The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease.
COVID-19 vaccine, even as the company's data showed it could reduce the chances of mild-to-severe disease.
The agency said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an "important identified risk" in its materials. The company has not yet agreed to do so. "Despite the wide availability of authorized or approved vaccines, the SARS-CoV-2 pandemic is not well controlled in the U.S. ... there remains a desire for vaccines that have been developed using well-understood technology platforms," it said.
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