FDA panel recommends mRNA flu vaccine for older adults

A first-of-its-kind flu shot is a step closer to being available to the public after a Food and Drug Administration (FDA) advisory panel voted Thursday to recommend Moderna’s mRNA-based vaccine for approval. 

The FDA’s independent vaccine advisors voted unanimously 9-0 that the benefits outweigh the risks for Moderna’s mFlusiva shot in people ages 50 to 64 as well as 65 and older. 

Moderna is seeking standard approval for its vaccine in the younger group and an accelerated approval in the latter. The company will be required to run an additional clinical trial after the vaccine reaches the market in the older group. 

But the next steps are uncertain.  

Advisory committee recommendations are non-binding, and the FDA needs to make a final decision on approval by Aug. 5. Currently, the FDA has no permanent vaccine chief nor a commissioner, so it’s not clear who will make the final decision on Moderna’s flu shot. 

The vaccine then needs to be formally recommended by the Centers for Disease Control and Prevention’s (CDC) advisory committee, which a federal judge has blocked from meeting with its current membership.  

Once the panel makes a recommendation, the CDC director will decide whether to adopt it, change it or reject it. CDC also has no........

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