By Liz Moyer
Investir.com — Novavax Inc (NASDAQ:) Shares plunged 20% on Friday after the Food and Drug Administration flagged heart inflammation risk linked to the company’s Covid-19 vaccine.
The comments came in a information document released ahead of the June 7 FDA meeting to decide whether to approve Novavax’s vaccine for emergency use. The vaccine has already been approved in Australia, India and most of Europe.
“Several events of myocarditis/pericarditis have been reported temporally related to NVX, and the FDA considers some of these events to be potentially related to vaccination,” the briefing statement states.
Heart inflammation has also been seen after vaccinations with mRNA technology, which Novavax’s vaccine does not use. The FDA briefing said that if related to a cause, the risk of myocarditis may be higher than reported for Novavax. No cases of myocarditis related to mRNA vaccines were reported prior to licensing.
Novavax said in a statement Friday that data from its placebo-controlled studies show “the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%). Additionally, in the post-crossover portions of our studies, the cases we’ve seen are all within the expected rate.”
The vaccine maker added, “Based on our interpretation of all clinical data supporting NVX-CoV2373, including more than 50,000 clinical trial participants, we believe there is not enough evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis.”