FDA advisory committee unanimously recommends new flu shot for adults 50 and over
The U.S. Food and Drug Administration‘s advisory panel voted unanimously on June 18 to recommend Moderna’s mRNA influenza vaccine, mFlusiva, for adults 50 and older, Nathaniel Weixel reports for The Hill.
“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,” Weixel writes.
However, the path forward for the vaccine is uncertain. That’s because the advisory committee recommendations are nonbinding, and the FDA needs to make a final decision on approval by Aug. 5. That said, Weixel reports that it is not clear who will make this final decision since the FDA has no permanent vaccine chief nor a commissioner.
And on top of that, Weixel reports that the vaccine will then need to be formally recommended by the Centers for Disease Control and Prevention’s advisory committee, “which a federal judge has blocked from meeting with its current membership.” National Institutes of Health Director Jay Bhattacharya is the acting CDC director.
Because adults 65 and older are at increased risk of developing serious complications from flu, this population needs to get vaccinated. And while there are vaccines on the market that are specifically meant for older populations, Weixel reports that they take longer to manufacture and are not as flexible as the mRNA platform in targeting a specific strain of virus.