FDA Approves Moderna's mRNA Flu Shot

The Food and Drug Administration (FDA) has approved Moderna’s mRNA-based flu vaccine, mFlusiva, for adults aged 50 and older. This marks the first time the Nobel Prize-winning mRNA technology, key to ending the COVID-19 pandemic, is used for seasonal influenza vaccines.

According to TimesLIVE and PBS, mFlusiva is intended for adults aged 50 or older. The vaccine has begun arriving in pharmacies ahead of the northern hemisphere’s autumn vaccination season, with Moderna expecting some doses to be available soon at select retailers.

The FDA granted full approval for mFlusiva’s use in people ages 50 to 64 based on a study of 40,000 participants that found a 27% reduction in flu cases compared to other commonly used flu vaccines. For those aged 65 and older, the Cambridge-based manufacturer received accelerated approval pending further studies.

Moderna’s data showed no major safety issues, although temporary reactions such as injection site pain, fever, headache, tiredness, and aches were reported more frequently than with current flu shots. The Guardian noted that while there are multiple flu vaccine options in the U.S., including three specifically recommended for people aged 65 or older, tens of thousands of Americans die from influenza annually.

This approval comes after a highly unusual public dispute over mFlusiva earlier this year. A then-top FDA official initially blocked Moderna’s application, signaling heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr., according to TimesLIVE and PBS. Days later, the agency reversed its decision following Moderna’s public challenge, and in June, an independent panel of advisers unanimously recommended the vaccine's approval.