FDA Approves Moderna's mRNA Flu Vaccine After Initial Pushback

TL;DR

Moderna's mFLUSIVA, an mRNA-based seasonal flu vaccine, has received FDA approval.
It is approved for adults aged 50 and older and is the first mRNA flu vaccine to gain FDA approval.
The approval process involved initial pushback from the FDA regarding the clinical trial design.
Moderna revised its application and agreed to conduct an additional study on older adults.
The vaccine is expected to be available for the 2026-27 flu season.

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