A Food and Drug Administration (FDA) panel voted against approving a booster dose of Pfizer’s COVID-19 vaccine for all Americans aged 16 and over Friday.
The agency’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly against approving the booster dose after a full day of presentations and testimony from researchers, doctors and government officials. Biden administration officials said last month that all Americans would be able to get a booster shot beginning the week of Sep. 20, even though the shot hadn’t yet been approved by the FDA.
WASHINGTON (AP) — FDA advisory panel soundly rejects a plan to offer Pfizer booster shots against COVID-19 to most Americans.
— Zeke Miller (@ZekeJMiller) September 17, 2021
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices was set to meet Wednesday, Sep. 22 to consider whatever FDA decision came out of this meeting. That committee recommends how FDA-approved vaccines are to be distributed and administered.
The panel did vote to approve the booster for Americans 65 and older and those at high risk of severe illness from COVID-19. Several members of the FDA panel expressed confidence the boosters showed efficacy and necessity for senior citizens but said that data cannot necessarily be extrapolated to the entire population.
Others also expressed concern over the potential side effect of myocarditis in young men, which has not been extensively studied with regard to boosters. (RELATED: FDA Officials Advise Against Vaccination Of Kids Under 12, Fauci Says It’s Just A Matter Of Time)
Two of the top vaccine officials at the FDA, Marion Gruber and Phil Krause, are resigning later this year after butting heads with the Biden administration over the booster question. The pair, who recently signed a letter arguing that boosters aren’t yet needed for the general public, was reportedly frustrated that the Biden team was going in public to push the necessity of booster shots before the FDA was allowed to do its work on the subject.