HAP's Latest News

FDA Panel Recommends J&J Booster Dose, Reviews Mix-and-Match Approach

October 15, 2021

The U.S. Food and Drug Administration’s (FDA) advisory panel unanimously recommended approving a booster dose of Johnson & Johnson’s COVID-19 vaccine this afternoon.

The Vaccines and Related Biological Products Advisory Committee said there was enough evidence to support the safety and effectiveness of an additional dose of the vaccine at least two months after individuals received their initial shot.

The Johnson & Johnson vaccine is available under emergency authorization for people 18 and older. About 15 million American adults have received the vaccine to date and would be eligible for boosters if the recommendation is approved.

The decision comes after presentations from the FDA and company representatives evaluating the safety and effectiveness of a booster dose.

Johnson & Johnson officials said their vaccine provides protection against severe disease, but an additional dose would raise that level of protection. FDA staff highlighted a recent study indicating the level of protection from Johnson & Johnson’s vaccine fell below the mRNA-based options.

The advisory panel’s recommendation is non-binding. The FDA is expected to make a booster recommendation in the coming days. A Centers for Disease Control and Prevention (CDC) advisory panel will review booster information next week.

The CDC also will review the recommendation to allow booster doses for certain high-risk groups who received the Moderna vaccine.

In addition, the FDA panel reviewed results from a study from the National Institutes of Health evaluating the safety of a so-called mix-and-match approach for booster doses. The advisory panel did not make a formal recommendation, but expressed a desire to be agile to respond to pandemic.

HAP will continue to provide COVID-19 vaccine updates to members and the general public.

A replay and presentations from today’s meeting are available online.