An adviser to the U.S. Food and Drug Administration (FDA) during an interview advised young people not to receive the recently approved bivalent COVID-19 vaccine booster doses due to a lack of human testing.
Dr. Paul Offit, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, told CNN this weekend that he isn’t convinced that the new Omicron subvariant-specific boosters will provide any benefit to healthy, younger adults.
“When you’re asking people to get a vaccine, I think there has to be clear evidence of benefit,” he said in an on-air interview. “And we’re not going to have clinical studies, obviously, before this launches, but you’d like to have at least human data [on] people getting this vaccine, you see a clear and dramatic increase in neutralizing antibiotics, and then at least you have a correlate of protection against [Omicron subvariant] BA.4, BA.5.
“Because if you don’t have that, if there’s not clear evidence of benefit, then it’s not fair to ask people to take a risk, no matter how small. The benefits should be clear,” Offit said. “A healthy young person is unlikely to benefit from the extra dose.”
As for how the updated booster compares with the previous monovalent shot, “we don’t know for sure,” he wrote last week for The Wall Street Journal, “because the Food and Drug Administration authorized the new shot without clinical trials.”
During an FDA Vaccine Advisory Committee meeting, Offit voted against the authorization.
On Sept. 1, the Centers for Disease Control and Prevention (CDC) issued a recommendation to offer reformulated bivalent booster doses manufactured by Pfizer and Moderna.
The CDC recommendation is for Pfizer’s vaccine booster for Americans aged 12 years and older and for Moderna’s vaccine booster for U.S. adults. People are advised to get the updated vaccine boosters at least two months after their most recent shot.
The old COVID-19 boosters are no longer available, having been replaced by the bivalent ones. But the primary series of vaccines will remain the same, which is based on the original COVID-19 strain that emerged in Wuhan, China.
As she signed off on recommending the boosters, CDC Director Dr. Rochelle Walensky stated they were “formulated to better protect against the most recently circulating COVID-19 variant” and can “help restore protection” to the virus.
Her comment came as doctors questioned the lack of human data on the updated booster shots in a CDC advisory panel meeting earlier this month.
“I really do struggle with a vaccine that has no clinical data that has been reported for humans,” Dr. Oliver Brooks, one of the advisory committee members, said in the panel meeting.
But a CDC official, Dr. Melinda Wharton, downplayed concerns and said that members should consider that influenza vaccines are updated each year without any human data. Noting that “there will be some bumps in the road” as officials transition to the bivalent vaccines, Wharton said that it’s necessary to move toward updated shots that she believes will provide more protection.
Data published last week on the CDC’s website show that few Americans who are eligible for the bivalent shots have actually received them, coming weeks after they were approved on Sept. 1. About 4.4 million people have taken the updated shot, while the American Health Association had estimated that more than 200 million Americans were eligible.
The FDA and CDC didn’t respond by press time to a request for comment on Offit’s recent public statements.
Zachary Stieber contributed to this report.