FDA Adviser Expresses Frustration Over FDA’s Authorization Of COVID-19 Booster Shot For Kids

A prominent advisor to the Food and Drug Administration (FDA) criticized the agency’s recent decision to authorize COVID-19 booster vaccines for children older than four.

The comments were made by Dr. Paul Offit, Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a co-inventor of the rotavirus vaccine. Offit is also a member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Offit made the remarks in response to the FDA’s announcement this week that they had authorized the Moderna and Pfizer COVID-19 vaccines to be used in a single booster dose for young children.

Offit emphasized that there was not enough evidence to support the FDA’s decision.

“I don’t see evidence that an otherwise healthy young person needs another dose of vaccine,” Offit said. “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?” Offit asked. “Why did we waste all of that vaccine?”

There is also the financial cost of federal investments in bivalent booster shots. The Biden administration recently bought $5 billion worth of boosters, but only about 5% of Americans have received a dose since they were authorized in early September.

Offit explained that normal procedures are being bypassed to ensure booster vaccines are authorized as soon as possible, and this practice puts American lives at risk.

“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.”

Standard practice dictates that vaccines must receive approval by a majority vote of the members of VRBPAC, along with a separate analysis and vote conducted by a vaccine expert committee at the Centers for Disease Control and Prevention.

The first COVID-19 vaccines went through this process, but for some reason, the FDA has authorized booster shots without consulting the expert committees.
“A lot of us have been frustrated by this; not just me,” Offit added.