Moderna's mRNA flu shot to get FDA review

Source: The Hill

05/22/26 6:52 PM ET


After some initial back-and-forth, Moderna’s candidate for a mRNA flu vaccine will get a review by a Food and Drug Administration (FDA) advisory panel next month.

The panel will meet June 18 to discuss and make recommendations on the safety and effectiveness of Moderna’s MFLUSIVA flu vaccine, according to a Federal Register notice published Thursday. The FDA is set to make a decision by Aug. 5, in time for the next flu season.

The FDA initially refused to review the vaccine in February before abruptly reversing course a week later.

This decision comes following the abrupt departure of former FDA Commissioner Marty Makary and not long after the departure of Vinay Prasad, the controversial former top vaccine regulator. While in office, Makary publicly spoke of faster, more flexible reviews, but companies did not see that play out in practice.

Read more: https://thehill.com/newsletters/health-care/5892283-modernas-mrna-flu-shot-to-get-fda-review/