Moderna’s mRNA flu shot to get FDA review 

Moderna’s mRNA flu shot to get FDA review 

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. 

© AP Photo/Bill Sikes, File

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.   

It was Prasad who initially rejected Moderna’s application due to what he said were research design flaws. Application refusals are rare, and critics said the episode pointed to a hostile environment for mRNA vaccines under Health and Human Services Secretary Robert F. Kennedy Jr. 

Moderna spent years and hundreds of millions of dollars developing the vaccine, and the agency’s refusal to even consider the application drew sharp criticism from the company, Wall Street and the biotech industry. 

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