A postmarket study could help resolve the ongoing debate surrounding Moderna’s flu vaccine candidate, according to an FDA official. This suggestion comes after the FDA refused to file Moderna’s Biologics License Application (BLA) for the vaccine, citing changing advice. The refusal has raised concerns from Moderna’s CEO and prompted defense from HHS regarding the FDA’s decision.
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Moderna Flu Vaccine Debate Could Resolve With Postmarket Study, FDA’s Makary Suggests
A postmarket study could help resolve the ongoing debate surrounding Moderna’s flu vaccine candidate, according to an FDA official. This suggestion comes after the FDA refused to file Moderna’s Biologics License Application (BLA) for the vaccine, citing changing advice. The refusal has raised concerns from Moderna’s CEO and prompted defense from HHS regarding the FDA’s decision.