FDA Advisers Vote in Favor of J&J COVID-19 Vaccine

An FDA vaccine advisory committee on Friday cleared the way for authorization of a third COVID-19 vaccine in the U.S. The committee voted unanimously (22–0) that the benefits of the single-dose Johnson & Johnson vaccine outweigh the potential risks. The FDA is expected to issue an emergency use authorization for the vaccine in the coming days.

The company has requested that its Ad26.COV2.S vaccine be authorized for use in people ages 18 years and older. It is a replication-incompetent adenovirus type 26-vectored vaccine that encodes a stabilized variant of the SARS-CoV-2 spike protein. It’s the first non-mRNA vaccine to reach this stage.

In the vaccine’s clinical trial, overall efficacy against laboratory-confirmed moderate-to-severe/critical COVID-19 was 67% after at least 14 days post-vaccination. The vaccine can be stored at 2–8°C for up to 3 months, making it easier to distribute than the authorized mRNA vaccines.

FDA briefing materials on Ad26.COV2.S