Novavax: There is ‘insufficient evidence’ tying its COVID-19 vaccine to heart inflammation

Novavax Inc. said Friday that the company believes “there is insufficient evidence to establish a causal relationship” between its COVID-19 vaccine candidate and instances of myocarditis and pericarditis. Novavax’s stock tumbled about 22% in trading on Friday after the Food and Drug Administration said the company’s experimental two-dose vaccine could have a higher risk for myocarditis than what has been reported for the mRNA vaccines since they were authorized. (Both the Moderna Inc. and BioNTech SE /Pfizer Inc. vaccines have since been fully approved by the FDA.) The regulator’s report was released ahead of Tuesday’s advisory committee meeting, where the group of advisors is set to vote on whether the benefits of Novavax’s vaccine outweigh the risks. Novavax’s stock is down 69.7% so far this year, while the broader S&P 500 has declined 12.3%.7% so far this year, while the broader S&P 500 has declined 12.3%.

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