Pfizer-BioNTech’s COVID-19 vaccine booster for people 16 years old and over was overwhelmingly rejected by a U.S. Food and Drug Administration (FDA) advisory panel on Friday.
The vote was 2-16, and the vote will now go before the FDA for a final decision, reports Fox News. The panel’s members included members of the FDA’s Vaccines and Related Biological Products Advisory Committee, officials from the Centers for Disease Control and Prevention, Israel’s Health Ministry, as well as vaccine experts and Pfizer representatives.
While the panel said that older and more vulnerable populations may benefit from the booster, the reported increased risk of heart inflammation for young males ultimately doomed the booster from getting recommended.
“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% vaccine efficacy within two months after the second dose to about 84% by six months and amid the dominant delta variant,” Fox News reported. “While protection dropped against infections, it remained effective in preventing hospitalizations.”
Gruber cited evidence suggesting reductions in efficacy owed to waning immunity over time as opposed to the delta variant escaping vaccine protection. Additional data suggested a third Pfizer dose would ramp up protection on par or better than the second dose, however concerns were raised over a potential increased risk of heart inflammation among some recipients, particularly among males ages 16-17. The FDA panel’s review included Pfizer’s trial results with some 300 participants ages 18-55 who received a booster dose about six months after the second dose.
This story is developing.