Reference:
FDA. (2021). Vaccines and related biological products advisory committee meeting: February 26, 2021. Janssen Ad26.COV2.S vaccine for the prevention of COVID-19. FDA Briefing Document.
Summary:
The FDA briefing document details the Emergency Use Authorization (EUA) request submitted by Janssen Biotech for the Ad26.COV2.S vaccine aimed at preventing COVID-19. This single-dose adenovirus vector vaccine demonstrated a vaccine efficacy (VE) of approximately 66.9% against moderate to severe COVID-19 in a Phase 3 trial involving nearly 40,000 participants. The trial highlighted a favourable safety profile, with common adverse reactions including pain at the injection site and mild systemic effects. Significant findings included no COVID-19-related deaths in the vaccinated group, contrasting with seven deaths in the placebo group. The document outlines the need for continued monitoring of the vaccine’s efficacy and safety, especially in subgroups with varying demographics. The VRBPAC discussed whether the benefits of the vaccine outweigh its risks and recommended further clinical trials for long-term data.