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In Case You Missed It: COVID
Top questions answered about COVID-19 boosters for your patients
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.
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.
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.
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.
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.
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.
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.
COVID-19 a rare trigger for Guillain-Barré syndrome
Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.
“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.
The study was published online in the journal Brain.
No uptick in pandemic cases
Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.
To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.
The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.
Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”
Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.
The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.
Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.
All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.
All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).
The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days.
More research needed
The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”
Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”
“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2.
“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.
The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.
A version of this article first appeared on Medscape.com.
Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.
“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.
The study was published online in the journal Brain.
No uptick in pandemic cases
Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.
To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.
The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.
Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”
Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.
The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.
Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.
All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.
All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).
The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days.
More research needed
The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”
Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”
“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2.
“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.
The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.
A version of this article first appeared on Medscape.com.
Although Guillain-Barré syndrome may rarely follow a recent infection with SARS-CoV-2, a strong relationship of GBS with the novel coronavirus is unlikely, say researchers with the International GBS Outcome Study (IGOS) consortium.
“Our study shows that COVID-19 may precede Guillain-Barré syndrome in rare cases, but the existence of a true association or causal relation still needs to be established,” Bart Jacobs, MD, PhD, department of neurology and immunology, Erasmus Medical Center and University Medical Center, both in Rotterdam, the Netherlands, said in a statement.
The study was published online in the journal Brain.
No uptick in pandemic cases
Since the beginning of the pandemic, there are reports of more than 90 GBS diagnoses following a possible COVID-19 infection. However, it remains unclear whether COVID-19 is another potential infectious trigger or whether the reported cases are coincidental.
To investigate further, Dr. Jacobs and the IGOS consortium reviewed 49 patients (median age, 56 years) with GBS who were added to their ongoing prospective observational cohort study between Jan. 30 and May 30, 2020.
The patients came from China, Denmark, France, Greece, Italy, Japan, the Netherlands, Spain, Switzerland, and the United Kingdom.
Of the 49 GBS patients, 8 (16%) had a confirmed and 3 (6%) had a probable SARS-CoV-2 infection; 15 had possible SARS-CoV-2 infection, 21 had no suspicion of SARS-CoV-2 infection, and 2 were “unclassifiable.”
Of the 11 patients with confirmed/probable SARS-CoV-2 infection, 9 had no serological evidence of any other recent preceding infection known to be associated with GBS.
The other two had serological evidence of a recent Campylobacter jejuni infection, which could have played a role in GBS onset, the researchers noted.
Most patients with a confirmed/probable SARS-CoV-2 infection had a sensorimotor GBS variant (73%), although Miller Fisher syndrome–GBS overlap (18%) and an ataxic variant (9%) were also found.
All patients with a confirmed/probable SARS-CoV-2 infection had a severe form of GBS. Common early neurologic features were facial weakness (64%), sensory deficits (82%), and autonomic dysfunction (64%), although not significantly different, compared with the other patients.
All eight patients who underwent nerve conduction study had a demyelinating subtype, which was more frequent than in the other GBS patients (47%; P = .012) as well as historical region and age-matched controls included in the IGOS cohort before the pandemic (52%, P = .016).
The median time from the onset of SARS-CoV-2 infection to neurologic symptoms was 16 days and ranged from 12 to 22 days.
More research needed
The researchers noted that the 22% frequency of a preceding SARS-CoV-2 infection in this study population was “higher than estimates of the contemporaneous background prevalence of SARS-CoV-2, which may be a result of recruitment bias during the pandemic, but could also indicate that GBS may rarely follow a recent SARS-CoV-2 infection.”
Importantly, however, they did not find more patients diagnosed with GBS during the first 4 months of the pandemic, compared with previous years, “suggesting that a strong association between SARS-CoV-2 and GBS is unlikely.”
“Should SARS-CoV-2 indeed be able to trigger GBS, our data are consistent with a postinfectious disease mechanism rather than direct viral invasion,” they noted, adding that the study was not designed to quantify a causative link between GBS and SARS-CoV-2.
“An unbiased multicenter, international, case-control study is needed to determine whether there is an association or not,” they wrote.
The IGOS is financially supported by the GBS-CIDP Foundation International, Gain, Erasmus MC University Medical Center Rotterdam, Glasgow University, CSL Behring, Grifols, Annexon and Hansa Biopharma. Dr. Jacobs received grants from Grifols, CSL-Behring, Annexon, Prinses Beatrix Spierfonds, Hansa Biopharma, and GBS-CIDP Foundation International and is on the global medical advisory board of the GBS CIDP Foundation International.
A version of this article first appeared on Medscape.com.
CDC chief overrules panel, OKs boosters for health care workers
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 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 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.
Long COVID appears to ‘impair’ survival in cancer patients
More than one in six cancer patients experience long-term sequelae following SARS-CoV-2 infection, placing them at increased risk of discontinuing their cancer treatment or dying, according to European registry data.
Given the “high lethality” of COVID-19 in cancer patients and the risk for long-term complications following infection in the general population, Alessio Cortellini, MD, a consultant medical oncologist at Hammersmith Hospital and Imperial College London, and colleagues wanted to explore the “prevalence and clinical significance of COVID-19 sequelae in cancer patients and their oncological continuity of care.”
Dr. Cortellini presented the OnCovid registry research on Sept. 21 at the 2021 European Society for Medical Oncology Congress. He reported that overall, the data suggest that post–COVID-19 complications may “impair” patients’ cancer survival as well as their cancer care.
The OnCovid registry data showed that the 15% of cancer patients who had long-term COVID-19 complications were 76% more likely to die than those without sequelae. Cancer patients with COVID-19 sequelae were significantly more likely to permanently stop taking their systemic anticancer therapy, and they were more than 3.5 times more likely to die than those who continued their treatment as planned. In terms of long-term complications, almost half of patients experienced dyspnea, and two-fifths reported chronic fatigue.
“This data confirms the need to continue to prioritize cancer patients,” Antonio Passaro, MD, PhD, division of thoracic oncology, European Institute of Oncology IRCCS, Milan, commented in a press release. “In the fight against the pandemic, it is of the utmost importance that we do not neglect to study and understand the curves of cancer incidence and mortality.”
Invited to discuss the results, Anne-Marie C. Dingemans, MD, PhD, a pulmonologist and professor of thoracic oncology at Erasmus Medical Center, Rotterdam, the Netherlands, said COVID-19 remains a “very important” issue for cancer patients.
Interestingly, Dr. Dingemans noted that COVID-19 sequelae in patients with cancer appear to occur slightly less frequently, compared with estimates in the general population – which range from 13% to 60% – though patients with cancer tend to have more respiratory problems.
However, Dr. Dingemans added, the difficulty with comparing sequelae rates between cancer patients and the general population is that cancer patients “probably already have a lot of symptoms” associated with long COVID, such as dyspnea and fatigue, and may not be aware that they are experiencing COVID sequelae.
The registry results
To investigate the long-term impact of COVID-19 on survival and continuity of care, the team examined data from the OnCovid registry, which was established at the beginning of the pandemic to study consecutive patients aged 18 years and older with confirmed SARS-CoV-2 infection and a history of solid or hematologic malignancies.
At the data cutoff on March 1, 2021, the registry included 35 institutions in six European countries. The institutions collected information on patient demographics and comorbidities, cancer history, anticancer therapy, COVID-19 investigations, and COVID-19–specific therapies.
For the current analysis, the team included 1,557 of 2,634 patients who had undergone a clinical reassessment after recovering from COVID-19. Information sufficient to conduct multivariate analysis was available for 840 of these patients.
About half of the patients were younger than 60 years, and just over half were women. The most common cancer diagnoses were breast cancer (23.4%), gastrointestinal tumors (16.5%), gynecologic/genitourinary tumors (19.3%), and hematologic cancers (14.1%), with even distribution between local/locoregional and advanced disease.
The median interval between COVID-19 recovery and reassessment was 44 days, and the mean post–COVID-19 follow-up period was 128 days.
About 15% of patients experienced at least one long-term sequela from COVID-19. The most common were dyspnea/shortness of breath (49.6%), fatigue (41.0%), chronic cough (33.8%), and other respiratory complications (10.7%).
Dr. Cortellini noted that cancer patients who experienced sequelae were more likely to be male, aged 65 years or older, to have at least two comorbidities, and to have a history of smoking. In addition, cancer patients who experienced long-term complications were significantly more likely to have had COVID-19 complications, to have required COVID-19 therapy, and to have been hospitalized for the disease.
Factoring in gender, age, comorbidity burden, primary tumor, stage, receipt of anticancer and anti–COVID-19 therapy, COVID-19 complications, and hospitalization, the team found that COVID-19 sequelae were independently associated with an increased risk for death (hazard ratio, 1.76).
Further analysis of patterns of systemic anticancer therapy in 471 patients revealed that 14.8% of COVID-19 survivors permanently discontinued therapy and that a dose or regimen adjustment occurred for 37.8%.
Patients who permanently discontinued anticancer therapy were more likely to be former or current smokers, to have had COVID-19 complications or been hospitalized for COVID-19, and to have had COVID-19 sequelae at reassessment. The investigators found no association between permanent discontinuation of therapy and cancer disease stage.
Dr. Cortellini and colleagues reported that permanent cessation of systemic anticancer therapy was associated with an increased risk for death. A change in dose or regimen did not affect survival.
The most common reason for stopping therapy permanently was deterioration of the patient’s performance status (61.3%), followed by disease progression (29.0%). Dose or regimen adjustments typically occurred to avoid immune suppression (50.0%), hospitalization (25.8%), and intravenous drug administration (19.1%).
Dr. Cortellini concluded his presentation by highlighting the importance of increasing awareness of long COVID in patients with cancer as well as early treatment of COVID-19 sequelae to improve patient outcomes.
The study was funded by the Imperial College Biomedical Research Center. Dr. Cortellini has relationships with MSD, Bristol-Myers Squibb, Roche, Novartis, AstraZeneca, Astellas, and Sun Pharma. Dr. Dingemans has relationships with Roche, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Jansen, Chiesi, Amgen, Pfizer, Bayer, Takeda, Pharmamar, and Sanofi.
A version of this article first appeared on Medscape.com.
More than one in six cancer patients experience long-term sequelae following SARS-CoV-2 infection, placing them at increased risk of discontinuing their cancer treatment or dying, according to European registry data.
Given the “high lethality” of COVID-19 in cancer patients and the risk for long-term complications following infection in the general population, Alessio Cortellini, MD, a consultant medical oncologist at Hammersmith Hospital and Imperial College London, and colleagues wanted to explore the “prevalence and clinical significance of COVID-19 sequelae in cancer patients and their oncological continuity of care.”
Dr. Cortellini presented the OnCovid registry research on Sept. 21 at the 2021 European Society for Medical Oncology Congress. He reported that overall, the data suggest that post–COVID-19 complications may “impair” patients’ cancer survival as well as their cancer care.
The OnCovid registry data showed that the 15% of cancer patients who had long-term COVID-19 complications were 76% more likely to die than those without sequelae. Cancer patients with COVID-19 sequelae were significantly more likely to permanently stop taking their systemic anticancer therapy, and they were more than 3.5 times more likely to die than those who continued their treatment as planned. In terms of long-term complications, almost half of patients experienced dyspnea, and two-fifths reported chronic fatigue.
“This data confirms the need to continue to prioritize cancer patients,” Antonio Passaro, MD, PhD, division of thoracic oncology, European Institute of Oncology IRCCS, Milan, commented in a press release. “In the fight against the pandemic, it is of the utmost importance that we do not neglect to study and understand the curves of cancer incidence and mortality.”
Invited to discuss the results, Anne-Marie C. Dingemans, MD, PhD, a pulmonologist and professor of thoracic oncology at Erasmus Medical Center, Rotterdam, the Netherlands, said COVID-19 remains a “very important” issue for cancer patients.
Interestingly, Dr. Dingemans noted that COVID-19 sequelae in patients with cancer appear to occur slightly less frequently, compared with estimates in the general population – which range from 13% to 60% – though patients with cancer tend to have more respiratory problems.
However, Dr. Dingemans added, the difficulty with comparing sequelae rates between cancer patients and the general population is that cancer patients “probably already have a lot of symptoms” associated with long COVID, such as dyspnea and fatigue, and may not be aware that they are experiencing COVID sequelae.
The registry results
To investigate the long-term impact of COVID-19 on survival and continuity of care, the team examined data from the OnCovid registry, which was established at the beginning of the pandemic to study consecutive patients aged 18 years and older with confirmed SARS-CoV-2 infection and a history of solid or hematologic malignancies.
At the data cutoff on March 1, 2021, the registry included 35 institutions in six European countries. The institutions collected information on patient demographics and comorbidities, cancer history, anticancer therapy, COVID-19 investigations, and COVID-19–specific therapies.
For the current analysis, the team included 1,557 of 2,634 patients who had undergone a clinical reassessment after recovering from COVID-19. Information sufficient to conduct multivariate analysis was available for 840 of these patients.
About half of the patients were younger than 60 years, and just over half were women. The most common cancer diagnoses were breast cancer (23.4%), gastrointestinal tumors (16.5%), gynecologic/genitourinary tumors (19.3%), and hematologic cancers (14.1%), with even distribution between local/locoregional and advanced disease.
The median interval between COVID-19 recovery and reassessment was 44 days, and the mean post–COVID-19 follow-up period was 128 days.
About 15% of patients experienced at least one long-term sequela from COVID-19. The most common were dyspnea/shortness of breath (49.6%), fatigue (41.0%), chronic cough (33.8%), and other respiratory complications (10.7%).
Dr. Cortellini noted that cancer patients who experienced sequelae were more likely to be male, aged 65 years or older, to have at least two comorbidities, and to have a history of smoking. In addition, cancer patients who experienced long-term complications were significantly more likely to have had COVID-19 complications, to have required COVID-19 therapy, and to have been hospitalized for the disease.
Factoring in gender, age, comorbidity burden, primary tumor, stage, receipt of anticancer and anti–COVID-19 therapy, COVID-19 complications, and hospitalization, the team found that COVID-19 sequelae were independently associated with an increased risk for death (hazard ratio, 1.76).
Further analysis of patterns of systemic anticancer therapy in 471 patients revealed that 14.8% of COVID-19 survivors permanently discontinued therapy and that a dose or regimen adjustment occurred for 37.8%.
Patients who permanently discontinued anticancer therapy were more likely to be former or current smokers, to have had COVID-19 complications or been hospitalized for COVID-19, and to have had COVID-19 sequelae at reassessment. The investigators found no association between permanent discontinuation of therapy and cancer disease stage.
Dr. Cortellini and colleagues reported that permanent cessation of systemic anticancer therapy was associated with an increased risk for death. A change in dose or regimen did not affect survival.
The most common reason for stopping therapy permanently was deterioration of the patient’s performance status (61.3%), followed by disease progression (29.0%). Dose or regimen adjustments typically occurred to avoid immune suppression (50.0%), hospitalization (25.8%), and intravenous drug administration (19.1%).
Dr. Cortellini concluded his presentation by highlighting the importance of increasing awareness of long COVID in patients with cancer as well as early treatment of COVID-19 sequelae to improve patient outcomes.
The study was funded by the Imperial College Biomedical Research Center. Dr. Cortellini has relationships with MSD, Bristol-Myers Squibb, Roche, Novartis, AstraZeneca, Astellas, and Sun Pharma. Dr. Dingemans has relationships with Roche, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Jansen, Chiesi, Amgen, Pfizer, Bayer, Takeda, Pharmamar, and Sanofi.
A version of this article first appeared on Medscape.com.
More than one in six cancer patients experience long-term sequelae following SARS-CoV-2 infection, placing them at increased risk of discontinuing their cancer treatment or dying, according to European registry data.
Given the “high lethality” of COVID-19 in cancer patients and the risk for long-term complications following infection in the general population, Alessio Cortellini, MD, a consultant medical oncologist at Hammersmith Hospital and Imperial College London, and colleagues wanted to explore the “prevalence and clinical significance of COVID-19 sequelae in cancer patients and their oncological continuity of care.”
Dr. Cortellini presented the OnCovid registry research on Sept. 21 at the 2021 European Society for Medical Oncology Congress. He reported that overall, the data suggest that post–COVID-19 complications may “impair” patients’ cancer survival as well as their cancer care.
The OnCovid registry data showed that the 15% of cancer patients who had long-term COVID-19 complications were 76% more likely to die than those without sequelae. Cancer patients with COVID-19 sequelae were significantly more likely to permanently stop taking their systemic anticancer therapy, and they were more than 3.5 times more likely to die than those who continued their treatment as planned. In terms of long-term complications, almost half of patients experienced dyspnea, and two-fifths reported chronic fatigue.
“This data confirms the need to continue to prioritize cancer patients,” Antonio Passaro, MD, PhD, division of thoracic oncology, European Institute of Oncology IRCCS, Milan, commented in a press release. “In the fight against the pandemic, it is of the utmost importance that we do not neglect to study and understand the curves of cancer incidence and mortality.”
Invited to discuss the results, Anne-Marie C. Dingemans, MD, PhD, a pulmonologist and professor of thoracic oncology at Erasmus Medical Center, Rotterdam, the Netherlands, said COVID-19 remains a “very important” issue for cancer patients.
Interestingly, Dr. Dingemans noted that COVID-19 sequelae in patients with cancer appear to occur slightly less frequently, compared with estimates in the general population – which range from 13% to 60% – though patients with cancer tend to have more respiratory problems.
However, Dr. Dingemans added, the difficulty with comparing sequelae rates between cancer patients and the general population is that cancer patients “probably already have a lot of symptoms” associated with long COVID, such as dyspnea and fatigue, and may not be aware that they are experiencing COVID sequelae.
The registry results
To investigate the long-term impact of COVID-19 on survival and continuity of care, the team examined data from the OnCovid registry, which was established at the beginning of the pandemic to study consecutive patients aged 18 years and older with confirmed SARS-CoV-2 infection and a history of solid or hematologic malignancies.
At the data cutoff on March 1, 2021, the registry included 35 institutions in six European countries. The institutions collected information on patient demographics and comorbidities, cancer history, anticancer therapy, COVID-19 investigations, and COVID-19–specific therapies.
For the current analysis, the team included 1,557 of 2,634 patients who had undergone a clinical reassessment after recovering from COVID-19. Information sufficient to conduct multivariate analysis was available for 840 of these patients.
About half of the patients were younger than 60 years, and just over half were women. The most common cancer diagnoses were breast cancer (23.4%), gastrointestinal tumors (16.5%), gynecologic/genitourinary tumors (19.3%), and hematologic cancers (14.1%), with even distribution between local/locoregional and advanced disease.
The median interval between COVID-19 recovery and reassessment was 44 days, and the mean post–COVID-19 follow-up period was 128 days.
About 15% of patients experienced at least one long-term sequela from COVID-19. The most common were dyspnea/shortness of breath (49.6%), fatigue (41.0%), chronic cough (33.8%), and other respiratory complications (10.7%).
Dr. Cortellini noted that cancer patients who experienced sequelae were more likely to be male, aged 65 years or older, to have at least two comorbidities, and to have a history of smoking. In addition, cancer patients who experienced long-term complications were significantly more likely to have had COVID-19 complications, to have required COVID-19 therapy, and to have been hospitalized for the disease.
Factoring in gender, age, comorbidity burden, primary tumor, stage, receipt of anticancer and anti–COVID-19 therapy, COVID-19 complications, and hospitalization, the team found that COVID-19 sequelae were independently associated with an increased risk for death (hazard ratio, 1.76).
Further analysis of patterns of systemic anticancer therapy in 471 patients revealed that 14.8% of COVID-19 survivors permanently discontinued therapy and that a dose or regimen adjustment occurred for 37.8%.
Patients who permanently discontinued anticancer therapy were more likely to be former or current smokers, to have had COVID-19 complications or been hospitalized for COVID-19, and to have had COVID-19 sequelae at reassessment. The investigators found no association between permanent discontinuation of therapy and cancer disease stage.
Dr. Cortellini and colleagues reported that permanent cessation of systemic anticancer therapy was associated with an increased risk for death. A change in dose or regimen did not affect survival.
The most common reason for stopping therapy permanently was deterioration of the patient’s performance status (61.3%), followed by disease progression (29.0%). Dose or regimen adjustments typically occurred to avoid immune suppression (50.0%), hospitalization (25.8%), and intravenous drug administration (19.1%).
Dr. Cortellini concluded his presentation by highlighting the importance of increasing awareness of long COVID in patients with cancer as well as early treatment of COVID-19 sequelae to improve patient outcomes.
The study was funded by the Imperial College Biomedical Research Center. Dr. Cortellini has relationships with MSD, Bristol-Myers Squibb, Roche, Novartis, AstraZeneca, Astellas, and Sun Pharma. Dr. Dingemans has relationships with Roche, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Jansen, Chiesi, Amgen, Pfizer, Bayer, Takeda, Pharmamar, and Sanofi.
A version of this article first appeared on Medscape.com.
Remdesivir sharply cuts COVID hospitalization risk, Gilead says
Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.
The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.
Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.
Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.
“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.
Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.
The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.
A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
Use of remdesivir controversial
Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.
However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.
The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”
The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.
The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.
A version of this article first appeared on Medscape.com.
Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.
The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.
Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.
Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.
“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.
Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.
The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.
A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
Use of remdesivir controversial
Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.
However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.
The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”
The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.
The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.
A version of this article first appeared on Medscape.com.
Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.
The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.
Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.
Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.
“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.
Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.
The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.
A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
Use of remdesivir controversial
Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.
However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.
The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”
The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.
The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.
A version of this article first appeared on Medscape.com.
Study identifies pandemic-related stressor in Parkinson’s disease
a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.
Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.
“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.
“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.
Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.
The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.
The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
Vulnerable subgroups
“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.
“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”
When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.
The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.
The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”
Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.
“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.
“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.
What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”
Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.
a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.
Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.
“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.
“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.
Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.
The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.
The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
Vulnerable subgroups
“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.
“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”
When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.
The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.
The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”
Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.
“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.
“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.
What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”
Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.
a team of researchers in the Netherlands reported, but they also identified meaningful targets for intervention.
Lisanne Dommershuijsen, MSc, a PhD candidate and researcher in epidemiology at the Erasmus University Medical Center in Rotterdam, the Netherlands, reported on a cross-sectional study of 833 participants with Parkinson’s disease in the PRIME-NL study at the International Congress of Parkinson’s Disease and Movement Disorders. The average age of participants was 70.2 and 38% were women.
“We studied targeted hypothetical interventions on COVID-19 stressors in people with Parkinson’s disease,” Ms. Dommershuijsen said. “This disruption in normal life caused considerable psychological stress in community-dwelling individuals. People with Parkinson’s disease might be especially vulnerable to this stress.
“For instance, because reduced levels of physical activity have worsened symptoms or because people with Parkinson’s often have difficulty with flexible [adaptations] to drastic and rapid changes in daily routines, such as those introduced by the COVID-19 pandemic, previous studies found that COVID-19 worsened depression and anxiety symptoms and reduced quality of life (QOL) in people with Parkinson’s disease,” Ms. Dommershuijsen said.
Hence, the goal of the study was to identify the most vulnerable subgroups in the Parkinson’s population and to suggest potential interventions to ameliorate these impacts, she said.
The study focused on eight different stressors that emerged in the pandemic: access to care, medicine and nursing services; loss of social contact; canceled social events; tension or conflict in the home; inability to perform physical activity or relax; and COVID-19 symptoms. The outcomes of interest were depression, as measured with the Beck Depression Inventory (BDI); anxiety, as measured with the Spielberger State-Trait Anxiety Inventory (STAI); and QOL, with the Parkinson’s Disease Quality of Life Questionnaire. The aggregate resulted in a scale of 0-40, with the mean stressor score in the study being 9.6, Ms. Dommershuijsen said.
The BDI and STAI scores for social stressors – loss of social contacts, social events canceled and tension or conflict at home – exceeded those for the so-called care stressors – problems accessing care, medication or nursing – she said, although all eight stressors yielded higher BDI and STAI scores across the board.
Vulnerable subgroups
“When we looked at vulnerable subgroups of people with Parkinson’s disease, we found more pronounced associations between the COVID-19 stress and mental health in women, in highly educated participants, and in participants with advanced Parkinson’s disease,” Ms. Dommershuijsen said. The impact on women and people with advanced disease is explainable, Ms. Dommershuijsen added in an interview; the former because depressive symptoms are more common in women, and the latter because loss of access to care impacts mental wellness.
“The finding that social stressors were more related to anxiety in highly educated people was surprising to us, given that depression in general is more common in people with a lower education,” she said in an interview. “One previous study of the general population suggested this might be related to expectations about available resources, but this findings and the possible explanation warrants further investigation.”
When the study stratified for coping strategies, the COVID-19 stressors had a smaller effect on depressive and anxiety symptoms in Parkinson’s disease patients prone to confrontive coping and planful problem solving, she said. “Whereas, we observed a larger effect of these stressors in people who are prone to using distancing or seeking social support as coping mechanisms,” Ms. Dommershuijsen said.
The researchers also created a model of a hypothetical 50% reduction in COVID-19 stressors among all study participants, but the effect wasn’t clinically relevant, Ms. Dommershuijsen said. However, in people with advanced Parkinson’s disease – that is, with an Movement Disorder Society–Unified Parkinson Disease Rating Scale score above median – the effect was clinically relevant in all outcomes.
The potential interventions the study identified were telemedicine via virtual consultations to alleviate care stressors, and virtual support groups and online classes to address social stressors. “However, a more personalized approach is needed to target tension or conflict at home, which was the most important social stressor influencing depression and anxiety symptoms in our study,” she said. “Social work can play an important role here.”
Asked to comment on the study, Roy Alcalay, MD, professor of neurology at Columbia University Irving Medical Center in New York, said in an interview that the findings align with his research on the impact of COVID-19 and related restrictions on people with Parkinson’s disease.
“The pandemic has affected people in different ways,” he said. “Initially very acutely, people just didn’t have access to doctors. There was also the acute question in movement disorders, but also in other diseases where the people with Parkinson’s disease are going to have the worse outcome when they have COVID-19.” Dr. Alcalay authored two recent papers on the impact of COVID-19 in people with Parkinson’s disease.
“Then we see that, in addition to that question, there’s the question of even if they don’t have COVID-19, just the social distancing and the lack of access to health care, and specifically to physical and occupational therapy and other services, can be quite damaging,” he said.
What’s commendable about the study, he said, was that it just doesn’t highlight the problem. “They’re also highlighting potential solutions, that planful problem solving and coping strategies can be helpful to people.”
Neither Ms. Dommershuijsen nor Dr. Alcalay have any relevant relationships to disclose.
FROM MDS VIRTUAL CONGRESS 2021
New COVID-19 strain has reached the U.S.
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.
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.
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.
COVID-19 vaccines in pregnancy may protect baby, too
Women who receive COVID-19 vaccines during pregnancy pass antibodies to their babies, which could protect newborns from the disease, research has shown.
.
Researchers with New York University Langone Health conducted a study that included pregnant women who had received at least one dose of an mRNA COVID-19 vaccine (Pfizer/BioNTech or Moderna) by June 4.
All neonates had antibodies to the spike protein at high titers, the researchers found.
Unlike similar prior studies, the researchers also looked for antibodies to the nucleocapsid protein, which would have indicated the presence of antibodies from natural COVID-19 infection. They did not detect antibodies to the nucleocapsid protein, and the lack of these antibodies suggests that the antibodies to the spike protein resulted from vaccination and not from prior infection, the researchers said.
The participants had a median time from completion of the vaccine series to delivery of 13 weeks. The study was published online in the American Journal of Obstetrics & Gynecology MFM.
“The presence of these anti-spike antibodies in the cord blood should, at least in theory, offer these newborns some degree of protection,” said study investigator Ashley S. Roman, MD, director of the division of maternal-fetal medicine at NYU Langone Health. “While the primary rationale for vaccination during pregnancy is to keep moms healthy and keep moms out of the hospital, the outstanding question to us was whether there is any fetal or neonatal benefit conferred by receiving the vaccine during pregnancy.”
Questions remain about the degree and durability of protection for newborns from these antibodies. An ongoing study, MOMI-VAX, aims to systematically measure antibody levels in mothers who receive COVID-19 vaccines during pregnancy and in their babies over time.
The present study contributes welcome preliminary evidence suggesting a benefit to infants, said Emily Adhikari, MD, of the University of Texas Southwestern Medical Center in Dallas, who was not involved in the study.
Still, “the main concern and our priority as obstetricians is to vaccinate pregnant women to protect them from severe or critical illness,” she said.
Although most individuals infected with SARS-CoV-2 recover, a significant portion of pregnant women get seriously sick, Dr. Adhikari said. “With this recent Delta surge, we are seeing more pregnant patients who are sicker,” said Dr. Adhikari, who has published research from one hospital describing this trend.
When weighing whether patients should receive COVID-19 vaccines in pregnancy, the risks from infection have outweighed any risk from vaccination to such an extent that there is “not a comparison to make,” Dr. Adhikari said. “The risks of the infection are so much higher.
“For me, it is a matter of making sure that my patient understands that we have really good safety data on these vaccines and there is no reason to think that a pregnant person would be harmed by them. On the contrary, the benefit is to protect and maybe even save your life,” Dr. Adhikari said. “And now we have more evidence that the fetus may also benefit.”
The rationale for vaccinations during pregnancy can vary, Dr. Roman said. Flu shots in pregnancy mainly are intended to protect the mother, though they confer protection for newborns as well. With the whooping cough vaccine given in the third trimester, however, the primary aim is to protect the baby from whooping cough in the first months of life, Dr. Roman said.
“I think it is really important for pregnant women to understand that antibodies crossing the placenta is a good thing,” she added.
As patients who already have received COVID-19 vaccines become pregnant and may become eligible for a booster dose, Dr. Adhikari will offer it, she said, though she has confidence in the protection provided by the initial immune response.
Dr. Roman and Dr. Adhikari had no disclosures.
Women who receive COVID-19 vaccines during pregnancy pass antibodies to their babies, which could protect newborns from the disease, research has shown.
.
Researchers with New York University Langone Health conducted a study that included pregnant women who had received at least one dose of an mRNA COVID-19 vaccine (Pfizer/BioNTech or Moderna) by June 4.
All neonates had antibodies to the spike protein at high titers, the researchers found.
Unlike similar prior studies, the researchers also looked for antibodies to the nucleocapsid protein, which would have indicated the presence of antibodies from natural COVID-19 infection. They did not detect antibodies to the nucleocapsid protein, and the lack of these antibodies suggests that the antibodies to the spike protein resulted from vaccination and not from prior infection, the researchers said.
The participants had a median time from completion of the vaccine series to delivery of 13 weeks. The study was published online in the American Journal of Obstetrics & Gynecology MFM.
“The presence of these anti-spike antibodies in the cord blood should, at least in theory, offer these newborns some degree of protection,” said study investigator Ashley S. Roman, MD, director of the division of maternal-fetal medicine at NYU Langone Health. “While the primary rationale for vaccination during pregnancy is to keep moms healthy and keep moms out of the hospital, the outstanding question to us was whether there is any fetal or neonatal benefit conferred by receiving the vaccine during pregnancy.”
Questions remain about the degree and durability of protection for newborns from these antibodies. An ongoing study, MOMI-VAX, aims to systematically measure antibody levels in mothers who receive COVID-19 vaccines during pregnancy and in their babies over time.
The present study contributes welcome preliminary evidence suggesting a benefit to infants, said Emily Adhikari, MD, of the University of Texas Southwestern Medical Center in Dallas, who was not involved in the study.
Still, “the main concern and our priority as obstetricians is to vaccinate pregnant women to protect them from severe or critical illness,” she said.
Although most individuals infected with SARS-CoV-2 recover, a significant portion of pregnant women get seriously sick, Dr. Adhikari said. “With this recent Delta surge, we are seeing more pregnant patients who are sicker,” said Dr. Adhikari, who has published research from one hospital describing this trend.
When weighing whether patients should receive COVID-19 vaccines in pregnancy, the risks from infection have outweighed any risk from vaccination to such an extent that there is “not a comparison to make,” Dr. Adhikari said. “The risks of the infection are so much higher.
“For me, it is a matter of making sure that my patient understands that we have really good safety data on these vaccines and there is no reason to think that a pregnant person would be harmed by them. On the contrary, the benefit is to protect and maybe even save your life,” Dr. Adhikari said. “And now we have more evidence that the fetus may also benefit.”
The rationale for vaccinations during pregnancy can vary, Dr. Roman said. Flu shots in pregnancy mainly are intended to protect the mother, though they confer protection for newborns as well. With the whooping cough vaccine given in the third trimester, however, the primary aim is to protect the baby from whooping cough in the first months of life, Dr. Roman said.
“I think it is really important for pregnant women to understand that antibodies crossing the placenta is a good thing,” she added.
As patients who already have received COVID-19 vaccines become pregnant and may become eligible for a booster dose, Dr. Adhikari will offer it, she said, though she has confidence in the protection provided by the initial immune response.
Dr. Roman and Dr. Adhikari had no disclosures.
Women who receive COVID-19 vaccines during pregnancy pass antibodies to their babies, which could protect newborns from the disease, research has shown.
.
Researchers with New York University Langone Health conducted a study that included pregnant women who had received at least one dose of an mRNA COVID-19 vaccine (Pfizer/BioNTech or Moderna) by June 4.
All neonates had antibodies to the spike protein at high titers, the researchers found.
Unlike similar prior studies, the researchers also looked for antibodies to the nucleocapsid protein, which would have indicated the presence of antibodies from natural COVID-19 infection. They did not detect antibodies to the nucleocapsid protein, and the lack of these antibodies suggests that the antibodies to the spike protein resulted from vaccination and not from prior infection, the researchers said.
The participants had a median time from completion of the vaccine series to delivery of 13 weeks. The study was published online in the American Journal of Obstetrics & Gynecology MFM.
“The presence of these anti-spike antibodies in the cord blood should, at least in theory, offer these newborns some degree of protection,” said study investigator Ashley S. Roman, MD, director of the division of maternal-fetal medicine at NYU Langone Health. “While the primary rationale for vaccination during pregnancy is to keep moms healthy and keep moms out of the hospital, the outstanding question to us was whether there is any fetal or neonatal benefit conferred by receiving the vaccine during pregnancy.”
Questions remain about the degree and durability of protection for newborns from these antibodies. An ongoing study, MOMI-VAX, aims to systematically measure antibody levels in mothers who receive COVID-19 vaccines during pregnancy and in their babies over time.
The present study contributes welcome preliminary evidence suggesting a benefit to infants, said Emily Adhikari, MD, of the University of Texas Southwestern Medical Center in Dallas, who was not involved in the study.
Still, “the main concern and our priority as obstetricians is to vaccinate pregnant women to protect them from severe or critical illness,” she said.
Although most individuals infected with SARS-CoV-2 recover, a significant portion of pregnant women get seriously sick, Dr. Adhikari said. “With this recent Delta surge, we are seeing more pregnant patients who are sicker,” said Dr. Adhikari, who has published research from one hospital describing this trend.
When weighing whether patients should receive COVID-19 vaccines in pregnancy, the risks from infection have outweighed any risk from vaccination to such an extent that there is “not a comparison to make,” Dr. Adhikari said. “The risks of the infection are so much higher.
“For me, it is a matter of making sure that my patient understands that we have really good safety data on these vaccines and there is no reason to think that a pregnant person would be harmed by them. On the contrary, the benefit is to protect and maybe even save your life,” Dr. Adhikari said. “And now we have more evidence that the fetus may also benefit.”
The rationale for vaccinations during pregnancy can vary, Dr. Roman said. Flu shots in pregnancy mainly are intended to protect the mother, though they confer protection for newborns as well. With the whooping cough vaccine given in the third trimester, however, the primary aim is to protect the baby from whooping cough in the first months of life, Dr. Roman said.
“I think it is really important for pregnant women to understand that antibodies crossing the placenta is a good thing,” she added.
As patients who already have received COVID-19 vaccines become pregnant and may become eligible for a booster dose, Dr. Adhikari will offer it, she said, though she has confidence in the protection provided by the initial immune response.
Dr. Roman and Dr. Adhikari had no disclosures.
FROM AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY MFM
Pandemic restrictions ignite innovative pivot for psychiatry
As medical school faculty members – and our students – know well, the COVID-19 pandemic forced us to become creative and shift much of our curricula online. Many hospitals chose to limit medical student rotations because of safety concerns. Students fell victim to canceled psychiatry rotations and electives during the pandemic’s early days. Privacy issues, combined with stigma tied to mental illness, made this shift to virtual instruction particularly challenging. But as a field, we persevered! And, as we learned during our shift toward telemedicine, many of the changes we made in medical education are probably here to stay.
Our team at the New York Institute of Technology College of Osteopathic Medicine (NYITCOM) was able to implement a novel curriculum that allowed our students to learn psychiatry and maintain high-quality medical school education.
We developed an online course for third-year students’ rotation in psychiatry, with several modules that focused on a variety of psychiatric topics and disorders, including the basic classifications and categories of depression, anxiety, personality disorders, and psychotic disorders. There were also video encounters available showing actual patient encounters. On completion of the online module, a faculty session was held to discuss topics of concern/confusion to the students, areas of interest, and a variety of related topics, such as professionalism in psychiatry, essentials of the mental status exam, management of diverse populations, and COVID repercussions in psychiatry.
For fourth-year students, we developed a telemedicine psychiatry elective, which allowed the students to observe psychiatric evaluations, psychiatric medication review visits, and even follow-up psychotherapy sessions, with the school’s clinical psychologists. The new method was minimally invasive, and it was accepted by patients and welcomed by the students.
During a time when hospitals were limiting onsite student rotations and discouraging patient contact, medical students still needed to experience patient interactions. As the director of the school’s Center for Behavioral Health, I designed an additional program that allowed students to participate in observing patients who presented with psychiatric complaints and symptoms. It had to be confidential in nature, accessible, and safe.
I recalled my own training in a hospital setting, where students and residents were allowed to observe a patient being evaluated by an attending, through a one-way mirror. It was a method that was acceptable at the time in a hospital, but unfortunately, not in a private office setting. As such, students and residents experienced such an interaction in acute inpatient and/or outpatient clinics of a hospital. The experience was invaluable.
The concept was simple, yet very efficient. The clinicians in the Center for Behavioral Health were seeing all patients with psychiatric needs via a HIPAA-compliant telemedicine platform. Access was granted for students – with the patient’s consent – and they “entered the session” without being seen or heard. This presented little to no distraction to the patient, and the student was able to observe a range of clinical sessions.
The course also provided online supplemental modules, including essential psychiatric topics, psychopharmacology, and a psychotherapeutic module that discussed a myriad of therapeutic interventions. In addition, the student was supervised weekly by the course director, the psychopharmacologist, and the clinical psychologist. The course director provided daily wrap-up reviews as well.
Originally, this new approach was envisioned as a temporary solution for use during the pandemic. But it has become clear that this approach would be beneficial post pandemic as well. Most of the students who participated in the course were actually interested in pursuing psychiatry as their future specialty. It allowed them to observe a population of patients firsthand that they might encounter in private practice, as opposed to only hospital settings.
Being present in a session with a patient with psychiatric symptoms and diagnoses has always been a challenge. Many patients refuse to have another medical professional in the room because of the intimate details being discussed and their associated stigma. The patients’ inability to see or hear the student during the sessions allows them to ignore the students’ presence – or at least not be intimidated by it. This, therefore, allows the students access and affords them a unique and memorable educational experience.
The pandemic curtailed and altered medical students’ traditional exposure to patients, but we found innovative ways to redefine it. As difficult as COVID-19 has been for the health care community, we have been able to use the restrictions forced by the pandemic to identify innovative ways to improve the education of our medical students.
In addition to serving as director of the Center for Behavioral Health at NYITCOM in Old Westbury, N.Y., Dr. Jarkon is assistant professor in the department of family medicine. She has no disclosures.
As medical school faculty members – and our students – know well, the COVID-19 pandemic forced us to become creative and shift much of our curricula online. Many hospitals chose to limit medical student rotations because of safety concerns. Students fell victim to canceled psychiatry rotations and electives during the pandemic’s early days. Privacy issues, combined with stigma tied to mental illness, made this shift to virtual instruction particularly challenging. But as a field, we persevered! And, as we learned during our shift toward telemedicine, many of the changes we made in medical education are probably here to stay.
Our team at the New York Institute of Technology College of Osteopathic Medicine (NYITCOM) was able to implement a novel curriculum that allowed our students to learn psychiatry and maintain high-quality medical school education.
We developed an online course for third-year students’ rotation in psychiatry, with several modules that focused on a variety of psychiatric topics and disorders, including the basic classifications and categories of depression, anxiety, personality disorders, and psychotic disorders. There were also video encounters available showing actual patient encounters. On completion of the online module, a faculty session was held to discuss topics of concern/confusion to the students, areas of interest, and a variety of related topics, such as professionalism in psychiatry, essentials of the mental status exam, management of diverse populations, and COVID repercussions in psychiatry.
For fourth-year students, we developed a telemedicine psychiatry elective, which allowed the students to observe psychiatric evaluations, psychiatric medication review visits, and even follow-up psychotherapy sessions, with the school’s clinical psychologists. The new method was minimally invasive, and it was accepted by patients and welcomed by the students.
During a time when hospitals were limiting onsite student rotations and discouraging patient contact, medical students still needed to experience patient interactions. As the director of the school’s Center for Behavioral Health, I designed an additional program that allowed students to participate in observing patients who presented with psychiatric complaints and symptoms. It had to be confidential in nature, accessible, and safe.
I recalled my own training in a hospital setting, where students and residents were allowed to observe a patient being evaluated by an attending, through a one-way mirror. It was a method that was acceptable at the time in a hospital, but unfortunately, not in a private office setting. As such, students and residents experienced such an interaction in acute inpatient and/or outpatient clinics of a hospital. The experience was invaluable.
The concept was simple, yet very efficient. The clinicians in the Center for Behavioral Health were seeing all patients with psychiatric needs via a HIPAA-compliant telemedicine platform. Access was granted for students – with the patient’s consent – and they “entered the session” without being seen or heard. This presented little to no distraction to the patient, and the student was able to observe a range of clinical sessions.
The course also provided online supplemental modules, including essential psychiatric topics, psychopharmacology, and a psychotherapeutic module that discussed a myriad of therapeutic interventions. In addition, the student was supervised weekly by the course director, the psychopharmacologist, and the clinical psychologist. The course director provided daily wrap-up reviews as well.
Originally, this new approach was envisioned as a temporary solution for use during the pandemic. But it has become clear that this approach would be beneficial post pandemic as well. Most of the students who participated in the course were actually interested in pursuing psychiatry as their future specialty. It allowed them to observe a population of patients firsthand that they might encounter in private practice, as opposed to only hospital settings.
Being present in a session with a patient with psychiatric symptoms and diagnoses has always been a challenge. Many patients refuse to have another medical professional in the room because of the intimate details being discussed and their associated stigma. The patients’ inability to see or hear the student during the sessions allows them to ignore the students’ presence – or at least not be intimidated by it. This, therefore, allows the students access and affords them a unique and memorable educational experience.
The pandemic curtailed and altered medical students’ traditional exposure to patients, but we found innovative ways to redefine it. As difficult as COVID-19 has been for the health care community, we have been able to use the restrictions forced by the pandemic to identify innovative ways to improve the education of our medical students.
In addition to serving as director of the Center for Behavioral Health at NYITCOM in Old Westbury, N.Y., Dr. Jarkon is assistant professor in the department of family medicine. She has no disclosures.
As medical school faculty members – and our students – know well, the COVID-19 pandemic forced us to become creative and shift much of our curricula online. Many hospitals chose to limit medical student rotations because of safety concerns. Students fell victim to canceled psychiatry rotations and electives during the pandemic’s early days. Privacy issues, combined with stigma tied to mental illness, made this shift to virtual instruction particularly challenging. But as a field, we persevered! And, as we learned during our shift toward telemedicine, many of the changes we made in medical education are probably here to stay.
Our team at the New York Institute of Technology College of Osteopathic Medicine (NYITCOM) was able to implement a novel curriculum that allowed our students to learn psychiatry and maintain high-quality medical school education.
We developed an online course for third-year students’ rotation in psychiatry, with several modules that focused on a variety of psychiatric topics and disorders, including the basic classifications and categories of depression, anxiety, personality disorders, and psychotic disorders. There were also video encounters available showing actual patient encounters. On completion of the online module, a faculty session was held to discuss topics of concern/confusion to the students, areas of interest, and a variety of related topics, such as professionalism in psychiatry, essentials of the mental status exam, management of diverse populations, and COVID repercussions in psychiatry.
For fourth-year students, we developed a telemedicine psychiatry elective, which allowed the students to observe psychiatric evaluations, psychiatric medication review visits, and even follow-up psychotherapy sessions, with the school’s clinical psychologists. The new method was minimally invasive, and it was accepted by patients and welcomed by the students.
During a time when hospitals were limiting onsite student rotations and discouraging patient contact, medical students still needed to experience patient interactions. As the director of the school’s Center for Behavioral Health, I designed an additional program that allowed students to participate in observing patients who presented with psychiatric complaints and symptoms. It had to be confidential in nature, accessible, and safe.
I recalled my own training in a hospital setting, where students and residents were allowed to observe a patient being evaluated by an attending, through a one-way mirror. It was a method that was acceptable at the time in a hospital, but unfortunately, not in a private office setting. As such, students and residents experienced such an interaction in acute inpatient and/or outpatient clinics of a hospital. The experience was invaluable.
The concept was simple, yet very efficient. The clinicians in the Center for Behavioral Health were seeing all patients with psychiatric needs via a HIPAA-compliant telemedicine platform. Access was granted for students – with the patient’s consent – and they “entered the session” without being seen or heard. This presented little to no distraction to the patient, and the student was able to observe a range of clinical sessions.
The course also provided online supplemental modules, including essential psychiatric topics, psychopharmacology, and a psychotherapeutic module that discussed a myriad of therapeutic interventions. In addition, the student was supervised weekly by the course director, the psychopharmacologist, and the clinical psychologist. The course director provided daily wrap-up reviews as well.
Originally, this new approach was envisioned as a temporary solution for use during the pandemic. But it has become clear that this approach would be beneficial post pandemic as well. Most of the students who participated in the course were actually interested in pursuing psychiatry as their future specialty. It allowed them to observe a population of patients firsthand that they might encounter in private practice, as opposed to only hospital settings.
Being present in a session with a patient with psychiatric symptoms and diagnoses has always been a challenge. Many patients refuse to have another medical professional in the room because of the intimate details being discussed and their associated stigma. The patients’ inability to see or hear the student during the sessions allows them to ignore the students’ presence – or at least not be intimidated by it. This, therefore, allows the students access and affords them a unique and memorable educational experience.
The pandemic curtailed and altered medical students’ traditional exposure to patients, but we found innovative ways to redefine it. As difficult as COVID-19 has been for the health care community, we have been able to use the restrictions forced by the pandemic to identify innovative ways to improve the education of our medical students.
In addition to serving as director of the Center for Behavioral Health at NYITCOM in Old Westbury, N.Y., Dr. Jarkon is assistant professor in the department of family medicine. She has no disclosures.
FDA OKs Pfizer COVID booster for 65 and over, those at high risk
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 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 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.