By Liz Moyer

Investing.com — Novavax Inc (NASDAQ:) shares plunged 20% on Friday after the Meals and Drug Administration flagged the danger of coronary heart irritation linked to the corporate’s vaccine towards Covid-19.

The feedback got here in a briefing document launched forward of the FDA’s June 7 assembly to resolve on whether or not to approve Novavax’s vaccine for emergency use. The vaccine has already been authorised in Australia, India and most of Europe.

“A number of occasions of myocarditis/pericarditis had been reported in temporal relationship to NVX, and FDA considers a few of these occasions probably associated to vaccination,” the briefing doc mentioned.

Coronary heart irritation has additionally been discovered after vaccinations with mRNA know-how, which Novavax’s vaccine would not use. The FDA briefing doc mentioned if causally associated, the danger of myocarditis could possibly be larger than reported for Novavax. There weren’t any reported pre-authorization incidences of myocarditis linked to mRNA vaccines.

Novavax mentioned in an announcement Friday that information from its placebo-controlled research present “the speed of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%). Moreover, within the post-crossover parts of our research, the instances we’ve got seen are all inside the anticipated charge.”

The vaccine maker added, “Based mostly on our interpretation of all of the medical information supporting NVX-CoV2373, together with over 50,000 members in medical trials, we consider there’s inadequate proof to determine a causal relationship. We are going to proceed to observe all antagonistic occasions, together with myocarditis and pericarditis.”