On Friday, an influential Food and Drug Administration advisory committee voted against approving administering booster shots of Pfizer and BioNTech's COVID-19 vaccine to the general public. According to CNBC, the FDA panel voted 16 - 2 against the proposal, stating that they need more data.
The possibility of booster shots for older populations is still there, with scientists continuing to debate about the need for a third dose after the initial vote.
"It's likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don't think we're there yet in terms of the data," said Dr. Ofer Levy after the initial vote. The vote comes as the Biden administration had previously stated that it wanted to start offering booster shots to the general public by next week, pending authorization from the FDA.
According to CNBC, the decision by the FDA's Vaccines and Related Biological Products Advisory Committee is nonbonding. The agency has gone against the advice of the committee on occasion, but generally follows it.
A final FDA decision could come later Friday, with the CDC also scheduling a two-day meeting next week to discuss plans to distribute the third shots across the US.
An FDA advisory panel later on Friday endorsed emergency approval for the Pfizer-BioNTech COVID-19 vaccine booster shot for Americans ages 65 years and older and patients at high risk of severe COVID-19. That vote was 18 - 0.
During the deliberations, FDA panel members suggested older, vulnerable populations may benefit from boosters, but noted insufficient data among younger groups and concerns over potential increased risk for heart inflammation, particularly among males ages 16 to 17, according to Fox News.
The committee was charged with voting whether the safety and effectiveness data from Pfizer's clinical trial supported approval of the company's booster dose among patients 16 years and older. The meeting included members of the FDA's Vaccines and Related Biological Products Advisory Committee, (VRBPAC), as well as officials from the Centers for Disease Control and Prevention (CDC), lsrael’s Health Ministry, vaccine experts and Pfizer representatives.
Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, noted Phase 3 trial data indicating waning protection over time, from 96 percent vaccine efficacy within two months after the second dose to about 84 percent by six months and amid the Delta variant. While protection dropped against infections, it remained effective in preventing hospitalizations.
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