U.S. FDA flags risk of heart inflammation after Novavax COVID vaccine

The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease. In Novavax's nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot. 'These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines,' FDA staff wrote in briefing documents released on Friday.