The Defender | 16 Sep 2021
In a 23-page report released Wednesday, FDA officials said, based on their analysis of data submitted by Pfizer and BioNTech, they could not yet take a stance on whether to recommend COVID boosters for the general public.
The report analyzed data submitted by Pfizer and BioNTech as part of the drugmakers’ request for authorization for their vaccine to be given as a booster shot in people 16 years and older.
Officials declined to take a stance on whether to back additional doses of Pfizer’s COVID vaccine saying all available data hasn’t been verified.
“There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” FDA officials wrote in a 23-page document published on the agency’s website. “Some of these studies, including data from the vaccination program in Israel, will be summarized during the Sept. 17, 2021 VRBPAC [Vaccines and Related Biological Products Advisory Committee] meeting.”
According to STAT, drug companies and some researchers point to data showing the efficacy of the vaccines to protect against all infections is waning and that a third shot will provide additional protection.
Others cite data showing the vaccines are still keeping people out of the hospital and preventing them from dying, indicating a booster is not needed yet.
In separate documents released Wednesday by Pfizer, the drugmaker argued a third dose of its COVID vaccine six months after a second shot restores protection from infection to 95%.