FDA panel unanimously recommends J&J Covid booster shots to adults

An influential Food and Drug Administration advisory committee on Friday said the agency should authorize boosters of Johnson & Johnson‘s single-shot Covid-19 vaccine to the more than 15 million Americans who have already received the initial dose.

The unanimous vote – by the agency’s Vaccines and Related Biological Products Advisory Committee – is a critical step before the U.S. can begin giving second shots to J&J recipients, some of whom have said they are anxious to get the additional protection. One dose of J&J’s vaccine has been shown in studies to be comparatively less effective than the two-dose messenger RNA vaccines made by Pfizer–BioNTech and Moderna.

The panel recommended the boosters to everyone 18 and over who’s already received J&J’s first shot at least two months after the initial dose. Many committee members said it should be considered a two-dose vaccine much like Moderna and Pfizer’s.

The same committee on Thursday recommended Moderna booster shots to people ages 65 and older and other high-risk adults, in line with guidelines for Pfizer’s vaccine.

The FDA usually follows the advice of the committee, and a final decision by its regulators could come within days. The agency is not the final go-ahead, however. Next week, a Centers for Disease Control and Prevention vaccine advisory group will decide who should get the extra J&J shots. If it issues a recommendation and CDC Director Dr. Rochelle Walensky signs off, booster shots could begin immediately.

J&J, which received authorization for its vaccine in late February, asked the agency to approve a booster shot of its one-dose vaccine for people ages 18 and older on Oct. 5. It has submitted data that shows a second dose boasts similar performance to the mRNA vaccines, boosting protection against symptomatic infection from 72% to 94% when administered two months after the first dose in the United States.

Days before the meeting Friday, FDA scientists published an analysis on J&J’s application for a booster, questioning the strength of the data. The FDA said people may benefit from a second dose, but added the information provided by the company was limited and the agency hadn’t verified all of it yet. It acknowledged a single J&J dose was consistently less effective than the mRNA vaccines in clinical trials and in real-world studies.

Before the vote, some committee members asked the FDA whether they could postpone a decision on boosters, saying it may be too early as there are still a number of outstanding questions. Other members wondered why the agency brought J&J’s application before the committee before it was able to verify all of the data.

“Is there an option of saying it’s a little early? There are a number of issues that are still outstanding,” said Dr. Cody…