An advisor on the Food and Drug Administration’s (FDA) vaccine expert committee is not pleased with the agency’s decision to rush through authorization of new bivalent boosters for children.
Dr. Paul Offit, Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, is a member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and a co-inventor of the rotavirus vaccine. He told the Daily Caller he’s frustrated by the FDA’s decision to authorize new COVID-19 boosters for kids aged five and over.
Today, FDA amended the EUA of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. https://t.co/C2Sx5Nkk0R pic.twitter.com/xsPfO2Mek3
— U.S. FDA (@US_FDA) October 12, 2022
“I don’t see evidence that an otherwise healthy young person needs another dose of vaccine,” Offit said.
The FDA made the decision to give Emergency Use Authorization (EUA) to the bivalent COVID-19 boosters for kids aged five and older on Wednesday, after previously doing so for anyone 12 and up. The bivalent boosters were developed by Moderna and Pfizer to more specifically target the Omicron variant of the virus. The EUA for the original, monovalent vaccines was withdrawn when the bivalent shots became available, a decision Offit said “disappointed” him.
“All the data that has been presented so far has not in any way supported the notion that the bivalent vaccine was any better than the monovalent vaccine. So why did we stop using the monovalent vaccine? Why did we waste all of that vaccine?”
The Biden administration ordered $5 billion worth of bivalent boosters in recent months, hardly any of which have been used. Since the new boosters were first authorized in early September, just around 5% of eligible Americans have gotten a dose.
Offit said the data just isn’t there to support a wide need for the new boosters, and that other members of VRBPAC and the vaccine research community are at a loss for why the FDA is bypassing its own advisors to authorize them.
“You need to do those studies before you make that recommendation,” he said. “Normally it goes data, committee, policy. Now it’s just sort of policy.” (RELATED: CDC Caught Using False Data To Recommend Kids’ COVID Vaccine)
Typically, data on a new vaccine would be presented to VRBPAC, which would then vote on whether or not to recommend the FDA authorizes its use. If the FDA did decide to move forward, the data would then go to the vaccine expert committee at the Centers for Disease Control and Prevention (CDC) who would conduct their own review and vote. Finally, the CDC director would determine whether or not to recommend the shot to the relevant demographic.
That was the process used to authorize the first COVID-19 vaccines. However, recent booster approvals have moved forward without the nod of approval from VRBPAC or the CDC’s Advisory Committee on Immunization Practices (ACIP).
“A lot of us have been frustrated by this, not just me,” Offit said.
The FDA did not immediately respond to the Daily Caller’s request for comment.