Topline
Pfizer-BioNTech could file a request as soon as Tuesday for emergency authorization for a second Covid booster shot for people 65 and older, an age group for which the U.S. Food and Drug Administration has usually been quick to approve new vaccine shots, the Washington Post reported Tuesday citing unnamed sources.
A resident at The Palace, an independent living community for seniors, at Coral Gables in Miami, … [+]
Eva Marie Uzcategui Trinkl/Anadolu Agency via Getty Images
Key Facts
Pfizer’s application to the FDA is anticipated to include data from real-world studies in Israel, where a second booster shot has already been authorized for older individuals, three unnamed sources told the Washington Post.
The FDA could assess Pfizer’s application quickly, particularly if the agency determines the data supporting the application is straightforward, the Washington Post reported.
Senior citizens are already the most vaccinated and most boosted age group in the U.S.— 95% of people 65 and older have received at least one Covid shot compared to 76.7% of the general population, and 88.9% have been fully vaccinated compared to 65.3% of the general population, while 66.8% had received a booster dose compared to 44.3% of the general population, according to data from the U.S. Centers for Disease Control and Prevention.
Pfizer did not immediately respond to a request for comment.
Key Background
When deciding whether to issue an authorization, the FDA must assess what the available scientific evidence indicates about the known or potential risks and benefits of a vaccine dose to a particular group. The FDA has previously been quick to approve Covid vaccine doses for older people, who are generally at higher risk of severe Covid symptoms. September 17, the agency’s vaccine advisory panel voted strongly against authorizing Pfizer’s first booster shot for all people 16 and up, but voted unanimously to recommend a first booster dose for people 65 and up, as well as people “at high risk of severe Covid-19” and some people whose jobs could expose them to Covid. September 22, the FDA authorized a Pfizer booster dose for all people 65 and older and to younger people at high risk of severe Covid. The agency did not expand eligibility for Pfizer’s booster to all people 16 and over until December 9. March 10, Pfizer CEO Albert Bourla told the Washington Post that the omicron variant had seriously eroded the protection offered by a two-dose vaccination, and that a second booster shot will probably eventually be necessary for everyone.
Further Reading
“FDA Advisory Panel Recommends Against Pfizer Covid Boosters—Except For People Over 65” (Forbes)
