Moderna’s vaccine regulatory hokey-cokey
By 
Phillip Broadwith2026-02-20T14:11:00
US FDA initially refused to accept flu vaccine for review, but has since reversed that decision
On 10 February, the US Food and Drug Administration (FDA) told Moderna that it would not accept the company’s application for a new influenza vaccine – a decision that reportedly involved senior leaders overruling advice from FDA staff, although the agency denied this was the case. A week later, the FDA has reversed its decision and is accepting the drug for review.