggrin, a protein, which is then cleaved to form filaggrin, which helps to organize the cytoskeleton of the skin and is an important structural component of the skin. The understanding is that patients who have filaggrin mutations tend to have earlier onset and more persistent disease, Dr. Chiesa Fuxench, of the department of dermatology at the University of Pennsylvania, Philadelphia, said during the Revolutionizing Atopic Dermatitis virtual symposium.
“Prior studies have shown that mutations in the FLG gene can confer a risk of developed AD that is two- to sevenfold with variants R501X and the 22804del4 frequently described. It is important to note that most of these findings have been described primarily in populations of European descent, with other variants being found in populations of African nation descent, and seem to be more prevalent in populations with early onset disease.”
Environmental factors
Other AD-related risk factors that have been previously described in the literature include environmental factors such as climate, diet, breastfeeding, obesity, pollution, tobacco smoke, pet ownership, and microbiome or gut microflora. “The list of culprits is ever increasing,” she said. “However, it’s important to recognize that data to support some of these associations are lacking, and oftentimes, a lot of the results are contradictory.”
As part of the International Study of Asthma and Allergies in Childhood, researchers evaluated the association between climate factors with the 12-month period prevalence rates of symptoms of atopic eczema in children. They found that patients who lived at higher latitudes and those who lived in areas where there were lower mean outdoor temperatures tended to have a higher prevalence of eczema symptoms. Worldwide, they found that symptoms of eczema were also prevalent in areas where there was lower indoor humidity.
“The authors concluded that they can’t really demonstrate a cause and effect, and that while latitude and temperature changes appear to affect the prevalence of eczema, they may do so indirectly, perhaps to changes in behavior and differences in sun exposure,” said Dr. Chiesa Fuxench, who was not involved with the study. “For example, we know that vitamin D is a protective risk factor for AD. Low vitamin D has been associated with more severe disease in some studies. We also know that UV exposure leads to the conversion of filaggrin degradation products such as trans-urocanic acid into cis-urocanic acid, which has been demonstrated to have immunosuppressive effects.”
A systematic review and meta-analysis of nine articles found small associations, which were significant, between being born in the winter (odds ratio, 1.15) and fall (OR, 1.16) and the risk of developing AD, compared with being born in the spring and summer. However, an analysis of satellite-derived data on air temperature across the United States from 1993 to 2011 found that as ambient air temperature increases, so did the risk for an ambulatory visit for AD to physicians from the National Ambulatory Medical Care Survey.
In all areas but the south, the largest number of AD visits occur in the spring. In the south, more AD visits occur in the summer. “This raises the point that we don’t really know everything when it comes to the influence of temperature and climate change on AD,” Dr. Chiesa Fuxench said.
Several maternal and neonatal risk factors for AD have been described in the literature, including the effect of prenatal exposure to antibiotics. In one large analysis, investigators assessed the association among 18-month-old children in the Danish National Birth Cohort, which included 62,560 mother-child pairs. They found that prenatal antibiotic use was associated with an increased odds of AD among children born to atopic mothers but only when used during all three trimesters (adjusted OR, 1.45). When they further stratified these analyses by type of birth (vaginal versus C-section), the association persisted in both groups, but was stronger among those delivered by C-section.
Probiotics
The role of probiotics to reduce the risk for AD has also been investigated. “We do know that probiotics could potentially be helpful, and it is often a readily available intervention,” Dr. Chiesa Fuxench said. “But the question still is how and when to supplement.”
In a systematic review and meta-analysis, researchers examined supplementation with probiotics given to breastfeeding mothers, pregnant mothers, or directly given to infants, and the risk of developing AD up to 18 months of age. They found that overall, probiotic exposure resulted in decreased risk of developing AD. In stratified analyses, the strongest association was observed for those who received probiotics during their pregnancy, during breastfeeding, and as an infant, which conferred about a 25% reduced risk.
Antibiotic exposure
What about early-life exposure to antibiotics on one’s risk for developing AD? A meta-analysis of 22 studies found that children who had been exposed to antibiotics during the first 2 years of life had an increased risk of eczema (OR, 1.26), compared with children who had not been exposed during the same period of time. “Interesting hypotheses can be generated from this study,” she said. “Perhaps future steps should focus on the impact of antibiotic exposure, the gut microbiome, and maternal risk factors for AD.”
In a separate study that supported these findings, researchers evaluated the association between the use of acid-suppressive medications and antibiotics during infancy and the development of allergic disease in early childhood. They found that exposure to either of these medications during the first six months of infancy resulted in a mild increased risk of developing AD, and concluded that they should be used during infancy only in situations of clear clinical benefit. “We should be good stewards of antibiotic use, in particular due to concern for antibiotic resistance in the population overall,” Dr. Chiesa Fuxench said.
Prevention strategies
Several AD prevention strategies have also been described in the medical literature, including the use of daily emollients during infancy. In a multicenter trial carried out in the United Kingdom, researchers tested whether daily use of emollient in the first year of life could prevent eczema in high-risk children, which was defined as having at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma. The primary outcome was eczema at age 2 years. The researchers found no evidence to suggest that daily emollient use during the first year of life prevents eczema.
Another study, the PreventADALL trial of 2,397 infants, consisted of four treatment arms: a control group advised to follow national guidelines on infant nutrition; a skin intervention group that was asked to use skin emollients, a food intervention group with early introduction of peanut, cow’s milk, wheat, and egg, and a combined skin and food intervention. The investigators found no difference in the risk reduction of developing AD among patients who were treated with skin emollients or early complementary feeding, and concluded that these types of interventions should not be considered as interventions to prevent AD in this cohort of patients.
However, Dr. Chiesa Fuxench emphasized that emollients and moisturizers are an important part of the treatment regimen for AD patients. A Cochrane systematic review of nearly 80 randomized, controlled trials evaluating the use of emollients in eczema found that most moisturizers showed some beneficial effects in addition to active treatment, including prolonging the time to flare, reducing the number of flares, and reducing the amount of topical corticosteroids used.
For treatment, Dr. Chiesa Fuxench recommends a proactive approach focused on short-term induction therapy with intensive topical anti-inflammatories until the affected area is almost healed, followed by maintenance therapy that involves use of a long-term, low- to mid-potency steroid or a topical calcineurin inhibitor to previously affected areas. “These interventions have been shown to decrease the risk of recurrence and can shorten the treatment duration in the event of a flare,” she said.
She also favors a time-contingent approach to treating patients with AD. “As physicians, we tend to do our visits more as symptom contingent, which means when a patient is flaring. This reinforces the view that this is a difficult disease to treat, and that there is no hope,” she pointed out. But for chronic diseases, she added, “a time-contingent approach with appointments at set intervals leads to a different perception. It can result in better compliance, because skin care might be performed more regularly. It’s analogous to when you know you’re going to see the dentist so you floss more regularly the week before your appointment. There also seems to be less pressure on physicians and patients because you are seeing each other more frequently; you can talk more openly about what’s working and what’s not.”
Dr. Chiesa Fuxench reported having no disclosures relevant to her presentation.
FROM REVOLUTIONIZING AD 2020
Variant found in NYC, Northeast
, according to CNN.
The variant, called B.1.526, has appeared in diverse neighborhoods in New York City and is “scattered in the Northeast,” the researchers said.
“We observed a steady increase in the detection rate from late December to mid-February, with an alarming rise to 12.7% in the past two weeks,” researchers from Columbia University Medical Center wrote in a report, which was published as a preprint Feb. 25.
On Feb. 22, the team released another preprint about the B.1.1.7 and B.1.351 variants first identified in the United Kingdom and South Africa, respectively, which also mentions the B.1.526 variant in the U.S. Neither report has been peer reviewed.
Viruses mutate often, and several coronavirus variants have been identified and followed during the pandemic. Not all mutations are significant or are necessarily more contagious or dangerous. Researchers have been tracking the B.1.526 variant in the U.S. to find out if there are significant mutations that could be a cause for concern.
In the most recent preprints, the variant appears to have the same mutation found in B.1.351, called E484K, which may allow the virus to evade vaccines and the body’s natural immune response. The E484K mutation has shown up in at least 59 lines of the coronavirus, the research team said. That means the virus is evolving independently across the country and world, which could give the virus an advantage.
“A concern is that it might be beginning to overtake other strains, just like the U.K. and South African variants,” David Ho, MD, the lead study author and director of the Aaron Diamond AIDS Research Center at Columbia, told CNN.
“However, we don’t have enough data to firm up this point now,” he said.
In a separate preprint posted Feb. 23, a research team at the California Institute of Technology developed a software tool that noticed the rise of B.1.526 in the New York region. The preprint hasn’t yet been peer reviewed.
“It appears that the frequency of lineage B.1.526 has increased rapidly in New York,” they wrote.
Both teams also reported on another variant, called B.1.427/B.1.429, which appears to be increasing in California. The variant could be more contagious and cause more severe disease, they said, but the research is still in the early stages.
Researchers at the University of California, San Francisco, have tested virus samples from recent outbreaks in California and also found that the variant is becoming more common. The variant didn’t appear in samples from September but was in half of the samples by late January. It has a different pattern of mutations than other variants, and one called L452R may affect the spike protein on the virus and allow it attach to cells more easily.
“Our data shows that this is likely the key mutation that makes this variant more infectious,” Charles Chiu, MD, associate director of the clinical microbiology lab at UCSF, told CNN.
The team also noticed that patients with a B.1.427/B.1.429 infection had more severe COVID-19 cases and needed more oxygen, CNN reported. The team plans to post a preprint once public health officials in San Francisco review the report.
Right now, the CDC provides public data for three variants: B.1.1.7, B.1.351, and P.1, which was first identified in Brazil. The U.S. has reported 1,881 B.1.1.7 cases across 45 states, 46 B.1.351 cases in 14 states, and five P.1 cases in four states, according to a CDC tally as of Feb. 23.
At the moment, lab officials aren’t able to tell patients or doctors whether someone has been infected by a variant, according to Kaiser Health News. High-level labs conduct genomic sequencing on samples and aren’t able to communicate information back to individual people.
But the Association of Public Health Laboratories and public health officials in several states are pushing for federal authorization of a test that could sequence the full genome and notify doctors. The test could be available in coming weeks, the news outlet reported.
A version of this article first appeared on WebMD.com.
, according to CNN.
The variant, called B.1.526, has appeared in diverse neighborhoods in New York City and is “scattered in the Northeast,” the researchers said.
“We observed a steady increase in the detection rate from late December to mid-February, with an alarming rise to 12.7% in the past two weeks,” researchers from Columbia University Medical Center wrote in a report, which was published as a preprint Feb. 25.
On Feb. 22, the team released another preprint about the B.1.1.7 and B.1.351 variants first identified in the United Kingdom and South Africa, respectively, which also mentions the B.1.526 variant in the U.S. Neither report has been peer reviewed.
Viruses mutate often, and several coronavirus variants have been identified and followed during the pandemic. Not all mutations are significant or are necessarily more contagious or dangerous. Researchers have been tracking the B.1.526 variant in the U.S. to find out if there are significant mutations that could be a cause for concern.
In the most recent preprints, the variant appears to have the same mutation found in B.1.351, called E484K, which may allow the virus to evade vaccines and the body’s natural immune response. The E484K mutation has shown up in at least 59 lines of the coronavirus, the research team said. That means the virus is evolving independently across the country and world, which could give the virus an advantage.
“A concern is that it might be beginning to overtake other strains, just like the U.K. and South African variants,” David Ho, MD, the lead study author and director of the Aaron Diamond AIDS Research Center at Columbia, told CNN.
“However, we don’t have enough data to firm up this point now,” he said.
In a separate preprint posted Feb. 23, a research team at the California Institute of Technology developed a software tool that noticed the rise of B.1.526 in the New York region. The preprint hasn’t yet been peer reviewed.
“It appears that the frequency of lineage B.1.526 has increased rapidly in New York,” they wrote.
Both teams also reported on another variant, called B.1.427/B.1.429, which appears to be increasing in California. The variant could be more contagious and cause more severe disease, they said, but the research is still in the early stages.
Researchers at the University of California, San Francisco, have tested virus samples from recent outbreaks in California and also found that the variant is becoming more common. The variant didn’t appear in samples from September but was in half of the samples by late January. It has a different pattern of mutations than other variants, and one called L452R may affect the spike protein on the virus and allow it attach to cells more easily.
“Our data shows that this is likely the key mutation that makes this variant more infectious,” Charles Chiu, MD, associate director of the clinical microbiology lab at UCSF, told CNN.
The team also noticed that patients with a B.1.427/B.1.429 infection had more severe COVID-19 cases and needed more oxygen, CNN reported. The team plans to post a preprint once public health officials in San Francisco review the report.
Right now, the CDC provides public data for three variants: B.1.1.7, B.1.351, and P.1, which was first identified in Brazil. The U.S. has reported 1,881 B.1.1.7 cases across 45 states, 46 B.1.351 cases in 14 states, and five P.1 cases in four states, according to a CDC tally as of Feb. 23.
At the moment, lab officials aren’t able to tell patients or doctors whether someone has been infected by a variant, according to Kaiser Health News. High-level labs conduct genomic sequencing on samples and aren’t able to communicate information back to individual people.
But the Association of Public Health Laboratories and public health officials in several states are pushing for federal authorization of a test that could sequence the full genome and notify doctors. The test could be available in coming weeks, the news outlet reported.
A version of this article first appeared on WebMD.com.
, according to CNN.
The variant, called B.1.526, has appeared in diverse neighborhoods in New York City and is “scattered in the Northeast,” the researchers said.
“We observed a steady increase in the detection rate from late December to mid-February, with an alarming rise to 12.7% in the past two weeks,” researchers from Columbia University Medical Center wrote in a report, which was published as a preprint Feb. 25.
On Feb. 22, the team released another preprint about the B.1.1.7 and B.1.351 variants first identified in the United Kingdom and South Africa, respectively, which also mentions the B.1.526 variant in the U.S. Neither report has been peer reviewed.
Viruses mutate often, and several coronavirus variants have been identified and followed during the pandemic. Not all mutations are significant or are necessarily more contagious or dangerous. Researchers have been tracking the B.1.526 variant in the U.S. to find out if there are significant mutations that could be a cause for concern.
In the most recent preprints, the variant appears to have the same mutation found in B.1.351, called E484K, which may allow the virus to evade vaccines and the body’s natural immune response. The E484K mutation has shown up in at least 59 lines of the coronavirus, the research team said. That means the virus is evolving independently across the country and world, which could give the virus an advantage.
“A concern is that it might be beginning to overtake other strains, just like the U.K. and South African variants,” David Ho, MD, the lead study author and director of the Aaron Diamond AIDS Research Center at Columbia, told CNN.
“However, we don’t have enough data to firm up this point now,” he said.
In a separate preprint posted Feb. 23, a research team at the California Institute of Technology developed a software tool that noticed the rise of B.1.526 in the New York region. The preprint hasn’t yet been peer reviewed.
“It appears that the frequency of lineage B.1.526 has increased rapidly in New York,” they wrote.
Both teams also reported on another variant, called B.1.427/B.1.429, which appears to be increasing in California. The variant could be more contagious and cause more severe disease, they said, but the research is still in the early stages.
Researchers at the University of California, San Francisco, have tested virus samples from recent outbreaks in California and also found that the variant is becoming more common. The variant didn’t appear in samples from September but was in half of the samples by late January. It has a different pattern of mutations than other variants, and one called L452R may affect the spike protein on the virus and allow it attach to cells more easily.
“Our data shows that this is likely the key mutation that makes this variant more infectious,” Charles Chiu, MD, associate director of the clinical microbiology lab at UCSF, told CNN.
The team also noticed that patients with a B.1.427/B.1.429 infection had more severe COVID-19 cases and needed more oxygen, CNN reported. The team plans to post a preprint once public health officials in San Francisco review the report.
Right now, the CDC provides public data for three variants: B.1.1.7, B.1.351, and P.1, which was first identified in Brazil. The U.S. has reported 1,881 B.1.1.7 cases across 45 states, 46 B.1.351 cases in 14 states, and five P.1 cases in four states, according to a CDC tally as of Feb. 23.
At the moment, lab officials aren’t able to tell patients or doctors whether someone has been infected by a variant, according to Kaiser Health News. High-level labs conduct genomic sequencing on samples and aren’t able to communicate information back to individual people.
But the Association of Public Health Laboratories and public health officials in several states are pushing for federal authorization of a test that could sequence the full genome and notify doctors. The test could be available in coming weeks, the news outlet reported.
A version of this article first appeared on WebMD.com.
Pediatric COVID-19: Data to guide practice
With the daily stream of new information, it is difficult to keep up with data on how the coronavirus epidemic affects children and school attendance, as well as how pediatricians can advise parents. The following is a summary of recently published information about birth and infant outcomes, and symptoms seen in infants and children, along with a review of recent information on transmission in schools.
COVID-19 in newborns
In November 2020, the Centers for Disease Control and Prevention published data from 16 jurisdictions detailing pregnancy and infant outcomes of more than 5,000 women with SARS-CoV-2 infection. The data were collected from March to October 2020. More than 80% of the women found to be positive for SARS-CoV-2 were identified during their third trimester. The surveillance found that 12.9% of infants born to infected mothers were born preterm, compared with an expected rate in the population of approximately 10%, suggesting that third-trimester infection may be associated with an increase in premature birth. Among 610 infants born to infected mothers and tested for SARS-CoV-2 during their nursery stay, 2.6% were positive. The infant positivity rate was as high as 4.3% among infants who were born to women with a documented SARS-CoV-2 infection within 2 weeks of the delivery date. No newborn infections were found among the infants whose mothers’ infection occurred more than 14 days before delivery. Current CDC and American Academy of Pediatrics recommendations are to test infants born to mothers with suspected or confirmed SARS-CoV-2 infection.
Data on clinical characteristics of a series of hospitalized infants in Montreal was published in December 2020. The study identified infants 0-12 months old who were diagnosed or treated at a single Montreal hospital from February until May 2020. In all, 25 (2.0%) of 1,165 infants were confirmed to have SARS-CoV-2, and approximately 8 of those were hospitalized; 85% had gastrointestinal symptoms and 81% had a fever. Upper respiratory tract symptoms were present in 59%, and none of the hospitalized infants required supplemental oxygen. The data overall support the idea that infants are generally only mildly symptomatic when infected, and respiratory symptoms do not appear to be the most prevalent finding.
COVID-19 in children
The lack of prominent respiratory symptoms among children with SARS-CoV-2 infection symptoms was echoed in another study that evaluated more than 2,400 children in Alberta, Canada. Among the 1,987 children who tested positive for SARS-CoV-2, one-third (35.9%) were asymptomatic. Some symptoms were not helpful in differentiating children who tested positive vs. those who tested negative. The frequency of muscle or joint pain, myalgia, malaise, and respiratory symptoms such as nasal congestion, difficulty breathing, and sore throat was indistinguishable between the SARS-CoV-2–infected and –noninfected children. However, anosmia was much more prevalent (7.7%) among those who tested positive for SARS-CoV-2, compared with 1.1% of those who were negative. Headache was present in 15.7% of those who were positive vs. 6.3% of those who were negative. Fever was slightly more prevalent, at 25.5% among the positive patients and 15% of the negative patients.
The authors calculated likelihood ratios for individual symptoms and found that almost all individual symptoms had likelihood ratios of 1:1.8 for testing positive. However, nausea and vomiting had a likelihood ratio of 5.5, and for anosmia it was 7.3. The combination of symptoms of nausea, nausea and vomiting, and headache produced a likelihood ratio of nearly 66. The authors suggest that these data on ambulatory children indicate that, in general, respiratory symptoms are not helpful for distinguishing patients who are likely to be positive, although the symptoms of nausea, headache, and both along with fever can be highly predictive. The authors propose that it may be more helpful for schools to focus on identifying children with combinations of these high-yield symptoms for potential testing and exclusion from school rather than on random or isolated respiratory symptoms.
COVID-19 in schools
Transmission risk in different settings is certainly something parents quiz pediatricians about, so data released in January and February 2021 may help provide some context. A CDC report on the experience of 17 schools in Wisconsin from August to November 2020 is illuminating. In that study, the SARS-CoV-2 case rate in students, school teachers, and staff members was 63% of the rate in the general public at the time, suggesting that the mitigation strategies used by the schools were effective. In addition, among the students who contracted SARS-CoV-2, only 5% of cases were attributable to school exposure. No cases of SARS-CoV-2 among faculty or staff were linked to school exposure.
Indeed, data released on Feb. 2, 2021, demonstrate that younger adults are the largest source of sustaining the epidemic. On the basis of data from August to October 2020, the opening of schools does not appear to be associated with population-level changes in SARS-CoV-2–attributable deaths. For October 2020, the authors estimate that 2.7% of infections were from children 0-9 years old, 7.1% from those ages 10-19 years, but 34% from those 20-34 years old and 38% from those 35-49 years old, by far the largest two groups contributing to spread. It should be noted that ages 20-49 years are the peak working years for adults, but the source of the data did not allow the authors to conclude whether infections were work related or social activity related. Their data do suggest that prioritizing vaccination of younger working-age adults may put more of a dent in the pandemic spread than vaccinating older individuals.
In a similar vein, a systematic review and meta-analysis of recent studies looked at household transmission of SARS-CoV-2 and demonstrated an attack rate within households of 16.6%. Of note, secondary household attack rates were only 0.7% from asymptomatic cases and 18% from symptomatic cases, with spouses and adult household contacts having higher secondary attack rates than children in the household.
COVID-19 in student athletes
A recent MMWR report described a SARS-CoV-2 outbreak associated with a series of wrestling tournaments in Florida, held in December and January 2021. While everyone would like children to be able to participate in sports, such events potentially violate several of the precepts for preventing spread: Avoid close contact and don’t mix contacts from different schools. Moreover, the events occurred during some of the highest incident case rates in the counties where the tournaments took place.
On Dec. 4, 2020, the AAP released updated guidance for athletic activities and recommended cloth face coverings for student athletes during training, in competition, while traveling, and even while waiting on the sidelines and not actively playing. Notable exceptions to the recommendation were competitive cheerleading, gymnastics, wrestling, and water sports, where the risk for entanglement from face coverings was too high or was not practical.
Taken as a whole, the evolving data continue to show that school mitigation practices can be effective in reducing the risk for SARS-CoV-2 infection. In addition, SARS-CoV-2 rates among schoolchildren more closely mirror community rates and are probably more influenced by what happens outside the schools than inside the schools.
A version of this article first appeared on Medscape.com.
With the daily stream of new information, it is difficult to keep up with data on how the coronavirus epidemic affects children and school attendance, as well as how pediatricians can advise parents. The following is a summary of recently published information about birth and infant outcomes, and symptoms seen in infants and children, along with a review of recent information on transmission in schools.
COVID-19 in newborns
In November 2020, the Centers for Disease Control and Prevention published data from 16 jurisdictions detailing pregnancy and infant outcomes of more than 5,000 women with SARS-CoV-2 infection. The data were collected from March to October 2020. More than 80% of the women found to be positive for SARS-CoV-2 were identified during their third trimester. The surveillance found that 12.9% of infants born to infected mothers were born preterm, compared with an expected rate in the population of approximately 10%, suggesting that third-trimester infection may be associated with an increase in premature birth. Among 610 infants born to infected mothers and tested for SARS-CoV-2 during their nursery stay, 2.6% were positive. The infant positivity rate was as high as 4.3% among infants who were born to women with a documented SARS-CoV-2 infection within 2 weeks of the delivery date. No newborn infections were found among the infants whose mothers’ infection occurred more than 14 days before delivery. Current CDC and American Academy of Pediatrics recommendations are to test infants born to mothers with suspected or confirmed SARS-CoV-2 infection.
Data on clinical characteristics of a series of hospitalized infants in Montreal was published in December 2020. The study identified infants 0-12 months old who were diagnosed or treated at a single Montreal hospital from February until May 2020. In all, 25 (2.0%) of 1,165 infants were confirmed to have SARS-CoV-2, and approximately 8 of those were hospitalized; 85% had gastrointestinal symptoms and 81% had a fever. Upper respiratory tract symptoms were present in 59%, and none of the hospitalized infants required supplemental oxygen. The data overall support the idea that infants are generally only mildly symptomatic when infected, and respiratory symptoms do not appear to be the most prevalent finding.
COVID-19 in children
The lack of prominent respiratory symptoms among children with SARS-CoV-2 infection symptoms was echoed in another study that evaluated more than 2,400 children in Alberta, Canada. Among the 1,987 children who tested positive for SARS-CoV-2, one-third (35.9%) were asymptomatic. Some symptoms were not helpful in differentiating children who tested positive vs. those who tested negative. The frequency of muscle or joint pain, myalgia, malaise, and respiratory symptoms such as nasal congestion, difficulty breathing, and sore throat was indistinguishable between the SARS-CoV-2–infected and –noninfected children. However, anosmia was much more prevalent (7.7%) among those who tested positive for SARS-CoV-2, compared with 1.1% of those who were negative. Headache was present in 15.7% of those who were positive vs. 6.3% of those who were negative. Fever was slightly more prevalent, at 25.5% among the positive patients and 15% of the negative patients.
The authors calculated likelihood ratios for individual symptoms and found that almost all individual symptoms had likelihood ratios of 1:1.8 for testing positive. However, nausea and vomiting had a likelihood ratio of 5.5, and for anosmia it was 7.3. The combination of symptoms of nausea, nausea and vomiting, and headache produced a likelihood ratio of nearly 66. The authors suggest that these data on ambulatory children indicate that, in general, respiratory symptoms are not helpful for distinguishing patients who are likely to be positive, although the symptoms of nausea, headache, and both along with fever can be highly predictive. The authors propose that it may be more helpful for schools to focus on identifying children with combinations of these high-yield symptoms for potential testing and exclusion from school rather than on random or isolated respiratory symptoms.
COVID-19 in schools
Transmission risk in different settings is certainly something parents quiz pediatricians about, so data released in January and February 2021 may help provide some context. A CDC report on the experience of 17 schools in Wisconsin from August to November 2020 is illuminating. In that study, the SARS-CoV-2 case rate in students, school teachers, and staff members was 63% of the rate in the general public at the time, suggesting that the mitigation strategies used by the schools were effective. In addition, among the students who contracted SARS-CoV-2, only 5% of cases were attributable to school exposure. No cases of SARS-CoV-2 among faculty or staff were linked to school exposure.
Indeed, data released on Feb. 2, 2021, demonstrate that younger adults are the largest source of sustaining the epidemic. On the basis of data from August to October 2020, the opening of schools does not appear to be associated with population-level changes in SARS-CoV-2–attributable deaths. For October 2020, the authors estimate that 2.7% of infections were from children 0-9 years old, 7.1% from those ages 10-19 years, but 34% from those 20-34 years old and 38% from those 35-49 years old, by far the largest two groups contributing to spread. It should be noted that ages 20-49 years are the peak working years for adults, but the source of the data did not allow the authors to conclude whether infections were work related or social activity related. Their data do suggest that prioritizing vaccination of younger working-age adults may put more of a dent in the pandemic spread than vaccinating older individuals.
In a similar vein, a systematic review and meta-analysis of recent studies looked at household transmission of SARS-CoV-2 and demonstrated an attack rate within households of 16.6%. Of note, secondary household attack rates were only 0.7% from asymptomatic cases and 18% from symptomatic cases, with spouses and adult household contacts having higher secondary attack rates than children in the household.
COVID-19 in student athletes
A recent MMWR report described a SARS-CoV-2 outbreak associated with a series of wrestling tournaments in Florida, held in December and January 2021. While everyone would like children to be able to participate in sports, such events potentially violate several of the precepts for preventing spread: Avoid close contact and don’t mix contacts from different schools. Moreover, the events occurred during some of the highest incident case rates in the counties where the tournaments took place.
On Dec. 4, 2020, the AAP released updated guidance for athletic activities and recommended cloth face coverings for student athletes during training, in competition, while traveling, and even while waiting on the sidelines and not actively playing. Notable exceptions to the recommendation were competitive cheerleading, gymnastics, wrestling, and water sports, where the risk for entanglement from face coverings was too high or was not practical.
Taken as a whole, the evolving data continue to show that school mitigation practices can be effective in reducing the risk for SARS-CoV-2 infection. In addition, SARS-CoV-2 rates among schoolchildren more closely mirror community rates and are probably more influenced by what happens outside the schools than inside the schools.
A version of this article first appeared on Medscape.com.
With the daily stream of new information, it is difficult to keep up with data on how the coronavirus epidemic affects children and school attendance, as well as how pediatricians can advise parents. The following is a summary of recently published information about birth and infant outcomes, and symptoms seen in infants and children, along with a review of recent information on transmission in schools.
COVID-19 in newborns
In November 2020, the Centers for Disease Control and Prevention published data from 16 jurisdictions detailing pregnancy and infant outcomes of more than 5,000 women with SARS-CoV-2 infection. The data were collected from March to October 2020. More than 80% of the women found to be positive for SARS-CoV-2 were identified during their third trimester. The surveillance found that 12.9% of infants born to infected mothers were born preterm, compared with an expected rate in the population of approximately 10%, suggesting that third-trimester infection may be associated with an increase in premature birth. Among 610 infants born to infected mothers and tested for SARS-CoV-2 during their nursery stay, 2.6% were positive. The infant positivity rate was as high as 4.3% among infants who were born to women with a documented SARS-CoV-2 infection within 2 weeks of the delivery date. No newborn infections were found among the infants whose mothers’ infection occurred more than 14 days before delivery. Current CDC and American Academy of Pediatrics recommendations are to test infants born to mothers with suspected or confirmed SARS-CoV-2 infection.
Data on clinical characteristics of a series of hospitalized infants in Montreal was published in December 2020. The study identified infants 0-12 months old who were diagnosed or treated at a single Montreal hospital from February until May 2020. In all, 25 (2.0%) of 1,165 infants were confirmed to have SARS-CoV-2, and approximately 8 of those were hospitalized; 85% had gastrointestinal symptoms and 81% had a fever. Upper respiratory tract symptoms were present in 59%, and none of the hospitalized infants required supplemental oxygen. The data overall support the idea that infants are generally only mildly symptomatic when infected, and respiratory symptoms do not appear to be the most prevalent finding.
COVID-19 in children
The lack of prominent respiratory symptoms among children with SARS-CoV-2 infection symptoms was echoed in another study that evaluated more than 2,400 children in Alberta, Canada. Among the 1,987 children who tested positive for SARS-CoV-2, one-third (35.9%) were asymptomatic. Some symptoms were not helpful in differentiating children who tested positive vs. those who tested negative. The frequency of muscle or joint pain, myalgia, malaise, and respiratory symptoms such as nasal congestion, difficulty breathing, and sore throat was indistinguishable between the SARS-CoV-2–infected and –noninfected children. However, anosmia was much more prevalent (7.7%) among those who tested positive for SARS-CoV-2, compared with 1.1% of those who were negative. Headache was present in 15.7% of those who were positive vs. 6.3% of those who were negative. Fever was slightly more prevalent, at 25.5% among the positive patients and 15% of the negative patients.
The authors calculated likelihood ratios for individual symptoms and found that almost all individual symptoms had likelihood ratios of 1:1.8 for testing positive. However, nausea and vomiting had a likelihood ratio of 5.5, and for anosmia it was 7.3. The combination of symptoms of nausea, nausea and vomiting, and headache produced a likelihood ratio of nearly 66. The authors suggest that these data on ambulatory children indicate that, in general, respiratory symptoms are not helpful for distinguishing patients who are likely to be positive, although the symptoms of nausea, headache, and both along with fever can be highly predictive. The authors propose that it may be more helpful for schools to focus on identifying children with combinations of these high-yield symptoms for potential testing and exclusion from school rather than on random or isolated respiratory symptoms.
COVID-19 in schools
Transmission risk in different settings is certainly something parents quiz pediatricians about, so data released in January and February 2021 may help provide some context. A CDC report on the experience of 17 schools in Wisconsin from August to November 2020 is illuminating. In that study, the SARS-CoV-2 case rate in students, school teachers, and staff members was 63% of the rate in the general public at the time, suggesting that the mitigation strategies used by the schools were effective. In addition, among the students who contracted SARS-CoV-2, only 5% of cases were attributable to school exposure. No cases of SARS-CoV-2 among faculty or staff were linked to school exposure.
Indeed, data released on Feb. 2, 2021, demonstrate that younger adults are the largest source of sustaining the epidemic. On the basis of data from August to October 2020, the opening of schools does not appear to be associated with population-level changes in SARS-CoV-2–attributable deaths. For October 2020, the authors estimate that 2.7% of infections were from children 0-9 years old, 7.1% from those ages 10-19 years, but 34% from those 20-34 years old and 38% from those 35-49 years old, by far the largest two groups contributing to spread. It should be noted that ages 20-49 years are the peak working years for adults, but the source of the data did not allow the authors to conclude whether infections were work related or social activity related. Their data do suggest that prioritizing vaccination of younger working-age adults may put more of a dent in the pandemic spread than vaccinating older individuals.
In a similar vein, a systematic review and meta-analysis of recent studies looked at household transmission of SARS-CoV-2 and demonstrated an attack rate within households of 16.6%. Of note, secondary household attack rates were only 0.7% from asymptomatic cases and 18% from symptomatic cases, with spouses and adult household contacts having higher secondary attack rates than children in the household.
COVID-19 in student athletes
A recent MMWR report described a SARS-CoV-2 outbreak associated with a series of wrestling tournaments in Florida, held in December and January 2021. While everyone would like children to be able to participate in sports, such events potentially violate several of the precepts for preventing spread: Avoid close contact and don’t mix contacts from different schools. Moreover, the events occurred during some of the highest incident case rates in the counties where the tournaments took place.
On Dec. 4, 2020, the AAP released updated guidance for athletic activities and recommended cloth face coverings for student athletes during training, in competition, while traveling, and even while waiting on the sidelines and not actively playing. Notable exceptions to the recommendation were competitive cheerleading, gymnastics, wrestling, and water sports, where the risk for entanglement from face coverings was too high or was not practical.
Taken as a whole, the evolving data continue to show that school mitigation practices can be effective in reducing the risk for SARS-CoV-2 infection. In addition, SARS-CoV-2 rates among schoolchildren more closely mirror community rates and are probably more influenced by what happens outside the schools than inside the schools.
A version of this article first appeared on Medscape.com.
Janssen/J&J COVID-19 vaccine cuts transmission, new data show
The single-dose vaccine reduces the risk of asymptomatic transmission by 74% at 71 days, compared with placebo, according to documents released today by the U.S. Food and Drug Administration.
“The decrease in asymptomatic transmission is very welcome news too in curbing the spread of the virus,” Phyllis Tien, MD, told this news organization.
“While the earlier press release reported that the vaccine was effective against preventing severe COVID-19 disease, as well as hospitalizations and death, this new data shows that the vaccine can also decrease transmission, which is very important on a public health level,” said Dr. Tien, professor of medicine in the division of infectious diseases at the University of California, San Francisco.
“It is extremely important in terms of getting to herd immunity,” Paul Goepfert, MD, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama, Birmingham, said in an interview. “It means that this vaccine is likely preventing subsequent transmission after a single dose, which could have huge implications once we get the majority of folks vaccinated.”
The FDA cautioned that the numbers of participants included in the study are relatively small and need to be verified. However, the Johnson & Johnson vaccine might not be the only product offering this advantage. Early data suggest that the Pfizer/BioNTech vaccine also decreases transmission, providing further evidence that the protection offered by immunization goes beyond the individual.
The new analyses were provided by the FDA in advance of its review of the Janssen/Johnson & Johnson vaccine. The agency plans to fully address the Ad26.COV2.S vaccine at its Vaccines and Related Biological Products Advisory Committee Meeting on Friday, including evaluating its safety and efficacy.
The agency’s decision on whether or not to grant emergency use authorization (EUA) to the Johnson & Johnson vaccine could come as early as Friday evening or Saturday.
In addition to the newly released data, officials are likely to discuss phase 3 data, released Jan. 29, that reveal an 85% efficacy for the vaccine against severe COVID-19 illness globally, including data from South America, South Africa, and the United States. When the analysis was restricted to data from U.S. participants, the trial showed a 73% efficacy against moderate to severe COVID-19.
If and when the FDA grants an EUA, it remains unclear how much of the new vaccine will be immediately available. Initially, Johnson & Johnson predicted 18 million doses would be ready by the end of February, but others stated the figure will be closer to 2-4 million. The manufacturer’s contract with the U.S. government stipulates production of 100-million doses by the end of June.
Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the SF VA HealthCare System. Dr. Goepfert has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The single-dose vaccine reduces the risk of asymptomatic transmission by 74% at 71 days, compared with placebo, according to documents released today by the U.S. Food and Drug Administration.
“The decrease in asymptomatic transmission is very welcome news too in curbing the spread of the virus,” Phyllis Tien, MD, told this news organization.
“While the earlier press release reported that the vaccine was effective against preventing severe COVID-19 disease, as well as hospitalizations and death, this new data shows that the vaccine can also decrease transmission, which is very important on a public health level,” said Dr. Tien, professor of medicine in the division of infectious diseases at the University of California, San Francisco.
“It is extremely important in terms of getting to herd immunity,” Paul Goepfert, MD, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama, Birmingham, said in an interview. “It means that this vaccine is likely preventing subsequent transmission after a single dose, which could have huge implications once we get the majority of folks vaccinated.”
The FDA cautioned that the numbers of participants included in the study are relatively small and need to be verified. However, the Johnson & Johnson vaccine might not be the only product offering this advantage. Early data suggest that the Pfizer/BioNTech vaccine also decreases transmission, providing further evidence that the protection offered by immunization goes beyond the individual.
The new analyses were provided by the FDA in advance of its review of the Janssen/Johnson & Johnson vaccine. The agency plans to fully address the Ad26.COV2.S vaccine at its Vaccines and Related Biological Products Advisory Committee Meeting on Friday, including evaluating its safety and efficacy.
The agency’s decision on whether or not to grant emergency use authorization (EUA) to the Johnson & Johnson vaccine could come as early as Friday evening or Saturday.
In addition to the newly released data, officials are likely to discuss phase 3 data, released Jan. 29, that reveal an 85% efficacy for the vaccine against severe COVID-19 illness globally, including data from South America, South Africa, and the United States. When the analysis was restricted to data from U.S. participants, the trial showed a 73% efficacy against moderate to severe COVID-19.
If and when the FDA grants an EUA, it remains unclear how much of the new vaccine will be immediately available. Initially, Johnson & Johnson predicted 18 million doses would be ready by the end of February, but others stated the figure will be closer to 2-4 million. The manufacturer’s contract with the U.S. government stipulates production of 100-million doses by the end of June.
Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the SF VA HealthCare System. Dr. Goepfert has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The single-dose vaccine reduces the risk of asymptomatic transmission by 74% at 71 days, compared with placebo, according to documents released today by the U.S. Food and Drug Administration.
“The decrease in asymptomatic transmission is very welcome news too in curbing the spread of the virus,” Phyllis Tien, MD, told this news organization.
“While the earlier press release reported that the vaccine was effective against preventing severe COVID-19 disease, as well as hospitalizations and death, this new data shows that the vaccine can also decrease transmission, which is very important on a public health level,” said Dr. Tien, professor of medicine in the division of infectious diseases at the University of California, San Francisco.
“It is extremely important in terms of getting to herd immunity,” Paul Goepfert, MD, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama, Birmingham, said in an interview. “It means that this vaccine is likely preventing subsequent transmission after a single dose, which could have huge implications once we get the majority of folks vaccinated.”
The FDA cautioned that the numbers of participants included in the study are relatively small and need to be verified. However, the Johnson & Johnson vaccine might not be the only product offering this advantage. Early data suggest that the Pfizer/BioNTech vaccine also decreases transmission, providing further evidence that the protection offered by immunization goes beyond the individual.
The new analyses were provided by the FDA in advance of its review of the Janssen/Johnson & Johnson vaccine. The agency plans to fully address the Ad26.COV2.S vaccine at its Vaccines and Related Biological Products Advisory Committee Meeting on Friday, including evaluating its safety and efficacy.
The agency’s decision on whether or not to grant emergency use authorization (EUA) to the Johnson & Johnson vaccine could come as early as Friday evening or Saturday.
In addition to the newly released data, officials are likely to discuss phase 3 data, released Jan. 29, that reveal an 85% efficacy for the vaccine against severe COVID-19 illness globally, including data from South America, South Africa, and the United States. When the analysis was restricted to data from U.S. participants, the trial showed a 73% efficacy against moderate to severe COVID-19.
If and when the FDA grants an EUA, it remains unclear how much of the new vaccine will be immediately available. Initially, Johnson & Johnson predicted 18 million doses would be ready by the end of February, but others stated the figure will be closer to 2-4 million. The manufacturer’s contract with the U.S. government stipulates production of 100-million doses by the end of June.
Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the SF VA HealthCare System. Dr. Goepfert has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FPs need to remind patients they care for whole families
I think there are multiple factors explaining why the percentage of family physicians treating children declined again. Not the least of these is that pediatricians have a very limited scope of practice and need to market and attract patients, which they do quite a bit. There are even pediatric urgent care centers popping up all over the place now, some likely funded by venture capital just as other urgent care centers have been funded.
The loss of pediatric inpatient volume because of the effectiveness of vaccines that prevent many bacterial and viral illnesses means that fewer pediatric graduates are spending time in the hospital.
Family doctors used to retain their pediatric patients by delivering babies, seeing them in the newborn nursery, and beginning their relationship with the kids there. FPs are delivering fewer babies and the subsequent reduction in new kids in their practices has been a factor in this as well.
Finally, in multispecialty practices, pediatricians are employed there. Families immediately assume that their kids should be going to the pediatricians, not the family doctors. We need to keep talking up the fact that we take care of whole families to retain our pediatric practices.
Neil S. Calman, MD, is president and chief executive officer of the Institute for Family Health and is professor and chair of the Alfred and Gail Engelberg department of family medicine and community health at the Icahn School of Medicine at Mount Sinai and the Mount Sinai Health System, both in New York. Dr. Calman also serves on the editorial advisory board of Family Practice News.
I think there are multiple factors explaining why the percentage of family physicians treating children declined again. Not the least of these is that pediatricians have a very limited scope of practice and need to market and attract patients, which they do quite a bit. There are even pediatric urgent care centers popping up all over the place now, some likely funded by venture capital just as other urgent care centers have been funded.
The loss of pediatric inpatient volume because of the effectiveness of vaccines that prevent many bacterial and viral illnesses means that fewer pediatric graduates are spending time in the hospital.
Family doctors used to retain their pediatric patients by delivering babies, seeing them in the newborn nursery, and beginning their relationship with the kids there. FPs are delivering fewer babies and the subsequent reduction in new kids in their practices has been a factor in this as well.
Finally, in multispecialty practices, pediatricians are employed there. Families immediately assume that their kids should be going to the pediatricians, not the family doctors. We need to keep talking up the fact that we take care of whole families to retain our pediatric practices.
Neil S. Calman, MD, is president and chief executive officer of the Institute for Family Health and is professor and chair of the Alfred and Gail Engelberg department of family medicine and community health at the Icahn School of Medicine at Mount Sinai and the Mount Sinai Health System, both in New York. Dr. Calman also serves on the editorial advisory board of Family Practice News.
I think there are multiple factors explaining why the percentage of family physicians treating children declined again. Not the least of these is that pediatricians have a very limited scope of practice and need to market and attract patients, which they do quite a bit. There are even pediatric urgent care centers popping up all over the place now, some likely funded by venture capital just as other urgent care centers have been funded.
The loss of pediatric inpatient volume because of the effectiveness of vaccines that prevent many bacterial and viral illnesses means that fewer pediatric graduates are spending time in the hospital.
Family doctors used to retain their pediatric patients by delivering babies, seeing them in the newborn nursery, and beginning their relationship with the kids there. FPs are delivering fewer babies and the subsequent reduction in new kids in their practices has been a factor in this as well.
Finally, in multispecialty practices, pediatricians are employed there. Families immediately assume that their kids should be going to the pediatricians, not the family doctors. We need to keep talking up the fact that we take care of whole families to retain our pediatric practices.
Neil S. Calman, MD, is president and chief executive officer of the Institute for Family Health and is professor and chair of the Alfred and Gail Engelberg department of family medicine and community health at the Icahn School of Medicine at Mount Sinai and the Mount Sinai Health System, both in New York. Dr. Calman also serves on the editorial advisory board of Family Practice News.
Helping parents and children deal with a child’s limb deformity
After 15 years of limping and a gradual downhill slide in mobility, recreational walking had become uncomfortable enough that I’ve decided to shed my proudly worn cloak of denial and seek help. Even I could see that the x-ray made a total knee replacement the only option for some return to near normalcy. Scheduling a total knee replacement became a no-brainer.
My decision to accept the risks to reap the benefits of surgery is small potatoes compared with the decisions that the parents of a child born with a deformed lower extremity must face. In the Family Partnerships section of the February 2021 issue of Pediatrics you will find a heart-wrenching story of a family who embarked on what turned out to be painful and frustrating journey to lengthen their daughter’s congenitally deficient leg. In their own words, the mother and daughter describe how neither of them were prepared for the pain and life-altering complications the daughter has endured. Influenced by the optimism exuded by surgeons, the family gave little thought to the magnitude of the decision they were being asked to make. One has to wonder in retrospect if a well-timed amputation and prosthesis might have been a better decision. However, the thought of removing an extremity, even one that isn’t fully functional, is not one that most of us like to consider.
Over the last several decades I have read stories about people – usually athletes – born with short or deformed lower extremities who have faced the decision of amputation. I recall one college-age young man who despite his deformity and with the help of a prosthesis was a competitive multisport athlete. However, it became clear that his deformed foot was preventing him from accessing the most advanced prosthetic technology. Although he was highly motivated, he described his struggle with the decision to part with a portion of his body that despite its appearance and dysfunction had been with him since birth. On the other hand, I have read stories of young people who had become so frustrated by their deformity that they were more than eager to undergo amputation despite the concerns of their parents.
Early in my career I encountered a 3-year-old with phocomelia whose family was visiting from out of town and had come to our clinic because his older sibling was sick. The youngster, as I recall, had only one complete extremity, an arm. Like most 3-year-olds, he was driven to explore at breakneck speed. I will never forget watching him streak back and forth the length of our linoleum covered hallway like a crab skittering along the beach. His mother described how she and his well-meaning physicians were struggling unsuccessfully to get him to accept prostheses. Later I learned that his resistance is shared by many of the survivors of the thalidomide disaster who felt that the most frustrating period in their lives came when, again well-meaning, caregivers had tried to make them look and function more normally by fitting them with prostheses.
These anecdotal observations make clear a philosophy that we should have already internalized. In most clinic decisions the patient, pretty much regardless of age, should be a full participant in the process. And, to do this the patient and his or her family must be as informed as possible. Managing the aftermath of a traumatic amputation presents it own special set of challenges, but when it comes to elective amputation or prosthetic application for a congenital deficiency it is dangerous for us to insert our personal bias into the decision making.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
After 15 years of limping and a gradual downhill slide in mobility, recreational walking had become uncomfortable enough that I’ve decided to shed my proudly worn cloak of denial and seek help. Even I could see that the x-ray made a total knee replacement the only option for some return to near normalcy. Scheduling a total knee replacement became a no-brainer.
My decision to accept the risks to reap the benefits of surgery is small potatoes compared with the decisions that the parents of a child born with a deformed lower extremity must face. In the Family Partnerships section of the February 2021 issue of Pediatrics you will find a heart-wrenching story of a family who embarked on what turned out to be painful and frustrating journey to lengthen their daughter’s congenitally deficient leg. In their own words, the mother and daughter describe how neither of them were prepared for the pain and life-altering complications the daughter has endured. Influenced by the optimism exuded by surgeons, the family gave little thought to the magnitude of the decision they were being asked to make. One has to wonder in retrospect if a well-timed amputation and prosthesis might have been a better decision. However, the thought of removing an extremity, even one that isn’t fully functional, is not one that most of us like to consider.
Over the last several decades I have read stories about people – usually athletes – born with short or deformed lower extremities who have faced the decision of amputation. I recall one college-age young man who despite his deformity and with the help of a prosthesis was a competitive multisport athlete. However, it became clear that his deformed foot was preventing him from accessing the most advanced prosthetic technology. Although he was highly motivated, he described his struggle with the decision to part with a portion of his body that despite its appearance and dysfunction had been with him since birth. On the other hand, I have read stories of young people who had become so frustrated by their deformity that they were more than eager to undergo amputation despite the concerns of their parents.
Early in my career I encountered a 3-year-old with phocomelia whose family was visiting from out of town and had come to our clinic because his older sibling was sick. The youngster, as I recall, had only one complete extremity, an arm. Like most 3-year-olds, he was driven to explore at breakneck speed. I will never forget watching him streak back and forth the length of our linoleum covered hallway like a crab skittering along the beach. His mother described how she and his well-meaning physicians were struggling unsuccessfully to get him to accept prostheses. Later I learned that his resistance is shared by many of the survivors of the thalidomide disaster who felt that the most frustrating period in their lives came when, again well-meaning, caregivers had tried to make them look and function more normally by fitting them with prostheses.
These anecdotal observations make clear a philosophy that we should have already internalized. In most clinic decisions the patient, pretty much regardless of age, should be a full participant in the process. And, to do this the patient and his or her family must be as informed as possible. Managing the aftermath of a traumatic amputation presents it own special set of challenges, but when it comes to elective amputation or prosthetic application for a congenital deficiency it is dangerous for us to insert our personal bias into the decision making.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
After 15 years of limping and a gradual downhill slide in mobility, recreational walking had become uncomfortable enough that I’ve decided to shed my proudly worn cloak of denial and seek help. Even I could see that the x-ray made a total knee replacement the only option for some return to near normalcy. Scheduling a total knee replacement became a no-brainer.
My decision to accept the risks to reap the benefits of surgery is small potatoes compared with the decisions that the parents of a child born with a deformed lower extremity must face. In the Family Partnerships section of the February 2021 issue of Pediatrics you will find a heart-wrenching story of a family who embarked on what turned out to be painful and frustrating journey to lengthen their daughter’s congenitally deficient leg. In their own words, the mother and daughter describe how neither of them were prepared for the pain and life-altering complications the daughter has endured. Influenced by the optimism exuded by surgeons, the family gave little thought to the magnitude of the decision they were being asked to make. One has to wonder in retrospect if a well-timed amputation and prosthesis might have been a better decision. However, the thought of removing an extremity, even one that isn’t fully functional, is not one that most of us like to consider.
Over the last several decades I have read stories about people – usually athletes – born with short or deformed lower extremities who have faced the decision of amputation. I recall one college-age young man who despite his deformity and with the help of a prosthesis was a competitive multisport athlete. However, it became clear that his deformed foot was preventing him from accessing the most advanced prosthetic technology. Although he was highly motivated, he described his struggle with the decision to part with a portion of his body that despite its appearance and dysfunction had been with him since birth. On the other hand, I have read stories of young people who had become so frustrated by their deformity that they were more than eager to undergo amputation despite the concerns of their parents.
Early in my career I encountered a 3-year-old with phocomelia whose family was visiting from out of town and had come to our clinic because his older sibling was sick. The youngster, as I recall, had only one complete extremity, an arm. Like most 3-year-olds, he was driven to explore at breakneck speed. I will never forget watching him streak back and forth the length of our linoleum covered hallway like a crab skittering along the beach. His mother described how she and his well-meaning physicians were struggling unsuccessfully to get him to accept prostheses. Later I learned that his resistance is shared by many of the survivors of the thalidomide disaster who felt that the most frustrating period in their lives came when, again well-meaning, caregivers had tried to make them look and function more normally by fitting them with prostheses.
These anecdotal observations make clear a philosophy that we should have already internalized. In most clinic decisions the patient, pretty much regardless of age, should be a full participant in the process. And, to do this the patient and his or her family must be as informed as possible. Managing the aftermath of a traumatic amputation presents it own special set of challenges, but when it comes to elective amputation or prosthetic application for a congenital deficiency it is dangerous for us to insert our personal bias into the decision making.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].