FDA panel unanimously backs first-of-its-kind flu vaccine using mRNA technology

A new kind of flu vaccine moved a step closer to the U.S. market Thursday as federal health advisers recommended approval of the first made with the same mRNA technology that was key to ending the COVID-19 pandemic.

The Food and Drug Administration is evaluating Moderna’s new shot, dubbed mFlusiva, for older Americans ahead of the winter flu season. Moderna is seeking full approval for the vaccine’s use in people ages 50 to 64 — along with authorization for use in those 65 and older while it conducts additional testing.

The FDA’s independent advisory committee evaluated Moderna’s studies of the vaccine and voted unanimously that its benefits appear to outweigh any risks for both age groups. The FDA will consider that recommendation in making a final decision by early August.

Tens of thousands of Americans die from influenza every year, and older adults are among the most vulnerable. There are various types of flu vaccines already available in the U.S., including three specifically recommended for people 65 and older. But vaccines made with the Nobel Prize-winning mRNA technology are faster to manufacture than other types — something experts say might help if the shape-shifting flu virus mutates in a way that requires suddenly brewing new doses to match.

https://apnews.com/article/moderna-flu-vaccine-mrna-fda-advisers-mflusiva-488c68fe39244ca5ebad441a815b4ba2