Alliance for Pandemic Preparedness

February 24, 2021

Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Vaccines and Related Biological Products Advisory Committee Meeting

Category:

Topic:

Keywords (Tags):

The Johnson & Johnson single-dose Ad26.COV2.S vaccine candidate was determined by the FDA to have met the safety and efficacy requirements for emergency use authorization. Vaccine efficacy against laboratory-confirmed moderate to severe/critical COVID-19 across all geographic areas in which the trial was conducted was 66.9% when considering cases occurring at least 14 days after the single-dose vaccination and 66.1% considering cases occurring at least 28 days after vaccination. Efficacy against severe/critical COVID-19 occurring at least 14 days and at least 28 days after vaccination was 76.7% and 85.4%, respectively. As of February 5, 2021, there were 7 COVID-19 related deaths in the placebo group and no COVID-19 related deaths in the vaccine group. A subset of participants (n=6,736) was followed for self-reported reactions to the vaccine within 7 days following vaccination, and the most common adverse reactions were mild to moderate injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%). 

FDA. (Feb 26, 2021). Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Vaccines and Related Biological Products Advisory Committee Meeting. https://www.fda.gov/media/146217/download