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Subject FDA flags heart issues after taking NOVAVAX vaccine

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Original Message US Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc's vaccine, even as the company's data showed the vaccine was effective in reducing the risk of mild-to-severe Covid-19.

The FDA said it had requested Novavax to flag myocarditis and another kind of heart inflammation as an "important identified risk" in its materials. The company had not yet agreed to do so. Novavax said the number of myocarditis events in its clinical trial was "within the range of expected background cases."

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