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Moderna voluntarily withdraws BLA for mRNA-1083 vaccine candidate

Moderna (MRNA) announced that in consultation with the U.S. Food and Drug Administration, the Company has voluntarily withdrawn the pending Biologics License Application for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available. Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.

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