FDA to review flu vaccine it had previously rejected

The FDA will advance its review of Moderna’s previously rejected flu vaccine after the company met with regulators and amended its application. Moderna proposes full approval for ages 50–64 and accelerated approval for those 65 and older with a required additional study in older adults.

The FDA initially denied Moderna's application for a new flu vaccine, a decision that drew attention across the drug industry. After a Type A meeting and an amended application from Moderna, the agency has agreed to advance the submission for review. Moderna's updated proposal seeks full approval for people aged 50 to 64 and accelerated approval for people 65 and older, with a commitment to an additional study in older adults if approved. The FDA commissioner had earlier defended the prior denial, saying the original study design was flawed. What is known now: - The FDA will proceed with reviewing Moderna's flu vaccine after the company met with regulators and amended its application. - Moderna's submission requests full approval for ages 50–64 and accelerated approval for ages 65 and older, paired with a required additional study in older adults. - FDA Commissioner Marty Makary previously defended the initial denial by pointing to issues with Moderna's study design. Summary: The agency has agreed to advance Moderna's application for formal review after the meeting and amended filing. Undetermined at this time.