FDA panel considers a first-of-its-kind flu vaccine using mRNA technology
Moderna says a study of 40,000 adults 50 and older found its mRNA shot cut flu cases by 27% versus a standard vaccine.
- On Thursday, U.S. health advisers are debating Moderna's mFlusiva, the first mRNA flu vaccine, as the FDA advisory committee moves toward a final approval decision ahead of the winter flu season.
- Earlier this year, then-top FDA official Dr. Vinay Prasad blocked Moderna's application, citing concerns the shot should have compared to high-dose senior vaccines under Health Secretary Robert F. Kennedy Jr.'s heightened scrutiny. Days after the dispute, the FDA accepted the application.
- In a 40,000-person study of people age 50 and older, Moderna's vaccine reduced flu cases by about 27% compared to standard vaccines. The FDA published a favorable review ahead of the meeting, reporting no safety concerns.
- Moderna seeks full approval for the 50- to 64-year-old population and authorization for those 65 and older while conducting additional testing. The FDA's review noted the vaccine lacks data on very frail older adults and those with weak immune systems.
- Tens of thousands of Americans die from influenza annually, with older adults among the most vulnerable. Vaccines using Nobel Prize-winning mRNA technology manufacture faster than conventional types, potentially enabling rapid response if the shape-shifting flu virus mutates.
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LIVE NOW: FDA Vaccines Advisory Committee Meets on Moderna’s mRNA Influenza Vaccine MFLUSIVA
The FDA Vaccines and Related Biological Products Advisory Committee holds a meeting at 8:30 a.m. ET on June 18 to discuss and make recommendations on the safety and effectiveness of MFLUSIVA (Influenza Vaccine, mRNA), manufactured by Moderna TX Inc., with a requested indication in Biologics License Application STN 125869/0 for the prevention of influenza disease caused by influenza virus subtypes A and B represented in the vaccine, in persons 50…
Associated Press News
FDA panel considers a first-of-its-kind flu vaccine using mRNA technology
U.S. health advisers are debating a new kind of flu vaccine. The new shot is made with the same mRNA technology that was key to ending the COVID-19 pandemic.
FDA appears open to Moderna's flu vaccine ahead of adcomm
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