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.”