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 placebo. “These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA Covid-19 vaccines,” the FDA staff wrote in briefing documents released on Friday. Shares of the company fell nearly 14% after the FDA’s analysis of data from the company’s trial.
The FDA said it had requested Novavax to flag myocarditis and another kind of heart inflammation as an “important identified risk” in its materials. The company had not yet agreed to do so. Novavax said the number of myocarditis events in its clinical trial was “within the range of expected background cases.”
(With inputs from health)