FDA panel recommends new flu shot for adults 50 and above

An FDA advisory committee voted unanimously June 18th to recommend Moderna’s mRNA influenza vaccine, mFlusiva, for adults 50 and older.

Moderna is seeking standard approval for the vaccine in one adult age group and accelerated approval for older adults. If the vaccine reaches the market for the older group, the company would be required to conduct an additional clinical trial.

The recommendation is not binding. The FDA is expected to make a final approval decision by Aug. 5, though there is uncertainty over who will make that decision because the agency lacks a permanent vaccine chief and commissioner.

The vaccine would also need a formal recommendation from the Centers for Disease Control and Prevention’s advisory committee. That committee has been blocked by a federal judge from meeting with its current membership. National Institutes of Health Director Jay Bhattacharya is serving as acting CDC director.

Adults 65 and older face a higher risk of serious flu complications, making vaccination especially important for that population. Existing vaccines designed for older adults can take longer to manufacture, while mRNA technology may allow faster updates to match circulating strains.

“Having this technology available puts us in a better position to be prepared for emerging strains or pandemic strains in the future,” said Flor Munoz-Rivas, an infectious disease specialist at Texas Children’s Hospital.

Manufacturers now choose flu strains months before the annual vaccine is released, giving the virus time to evolve and potentially reducing vaccine effectiveness. The mRNA vaccines can be developed more quickly and updated later in the year if needed.

“I think that this particular platform adds exciting ways that we can actually move our vaccines to the future,” said panel member Hayley Gans, a professor of pediatrics at Stanford University Medical Center.