FDA Flags Heart Inflammation Risk Over Novavax COVID-19 Vaccine

A vial of the Phase 3 Novavax coronavirus vaccine prepared for use in a trial at St. George's University hospital in London, on Oct. 7, 2020. Alastair Grant/AP Photo

Staff with the U.S. Food and Drug Administration (FDA) on Friday flagged the risk of heart inflammation following the administration of the Novavax COVID-19 vaccine, although they concluded the shot reduces the risk of mild-to-severe COVID-19.

In the company’s nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of myocarditis, a type of heart inflammation also associated with mRNA vaccines, detected within 20 days post-vaccination. One patient in the trial reported myocarditis after receiving a placebo.