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Moderna Pulls Application for FDA Approval of Flu-COVID Shot After FDA Calls for New Clinical Trials
Moderna is withdrawing its application for U.S. Food and Drug Administration (FDA) approval of its mRNA-1083 combination flu and COVID-19 vaccine, the company announced today — just one day after the FDA said it would require new clinical trials to approve COVID-19 boosters for healthy people under 65.
According to Fierce Biotech, the company will resubmit its application when data from a Phase 3 trial of its mRNA-1010 flu vaccine, which is a component of the combined shot, are available later this year. The company expects to have interim data from the trial available this summer.
Markets reacted negatively to the news, with Moderna’s shares falling 1.4% in premarket trading on Wednesday, The Guardian reported.
According to Reuters, Moderna’s decision to withdraw its application at this time “is the latest sign of increased regulatory scrutiny of the vaccine approval process since Robert F. Kennedy Jr. took the top U.S. health job earlier this year.”
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