MDedge Endocrinology

When it comes to protecting diabetic hearts, sodium-glucose cotransporter-2 (SGLT2) inhibitors may have a slight edge over glucagonlike peptide-1 receptor agonists (GLP-1 RAs) according to the results of large, population-based, observational cohort study.

Around a 30% reduction in the risk for being hospitalized for heart failure was achieved in people with type 2 diabetes who were treated with a SGLT2 inhibitor over a GLP-1 RA regardless of whether the patients had a preexisting heart condition.

The findings, published in the Annals of Internal Medicine, also showed a 10% lower risk for myocardial infarction or stroke among those treated with a SGLT2 inhibitor who had preexisting cardiovascular disease (CVD), although there was no difference in risk between the two classes of drugs in those without preexisting CVD.

“These findings are important as they suggest that SGLT2 [inhibitors] and GLP-1 RA offer similar benefits in preventing myocardial infarction and stroke in patients with diabetes,” said study investigator Elisabetta Patorno, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, in an interview.

They also show “that SGLT2 [inhibitors] offer greater efficacy in preventing heart failure, which supports the existing guidelines,” she added.

Paul S. Jellinger, MD, MACE, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said these data were likely to be “additive to guidelines but not transformative.” The overall analysis results were “not surprising.” It was not unexpected that SGLT2 inhibitors provided a robust chronic heart failure (CHF) benefit, particularly in individuals with history of CVD, he said.

Dr. Jellinger, a clinical endocrinologist and professor of clinical medicine on the voluntary faculty at the University of Miami, observed, however, that “the similar CVD benefit in both drug classes in patients without known CVD adds to our knowledge in this somewhat controversial area and may be useful to the clinician in evaluating therapy in a diabetic individual without evidence of or at high risk for CHF.”

Furthermore, “the study also reminds us that, as demonstrated in published meta-analysis, there is also a modest CHF benefit associated with GLP-1 RA treatment particularly in patients with a history of CVD.”
 

Addressing the knowledge gap

Thanks to the results of many large-scale, prospective, cardiovascular outcomes studies, both SGLT2 inhibitors and GLP1 RA have been recommended as treatment for people with diabetes who have established CVD. But with no direct head-to-head trials having been conducted, there is a gap in knowledge and there is currently little guidance for physicians on which drug class to choose for an individual patient.

To try to clarify things, Dr. Patorno and associates looked at data from more than 370,000 people with type 2 diabetes who had been treated between April 2013 and December 2017 with either a SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin) or GLP-1 RA (albiglutide, dulaglutide, exenatide, or liraglutide).

One-to-one propensity score matching was used to create the study groups: participants were first grouped according to their history of CVD, and then by the class of drug they had been prescribed. The primary outcomes were hospitalization for MI, stroke, or heart failure.

Comparing the initiation of a SGLT2 inhibitor with GLP-1 RA therapy, the hazard ratios (HRs) for MI or stroke in patients with and without a history of CVD were a respective 0.90 (95% CI, 0.82 to 0.98) and 1.07 (0.97 to 1.18).

The corresponding hazard ratios for heart failure hospitalizations were 0.71 (0.64 to 0.79) and 0.69 (0.56 to 0.85).
 

Real-world studies are of ‘increasing value’

“As in other not-randomized studies based on real-world data, residual confounding cannot be completely ruled out,” Dr. Patorno acknowledged. She added, however that “state-of-the-art methodological strategies were implemented to minimize this possibility.”

Limitations notwithstanding, “real world studies are demonstrating increasing value,” observed Dr. Jellinger. Further large-scale cardiovascular outcomes trials that directly compare these two drug classes “are unlikely given the depth of information available now,” Dr. Jellinger suggested.

“This head-to-head retrospective study may be as close as we get and does represent the first effort at a comparison of these two classes.”

Dr. Patorno said of the potential clinical implications: “Because the two classes are equally effective for stroke and myocardial infarction, but the SGLT2 inhibitors are superior for heart failure, when considered in aggregate, SGLT2 inhibitors are likely to prevent more of these adverse cardiovascular events than GLP-1 RA.”

The study received no commercial funding and was supported by the Brigham and Women’s Hospital and Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics.

Dr. Patorno reported no conflicts of interest. Dr. Jellinger is on the speaker’s bureau for Astra Zeneca, Amgen, and Esperion, and has served on advisory boards for Corcept and Regeneron.

When it comes to protecting diabetic hearts, sodium-glucose cotransporter-2 (SGLT2) inhibitors may have a slight edge over glucagonlike peptide-1 receptor agonists (GLP-1 RAs) according to the results of large, population-based, observational cohort study.

Around a 30% reduction in the risk for being hospitalized for heart failure was achieved in people with type 2 diabetes who were treated with a SGLT2 inhibitor over a GLP-1 RA regardless of whether the patients had a preexisting heart condition.

The findings, published in the Annals of Internal Medicine, also showed a 10% lower risk for myocardial infarction or stroke among those treated with a SGLT2 inhibitor who had preexisting cardiovascular disease (CVD), although there was no difference in risk between the two classes of drugs in those without preexisting CVD.

“These findings are important as they suggest that SGLT2 [inhibitors] and GLP-1 RA offer similar benefits in preventing myocardial infarction and stroke in patients with diabetes,” said study investigator Elisabetta Patorno, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, in an interview.

They also show “that SGLT2 [inhibitors] offer greater efficacy in preventing heart failure, which supports the existing guidelines,” she added.

Paul S. Jellinger, MD, MACE, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said these data were likely to be “additive to guidelines but not transformative.” The overall analysis results were “not surprising.” It was not unexpected that SGLT2 inhibitors provided a robust chronic heart failure (CHF) benefit, particularly in individuals with history of CVD, he said.

Dr. Jellinger, a clinical endocrinologist and professor of clinical medicine on the voluntary faculty at the University of Miami, observed, however, that “the similar CVD benefit in both drug classes in patients without known CVD adds to our knowledge in this somewhat controversial area and may be useful to the clinician in evaluating therapy in a diabetic individual without evidence of or at high risk for CHF.”

Furthermore, “the study also reminds us that, as demonstrated in published meta-analysis, there is also a modest CHF benefit associated with GLP-1 RA treatment particularly in patients with a history of CVD.”
 

Addressing the knowledge gap

Thanks to the results of many large-scale, prospective, cardiovascular outcomes studies, both SGLT2 inhibitors and GLP1 RA have been recommended as treatment for people with diabetes who have established CVD. But with no direct head-to-head trials having been conducted, there is a gap in knowledge and there is currently little guidance for physicians on which drug class to choose for an individual patient.

To try to clarify things, Dr. Patorno and associates looked at data from more than 370,000 people with type 2 diabetes who had been treated between April 2013 and December 2017 with either a SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin) or GLP-1 RA (albiglutide, dulaglutide, exenatide, or liraglutide).

One-to-one propensity score matching was used to create the study groups: participants were first grouped according to their history of CVD, and then by the class of drug they had been prescribed. The primary outcomes were hospitalization for MI, stroke, or heart failure.

Comparing the initiation of a SGLT2 inhibitor with GLP-1 RA therapy, the hazard ratios (HRs) for MI or stroke in patients with and without a history of CVD were a respective 0.90 (95% CI, 0.82 to 0.98) and 1.07 (0.97 to 1.18).

The corresponding hazard ratios for heart failure hospitalizations were 0.71 (0.64 to 0.79) and 0.69 (0.56 to 0.85).
 

Real-world studies are of ‘increasing value’

“As in other not-randomized studies based on real-world data, residual confounding cannot be completely ruled out,” Dr. Patorno acknowledged. She added, however that “state-of-the-art methodological strategies were implemented to minimize this possibility.”

Limitations notwithstanding, “real world studies are demonstrating increasing value,” observed Dr. Jellinger. Further large-scale cardiovascular outcomes trials that directly compare these two drug classes “are unlikely given the depth of information available now,” Dr. Jellinger suggested.

“This head-to-head retrospective study may be as close as we get and does represent the first effort at a comparison of these two classes.”

Dr. Patorno said of the potential clinical implications: “Because the two classes are equally effective for stroke and myocardial infarction, but the SGLT2 inhibitors are superior for heart failure, when considered in aggregate, SGLT2 inhibitors are likely to prevent more of these adverse cardiovascular events than GLP-1 RA.”

The study received no commercial funding and was supported by the Brigham and Women’s Hospital and Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics.

Dr. Patorno reported no conflicts of interest. Dr. Jellinger is on the speaker’s bureau for Astra Zeneca, Amgen, and Esperion, and has served on advisory boards for Corcept and Regeneron.

When it comes to protecting diabetic hearts, sodium-glucose cotransporter-2 (SGLT2) inhibitors may have a slight edge over glucagonlike peptide-1 receptor agonists (GLP-1 RAs) according to the results of large, population-based, observational cohort study.

Around a 30% reduction in the risk for being hospitalized for heart failure was achieved in people with type 2 diabetes who were treated with a SGLT2 inhibitor over a GLP-1 RA regardless of whether the patients had a preexisting heart condition.

The findings, published in the Annals of Internal Medicine, also showed a 10% lower risk for myocardial infarction or stroke among those treated with a SGLT2 inhibitor who had preexisting cardiovascular disease (CVD), although there was no difference in risk between the two classes of drugs in those without preexisting CVD.

“These findings are important as they suggest that SGLT2 [inhibitors] and GLP-1 RA offer similar benefits in preventing myocardial infarction and stroke in patients with diabetes,” said study investigator Elisabetta Patorno, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, in an interview.

They also show “that SGLT2 [inhibitors] offer greater efficacy in preventing heart failure, which supports the existing guidelines,” she added.

Paul S. Jellinger, MD, MACE, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said these data were likely to be “additive to guidelines but not transformative.” The overall analysis results were “not surprising.” It was not unexpected that SGLT2 inhibitors provided a robust chronic heart failure (CHF) benefit, particularly in individuals with history of CVD, he said.

Dr. Jellinger, a clinical endocrinologist and professor of clinical medicine on the voluntary faculty at the University of Miami, observed, however, that “the similar CVD benefit in both drug classes in patients without known CVD adds to our knowledge in this somewhat controversial area and may be useful to the clinician in evaluating therapy in a diabetic individual without evidence of or at high risk for CHF.”

Furthermore, “the study also reminds us that, as demonstrated in published meta-analysis, there is also a modest CHF benefit associated with GLP-1 RA treatment particularly in patients with a history of CVD.”
 

Addressing the knowledge gap

Thanks to the results of many large-scale, prospective, cardiovascular outcomes studies, both SGLT2 inhibitors and GLP1 RA have been recommended as treatment for people with diabetes who have established CVD. But with no direct head-to-head trials having been conducted, there is a gap in knowledge and there is currently little guidance for physicians on which drug class to choose for an individual patient.

To try to clarify things, Dr. Patorno and associates looked at data from more than 370,000 people with type 2 diabetes who had been treated between April 2013 and December 2017 with either a SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin) or GLP-1 RA (albiglutide, dulaglutide, exenatide, or liraglutide).

One-to-one propensity score matching was used to create the study groups: participants were first grouped according to their history of CVD, and then by the class of drug they had been prescribed. The primary outcomes were hospitalization for MI, stroke, or heart failure.

Comparing the initiation of a SGLT2 inhibitor with GLP-1 RA therapy, the hazard ratios (HRs) for MI or stroke in patients with and without a history of CVD were a respective 0.90 (95% CI, 0.82 to 0.98) and 1.07 (0.97 to 1.18).

The corresponding hazard ratios for heart failure hospitalizations were 0.71 (0.64 to 0.79) and 0.69 (0.56 to 0.85).
 

Real-world studies are of ‘increasing value’

“As in other not-randomized studies based on real-world data, residual confounding cannot be completely ruled out,” Dr. Patorno acknowledged. She added, however that “state-of-the-art methodological strategies were implemented to minimize this possibility.”

Limitations notwithstanding, “real world studies are demonstrating increasing value,” observed Dr. Jellinger. Further large-scale cardiovascular outcomes trials that directly compare these two drug classes “are unlikely given the depth of information available now,” Dr. Jellinger suggested.

“This head-to-head retrospective study may be as close as we get and does represent the first effort at a comparison of these two classes.”

Dr. Patorno said of the potential clinical implications: “Because the two classes are equally effective for stroke and myocardial infarction, but the SGLT2 inhibitors are superior for heart failure, when considered in aggregate, SGLT2 inhibitors are likely to prevent more of these adverse cardiovascular events than GLP-1 RA.”

The study received no commercial funding and was supported by the Brigham and Women’s Hospital and Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics.

Dr. Patorno reported no conflicts of interest. Dr. Jellinger is on the speaker’s bureau for Astra Zeneca, Amgen, and Esperion, and has served on advisory boards for Corcept and Regeneron.

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

Micah Young/istockphoto.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Boosters for all COVID-19 vaccines are completely free.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

10. What does the future hold for booster shots?

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

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

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

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

Micah Young/istockphoto.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Boosters for all COVID-19 vaccines are completely free.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

10. What does the future hold for booster shots?

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

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

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

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

Micah Young/istockphoto.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Boosters for all COVID-19 vaccines are completely free.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

10. What does the future hold for booster shots?

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

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

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

New evidence suggests a drug used to lower blood sugar levels may also help extend the duration of preterm pregnancies in women with preeclampsia.

The findings from a small clinical trial, published Sept. 23 in the BMJ, showed that pregnant women who received the diabetes medication metformin prolonged their pregnancy by a week compared to those who received a placebo. Although this finding was not statistically significant, researchers said they are “cautiously optimistic” about the treatment of preterm preeclampsia.

“We hope that it will encourage others to test not only metformin but also other promising therapeutic candidates to treat and prevent preeclampsia,” study author Catherine Cluver, MBChB, FCOG, PhD, associate professor in the department of obstetrics and gynecology at Stellenbosch University in South Africa, said in an interview.

Preeclampsia, a condition that occurs about 1 in 25 pregnancies in the United States, happens when a woman develops high blood pressure and protein in her urine, according to the Centers for Disease Control and Prevention.

Preterm preeclampsia is a severe variant affecting 0.5% of all pregnancies, or 10% of those with preeclampsia, researchers wrote in the study. The condition is associated with more maternal and neonatal death and increases their risks of developing an illness.

Dr. Cluver said that when a mother develops preeclampsia, the lining of her blood vessels, or the endothelium, is affected and there are specific proteins in the blood that increase. Dr. Cluver’s preclinical study found that metformin improved endothelial function and decreased these biomarkers in laboratory work.

“We therefore set out to see if metformin could be used to prolong gestation in preterm preeclampsia,” she said.

For the study, Dr. Cluver and colleagues performed a double-blind, placebo-controlled clinical trial to compare the prolongation of pregnancies among women who were at least 26 months pregnant with preterm preeclampsia. They were treated with either 3 grams of extended-release metformin (90 women), or a matching placebo (90 women).*

In the treatment group, the average time from the start of the study to delivery was 17.7 days, compared to 10.1 days in the placebo group. The median difference was 7.6 days.

The researchers also found that 40% of women in the metformin group reached 34 weeks’ gestation compared with 28% of those in the placebo group. Fewer women in the metformin group delivered because of fetal indications such as fetal distress or other issues – 33% vs. 44%. However, the researchers said those results were not statistically significant.

They said they were cautiously optimistic when they found that the median time for prolongation of pregnancy in the metformin group was 17.5 days compared with 7.9 days in the placebo group, findings that were statistically significant.

Some adverse effects participants experienced while taking metformin during their pregnancy included diarrhea and an increase in nausea.

Although the study is important in maternal-fetal medicine and is a novel approach to preterm preeclampsia, the findings weren’t strong enough, but they point to the need for further study, said Victor Klein, MD, MBA, CPHRM, a specialist in high-risk pregnancy who was not involved in the study.

“Even though they did have an improved outcome, it wasn’t strong enough. It wasn’t long enough to prove that the medicine was useful or efficacious,” said Dr. Klein, vice chairman of obstetrics and gynecology at North Shore University Hospital, New York.

Metformin is also used to treat gestational diabetes, which is an “advantage of repurposing the drug is that it is likely to be safe,” the researchers wrote. They said longer term follow-up data might be worthwhile in future trials.

None of the experts had conflicts of interest to disclose.

*This story was updated on 10/6/2021.

New evidence suggests a drug used to lower blood sugar levels may also help extend the duration of preterm pregnancies in women with preeclampsia.

The findings from a small clinical trial, published Sept. 23 in the BMJ, showed that pregnant women who received the diabetes medication metformin prolonged their pregnancy by a week compared to those who received a placebo. Although this finding was not statistically significant, researchers said they are “cautiously optimistic” about the treatment of preterm preeclampsia.

“We hope that it will encourage others to test not only metformin but also other promising therapeutic candidates to treat and prevent preeclampsia,” study author Catherine Cluver, MBChB, FCOG, PhD, associate professor in the department of obstetrics and gynecology at Stellenbosch University in South Africa, said in an interview.

Preeclampsia, a condition that occurs about 1 in 25 pregnancies in the United States, happens when a woman develops high blood pressure and protein in her urine, according to the Centers for Disease Control and Prevention.

Preterm preeclampsia is a severe variant affecting 0.5% of all pregnancies, or 10% of those with preeclampsia, researchers wrote in the study. The condition is associated with more maternal and neonatal death and increases their risks of developing an illness.

Dr. Cluver said that when a mother develops preeclampsia, the lining of her blood vessels, or the endothelium, is affected and there are specific proteins in the blood that increase. Dr. Cluver’s preclinical study found that metformin improved endothelial function and decreased these biomarkers in laboratory work.

“We therefore set out to see if metformin could be used to prolong gestation in preterm preeclampsia,” she said.

For the study, Dr. Cluver and colleagues performed a double-blind, placebo-controlled clinical trial to compare the prolongation of pregnancies among women who were at least 26 months pregnant with preterm preeclampsia. They were treated with either 3 grams of extended-release metformin (90 women), or a matching placebo (90 women).*

In the treatment group, the average time from the start of the study to delivery was 17.7 days, compared to 10.1 days in the placebo group. The median difference was 7.6 days.

The researchers also found that 40% of women in the metformin group reached 34 weeks’ gestation compared with 28% of those in the placebo group. Fewer women in the metformin group delivered because of fetal indications such as fetal distress or other issues – 33% vs. 44%. However, the researchers said those results were not statistically significant.

They said they were cautiously optimistic when they found that the median time for prolongation of pregnancy in the metformin group was 17.5 days compared with 7.9 days in the placebo group, findings that were statistically significant.

Some adverse effects participants experienced while taking metformin during their pregnancy included diarrhea and an increase in nausea.

Although the study is important in maternal-fetal medicine and is a novel approach to preterm preeclampsia, the findings weren’t strong enough, but they point to the need for further study, said Victor Klein, MD, MBA, CPHRM, a specialist in high-risk pregnancy who was not involved in the study.

“Even though they did have an improved outcome, it wasn’t strong enough. It wasn’t long enough to prove that the medicine was useful or efficacious,” said Dr. Klein, vice chairman of obstetrics and gynecology at North Shore University Hospital, New York.

Metformin is also used to treat gestational diabetes, which is an “advantage of repurposing the drug is that it is likely to be safe,” the researchers wrote. They said longer term follow-up data might be worthwhile in future trials.

None of the experts had conflicts of interest to disclose.

*This story was updated on 10/6/2021.

New evidence suggests a drug used to lower blood sugar levels may also help extend the duration of preterm pregnancies in women with preeclampsia.

The findings from a small clinical trial, published Sept. 23 in the BMJ, showed that pregnant women who received the diabetes medication metformin prolonged their pregnancy by a week compared to those who received a placebo. Although this finding was not statistically significant, researchers said they are “cautiously optimistic” about the treatment of preterm preeclampsia.

“We hope that it will encourage others to test not only metformin but also other promising therapeutic candidates to treat and prevent preeclampsia,” study author Catherine Cluver, MBChB, FCOG, PhD, associate professor in the department of obstetrics and gynecology at Stellenbosch University in South Africa, said in an interview.

Preeclampsia, a condition that occurs about 1 in 25 pregnancies in the United States, happens when a woman develops high blood pressure and protein in her urine, according to the Centers for Disease Control and Prevention.

Preterm preeclampsia is a severe variant affecting 0.5% of all pregnancies, or 10% of those with preeclampsia, researchers wrote in the study. The condition is associated with more maternal and neonatal death and increases their risks of developing an illness.

Dr. Cluver said that when a mother develops preeclampsia, the lining of her blood vessels, or the endothelium, is affected and there are specific proteins in the blood that increase. Dr. Cluver’s preclinical study found that metformin improved endothelial function and decreased these biomarkers in laboratory work.

“We therefore set out to see if metformin could be used to prolong gestation in preterm preeclampsia,” she said.

For the study, Dr. Cluver and colleagues performed a double-blind, placebo-controlled clinical trial to compare the prolongation of pregnancies among women who were at least 26 months pregnant with preterm preeclampsia. They were treated with either 3 grams of extended-release metformin (90 women), or a matching placebo (90 women).*

In the treatment group, the average time from the start of the study to delivery was 17.7 days, compared to 10.1 days in the placebo group. The median difference was 7.6 days.

The researchers also found that 40% of women in the metformin group reached 34 weeks’ gestation compared with 28% of those in the placebo group. Fewer women in the metformin group delivered because of fetal indications such as fetal distress or other issues – 33% vs. 44%. However, the researchers said those results were not statistically significant.

They said they were cautiously optimistic when they found that the median time for prolongation of pregnancy in the metformin group was 17.5 days compared with 7.9 days in the placebo group, findings that were statistically significant.

Some adverse effects participants experienced while taking metformin during their pregnancy included diarrhea and an increase in nausea.

Although the study is important in maternal-fetal medicine and is a novel approach to preterm preeclampsia, the findings weren’t strong enough, but they point to the need for further study, said Victor Klein, MD, MBA, CPHRM, a specialist in high-risk pregnancy who was not involved in the study.

“Even though they did have an improved outcome, it wasn’t strong enough. It wasn’t long enough to prove that the medicine was useful or efficacious,” said Dr. Klein, vice chairman of obstetrics and gynecology at North Shore University Hospital, New York.

Metformin is also used to treat gestational diabetes, which is an “advantage of repurposing the drug is that it is likely to be safe,” the researchers wrote. They said longer term follow-up data might be worthwhile in future trials.

None of the experts had conflicts of interest to disclose.

*This story was updated on 10/6/2021.

The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.  

Sara Freeman/MDedge News

The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.

“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.

He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative

As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.  
 

New data from previously reported trials

There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.

New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.

And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.

“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.

Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
 

Consensus on type 1 diabetes management: Special considerations

Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.

The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.  

Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”

And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”

But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
 

Diabetes in 2021: It’s personal

Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).

According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”

An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”

The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.

And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
 

Next-generation incretin therapy: Is weight loss the treatment?

New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.

A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.

The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.

Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”

Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”

A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
 

COVID-19, hypoglycemia, bone, and much more

As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia. 

A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy. 

Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”

Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.

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

The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.  

Sara Freeman/MDedge News

The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.

“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.

He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative

As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.  
 

New data from previously reported trials

There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.

New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.

And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.

“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.

Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
 

Consensus on type 1 diabetes management: Special considerations

Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.

The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.  

Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”

And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”

But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
 

Diabetes in 2021: It’s personal

Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).

According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”

An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”

The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.

And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
 

Next-generation incretin therapy: Is weight loss the treatment?

New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.

A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.

The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.

Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”

Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”

A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
 

COVID-19, hypoglycemia, bone, and much more

As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia. 

A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy. 

Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”

Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.

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

The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.  

Sara Freeman/MDedge News

The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.

“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.

He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative

As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.  
 

New data from previously reported trials

There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.

New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.

And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.

“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.

Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
 

Consensus on type 1 diabetes management: Special considerations

Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.

The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.  

Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”

And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”

But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
 

Diabetes in 2021: It’s personal

Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).

According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”

An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”

The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.

And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
 

Next-generation incretin therapy: Is weight loss the treatment?

New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.

A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.

The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.

Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”

Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”

A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
 

COVID-19, hypoglycemia, bone, and much more

As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia. 

A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy. 

Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”

Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

She was not alone in feeling cautious.

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

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

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

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

Some felt squeamish about broadly recommending boosters at all.

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

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

Others agreed.

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

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

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

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

Next steps

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

She was not alone in feeling cautious.

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

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

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

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

Some felt squeamish about broadly recommending boosters at all.

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

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

Others agreed.

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

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

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

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

Next steps

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

She was not alone in feeling cautious.

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

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

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

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

Some felt squeamish about broadly recommending boosters at all.

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

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

Others agreed.

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

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

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

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

Next steps

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

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

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

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

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

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

A strain of COVID-19 first reported in Japan surfaced at a Kentucky nursing home in the spring.

Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.

On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.

About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.

However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.

“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.

Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.

Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.

Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.

The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”

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

A strain of COVID-19 first reported in Japan surfaced at a Kentucky nursing home in the spring.

Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.

On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.

About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.

However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.

“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.

Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.

Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.

Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.

The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”

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

A strain of COVID-19 first reported in Japan surfaced at a Kentucky nursing home in the spring.

Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.

On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.

About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.

However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.

“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.

Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.

Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.

Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.

The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”

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

Teens are identifying as transgender in record numbers. In 2017, 3-4 in 100 teens in the United States reported that they are or may be transgender. A more recent 2021 study suggests that the rate of transgender identification among America’s youth may be as high as 9 in 100. All of the major gender centers in the world have reported a several-thousand-percent increase in youth presenting with gender distress.

Origovisualis/Getty Images

How do we reconcile these numbers with 2013 data reporting the prevalence of adult gender dysphoria to be a rare 2-14 in 100,000? Reflection is warranted because many U.S. medical societies support providing youth who have transgender identification (over 1 million children and adolescents, using the latest estimates) with access to powerful endocrine interventions.

GnRH analogues (colloquially known as “puberty blockers”) are now available at Tanner stage 2 of puberty – a threshold crossed by females as young as 8-9 years old. Cross-sex hormones and surgeries follow, and mastectomies are now available to children as young as 13. Genital-altering surgeries, as well as the removal of the ovaries, uterus, and testes, can be obtained as soon as a patient turns 18.

What’s driving this massive increase in trans-identified youth? What are the risks, benefits, and uncertainties associated with hormonal and surgical interventions? Do such interventions improve the long-term psychological health of gender-dysphoric youth? How many will regret the irreversible changes made to their bodies during what may have been a temporary phase in their development?

We don’t know the answers to these questions, but we need to figure them out before offering such interventions. Frontline clinicians – especially those working with youth – will not be able to remain on the sidelines of this issue for much longer. Each clinician considering writing a prescription for puberty blockers or cross-sex hormones, or generating a referral for surgery, will need to answer for themselves: Just because I can, does it mean I should?

What’s contributing to the rapid rise of gender-dysphoric youth?

The etiology of the rapid rise of transgender identifications in young people is vigorously debated. Proponents of hormonal and surgical interventions for youth argue that the several-thousand-percent increase in the numbers of youth seeking gender reassignment is a reflection of more social acceptance of transgender identities, allowing more young people to “come out.” But closer examination of this claim reveals several inconsistencies.

Because adolescent and young adult females now account for 6-8 in 10 of the presenting cases (previously, prepubertal males were more common), one would expect a commensurate increase in the rate of transgender identification in older females. This has not occurred. In addition, more than three-quarters of currently presenting cases have significant mental health problems or suffer from neurocognitive comorbidities such as autism spectrum disorder or attention-deficit/hyperactivity disorder – a much higher burden of mental health comorbidities than the historical cohort with gender dysphoria.

There is legitimate concern that these comorbid mental health conditions, as well as the influence of social groups and online immersion into transgender topics, may be playing a role in the rapidly growing rate of transgender identification among these particularly vulnerable youth.

The initial study positing the theory that social influence is playing a role in the increased incidence of “late” or adolescent-onset (vs. childhood-onset) transgender-identified youth was harshly attacked by proponents of medical transitioning of youth, despite the fact that the study utilized methods similar to those used in other areas of health research. The study underwent an unprecedented second peer review and emerged with largely unchanged conclusions.

Since the study’s publication, a number of mental health clinicians working directly with gender-distressed youth have corroborated a rapid onset of transgender identification among teens with previously gender-normative childhoods.

Pioneers in gender dysphoria treatment are changing course

Several European countries that were pioneers in pediatric medical transition are now reversing course toward far more caution after their own evidence evaluations failed to show that medically transitioning gender-distressed youth improves mental health outcomes. In Sweden, following Karolinska Hospital’s announcement that it will no longer transition people under 18 outside of strictly regulated clinical trials, a number of other pediatric gender clinics followed suit and made the same decision.

In the United Kingdom, Keira Bell – a young woman who was treated with “affirmative” hormonal and surgical interventions before detransitioning – brought a challenge against the national gender clinic. Her landmark case and the UK High Court’s original judgement against the clinic have highlighted the urgency to reassess treatment approaches for the increasingly varied presentations of gender dysphoria in young people. As this article went to press, the UK’s national gender clinic won its appeal against Keira Bell, meaning that doctors there will once again be able to decide whether their patients under 16 can properly consent to puberty blockers. Keira Bell said she is disappointed with this decision and will be seeking permission to appeal to the Supreme Court. She said the medical service had become “politicized,” and added: “A global conversation has begun and has been shaped by this case. It has shone a light into the dark corners of a medical scandal that is harming children and harmed me. There is more to be done.”

And the UK National Health Service (NHS) has already commissioned an independent systematic review of data, which concluded that the evidence of benefit of hormonal interventions in gender dysphoric youth is of very low certainty and must be carefully weighed against the risks. An independent taskforce has also been convened to reassess the country’s approach to treating gender dysphoric youth.

Finland has arguably undertaken the biggest change of all. An early adopter of pediatric medical transition, researchers there noticed that adolescents who had mental health struggles at baseline failed to improve after transition. The Finnish national Gender Identity Development services issued new treatment guidelines in 2020 stating that psychotherapy, rather than gender reassignment, should be the first line of treatment for gender-dysphoric youth.

Leaders of America’s medical societies have been slower to respond. Recently, the Society for Evidence-Based Gender Medicine applied to share information about youth gender transitions at the yearly meeting of the American Academy of Pediatrics (AAP). The application was denied without explanation, despite the fact that 80% of rank-and-file pediatricians who voted on AAP resolutions days earlier endorsed a resolution calling for a reassessment of the evidence and more caution regarding gender transitions of minors.

The AAP leadership apparently ignored the resounding support for this resolution, but the clear message from that vote is that frontline pediatricians do not agree with the “one size fits all” approach of automatically affirming gender-distressed youth as transgender and proceeding to gender reassignment.

What we know and don’t know


There is now growing evidence that the “gender-affirming” model, based on the unproven assumption that gender reassignment is the best way to help gender-distressed youth, is not living up to its promise. This should not be surprising. Despite more than 50 years of experience with mature adult gender transitions, there is a lack of convincing evidence that transitions improve the psychological functioning of those with gender dysphoria, and studies on regret have been plagued by high dropout rates that prevent meaningful conclusions for practitioners and patients alike. Pediatric transitions are a much more recent phenomenon, with little to no quality data to guide decision-making.

We are witnessing a growing number of vocal regretters who underwent gender reassignment as teens and young adults under “gender-affirming” care protocols in recent years. A review of stories on the subreddit r/detrans, which counts over 20,000 members (not all are detransitioners, as the forum is open to those fully detransitioned, partially detransitioned, desisted [those who identified as transgender for a period of time in their youth but no longer do], and questioning their transition) is flush with first-hand accounts of regret and should be mandatory reading for any clinician who is considering becoming a prescriber of gender-affirmative care.  

Here is a brief outline of what we know – and more importantly, what we don’t know – about the practice of medically transitioning minors.

Most cases of early childhood-onset gender dysphoria self-resolve. Eleven out of 11 studies that followed the trajectory of gender-variant youth show that the most common outcome is natural resolution of gender dysphoria around or after puberty. Among those diagnosed as having gender identity disorder, 67% no longer met the diagnostic criteria as adults; among those subthreshold for diagnosis, 93% were not gender dysphoric as adults. Gender dysphoria in childhood is a far better predictor of future homosexuality than of future trans identity.

The future trajectory of people whose transgender identity emerged during or after puberty is entirely unknown. No one has studied future trajectories of patients whose transgender identity emerged for the first time after the onset of puberty – a previously rare but now increasingly common presentation. Growing numbers of young detransitioners and desisters are precisely from this demographic, suggesting that a transgender identity that emerges in adolescence may not be durable.

Social transition does not improve mental health outcomes. Recent studies show that while socially transitioned children can thrive in the short term, they do not fare any better than their non–socially transitioned dysphoric peers. It appears that peer relations, not the social transition status, predict mental health in gender-dysphoric children. We don’t yet know the long-term trajectories of socially transitioned minors, but emerging evidence suggests that they may be more likely to persist with gender-related distress rather than outgrow it, as previously observed. This in turn necessitates decades of invasive and risky medical interventions. In fact, the Dutch researchers who pioneered the protocol used to medically transition minors explicitly and strongly discouraged social transition of children and early adolescents.

Nearly 100% of children who begin puberty blockers will proceed to cross-sex hormones and surgeries. The two main studies that have evaluated the effects of puberty blockers on mental health found no improvements or improvements of marginal clinical significance. Both studies are also at critical risk of bias due to the absence of control groups.

Four additional studies looking at the mental health effects of puberty blockers were plagued by design limitations and also failed to show any convincing positive effects on psychological health. However, one effect of puberty blockers has been consistently replicated: At least four studies show that virtually all of the children who start puberty blockers proceed to cross-sex hormones. This suggests that rather than being a pause button, puberty blockers may serve as the “gas pedal” for gender transition.

Most of the long-term health risks are largely unknown. No long-term studies exist of patients who underwent medical transition as teens or young adults. Therefore, our ability to assess risks vs. benefits is limited. Puberty blockers have been demonstrated to significantly impair bone health, and it is not clear whether this will result in future osteoporosis. Cross-sex hormones are associated with roughly 3-5 times the risk for heart attacks and strokes, though long-term studies are of insufficient quality for accurate risk assessments. Other risks associated with these endocrine interventions will come to light as the practice continues to scale and as young people spend years and decades on these interventions. The risks to fertility are largely unknown, but it is almost certain that if puberty blockers are given at the early stages of puberty and followed by cross-sex hormones, sterility will result.

The medical pathway of “affirmative care” rests on a single Dutch study that is not applicable to the current populations of gender-dysphoric youth. Most of the youth presenting for care today would have been explicitly disqualified by the original Dutch protocol, as most have significant mental health comorbidities and post-puberty onset of trans identities. This fact has been recognized by the principal investigators of the Dutch protocol itself, who have recently begun to sound the alarm about the potential misapplication of their protocol and who suggest that psychotherapy – rather than gender reassignment – is more appropriate for many of the currently presenting cases.

On suicidality

The urgency to put gender-dysphoric youth through gender reassignment despite the dearth of evidence appears to stem from the notion that if we don’t intervene medically and in short order, these youth will commit suicide. However, studies using quality data reveal a markedly different reality.

While gender-dysphoric youth do have elevated rates of suicidality, it’s not uniquely high. In fact, it’s roughly similar to the rate of suicidality found in populations of youth referred for other mental health conditions. Quality long-term studies that explored whether transition leads to reduced suicidality have not been able to demonstrate a reduction.

Medicine has a pattern of enthusiastically embracing unproven medical interventions, only to find out years or decades later that the harms from those interventions outweigh the benefits. We owe it to our patients to be transparent about the limits of our knowledge and the fact that the “affirmative care” pathway is largely irreversible.

When the benefits of an intervention have not been shown to outweigh the risks, medical ethics dictate that such interventions should not occur outside of clinical trials. We must not conflate medical care for gender-dysphoric youth with experimental and risky interventions that are based on low-quality evidence. It’s time to hit pause on gender transitions for youth.

A brief history of the Dutch protocol

Before the mid-1990s, medical transition was primarily reserved for mature adults. However, noting the “never-disappearing masculine appearance” of many adult male transitioners, a team of Dutch researchers hypothesized that it might be appropriate to provide early intervention to a carefully selected group of adolescents before the irreversible physical changes of puberty occur.

To differentiate the majority of gender-dysphoric children who would outgrow their cross-sex identification by adulthood from the few who would probably not have resolution and would wish to transition later in life, the Dutch gender clinic designed a rigorous screening protocol, with multidisciplinary teams closely following prospective candidates for several years.

To qualify for early intervention, the adolescents had to have had persistent and severe cross-sex identification from early childhood (cases of adolescent-onset trans identity were disqualified); the distress had to worsen during puberty; and the adolescents had to be free from any other significant mental health conditions. For qualifying adolescents, puberty blockers were initiated no earlier than 12 years of age, cross-sex hormones at 16, and surgeries upon turning 18. Ongoing psychotherapy was provided through the entire assessment and intervention period.

The Dutch team published the final results of their research in 2014. The authors reported that at the average age of 21 (approximately 1.5 years post surgery), the young people were free from gender dysphoria and functioning well. Despite a postsurgical death from infection, several new diagnoses of metabolic illness, and multiple dropouts, the Western world enthusiastically embraced the early-intervention model. Concerningly, the only attempt to replicate the Dutch protocol outside of the Netherlands failed to show any psychological improvements, and to date, no long-term outcome data are available for the cohort of the 55 treated Dutch adolescents.

These progressively irreversible interventions form the basis of the “Dutch Protocol.” Currently, this protocol is being scaled in ways it was never designed for. For example, it strongly discouraged childhood social transition and did not transition adolescents with postpubertal onset of transgender identity or those with significant mental health comorbidities. Yet, treating such cases with the interventions outlined in the Dutch protocol is now common, and the age of eligibility for hormonal and surgical interventions has progressively lowered, with children as young as 8 now eligible to begin puberty blockers.

William Malone, MD, is an assistant professor of endocrinology practicing in Southern Idaho and an adviser to the Society for Evidence-Based Gender Medicine. A version of this article first appeared on Medscape.com.

Teens are identifying as transgender in record numbers. In 2017, 3-4 in 100 teens in the United States reported that they are or may be transgender. A more recent 2021 study suggests that the rate of transgender identification among America’s youth may be as high as 9 in 100. All of the major gender centers in the world have reported a several-thousand-percent increase in youth presenting with gender distress.

Origovisualis/Getty Images

How do we reconcile these numbers with 2013 data reporting the prevalence of adult gender dysphoria to be a rare 2-14 in 100,000? Reflection is warranted because many U.S. medical societies support providing youth who have transgender identification (over 1 million children and adolescents, using the latest estimates) with access to powerful endocrine interventions.

GnRH analogues (colloquially known as “puberty blockers”) are now available at Tanner stage 2 of puberty – a threshold crossed by females as young as 8-9 years old. Cross-sex hormones and surgeries follow, and mastectomies are now available to children as young as 13. Genital-altering surgeries, as well as the removal of the ovaries, uterus, and testes, can be obtained as soon as a patient turns 18.

What’s driving this massive increase in trans-identified youth? What are the risks, benefits, and uncertainties associated with hormonal and surgical interventions? Do such interventions improve the long-term psychological health of gender-dysphoric youth? How many will regret the irreversible changes made to their bodies during what may have been a temporary phase in their development?

We don’t know the answers to these questions, but we need to figure them out before offering such interventions. Frontline clinicians – especially those working with youth – will not be able to remain on the sidelines of this issue for much longer. Each clinician considering writing a prescription for puberty blockers or cross-sex hormones, or generating a referral for surgery, will need to answer for themselves: Just because I can, does it mean I should?

What’s contributing to the rapid rise of gender-dysphoric youth?

The etiology of the rapid rise of transgender identifications in young people is vigorously debated. Proponents of hormonal and surgical interventions for youth argue that the several-thousand-percent increase in the numbers of youth seeking gender reassignment is a reflection of more social acceptance of transgender identities, allowing more young people to “come out.” But closer examination of this claim reveals several inconsistencies.

Because adolescent and young adult females now account for 6-8 in 10 of the presenting cases (previously, prepubertal males were more common), one would expect a commensurate increase in the rate of transgender identification in older females. This has not occurred. In addition, more than three-quarters of currently presenting cases have significant mental health problems or suffer from neurocognitive comorbidities such as autism spectrum disorder or attention-deficit/hyperactivity disorder – a much higher burden of mental health comorbidities than the historical cohort with gender dysphoria.

There is legitimate concern that these comorbid mental health conditions, as well as the influence of social groups and online immersion into transgender topics, may be playing a role in the rapidly growing rate of transgender identification among these particularly vulnerable youth.

The initial study positing the theory that social influence is playing a role in the increased incidence of “late” or adolescent-onset (vs. childhood-onset) transgender-identified youth was harshly attacked by proponents of medical transitioning of youth, despite the fact that the study utilized methods similar to those used in other areas of health research. The study underwent an unprecedented second peer review and emerged with largely unchanged conclusions.

Since the study’s publication, a number of mental health clinicians working directly with gender-distressed youth have corroborated a rapid onset of transgender identification among teens with previously gender-normative childhoods.

Pioneers in gender dysphoria treatment are changing course

Several European countries that were pioneers in pediatric medical transition are now reversing course toward far more caution after their own evidence evaluations failed to show that medically transitioning gender-distressed youth improves mental health outcomes. In Sweden, following Karolinska Hospital’s announcement that it will no longer transition people under 18 outside of strictly regulated clinical trials, a number of other pediatric gender clinics followed suit and made the same decision.

In the United Kingdom, Keira Bell – a young woman who was treated with “affirmative” hormonal and surgical interventions before detransitioning – brought a challenge against the national gender clinic. Her landmark case and the UK High Court’s original judgement against the clinic have highlighted the urgency to reassess treatment approaches for the increasingly varied presentations of gender dysphoria in young people. As this article went to press, the UK’s national gender clinic won its appeal against Keira Bell, meaning that doctors there will once again be able to decide whether their patients under 16 can properly consent to puberty blockers. Keira Bell said she is disappointed with this decision and will be seeking permission to appeal to the Supreme Court. She said the medical service had become “politicized,” and added: “A global conversation has begun and has been shaped by this case. It has shone a light into the dark corners of a medical scandal that is harming children and harmed me. There is more to be done.”

And the UK National Health Service (NHS) has already commissioned an independent systematic review of data, which concluded that the evidence of benefit of hormonal interventions in gender dysphoric youth is of very low certainty and must be carefully weighed against the risks. An independent taskforce has also been convened to reassess the country’s approach to treating gender dysphoric youth.

Finland has arguably undertaken the biggest change of all. An early adopter of pediatric medical transition, researchers there noticed that adolescents who had mental health struggles at baseline failed to improve after transition. The Finnish national Gender Identity Development services issued new treatment guidelines in 2020 stating that psychotherapy, rather than gender reassignment, should be the first line of treatment for gender-dysphoric youth.

Leaders of America’s medical societies have been slower to respond. Recently, the Society for Evidence-Based Gender Medicine applied to share information about youth gender transitions at the yearly meeting of the American Academy of Pediatrics (AAP). The application was denied without explanation, despite the fact that 80% of rank-and-file pediatricians who voted on AAP resolutions days earlier endorsed a resolution calling for a reassessment of the evidence and more caution regarding gender transitions of minors.

The AAP leadership apparently ignored the resounding support for this resolution, but the clear message from that vote is that frontline pediatricians do not agree with the “one size fits all” approach of automatically affirming gender-distressed youth as transgender and proceeding to gender reassignment.

What we know and don’t know


There is now growing evidence that the “gender-affirming” model, based on the unproven assumption that gender reassignment is the best way to help gender-distressed youth, is not living up to its promise. This should not be surprising. Despite more than 50 years of experience with mature adult gender transitions, there is a lack of convincing evidence that transitions improve the psychological functioning of those with gender dysphoria, and studies on regret have been plagued by high dropout rates that prevent meaningful conclusions for practitioners and patients alike. Pediatric transitions are a much more recent phenomenon, with little to no quality data to guide decision-making.

We are witnessing a growing number of vocal regretters who underwent gender reassignment as teens and young adults under “gender-affirming” care protocols in recent years. A review of stories on the subreddit r/detrans, which counts over 20,000 members (not all are detransitioners, as the forum is open to those fully detransitioned, partially detransitioned, desisted [those who identified as transgender for a period of time in their youth but no longer do], and questioning their transition) is flush with first-hand accounts of regret and should be mandatory reading for any clinician who is considering becoming a prescriber of gender-affirmative care.  

Here is a brief outline of what we know – and more importantly, what we don’t know – about the practice of medically transitioning minors.

Most cases of early childhood-onset gender dysphoria self-resolve. Eleven out of 11 studies that followed the trajectory of gender-variant youth show that the most common outcome is natural resolution of gender dysphoria around or after puberty. Among those diagnosed as having gender identity disorder, 67% no longer met the diagnostic criteria as adults; among those subthreshold for diagnosis, 93% were not gender dysphoric as adults. Gender dysphoria in childhood is a far better predictor of future homosexuality than of future trans identity.

The future trajectory of people whose transgender identity emerged during or after puberty is entirely unknown. No one has studied future trajectories of patients whose transgender identity emerged for the first time after the onset of puberty – a previously rare but now increasingly common presentation. Growing numbers of young detransitioners and desisters are precisely from this demographic, suggesting that a transgender identity that emerges in adolescence may not be durable.

Social transition does not improve mental health outcomes. Recent studies show that while socially transitioned children can thrive in the short term, they do not fare any better than their non–socially transitioned dysphoric peers. It appears that peer relations, not the social transition status, predict mental health in gender-dysphoric children. We don’t yet know the long-term trajectories of socially transitioned minors, but emerging evidence suggests that they may be more likely to persist with gender-related distress rather than outgrow it, as previously observed. This in turn necessitates decades of invasive and risky medical interventions. In fact, the Dutch researchers who pioneered the protocol used to medically transition minors explicitly and strongly discouraged social transition of children and early adolescents.

Nearly 100% of children who begin puberty blockers will proceed to cross-sex hormones and surgeries. The two main studies that have evaluated the effects of puberty blockers on mental health found no improvements or improvements of marginal clinical significance. Both studies are also at critical risk of bias due to the absence of control groups.

Four additional studies looking at the mental health effects of puberty blockers were plagued by design limitations and also failed to show any convincing positive effects on psychological health. However, one effect of puberty blockers has been consistently replicated: At least four studies show that virtually all of the children who start puberty blockers proceed to cross-sex hormones. This suggests that rather than being a pause button, puberty blockers may serve as the “gas pedal” for gender transition.

Most of the long-term health risks are largely unknown. No long-term studies exist of patients who underwent medical transition as teens or young adults. Therefore, our ability to assess risks vs. benefits is limited. Puberty blockers have been demonstrated to significantly impair bone health, and it is not clear whether this will result in future osteoporosis. Cross-sex hormones are associated with roughly 3-5 times the risk for heart attacks and strokes, though long-term studies are of insufficient quality for accurate risk assessments. Other risks associated with these endocrine interventions will come to light as the practice continues to scale and as young people spend years and decades on these interventions. The risks to fertility are largely unknown, but it is almost certain that if puberty blockers are given at the early stages of puberty and followed by cross-sex hormones, sterility will result.

The medical pathway of “affirmative care” rests on a single Dutch study that is not applicable to the current populations of gender-dysphoric youth. Most of the youth presenting for care today would have been explicitly disqualified by the original Dutch protocol, as most have significant mental health comorbidities and post-puberty onset of trans identities. This fact has been recognized by the principal investigators of the Dutch protocol itself, who have recently begun to sound the alarm about the potential misapplication of their protocol and who suggest that psychotherapy – rather than gender reassignment – is more appropriate for many of the currently presenting cases.

On suicidality

The urgency to put gender-dysphoric youth through gender reassignment despite the dearth of evidence appears to stem from the notion that if we don’t intervene medically and in short order, these youth will commit suicide. However, studies using quality data reveal a markedly different reality.

While gender-dysphoric youth do have elevated rates of suicidality, it’s not uniquely high. In fact, it’s roughly similar to the rate of suicidality found in populations of youth referred for other mental health conditions. Quality long-term studies that explored whether transition leads to reduced suicidality have not been able to demonstrate a reduction.

Medicine has a pattern of enthusiastically embracing unproven medical interventions, only to find out years or decades later that the harms from those interventions outweigh the benefits. We owe it to our patients to be transparent about the limits of our knowledge and the fact that the “affirmative care” pathway is largely irreversible.

When the benefits of an intervention have not been shown to outweigh the risks, medical ethics dictate that such interventions should not occur outside of clinical trials. We must not conflate medical care for gender-dysphoric youth with experimental and risky interventions that are based on low-quality evidence. It’s time to hit pause on gender transitions for youth.

A brief history of the Dutch protocol

Before the mid-1990s, medical transition was primarily reserved for mature adults. However, noting the “never-disappearing masculine appearance” of many adult male transitioners, a team of Dutch researchers hypothesized that it might be appropriate to provide early intervention to a carefully selected group of adolescents before the irreversible physical changes of puberty occur.

To differentiate the majority of gender-dysphoric children who would outgrow their cross-sex identification by adulthood from the few who would probably not have resolution and would wish to transition later in life, the Dutch gender clinic designed a rigorous screening protocol, with multidisciplinary teams closely following prospective candidates for several years.

To qualify for early intervention, the adolescents had to have had persistent and severe cross-sex identification from early childhood (cases of adolescent-onset trans identity were disqualified); the distress had to worsen during puberty; and the adolescents had to be free from any other significant mental health conditions. For qualifying adolescents, puberty blockers were initiated no earlier than 12 years of age, cross-sex hormones at 16, and surgeries upon turning 18. Ongoing psychotherapy was provided through the entire assessment and intervention period.

The Dutch team published the final results of their research in 2014. The authors reported that at the average age of 21 (approximately 1.5 years post surgery), the young people were free from gender dysphoria and functioning well. Despite a postsurgical death from infection, several new diagnoses of metabolic illness, and multiple dropouts, the Western world enthusiastically embraced the early-intervention model. Concerningly, the only attempt to replicate the Dutch protocol outside of the Netherlands failed to show any psychological improvements, and to date, no long-term outcome data are available for the cohort of the 55 treated Dutch adolescents.

These progressively irreversible interventions form the basis of the “Dutch Protocol.” Currently, this protocol is being scaled in ways it was never designed for. For example, it strongly discouraged childhood social transition and did not transition adolescents with postpubertal onset of transgender identity or those with significant mental health comorbidities. Yet, treating such cases with the interventions outlined in the Dutch protocol is now common, and the age of eligibility for hormonal and surgical interventions has progressively lowered, with children as young as 8 now eligible to begin puberty blockers.

William Malone, MD, is an assistant professor of endocrinology practicing in Southern Idaho and an adviser to the Society for Evidence-Based Gender Medicine. A version of this article first appeared on Medscape.com.

Teens are identifying as transgender in record numbers. In 2017, 3-4 in 100 teens in the United States reported that they are or may be transgender. A more recent 2021 study suggests that the rate of transgender identification among America’s youth may be as high as 9 in 100. All of the major gender centers in the world have reported a several-thousand-percent increase in youth presenting with gender distress.

Origovisualis/Getty Images

How do we reconcile these numbers with 2013 data reporting the prevalence of adult gender dysphoria to be a rare 2-14 in 100,000? Reflection is warranted because many U.S. medical societies support providing youth who have transgender identification (over 1 million children and adolescents, using the latest estimates) with access to powerful endocrine interventions.

GnRH analogues (colloquially known as “puberty blockers”) are now available at Tanner stage 2 of puberty – a threshold crossed by females as young as 8-9 years old. Cross-sex hormones and surgeries follow, and mastectomies are now available to children as young as 13. Genital-altering surgeries, as well as the removal of the ovaries, uterus, and testes, can be obtained as soon as a patient turns 18.

What’s driving this massive increase in trans-identified youth? What are the risks, benefits, and uncertainties associated with hormonal and surgical interventions? Do such interventions improve the long-term psychological health of gender-dysphoric youth? How many will regret the irreversible changes made to their bodies during what may have been a temporary phase in their development?

We don’t know the answers to these questions, but we need to figure them out before offering such interventions. Frontline clinicians – especially those working with youth – will not be able to remain on the sidelines of this issue for much longer. Each clinician considering writing a prescription for puberty blockers or cross-sex hormones, or generating a referral for surgery, will need to answer for themselves: Just because I can, does it mean I should?

What’s contributing to the rapid rise of gender-dysphoric youth?

The etiology of the rapid rise of transgender identifications in young people is vigorously debated. Proponents of hormonal and surgical interventions for youth argue that the several-thousand-percent increase in the numbers of youth seeking gender reassignment is a reflection of more social acceptance of transgender identities, allowing more young people to “come out.” But closer examination of this claim reveals several inconsistencies.

Because adolescent and young adult females now account for 6-8 in 10 of the presenting cases (previously, prepubertal males were more common), one would expect a commensurate increase in the rate of transgender identification in older females. This has not occurred. In addition, more than three-quarters of currently presenting cases have significant mental health problems or suffer from neurocognitive comorbidities such as autism spectrum disorder or attention-deficit/hyperactivity disorder – a much higher burden of mental health comorbidities than the historical cohort with gender dysphoria.

There is legitimate concern that these comorbid mental health conditions, as well as the influence of social groups and online immersion into transgender topics, may be playing a role in the rapidly growing rate of transgender identification among these particularly vulnerable youth.

The initial study positing the theory that social influence is playing a role in the increased incidence of “late” or adolescent-onset (vs. childhood-onset) transgender-identified youth was harshly attacked by proponents of medical transitioning of youth, despite the fact that the study utilized methods similar to those used in other areas of health research. The study underwent an unprecedented second peer review and emerged with largely unchanged conclusions.

Since the study’s publication, a number of mental health clinicians working directly with gender-distressed youth have corroborated a rapid onset of transgender identification among teens with previously gender-normative childhoods.

Pioneers in gender dysphoria treatment are changing course

Several European countries that were pioneers in pediatric medical transition are now reversing course toward far more caution after their own evidence evaluations failed to show that medically transitioning gender-distressed youth improves mental health outcomes. In Sweden, following Karolinska Hospital’s announcement that it will no longer transition people under 18 outside of strictly regulated clinical trials, a number of other pediatric gender clinics followed suit and made the same decision.

In the United Kingdom, Keira Bell – a young woman who was treated with “affirmative” hormonal and surgical interventions before detransitioning – brought a challenge against the national gender clinic. Her landmark case and the UK High Court’s original judgement against the clinic have highlighted the urgency to reassess treatment approaches for the increasingly varied presentations of gender dysphoria in young people. As this article went to press, the UK’s national gender clinic won its appeal against Keira Bell, meaning that doctors there will once again be able to decide whether their patients under 16 can properly consent to puberty blockers. Keira Bell said she is disappointed with this decision and will be seeking permission to appeal to the Supreme Court. She said the medical service had become “politicized,” and added: “A global conversation has begun and has been shaped by this case. It has shone a light into the dark corners of a medical scandal that is harming children and harmed me. There is more to be done.”

And the UK National Health Service (NHS) has already commissioned an independent systematic review of data, which concluded that the evidence of benefit of hormonal interventions in gender dysphoric youth is of very low certainty and must be carefully weighed against the risks. An independent taskforce has also been convened to reassess the country’s approach to treating gender dysphoric youth.

Finland has arguably undertaken the biggest change of all. An early adopter of pediatric medical transition, researchers there noticed that adolescents who had mental health struggles at baseline failed to improve after transition. The Finnish national Gender Identity Development services issued new treatment guidelines in 2020 stating that psychotherapy, rather than gender reassignment, should be the first line of treatment for gender-dysphoric youth.

Leaders of America’s medical societies have been slower to respond. Recently, the Society for Evidence-Based Gender Medicine applied to share information about youth gender transitions at the yearly meeting of the American Academy of Pediatrics (AAP). The application was denied without explanation, despite the fact that 80% of rank-and-file pediatricians who voted on AAP resolutions days earlier endorsed a resolution calling for a reassessment of the evidence and more caution regarding gender transitions of minors.

The AAP leadership apparently ignored the resounding support for this resolution, but the clear message from that vote is that frontline pediatricians do not agree with the “one size fits all” approach of automatically affirming gender-distressed youth as transgender and proceeding to gender reassignment.

What we know and don’t know


There is now growing evidence that the “gender-affirming” model, based on the unproven assumption that gender reassignment is the best way to help gender-distressed youth, is not living up to its promise. This should not be surprising. Despite more than 50 years of experience with mature adult gender transitions, there is a lack of convincing evidence that transitions improve the psychological functioning of those with gender dysphoria, and studies on regret have been plagued by high dropout rates that prevent meaningful conclusions for practitioners and patients alike. Pediatric transitions are a much more recent phenomenon, with little to no quality data to guide decision-making.

We are witnessing a growing number of vocal regretters who underwent gender reassignment as teens and young adults under “gender-affirming” care protocols in recent years. A review of stories on the subreddit r/detrans, which counts over 20,000 members (not all are detransitioners, as the forum is open to those fully detransitioned, partially detransitioned, desisted [those who identified as transgender for a period of time in their youth but no longer do], and questioning their transition) is flush with first-hand accounts of regret and should be mandatory reading for any clinician who is considering becoming a prescriber of gender-affirmative care.  

Here is a brief outline of what we know – and more importantly, what we don’t know – about the practice of medically transitioning minors.

Most cases of early childhood-onset gender dysphoria self-resolve. Eleven out of 11 studies that followed the trajectory of gender-variant youth show that the most common outcome is natural resolution of gender dysphoria around or after puberty. Among those diagnosed as having gender identity disorder, 67% no longer met the diagnostic criteria as adults; among those subthreshold for diagnosis, 93% were not gender dysphoric as adults. Gender dysphoria in childhood is a far better predictor of future homosexuality than of future trans identity.

The future trajectory of people whose transgender identity emerged during or after puberty is entirely unknown. No one has studied future trajectories of patients whose transgender identity emerged for the first time after the onset of puberty – a previously rare but now increasingly common presentation. Growing numbers of young detransitioners and desisters are precisely from this demographic, suggesting that a transgender identity that emerges in adolescence may not be durable.

Social transition does not improve mental health outcomes. Recent studies show that while socially transitioned children can thrive in the short term, they do not fare any better than their non–socially transitioned dysphoric peers. It appears that peer relations, not the social transition status, predict mental health in gender-dysphoric children. We don’t yet know the long-term trajectories of socially transitioned minors, but emerging evidence suggests that they may be more likely to persist with gender-related distress rather than outgrow it, as previously observed. This in turn necessitates decades of invasive and risky medical interventions. In fact, the Dutch researchers who pioneered the protocol used to medically transition minors explicitly and strongly discouraged social transition of children and early adolescents.

Nearly 100% of children who begin puberty blockers will proceed to cross-sex hormones and surgeries. The two main studies that have evaluated the effects of puberty blockers on mental health found no improvements or improvements of marginal clinical significance. Both studies are also at critical risk of bias due to the absence of control groups.

Four additional studies looking at the mental health effects of puberty blockers were plagued by design limitations and also failed to show any convincing positive effects on psychological health. However, one effect of puberty blockers has been consistently replicated: At least four studies show that virtually all of the children who start puberty blockers proceed to cross-sex hormones. This suggests that rather than being a pause button, puberty blockers may serve as the “gas pedal” for gender transition.

Most of the long-term health risks are largely unknown. No long-term studies exist of patients who underwent medical transition as teens or young adults. Therefore, our ability to assess risks vs. benefits is limited. Puberty blockers have been demonstrated to significantly impair bone health, and it is not clear whether this will result in future osteoporosis. Cross-sex hormones are associated with roughly 3-5 times the risk for heart attacks and strokes, though long-term studies are of insufficient quality for accurate risk assessments. Other risks associated with these endocrine interventions will come to light as the practice continues to scale and as young people spend years and decades on these interventions. The risks to fertility are largely unknown, but it is almost certain that if puberty blockers are given at the early stages of puberty and followed by cross-sex hormones, sterility will result.

The medical pathway of “affirmative care” rests on a single Dutch study that is not applicable to the current populations of gender-dysphoric youth. Most of the youth presenting for care today would have been explicitly disqualified by the original Dutch protocol, as most have significant mental health comorbidities and post-puberty onset of trans identities. This fact has been recognized by the principal investigators of the Dutch protocol itself, who have recently begun to sound the alarm about the potential misapplication of their protocol and who suggest that psychotherapy – rather than gender reassignment – is more appropriate for many of the currently presenting cases.

On suicidality

The urgency to put gender-dysphoric youth through gender reassignment despite the dearth of evidence appears to stem from the notion that if we don’t intervene medically and in short order, these youth will commit suicide. However, studies using quality data reveal a markedly different reality.

While gender-dysphoric youth do have elevated rates of suicidality, it’s not uniquely high. In fact, it’s roughly similar to the rate of suicidality found in populations of youth referred for other mental health conditions. Quality long-term studies that explored whether transition leads to reduced suicidality have not been able to demonstrate a reduction.

Medicine has a pattern of enthusiastically embracing unproven medical interventions, only to find out years or decades later that the harms from those interventions outweigh the benefits. We owe it to our patients to be transparent about the limits of our knowledge and the fact that the “affirmative care” pathway is largely irreversible.

When the benefits of an intervention have not been shown to outweigh the risks, medical ethics dictate that such interventions should not occur outside of clinical trials. We must not conflate medical care for gender-dysphoric youth with experimental and risky interventions that are based on low-quality evidence. It’s time to hit pause on gender transitions for youth.

A brief history of the Dutch protocol

Before the mid-1990s, medical transition was primarily reserved for mature adults. However, noting the “never-disappearing masculine appearance” of many adult male transitioners, a team of Dutch researchers hypothesized that it might be appropriate to provide early intervention to a carefully selected group of adolescents before the irreversible physical changes of puberty occur.

To differentiate the majority of gender-dysphoric children who would outgrow their cross-sex identification by adulthood from the few who would probably not have resolution and would wish to transition later in life, the Dutch gender clinic designed a rigorous screening protocol, with multidisciplinary teams closely following prospective candidates for several years.

To qualify for early intervention, the adolescents had to have had persistent and severe cross-sex identification from early childhood (cases of adolescent-onset trans identity were disqualified); the distress had to worsen during puberty; and the adolescents had to be free from any other significant mental health conditions. For qualifying adolescents, puberty blockers were initiated no earlier than 12 years of age, cross-sex hormones at 16, and surgeries upon turning 18. Ongoing psychotherapy was provided through the entire assessment and intervention period.

The Dutch team published the final results of their research in 2014. The authors reported that at the average age of 21 (approximately 1.5 years post surgery), the young people were free from gender dysphoria and functioning well. Despite a postsurgical death from infection, several new diagnoses of metabolic illness, and multiple dropouts, the Western world enthusiastically embraced the early-intervention model. Concerningly, the only attempt to replicate the Dutch protocol outside of the Netherlands failed to show any psychological improvements, and to date, no long-term outcome data are available for the cohort of the 55 treated Dutch adolescents.

These progressively irreversible interventions form the basis of the “Dutch Protocol.” Currently, this protocol is being scaled in ways it was never designed for. For example, it strongly discouraged childhood social transition and did not transition adolescents with postpubertal onset of transgender identity or those with significant mental health comorbidities. Yet, treating such cases with the interventions outlined in the Dutch protocol is now common, and the age of eligibility for hormonal and surgical interventions has progressively lowered, with children as young as 8 now eligible to begin puberty blockers.

William Malone, MD, is an assistant professor of endocrinology practicing in Southern Idaho and an adviser to the Society for Evidence-Based Gender Medicine. A version of this article first appeared on Medscape.com.

Pregnant women should use paracetamol/acetaminophen only with a medical indication and at the lowest effective dose for the shortest possible time, according to an international consensus statement published online Sept. 23 in Nature Reviews Endocrinology.

With global rates of use high and risks considered negligible, the expert panel of 13 U.S. and European authors call for focused research into how this analgesic and febrifuge may impair fetal development and lead to adverse outcomes in children. They outline several precautionary measures to be taken in the meantime.

According to first author and epidemiologist Ann Z. Bauer, ScD, a postdoctoral research fellow at the University of Massachusetts in Lowell, and colleagues, this drug is used by an estimated 65% of pregnant women in the United States, and more than 50% worldwide. It is currently the active ingredient in more than 600 prescription and nonprescription medications, including Tylenol, which historically has been deemed safe in all trimesters of pregnancy.

But a growing body of experimental and epidemiological evidence suggests prenatal exposure to paracetamol (N-acetyl-p-aminophenol, or APAP) might alter fetal development and elevate the risks of neurodevelopmental, reproductive and urogenital disorders in both sexes. Exposure in utero has been linked, for example, to potential behavioral problems in children.

The new recommendations are based on a review of experimental animal and cell-based research as well as human epidemiological data published from January 1995 to October 2020. The authors include clinicians, epidemiologists, and scientists specializing in toxicology, endocrinology, reproductive medicine and neurodevelopment.
 

Recommendations

Although the new guidance does not differ markedly from current advice, the authors believe stronger communication and greater awareness of risks are needed. In addition to restricting use of this medication to low doses for short periods when medically necessary, expectant mothers should receive counseling before conception or early in pregnancy. If uncertain about its use, they should consult their physicians or pharmacists.

In other recommendations, the panel said:

• The 2015 FDA Drug Safety Communication recommendations should be updated based on evaluation of all available scientific evidence.
• The European Medicines Agency Pharmacovigilance Risk Assessment Committee should review the most recent epidemiologic and experimental research and issue an updated Drug Safety Communication.
• Obstetric and gynecological associations should update their guidance after reviewing all available research.
• The Acetaminophen Awareness Coalition (“Know Your Dose” Campaign) should add standardized warnings and specifically advise pregnant women to forgo APAP unless it’s medically indicated.
• All sales of APAP-containing medications should be accompanied by recommendations specifically for use in pregnancy. This information should include warning labels on packaging, and if possible, APAP should be sold only in pharmacies (as in France).

Mechanism of action

APAP is an endocrine disruptor (Neuroscientist. 2020 Sep 11. doi: 10.1177/1073858420952046). “Chemicals that disrupt the endocrine system are concerning because they can interfere with the activity of endogenous hormones that are essential for healthy neurological, urogenital, and reproductive development,” researchers wrote.

“The precise mechanism is not clear but its toxicity is thought to be due mainly to hormone disruption,” Dr. Bauer said in an interview.

Moreover, APAP readily crosses the placenta and blood–brain barrier, and changes in APAP metabolism during pregnancy might make women and their fetuses more vulnerable to its toxic effects. For instance, the molar dose fraction of APAP converted to the oxidative metabolite N-acetyl-p-benzoquinone imine increases during pregnancy. In addition to its hepatotoxicity, this poisonous byproduct is thought to be a genotoxin that increases DNA cleavage by acting on the enzyme topoisomerase II.

Asked for her perspective on the statement, Kjersti Aagaard, MD, PhD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, called the expert panel’s statement thoughtful and comprehensive, but she urged caution in interpreting the role of acetaminophen.

The challenge in linking any commonly used medication to adverse effects and congenital defects, she said, is “teasing out an association from causation. Given the commonality of the use of acetaminophen with the relative rarity of the outcomes, it is clear that not all cases of exposure result in adverse outcomes.”

As for judicious use, she said, one would be to reduce a high fever, which can cause miscarriage, neural tube defects, and potential heart disease in adulthood. Acetaminophen is the drug of choice in this case since nonsteroidal anti-inflammatory drugs such as ibuprofen are not recommended owing to their known risks to the fetal heart.

Dr. Aagaard emphasized that while acetaminophen use is temporally associated with learning and behavioral problems, and urogenital disorders at birth in male infants such as like hypospadias, so is exposure to multiple environmental chemicals and pollutants, as well as climate change. “It would be a real mistake with real life implications if we associated any congenital disease or disorder with a commonly used medication with known benefits if the true causal link lies elsewhere.”

She said the precautionary statements fall into the time-honored therapeutic principle of first do no harm. “However, the call for research action must be undertaken earnestly and sincerely.”

According to Dr. Bauer, the statement’s essential take-home message is that “physicians should educate themselves and educate women about what we’re learning about the risks of acetaminophen in pregnancy.” Risk can be minimized by using the lowest effective dose for the shortest time and only when medically indicated. “Pregnant women should speak to their physicians about acetaminophen. It’s about empowerment and making smart decisions,” she said.

This study received no specific funding. Coauthor Dr. R.T. Mitchell is supported by a UK Research Institute fellowship.

Pregnant women should use paracetamol/acetaminophen only with a medical indication and at the lowest effective dose for the shortest possible time, according to an international consensus statement published online Sept. 23 in Nature Reviews Endocrinology.

With global rates of use high and risks considered negligible, the expert panel of 13 U.S. and European authors call for focused research into how this analgesic and febrifuge may impair fetal development and lead to adverse outcomes in children. They outline several precautionary measures to be taken in the meantime.

According to first author and epidemiologist Ann Z. Bauer, ScD, a postdoctoral research fellow at the University of Massachusetts in Lowell, and colleagues, this drug is used by an estimated 65% of pregnant women in the United States, and more than 50% worldwide. It is currently the active ingredient in more than 600 prescription and nonprescription medications, including Tylenol, which historically has been deemed safe in all trimesters of pregnancy.

But a growing body of experimental and epidemiological evidence suggests prenatal exposure to paracetamol (N-acetyl-p-aminophenol, or APAP) might alter fetal development and elevate the risks of neurodevelopmental, reproductive and urogenital disorders in both sexes. Exposure in utero has been linked, for example, to potential behavioral problems in children.

The new recommendations are based on a review of experimental animal and cell-based research as well as human epidemiological data published from January 1995 to October 2020. The authors include clinicians, epidemiologists, and scientists specializing in toxicology, endocrinology, reproductive medicine and neurodevelopment.
 

Recommendations

Although the new guidance does not differ markedly from current advice, the authors believe stronger communication and greater awareness of risks are needed. In addition to restricting use of this medication to low doses for short periods when medically necessary, expectant mothers should receive counseling before conception or early in pregnancy. If uncertain about its use, they should consult their physicians or pharmacists.

In other recommendations, the panel said:

• The 2015 FDA Drug Safety Communication recommendations should be updated based on evaluation of all available scientific evidence.
• The European Medicines Agency Pharmacovigilance Risk Assessment Committee should review the most recent epidemiologic and experimental research and issue an updated Drug Safety Communication.
• Obstetric and gynecological associations should update their guidance after reviewing all available research.
• The Acetaminophen Awareness Coalition (“Know Your Dose” Campaign) should add standardized warnings and specifically advise pregnant women to forgo APAP unless it’s medically indicated.
• All sales of APAP-containing medications should be accompanied by recommendations specifically for use in pregnancy. This information should include warning labels on packaging, and if possible, APAP should be sold only in pharmacies (as in France).

Mechanism of action

APAP is an endocrine disruptor (Neuroscientist. 2020 Sep 11. doi: 10.1177/1073858420952046). “Chemicals that disrupt the endocrine system are concerning because they can interfere with the activity of endogenous hormones that are essential for healthy neurological, urogenital, and reproductive development,” researchers wrote.

“The precise mechanism is not clear but its toxicity is thought to be due mainly to hormone disruption,” Dr. Bauer said in an interview.

Moreover, APAP readily crosses the placenta and blood–brain barrier, and changes in APAP metabolism during pregnancy might make women and their fetuses more vulnerable to its toxic effects. For instance, the molar dose fraction of APAP converted to the oxidative metabolite N-acetyl-p-benzoquinone imine increases during pregnancy. In addition to its hepatotoxicity, this poisonous byproduct is thought to be a genotoxin that increases DNA cleavage by acting on the enzyme topoisomerase II.

Asked for her perspective on the statement, Kjersti Aagaard, MD, PhD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, called the expert panel’s statement thoughtful and comprehensive, but she urged caution in interpreting the role of acetaminophen.

The challenge in linking any commonly used medication to adverse effects and congenital defects, she said, is “teasing out an association from causation. Given the commonality of the use of acetaminophen with the relative rarity of the outcomes, it is clear that not all cases of exposure result in adverse outcomes.”

As for judicious use, she said, one would be to reduce a high fever, which can cause miscarriage, neural tube defects, and potential heart disease in adulthood. Acetaminophen is the drug of choice in this case since nonsteroidal anti-inflammatory drugs such as ibuprofen are not recommended owing to their known risks to the fetal heart.

Dr. Aagaard emphasized that while acetaminophen use is temporally associated with learning and behavioral problems, and urogenital disorders at birth in male infants such as like hypospadias, so is exposure to multiple environmental chemicals and pollutants, as well as climate change. “It would be a real mistake with real life implications if we associated any congenital disease or disorder with a commonly used medication with known benefits if the true causal link lies elsewhere.”

She said the precautionary statements fall into the time-honored therapeutic principle of first do no harm. “However, the call for research action must be undertaken earnestly and sincerely.”

According to Dr. Bauer, the statement’s essential take-home message is that “physicians should educate themselves and educate women about what we’re learning about the risks of acetaminophen in pregnancy.” Risk can be minimized by using the lowest effective dose for the shortest time and only when medically indicated. “Pregnant women should speak to their physicians about acetaminophen. It’s about empowerment and making smart decisions,” she said.

This study received no specific funding. Coauthor Dr. R.T. Mitchell is supported by a UK Research Institute fellowship.

Pregnant women should use paracetamol/acetaminophen only with a medical indication and at the lowest effective dose for the shortest possible time, according to an international consensus statement published online Sept. 23 in Nature Reviews Endocrinology.

With global rates of use high and risks considered negligible, the expert panel of 13 U.S. and European authors call for focused research into how this analgesic and febrifuge may impair fetal development and lead to adverse outcomes in children. They outline several precautionary measures to be taken in the meantime.

According to first author and epidemiologist Ann Z. Bauer, ScD, a postdoctoral research fellow at the University of Massachusetts in Lowell, and colleagues, this drug is used by an estimated 65% of pregnant women in the United States, and more than 50% worldwide. It is currently the active ingredient in more than 600 prescription and nonprescription medications, including Tylenol, which historically has been deemed safe in all trimesters of pregnancy.

But a growing body of experimental and epidemiological evidence suggests prenatal exposure to paracetamol (N-acetyl-p-aminophenol, or APAP) might alter fetal development and elevate the risks of neurodevelopmental, reproductive and urogenital disorders in both sexes. Exposure in utero has been linked, for example, to potential behavioral problems in children.

The new recommendations are based on a review of experimental animal and cell-based research as well as human epidemiological data published from January 1995 to October 2020. The authors include clinicians, epidemiologists, and scientists specializing in toxicology, endocrinology, reproductive medicine and neurodevelopment.
 

Recommendations

Although the new guidance does not differ markedly from current advice, the authors believe stronger communication and greater awareness of risks are needed. In addition to restricting use of this medication to low doses for short periods when medically necessary, expectant mothers should receive counseling before conception or early in pregnancy. If uncertain about its use, they should consult their physicians or pharmacists.

In other recommendations, the panel said:

• The 2015 FDA Drug Safety Communication recommendations should be updated based on evaluation of all available scientific evidence.
• The European Medicines Agency Pharmacovigilance Risk Assessment Committee should review the most recent epidemiologic and experimental research and issue an updated Drug Safety Communication.
• Obstetric and gynecological associations should update their guidance after reviewing all available research.
• The Acetaminophen Awareness Coalition (“Know Your Dose” Campaign) should add standardized warnings and specifically advise pregnant women to forgo APAP unless it’s medically indicated.
• All sales of APAP-containing medications should be accompanied by recommendations specifically for use in pregnancy. This information should include warning labels on packaging, and if possible, APAP should be sold only in pharmacies (as in France).

Mechanism of action

APAP is an endocrine disruptor (Neuroscientist. 2020 Sep 11. doi: 10.1177/1073858420952046). “Chemicals that disrupt the endocrine system are concerning because they can interfere with the activity of endogenous hormones that are essential for healthy neurological, urogenital, and reproductive development,” researchers wrote.

“The precise mechanism is not clear but its toxicity is thought to be due mainly to hormone disruption,” Dr. Bauer said in an interview.

Moreover, APAP readily crosses the placenta and blood–brain barrier, and changes in APAP metabolism during pregnancy might make women and their fetuses more vulnerable to its toxic effects. For instance, the molar dose fraction of APAP converted to the oxidative metabolite N-acetyl-p-benzoquinone imine increases during pregnancy. In addition to its hepatotoxicity, this poisonous byproduct is thought to be a genotoxin that increases DNA cleavage by acting on the enzyme topoisomerase II.

Asked for her perspective on the statement, Kjersti Aagaard, MD, PhD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, called the expert panel’s statement thoughtful and comprehensive, but she urged caution in interpreting the role of acetaminophen.

The challenge in linking any commonly used medication to adverse effects and congenital defects, she said, is “teasing out an association from causation. Given the commonality of the use of acetaminophen with the relative rarity of the outcomes, it is clear that not all cases of exposure result in adverse outcomes.”

As for judicious use, she said, one would be to reduce a high fever, which can cause miscarriage, neural tube defects, and potential heart disease in adulthood. Acetaminophen is the drug of choice in this case since nonsteroidal anti-inflammatory drugs such as ibuprofen are not recommended owing to their known risks to the fetal heart.

Dr. Aagaard emphasized that while acetaminophen use is temporally associated with learning and behavioral problems, and urogenital disorders at birth in male infants such as like hypospadias, so is exposure to multiple environmental chemicals and pollutants, as well as climate change. “It would be a real mistake with real life implications if we associated any congenital disease or disorder with a commonly used medication with known benefits if the true causal link lies elsewhere.”

She said the precautionary statements fall into the time-honored therapeutic principle of first do no harm. “However, the call for research action must be undertaken earnestly and sincerely.”

According to Dr. Bauer, the statement’s essential take-home message is that “physicians should educate themselves and educate women about what we’re learning about the risks of acetaminophen in pregnancy.” Risk can be minimized by using the lowest effective dose for the shortest time and only when medically indicated. “Pregnant women should speak to their physicians about acetaminophen. It’s about empowerment and making smart decisions,” she said.

This study received no specific funding. Coauthor Dr. R.T. Mitchell is supported by a UK Research Institute fellowship.

Bacteria get the rack ... the towel rack

Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.

Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.

pxfuel

Anti-vaxxers would like to be called ‘purebloods’

COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”

peterschreiber_media/iStock/Getty Images

Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.

Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.

Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
 

Hated broccoli? Blame your DNA

Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.

Hans Braxmeier/Pixabay

Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.

These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.

The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.

Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.

Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.

Bacteria get the rack ... the towel rack

Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.

Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.

pxfuel

Anti-vaxxers would like to be called ‘purebloods’

COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”

peterschreiber_media/iStock/Getty Images

Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.

Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.

Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
 

Hated broccoli? Blame your DNA

Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.

Hans Braxmeier/Pixabay

Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.

These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.

The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.

Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.

Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.

Bacteria get the rack ... the towel rack

Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.

Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.

pxfuel

Anti-vaxxers would like to be called ‘purebloods’

COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”

peterschreiber_media/iStock/Getty Images

Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.

Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.

Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
 

Hated broccoli? Blame your DNA

Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.

Hans Braxmeier/Pixabay

Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.

These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.

The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.

Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.

Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.

The U.S. Food and Drug Administration (FDA) late Sept. 22 granted emergency use authorization (EUA) for a third dose of the Pfizer COVID-19 vaccine for those over the age of 65 and a wide swath of Americans at higher risk for infection.

The agency’s move comes as a Centers for Disease Control and Prevention (CDC) panel ended the first day of a 2-day meeting. That panel, the Advisory Committee on Immunization Practices (ACIP), is expected to vote Sept. 23 to instruct doctors on how to administer the boosters.

The FDA officially authorized the vaccine not only for individuals 65 and older, but also for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release.

The recommendations align with those from an FDA advisory panel Sept. 17.

The agency determined that the benefits of a booster dose outweigh the risks for people now authorized to receive it, according to the news release.
 

Other questions remain

So, how will this work? That was the main question weighing on the minds of the CDC’s ACIP during their first day of a 2-day meeting where they are expected to make recommendations on booster doses for Americans.

The panel discussed situations the FDA will still need to consider, such as what should be done for Americans who were originally vaccinated with a Moderna or Johnson and Johnson vaccine, but are not covered under the revised EUA, which is only for those people who received Pfizer’s two-dose vaccine regimen.

“That’s going to leave half of the people immunized in this age group having received the vaccine and being told that they’re at risk now for waning immunity and hospitalization unable to get a booster dose,” said committee member Sarah S. Long, MD, a professor of pediatrics at Drexel University College of Medicine in Philadelphia. “So that’s a big public health panic that we would like to avoid.”

Johnson and Johnson recently reported that second doses of its vaccine boosted its efficacy to almost 94% against COVID-19. A new study, published ahead of peer review, suggests that the efficacy of the single-dose Johnson and Johnson shot has fallen to about 78% against symptomatic infection during the Delta surge.

Moderna has applied for permission to market third doses of its vaccine in the United States, but the FDA has given no timeline on when it might make a decision. 

Doran Fink, MD, PhD, deputy director of the FDA’s Division of Vaccines and Related Products Applications, a representative advising the committee Sept. 22, said the agency was working as rapidly as possible on Moderna’s submission.

Regarding the question of whether it was OK to mix vaccines, rather than match them, Dr. Fink said there are currently not enough data available to inform that decision.

Those answers are coming, though. John Beigel, MD, associate director of clinical research at the National Institute of Allergy and Infectious Diseases, revealed that the federal government has a study underway to see what happens when the vaccines are mixed with each other. 

He said that data from the study would be available later this fall, and would certainly help physicians and other healthcare providers know whether it’s effective or safe to use them interchangeably.
 

Correlates of immunity

The ACIP left much of its schedule open Sept. 23 to discuss extra Pfizer doses and vote on how they should be used.

Pfizer had originally applied to the FDA for an amendment to its FDA approval, which would have given doctors a freer hand to prescribe third doses as they saw fit, in patients as young as 16.

But the FDA’s Vaccines and Related Biological Products Advisory Committee voted Sept. 17 against granting the amendment. The committee was particularly concerned about the lack of data in teens ages 16 and 17, who have the highest risk for a rare side effect that causes heart inflammation that requires hospital care.

Instead, they recommended — and the FDA agreed per their decision Sept. 22 — that third doses should be given to people at higher risk for severe breakthrough infections because of advanced age or because they work in an occupation that puts them at high risk for exposure. 

The CDC panel heard important presentations on new science that is helping to identify the correlates of immunity. 

The correlates of immunity are biomarkers that can be measured in blood that help doctors understand how protected a person may be against COVID-19. These markers of immunity are not yet known for the COVID-19 vaccines.

Emerging evidence shows that booster doses of the Pfizer vaccine cause front-line immune defenders — called binding antibodies — to roughly triple soon after a person gets the third shot. 

Neutralizing antibodies also jump soon after two vaccine doses, but they fall over time, which is natural. The body doesn’t need these foot soldiers to be on guard all the time, so they go away. 

The body retains its memory of how to make them, however, so they can quickly be marshaled again, if needed.

Early studies suggest that antibodies account for about two thirds of a person’s protection against COVID, while the longer-lasting T-cells and B-cells account for about one third.

After the antibody levels fall, it may take a few days to recreate this army. In the meantime, the virus can try to break in. This can cause symptoms, which can make a person feel terrible, but for the most part, vaccinated individuals don’t need hospital care and are nearly always protected from dying — even against the Delta variant.

Those most likely to be at risk for a breakthrough infection are older, because immune function wanes with age.
 

Essential workers

Essential workers, such as those who work in healthcare, may also benefit from high antibody levels, which can minimize symptoms and help them get back to work more quickly.

Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, said that in her area staffing levels are critical right now.

“I’m actually sitting in one of the deepest red [states] with high rates of COVID. We don’t have enough health care workers currently to take care of the unvaccinated,” she said. 

“When we have beds, we are often missing staff, and so the idea of vaccinating health care workers is to be a little bit different than our idea of using vaccines in the general population,” Dr. Talbot said.

Oliver Brooks, MD, chief medical officer of the Watts Healthcare Corporation in Los Angeles, said he was in favor of making a public statement about the temporary nature of the potential recommendations Sept. 23, because they probably won’t cover all who might need a third shot.

“We may want to go on record stating what it is that would allow us to broaden our recommendation or restrict our recommendation,” Dr. Brooks said.

The considerations of who should get an extra dose are not always straightforward.

New modeling by the Harvard TH Chan School of Public Health and the CDC to assist the government’s decisions on boosters had a surprise finding: in nursing homes, it’s more effective to vaccinate healthcare workers than it is to give booster doses to these residents. Nursing homes are at the mercy of community transmission. 

In regions with high transmission, it’s easy for a caregiver to bring the virus into a facility — so the models found that the transmission from these workers is a more effective strategy than giving third doses to the already highly vaccinated group of seniors who live in them.

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

The U.S. Food and Drug Administration (FDA) late Sept. 22 granted emergency use authorization (EUA) for a third dose of the Pfizer COVID-19 vaccine for those over the age of 65 and a wide swath of Americans at higher risk for infection.

The agency’s move comes as a Centers for Disease Control and Prevention (CDC) panel ended the first day of a 2-day meeting. That panel, the Advisory Committee on Immunization Practices (ACIP), is expected to vote Sept. 23 to instruct doctors on how to administer the boosters.

The FDA officially authorized the vaccine not only for individuals 65 and older, but also for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release.

The recommendations align with those from an FDA advisory panel Sept. 17.

The agency determined that the benefits of a booster dose outweigh the risks for people now authorized to receive it, according to the news release.
 

Other questions remain

So, how will this work? That was the main question weighing on the minds of the CDC’s ACIP during their first day of a 2-day meeting where they are expected to make recommendations on booster doses for Americans.

The panel discussed situations the FDA will still need to consider, such as what should be done for Americans who were originally vaccinated with a Moderna or Johnson and Johnson vaccine, but are not covered under the revised EUA, which is only for those people who received Pfizer’s two-dose vaccine regimen.

“That’s going to leave half of the people immunized in this age group having received the vaccine and being told that they’re at risk now for waning immunity and hospitalization unable to get a booster dose,” said committee member Sarah S. Long, MD, a professor of pediatrics at Drexel University College of Medicine in Philadelphia. “So that’s a big public health panic that we would like to avoid.”

Johnson and Johnson recently reported that second doses of its vaccine boosted its efficacy to almost 94% against COVID-19. A new study, published ahead of peer review, suggests that the efficacy of the single-dose Johnson and Johnson shot has fallen to about 78% against symptomatic infection during the Delta surge.

Moderna has applied for permission to market third doses of its vaccine in the United States, but the FDA has given no timeline on when it might make a decision. 

Doran Fink, MD, PhD, deputy director of the FDA’s Division of Vaccines and Related Products Applications, a representative advising the committee Sept. 22, said the agency was working as rapidly as possible on Moderna’s submission.

Regarding the question of whether it was OK to mix vaccines, rather than match them, Dr. Fink said there are currently not enough data available to inform that decision.

Those answers are coming, though. John Beigel, MD, associate director of clinical research at the National Institute of Allergy and Infectious Diseases, revealed that the federal government has a study underway to see what happens when the vaccines are mixed with each other. 

He said that data from the study would be available later this fall, and would certainly help physicians and other healthcare providers know whether it’s effective or safe to use them interchangeably.
 

Correlates of immunity

The ACIP left much of its schedule open Sept. 23 to discuss extra Pfizer doses and vote on how they should be used.

Pfizer had originally applied to the FDA for an amendment to its FDA approval, which would have given doctors a freer hand to prescribe third doses as they saw fit, in patients as young as 16.

But the FDA’s Vaccines and Related Biological Products Advisory Committee voted Sept. 17 against granting the amendment. The committee was particularly concerned about the lack of data in teens ages 16 and 17, who have the highest risk for a rare side effect that causes heart inflammation that requires hospital care.

Instead, they recommended — and the FDA agreed per their decision Sept. 22 — that third doses should be given to people at higher risk for severe breakthrough infections because of advanced age or because they work in an occupation that puts them at high risk for exposure. 

The CDC panel heard important presentations on new science that is helping to identify the correlates of immunity. 

The correlates of immunity are biomarkers that can be measured in blood that help doctors understand how protected a person may be against COVID-19. These markers of immunity are not yet known for the COVID-19 vaccines.

Emerging evidence shows that booster doses of the Pfizer vaccine cause front-line immune defenders — called binding antibodies — to roughly triple soon after a person gets the third shot. 

Neutralizing antibodies also jump soon after two vaccine doses, but they fall over time, which is natural. The body doesn’t need these foot soldiers to be on guard all the time, so they go away. 

The body retains its memory of how to make them, however, so they can quickly be marshaled again, if needed.

Early studies suggest that antibodies account for about two thirds of a person’s protection against COVID, while the longer-lasting T-cells and B-cells account for about one third.

After the antibody levels fall, it may take a few days to recreate this army. In the meantime, the virus can try to break in. This can cause symptoms, which can make a person feel terrible, but for the most part, vaccinated individuals don’t need hospital care and are nearly always protected from dying — even against the Delta variant.

Those most likely to be at risk for a breakthrough infection are older, because immune function wanes with age.
 

Essential workers

Essential workers, such as those who work in healthcare, may also benefit from high antibody levels, which can minimize symptoms and help them get back to work more quickly.

Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, said that in her area staffing levels are critical right now.

“I’m actually sitting in one of the deepest red [states] with high rates of COVID. We don’t have enough health care workers currently to take care of the unvaccinated,” she said. 

“When we have beds, we are often missing staff, and so the idea of vaccinating health care workers is to be a little bit different than our idea of using vaccines in the general population,” Dr. Talbot said.

Oliver Brooks, MD, chief medical officer of the Watts Healthcare Corporation in Los Angeles, said he was in favor of making a public statement about the temporary nature of the potential recommendations Sept. 23, because they probably won’t cover all who might need a third shot.

“We may want to go on record stating what it is that would allow us to broaden our recommendation or restrict our recommendation,” Dr. Brooks said.

The considerations of who should get an extra dose are not always straightforward.

New modeling by the Harvard TH Chan School of Public Health and the CDC to assist the government’s decisions on boosters had a surprise finding: in nursing homes, it’s more effective to vaccinate healthcare workers than it is to give booster doses to these residents. Nursing homes are at the mercy of community transmission. 

In regions with high transmission, it’s easy for a caregiver to bring the virus into a facility — so the models found that the transmission from these workers is a more effective strategy than giving third doses to the already highly vaccinated group of seniors who live in them.

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

The U.S. Food and Drug Administration (FDA) late Sept. 22 granted emergency use authorization (EUA) for a third dose of the Pfizer COVID-19 vaccine for those over the age of 65 and a wide swath of Americans at higher risk for infection.

The agency’s move comes as a Centers for Disease Control and Prevention (CDC) panel ended the first day of a 2-day meeting. That panel, the Advisory Committee on Immunization Practices (ACIP), is expected to vote Sept. 23 to instruct doctors on how to administer the boosters.

The FDA officially authorized the vaccine not only for individuals 65 and older, but also for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release.

The recommendations align with those from an FDA advisory panel Sept. 17.

The agency determined that the benefits of a booster dose outweigh the risks for people now authorized to receive it, according to the news release.
 

Other questions remain

So, how will this work? That was the main question weighing on the minds of the CDC’s ACIP during their first day of a 2-day meeting where they are expected to make recommendations on booster doses for Americans.

The panel discussed situations the FDA will still need to consider, such as what should be done for Americans who were originally vaccinated with a Moderna or Johnson and Johnson vaccine, but are not covered under the revised EUA, which is only for those people who received Pfizer’s two-dose vaccine regimen.

“That’s going to leave half of the people immunized in this age group having received the vaccine and being told that they’re at risk now for waning immunity and hospitalization unable to get a booster dose,” said committee member Sarah S. Long, MD, a professor of pediatrics at Drexel University College of Medicine in Philadelphia. “So that’s a big public health panic that we would like to avoid.”

Johnson and Johnson recently reported that second doses of its vaccine boosted its efficacy to almost 94% against COVID-19. A new study, published ahead of peer review, suggests that the efficacy of the single-dose Johnson and Johnson shot has fallen to about 78% against symptomatic infection during the Delta surge.

Moderna has applied for permission to market third doses of its vaccine in the United States, but the FDA has given no timeline on when it might make a decision. 

Doran Fink, MD, PhD, deputy director of the FDA’s Division of Vaccines and Related Products Applications, a representative advising the committee Sept. 22, said the agency was working as rapidly as possible on Moderna’s submission.

Regarding the question of whether it was OK to mix vaccines, rather than match them, Dr. Fink said there are currently not enough data available to inform that decision.

Those answers are coming, though. John Beigel, MD, associate director of clinical research at the National Institute of Allergy and Infectious Diseases, revealed that the federal government has a study underway to see what happens when the vaccines are mixed with each other. 

He said that data from the study would be available later this fall, and would certainly help physicians and other healthcare providers know whether it’s effective or safe to use them interchangeably.
 

Correlates of immunity

The ACIP left much of its schedule open Sept. 23 to discuss extra Pfizer doses and vote on how they should be used.

Pfizer had originally applied to the FDA for an amendment to its FDA approval, which would have given doctors a freer hand to prescribe third doses as they saw fit, in patients as young as 16.

But the FDA’s Vaccines and Related Biological Products Advisory Committee voted Sept. 17 against granting the amendment. The committee was particularly concerned about the lack of data in teens ages 16 and 17, who have the highest risk for a rare side effect that causes heart inflammation that requires hospital care.

Instead, they recommended — and the FDA agreed per their decision Sept. 22 — that third doses should be given to people at higher risk for severe breakthrough infections because of advanced age or because they work in an occupation that puts them at high risk for exposure. 

The CDC panel heard important presentations on new science that is helping to identify the correlates of immunity. 

The correlates of immunity are biomarkers that can be measured in blood that help doctors understand how protected a person may be against COVID-19. These markers of immunity are not yet known for the COVID-19 vaccines.

Emerging evidence shows that booster doses of the Pfizer vaccine cause front-line immune defenders — called binding antibodies — to roughly triple soon after a person gets the third shot. 

Neutralizing antibodies also jump soon after two vaccine doses, but they fall over time, which is natural. The body doesn’t need these foot soldiers to be on guard all the time, so they go away. 

The body retains its memory of how to make them, however, so they can quickly be marshaled again, if needed.

Early studies suggest that antibodies account for about two thirds of a person’s protection against COVID, while the longer-lasting T-cells and B-cells account for about one third.

After the antibody levels fall, it may take a few days to recreate this army. In the meantime, the virus can try to break in. This can cause symptoms, which can make a person feel terrible, but for the most part, vaccinated individuals don’t need hospital care and are nearly always protected from dying — even against the Delta variant.

Those most likely to be at risk for a breakthrough infection are older, because immune function wanes with age.
 

Essential workers

Essential workers, such as those who work in healthcare, may also benefit from high antibody levels, which can minimize symptoms and help them get back to work more quickly.

Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, said that in her area staffing levels are critical right now.

“I’m actually sitting in one of the deepest red [states] with high rates of COVID. We don’t have enough health care workers currently to take care of the unvaccinated,” she said. 

“When we have beds, we are often missing staff, and so the idea of vaccinating health care workers is to be a little bit different than our idea of using vaccines in the general population,” Dr. Talbot said.

Oliver Brooks, MD, chief medical officer of the Watts Healthcare Corporation in Los Angeles, said he was in favor of making a public statement about the temporary nature of the potential recommendations Sept. 23, because they probably won’t cover all who might need a third shot.

“We may want to go on record stating what it is that would allow us to broaden our recommendation or restrict our recommendation,” Dr. Brooks said.

The considerations of who should get an extra dose are not always straightforward.

New modeling by the Harvard TH Chan School of Public Health and the CDC to assist the government’s decisions on boosters had a surprise finding: in nursing homes, it’s more effective to vaccinate healthcare workers than it is to give booster doses to these residents. Nursing homes are at the mercy of community transmission. 

In regions with high transmission, it’s easy for a caregiver to bring the virus into a facility — so the models found that the transmission from these workers is a more effective strategy than giving third doses to the already highly vaccinated group of seniors who live in them.

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