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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Moderna Has Some Key Approvals Ahead. Is the Stock a Buy?
Key PointsModera grew revenue by 260% year over year in the first quarter.The company is trying its mRNA platform in oncology vaccines.Moderna is looking forward to U.S. approval of a combination COVID-19 and flu vaccine.10 stocks we like better than Moderna › Shares of Moderna (NASDAQ: MRNA) jumped during the COVID-19 pandemic, but when its COVID-19 vaccine revenue dried up, the stock slumped. However, the company has recently shown it isn't a …
Key FDA committee unanimously recommends its first vaccine since 2023
The Food and Drug Administration’s top vaccine advisory committee voted unanimously today to recommend Moderna’s mRNA influenza vaccine, mFlusiva, for adults 50 and over. This was its first time reviewing a new vaccine application since 2023.The vote by the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, is a step towards what may be the first vaccine filed and approved under the second Trump administration despite sustai…
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