FDA panel considers a first-of-its-kind flu vaccine using mRNA technology
The panel cited strong trial results and no major safety concerns, with Moderna saying the shot cut flu cases by 26.6% in 40,805 adults.
- 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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NEWS HEADLINES: New Moderna mRNA Jab Approved By FDA Vaccine Advisory Panel – 100PercentFedUp.com – by Danielle
The Food and Drug Administration’s vaccine advisory panel approved Moderna’s new flu vaccine, which uses the same mRNA technology as the COVID-19 jab, for older adults. The committee overwhelmingly backed the vaccine, known as mFlusiva or mRNA-1010, for two age brackets. One vote was for adults ages 50 to 64, while the other was for the 65-and-older age group. Both votes were 9-0 in favor of approving the mRNA jab. The FDA’s vaccine advisory pan…
New Moderna mRNA Jab Approved By FDA Vaccine Advisory Panel – 100PercentFedUp.com – by Danielle
The Food and Drug Administration’s vaccine advisory panel approved Moderna’s new flu vaccine, which uses the same mRNA technology as the COVID-19 jab, for older adults. The committee overwhelmingly backed the vaccine, known as mFlusiva or mRNA-1010, for two age brackets. One vote was for adults ages 50 to 64, while the other was for the 65-and-older age group. Both votes were 9-0 in favor of approving the mRNA jab. The FDA’s vaccine advisory pa…
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FDA Panel Backs Moderna’s mRNA Flu Shot for Adults 50 and Older
Federal vaccine advisers unanimously recommended approval of Moderna’s influenza vaccine, which would become the first flu shot in the United States to use mRNA technology. The post FDA Panel Backs Moderna’s mRNA Flu Shot for Adults 50 and Older first appeared on [your]NEWS.
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