US FDA flags risk of heart inflammation after Novavax COVID vaccine

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The US Food and Drug Administration has raised concerns about a possible risk of heart inflammation from Novavax Inc\u0027s COVID-19 vaccine, even as the company\u0027s data showed it could reduce the chances of mild-to-severe disease. In Novavax\u0027s nearly 30,000 patient trial, conducted between December 2020 an

The US Food and Drug Administration has raised 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.

Shares of the company fell nearly 14 per cent after the FDA's analysis of data from the company's trial. "Based on our interpretation of all the clinical data supporting NVX-CoV2373 ... we believe there is insufficient evidence to establish a causal relationship," the company said in a statement.Novavax has said the shot, NVX-CoV2373, will play a role in driving vaccination among those who have been hesitant to get immunized and it has started an educational effort on vaccine choices.

"Based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease," the FDA staff said.

 

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