Vaccine Panel Backs J&J Booster Vaccine

FDA’s Vaccine and Related Biological Products Advisory Committee 10/15 unanimously (19-0) voted to recommend Johnson & Johnson’s Covid-19 booster vaccine in all adults two months after receiving their initial J&J dose. To date, about 15 million people have received their first J&J shot in the U.S.

The positive vote came as a briefing document released prior to the meeting had FDA not taking a position on whether it should authorize the booster shot, and agency reviewers raising questions about the company’s evidence. The reviewers said a test used by the company was likely not sensitive enough to accurately determine the benefit of a booster shot. They also said they didn’t have enough time to independently review much of the trial data submitted by J&J in support of its application to expand the vaccine’s emergency use authorization to include a booster shot.