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Investing.com — Novavax Inc (NASDAQ:NVAX) shares plunged 20% on Friday after the Food and Drug Administration flagged the risk of heart inflammation linked to the company’s vaccine against Covid-19.
The comments came in a briefing document released ahead of the FDA’s June 7 meeting to decide on whether to approve Novavax’s vaccine for emergency use. The vaccine has already been approved in Australia, India and most of Europe.
“Multiple events of myocarditis/pericarditis were reported in temporal relationship to NVX, and FDA considers some of these events potentially related to vaccination,” the briefing document said.
Heart inflammation has also been found after vaccinations with mRNA technology, which Novavax’s vaccine doesn’t use. The FDA briefing document said if causally related, the risk of myocarditis could be higher than reported for Novavax. There weren’t any reported pre-authorization incidences of myocarditis linked to mRNA vaccines.
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%). Furthermore, in the post-crossover portions of our studies, the cases we have seen are all within the expected rate.”
The vaccine maker added, “Based on our interpretation of all the clinical data supporting NVX-CoV2373, including over 50,000 participants in clinical trials, we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis.”
