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.
“These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines,” FDA staff wrote in briefing documents that were released on Friday….