But it recommended third doses for the elderly and other at-risk groups
U.S. Food and Drug Administration committee voted unanimously Friday to recommend booster doses of Pfizer-BioNTech’s COVID-19 vaccine for those over age 65 and those at higher risk of exposure to the virus, including healthcare, frontline and essential workers, under emergency use authorization, but stopped short of recommending boosters for the general population.
The committee advised that most of the U.S. population will have to wait to get a booster dose, guidance that directly contradicts the recommendation by U.S. President Joe Biden’s health team, which planned to start widely rolling out boosters on Sept. 20, pending FDA authorization or approval. In making its case for a booster, Pfizer-BioNTech acknowledged that about a month after the second of the two doses in the regimen, its vaccine is 96% efficacious in protecting people from symptoms of COVID-19. About two to four months later, that efficacy slips to 90%, and by six months, it drops to 84%—about a 6% decline every two months.
That’s why the company asked the FDA for a booster dose—to restore some of that initial vaccine protection. The company presented data from 23 people in the original phase 1 study of the vaccine who received a booster dose six to eight months after the second dose, as well as 306 people who were originally receiving placebo but, after the vaccine received emergency use authorization in December, switched to get two doses of vaccine.
“The booster improved protection against COVID-19 10-fold against confirmed infection…and helped Israel to dampen severe cases in its fourth wave,” Alroy-Preis told the committee.
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