FDA greenlights Moderna's mRNA flu shot for seniors, a first for the technology

The Food and Drug Administration approved Moderna’s messenger RNA influenza vaccine, named mFlusiva, for adults 50 years and older, making it the first licensed flu shot using this platform. The agency granted a standard approval for ages 50-64 and an accelerated approval for those 65 and above, with the company agreeing to a Phase 4 trial to compare effectiveness against high-dose and adjuvanted comparators. Earlier this year, FDA biologics chief Vinay Prasad had issued a rare refusal-to-file notice, which was later reversed after Moderna disclosed the agency’s stance; Prasad departed the FDA in April.

Moderna CEO Stéphane Bancel highlighted the vaccine’s potential to broaden options for seniors and to speed future flu-pandemic responses. The company expects initial doses before the flu season and is pursuing regulatory reviews in the EU, Canada and Australia. An advisory panel voted unanimously that the benefits outweigh risks, noting a 27% reduction in confirmed influenza among 50-64-year-olds, with mild, short-lived side effects.