FDA advisory panel votes 19-0 to endorse booster dose of J&J vaccine

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

A Food and Drug Administration advisory panel voted Friday that booster shots should be made available to people who have received the Johnson & Johnson Covid-19 vaccine.

Unlike the authorizations for boosters for the Pfizer/BioNTech and Moderna vaccines, no restrictions were put on the J&J booster. The panel effectively said that the J&J vaccine, like the other vaccines, requires two doses to be effective.

After sometimes heated discussion, the Vaccines and Related Biological Products Advisory Committee voted 19 to 0 that anyone who received the J&J vaccine should be offered a second dose.

“I think this frankly was always a two-dose vaccine,” Paul Offit, a researcher at Children’s Hospital of Philadelphia, said at the meeting. “It’s hard to recommend this as one dose vaccine.”

But panelists were also critical of data suggesting that the vaccine be given as a booster dose at six months, saying the data came from only 17 patients. However, they said they would not want to deny boosters to anyone who had not yet received one.

“If the vaccine isn’t adequate, then it should be boosted in everybody,”  said Eric Rubin editor-in-chief of The New England Journal of Medicine. “I’m not sure why you’re asking for an indication that would apply to millions of patients with a data set that includes 17 patients.”

The FDA is not bound by the votes of its advisory committees, which it convenes to ask for guidance, but it generally follows their advice. The booster shot would be granted an emergency use authorization, used to speed the approval of products during public health emergencies, and not a traditional approval.

This summer, the Biden administration said it intended to make booster shots broadly available as early as September. But many scientists have pushed back, saying there is not enough evidence that the efficacy of the vaccines against severe Covid, hospitalizations, and death is waning.

After the main vote was taken, the panel also discussed data from a study funded by the National Institutes of Health that evaluated the safety and efficacy of  “mix-and-match” boosters, in which people get a booster different than their initial vaccine.

The study had big caveats — volunteers weren’t assigned to one booster or another randomly, and hadn’t been followed long — but some panelists expressed hope that the FDA could find a way to make them available to at least some people. It’s not clear there is a pathway for the mix-and-match approach based on such limited data.

The panel’s chair, Arnold Monto, also brought up another big idea: lowering the age at which people without risk factors can get the Moderna and Pfizer vaccines from 65 years to 40. Some panelists were also open to that idea, but the FDA declined to hold a vote.

One worry on the part of panelists and outside experts is that the FDA held the panel before it could vet the data from J&J’s studies as closely as it usually does.

Panelist James Hildreth, the CEO of Meharry Medical College, told the FDA he thought it important that the FDA still conduct its normal analysis and, that if issues arise in the data, “appropriate actions will be taken.”

Norman Baylor, a former head of the FDA office that reviews vaccines, echoed that concern on a press call. “It does set a bad precedent,” Baylor said.