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Why didn’t FDA advisers want to recommend Covid-19 booster injections for everyone?


They recommended a more limited step: emergency use authorization for people 65 years of age and older and for people at high risk of serious infection. Then they came back and added health workers and others at high risk of infection at work – even if they were not at particularly high risk of serious illness.

But why not just go ahead and say anyone who wants a booster can get one? Members of the Advisory Committee on Vaccines and Related Biologics spoke effusively as to why.

“The stated purpose of this vaccine has been to protect against serious disease,” said Dr. Paul Offit, professor of pediatrics at Children’s Hospital of Philadelphia, at the meeting. “The data shows that these vaccines do just that,” he added. “This is exactly what you would expect.”

Even Pfizer said its vaccine still significantly prevents serious illness, hospitalizations and death in the United States, with an effectiveness of over 90%. The company argued that it might not last longer, but many VRBPAC members did not buy it.

They don’t see enough evidence to warrant booster shots for everyone

“In my opinion, we need this in our arsenal – a booster now, especially for the elderly and (those with) other high-risk conditions – but I share my colleagues’ angst about the matter. the paucity of safety data, ”said Dr. Mark Sawyer, professor of clinical pediatrics at the University of California, San Diego.

“I hope the CDC will roll out this gradually.”

Dr Michael Kurilla, an infectious disease specialist at the National Center for Advancing Translational Sciences, said he suspected Pfizer was going too far in extrapolating data on the elderly to a younger population.

Why didn’t FDA advisers want to recommend Covid-19 booster injections for everyone?

“So it’s not clear that everyone needs strengthening except for a subset of the population who would clearly be at high risk for serious illness,” Kurilla said. “It’s not clear to me that the data we’re seeing right now is applicable to the general population.”

They would like a lot more data and a chance to look for the wrong conclusions

Dr Philip Krause, deputy director of the FDA’s Office of Vaccine Research and Review, noted that Pfizer was using data that had not been reviewed by experts.

“One of the problems is that much of the data that has been presented and discussed today is not peer reviewed and has not been reviewed by the FDA,” Krause said.

Krause, along with another FDA vaccine official, Marion Gruber, signed an article published by The Lancet earlier this week, saying it was too early to start giving people reminders.

Kurilla noted that Pfizer’s studies relied heavily on antibody measurements, without examining other important aspects of the immune response.

Why didn’t FDA advisers want to recommend Covid-19 booster injections for everyone?

“It’s a little disappointing that there have been very few reports on cellular immune responses and an entire focus on neutralizing antisera,” Kurilla said. Immunologists point out that lasting protection comes from immune cells called B cells and T cells, and Pfizer only presented data on the antibody response.

“We lack data, including solid data on the doses of vaccine that have been administered,” said Dr. Hayley Ganz, professor of pediatrics at Stanford University Medical Center.

They worry about young adults and teens

“We are being asked to approve this as a three dose vaccine for people 16 years of age and older, without any clear evidence, the third dose for a younger person, compared to an older person, has value.” , Offit said. .

“If it doesn’t have value, then the risks may outweigh the benefits. And we know the 16-29 year old is at higher risk for myocarditis,” he added.

Why didn’t FDA advisers want to recommend Covid-19 booster injections for everyone?

Dr Doran Fink of the FDA told the meeting that the agency was not sure either. “We really don’t have enough data yet to know what the risk of myocarditis or pericarditis would be following a booster dose,” he said. Studies have shown that young adults and older adolescents, especially men, are at a higher risk of this rare heart inflammation after receiving an mRNA vaccine like that from Pfizer, although the problem resolves quickly with a fast processing.

Details on that risk might not come out, however, Fink said, until the booster doses have been given more widely.

“We have discussed the need for such surveys with vaccine manufacturers,” Fink said.

“I don’t think we would feel comfortable giving it to a 16 year old for all the reasons everyone has mentioned,” said Dr Eric Rubin, chair of the Department of Immunology and Diseases. infectious diseases from the Harvard TH Chan School of Public Health.

They think it’s more important to get more people vaccinated the first time

Dr Cody Meissner, professor of pediatrics at Tufts University School of Medicine, said he didn’t think boosters would significantly help control the pandemic.

“It is very important that the main message that we are still giving is that we have to get two doses for everyone. Everyone has received the primary series,” he said. “This booster dose is not likely to make much of a difference in the behavior of this pandemic.”

Why didn’t FDA advisers want to recommend Covid-19 booster injections for everyone?

“It’s a frustrating place when we have more than enough vaccine stocks in the United States and yet we haven’t been able to achieve the level of coverage that would result in much better control of the pandemic than we did. “said Dr. Melinda Wharton, director of the division of immunization services at the United States Centers for Disease Control and Prevention.

“Boosters are probably not the action that will have the greatest impact on health in the United States,” she said.

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