FDA confirms safety, efficacy of J&J vaccine

The FDA has confirmed a third vaccine is effective and safe in protecting against COVID-19. The vaccine, manufactured by Johnson &Johnson, is overall 67% effective beginning 14 days after vaccination, 77% effective against severe illness and completely effective against death from COVID-19. Efficacy increased overtime and was demonstrated against more infectious variants seen in South Africa and Brazil.

WashU Med was a site for the phase 3 clinical trial evaluating the vaccine; that trial was led by Rachel Presti, MD, PhD, an associate professor of medicine and medical director of Washington University’s Infectious Diseases Clinical Research Unit. Unlike the Moderna and Pfizer vaccines, the Johnson & Johnson vaccine requires only one dose. The FDA will consider granting Emergency Use Authorization to the vaccine in the next few days, which would open the door to begin distribution in the U.S. shortly thereafter.