FDA panel issues narrow recommendation for Covid vaccine booster doses

For an archived version of live coverage of the hearing of the FDA’s advisory panel, click here.

An advisory panel to the Food and Drug Administration on Friday recommended against a booster dose of a Covid-19 vaccine for most Americans at this time — a major rebuke to the Biden administration — but voted unanimously to recommend one to Americans who are 65 or older.

The FDA is not required to follow the recommendation of its advisory committees but generally does. If the recommendation is adopted by the FDA and Centers for Disease Control and Prevention, it would put the U.S. policy on a par with countries like the United Kingdom.

After seven hours of deliberation, members of the Vaccines and Related Biological Products Advisory Committee voted 16 to 2 against a proposal to administer a third dose of the vaccine developed by Pfizer and BioNTech to individuals 16 years and older. The vote to recommend a booster to people 65 years and older — as well as people who are at risk of severe Covid — was 18 to 0.

It was not immediately clear who would qualify as high risk; fleshing that out will likely fall to the CDC’s advisory committee, the Advisory Committee on Immunization Practices.

The panelists acknowledged that data show that the protection conferred to the vaccinated is waning over time, but argued the overwhelming number of vaccinated people have sufficient protection at this time to cope with any infection without requiring hospitalization or risking death.

The vaccine “may eventually be indicated for the general population, I just don’t think we’re there yet,” said Ofer Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital.

Peter Marks, who is in charge of the FDA biologics center that decides on vaccine approvals, voted to recommend a booster dose.

“It’s no secret here that there is still debate over the need for an additional Covid-19 vaccine at this phase of the pandemic,” he said. “But the emerging evidence such as that from our Israeli colleagues is very helpful. We also know that breakthrough infections, including some that are severe, are occurring in the United States.”

The vote puts the FDA in a difficult position. In August, President Biden, the agency’s commissioner, Janet Woodcock, and other top health officials in the administration took the unusual step of saying booster doses would be authorized to most Americans before the FDA and CDC had weighed in on the data.

In recent weeks, it became increasingly clear that many outside experts to did not support that decision. The World Health Organization has also been highly critical of the idea of boosting in affluent countries while most people in developing countries haven’t yet received a dose of vaccine.

A separate meeting has been scheduled of ACIP for next week. While the FDA issues decisions on whether to approve vaccines, ACIP advises the CDC on whether it should recommend use of vaccines the FDA has approved.

Most experts believe booster doses may eventually be needed. The question is when.

“I think having a late boost is going to make this a much better vaccine,” Barney Graham, who designed the structure for the vaccines made by Moderna and a number of other producers while he was deputy director of the Vaccine Research Center at the National Institutes of Health, told STAT in a recent interview.