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Shares of Novavax (NASDAQ:NVAX) are down more than 13% today after the U.S. Food and Drug Administration (FDA) released briefing documents concerning the company’s COVID-19 vaccine.
The FDA’s staff said today that the company’s vaccine reduces the risk of mild-to-severe COVID-19 and that it was likely the shot could provide some level of protection against the Omicron variant.
“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,” FDA staff said.
Novavax’s study showed an efficacy rate of 90.4%.
However, the Novavax stock price was hit after the briefing documents flagged the possible risk of myocarditis.
The FDA’s outside advisers are meeting next week to discuss the vaccine’s authorization in adults.
Novavax stock price is down over 65% YTD.