FDA vaccine advisers on Wednesday unanimously endorsed Moderna’s seasonal mRNA influenza vaccine candidate, mRNA-1010, setting the stage for an FDA decision on licensure. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9–0 that benefits outweigh risks for adults aged 50–64, and again 9–0 for adults aged 65 and older. Moderna is seeking standard approval for the younger group and accelerated approval for the older group. The advisory turnaround comes after prior FDA resistance to reviewing the submission. FDA is expected to decide by Aug. 5, with staff presentations indicating sufficient hurdles for approval via differing regulatory pathways.
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