FDA Committee Votes Against COVID-19 Vaccine Booster for General Population

This story has been updated.

The FDA Vaccines and Related Biological Products Advisory Committee recommended against a COVID-19 vaccine booster shot for individuals 16 years and older in a 16 to 2 vote, but unanimously recommend the booster in individuals 65 years and older and those at high risk of severe COVID-19.

The FDA is not obliged to follow the recommendations of its advisory committee, but it usually does.

The committee was reviewing the data for an application from Pfizer and BioNTech for a third dose of their COVID-19 vaccine to be given 6 months after people received their second dose. The Biden administration may need to rethink its COVID-19 plan as it has been promoting booster shots as a way to provide greater protection.

Although the committee only discussed the Pfizer/BioNTech vaccine, Moderna has also submitted data for a COVID-19 vaccine booster, and Friday's vote could have implications for that application.

The FDA gave full approval to the Pfizer/BioNTech vaccine last month, meaning the vaccine is fully licensed; the Moderna vaccine remains under an emergency use authorization (EUA).

The FDA committee heard presentations from infectious disease experts, including research out of Israel, which has already started delivering booster shots.

In the discussion before the first vote, the panel members largely questioned younger individuals receiving a booster. “It’s not clear to me that the data we’re seeing right now is applicable and necessary to the general population,” said Michael Kurilla, MD, PhD, director of the Division of Clinical Innovation, National Center for Advancing Translation Sciences, National Institutes of Health.

Mark Sawyer, MD, professor of clinical pediatrics at UC San Diego, was one of the few yes votes on the first question for the general population.

“I think it was the quickest, most efficient way, and most flexible way for providers to be able to target certain populations," he said.

All 18 members voted yes on the second question of whether a booster dose should be used in individuals 65 years and older and individuals at high risk of severe COVID-19.

Sawyer also voted yes on the second question and clarified he was in favor of the restriction to high-risk groups as long as the CDC Advisory Committee on Immunization Practices “provides enough additional guidance about exactly who we think are most concerning.”

Although he voted yes, committee members Steven Pergam, MD, medical director, Infection Prevention, Seattle Cancer Care Alliance, expressed hesitation over the qualification of high-risk, severe COVID-19.

“Because I do think this will potentially put health care workers in a different situation. They’re not necessarily at risk for severe COVID, but developing COVID,” he said. “I just want to reiterate that I think that health care workers are particularly a high-risk group for acquisition as the antibodies wane, and we have not addressed that in this particular statement.”

A CDC advisory panel is expected to discuss the issue of boosters next Wednesday. The Associated Press reported that the CDC has said it is considering boosters for older people, nursing home residents, and health care workers.

After the FDA committee of outside experts agreed that an EUA for older adults or those at risk of severe disease had benefits that outweighed any risks of a booster, members immediately began discussing whether other groups should be included as well, such as health care workers, other workers at risk of contracting or spreading the disease due to their jobs, or others.

Peter Marks, MD, PhD, the director of the FDA's Center for Biologics Evaluation and Research, asked that the panel be informally polled as to whether these groups should be included in an EUA for booster shots.

"What we will be taking that to mean at the FDA is health care workers, frontline workers such as teachers, and potentially essential infrastructure workers as well," he said.

That informal question also had a unanimous positive response from the panel.