They did recommend a more limited step: emergency use authorization for people 65 and older, and for people at high risk of severe infection. Then they went back and added in health care workers and other people at high risk of getting infected at work — even if they are not at especially high risk of severe disease.
But why not just go ahead and say everyone who wants a booster can get one? Members of the Vaccines and Related Biological Products Advisory Committee were effusively vocal about why not.
Even Pfizer said its vaccine was still very much preventing severe disease, hospitalizations and deaths in the US, with an effectiveness of more than 90%. The company argued that this might not last much longer, but many members of VRBPAC didn’t buy it.
They don’t see enough evidence to justify booster shots for everyone
“It is my opinion that we need this in our armamentarium — a booster dose now, particularly for the elderly and (those with) other high-risk conditions — but I share my colleagues’ angst about the sparsity of safety data,” said Dr. Mark Sawyer, a professor of clinical pediatrics at the University of California San Diego.
“I am hopeful that CDC rolls this out in a gradual fashion.”
Dr. Michael Kurilla, an infectious disease specialist at the National Center for Advancing Translational Sciences, said he suspected Pfizer went too far in extrapolating data on older people to a younger population.
“So it’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” Kurilla said. “It is not clear to me that the data we are seeing now is applicable to the general population.”
They would like a lot more data and a chance to look for mistaken conclusions
Dr. Philip Krause, deputy director of the FDA’s Office of Vaccines Research and Review, noted that Pfizer was using data that had not been reviewed by experts.
“One of the issues in this is that much of the data that’s been presented and being discussed today is not peer-reviewed and has not been reviewed by FDA,” Krause said.
Krause, along with another FDA vaccine official, Marion Gruber, signed a paper published The Lancet earlier this week that argued it’s too soon to start giving people boosters.
Kurilla noted that Pfizer’s studies relied heavily on measurements of antibodies, without looking at other important aspects of immune response.
“It’s a little disappointing that there’s been very little reporting of the cellular immune responses and an entire focus on the neutralizing antisera,” Kurilla said. Immunologists point out that long-lasting…
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