New mRNA Flu Shot Moves Closer to Approval

A fresh flu vaccine built with the same mRNA tech that helped stop COVID‑19 is getting a green light from U. S. health experts. The FDA’s panel said the benefits outweigh the risks for people aged 50 to 64, and it will also consider using it in those 65 and older while more tests are done. The vaccine, called mFlusiva, could help protect the most vulnerable group—older adults—who lose tens of thousands of lives to flu each year. Existing shots exist, but this mRNA version can be made faster, which might help if the virus changes quickly. In a study of 40, 000 people over 50, the new shot cut flu cases by about 27% compared with a standard vaccine. A smaller group of seniors over 65 also showed strong immune responses, better than the high‑dose flu shot usually given to them. The data were described as “very compelling” by an FDA adviser.Moderna says its quick production could stop thousands of hospital visits if the flu mutates after a vaccine is made. The current yearly recipe for flu shots is set months before the season, so a mismatch can happen. The FDA may approve the vaccine for older adults before next winter, though more information is needed about frail seniors or those with weak immune systems. If approved, Moderna plans a large study of 400, 000 seniors to compare the mRNA shot with current special‑for‑seniors shots over two seasons. Safety reports show no major issues, but the vaccine can cause short‑term side effects like pain at the injection site, fever, headache, tiredness and aches—common with many vaccines. These reactions signal the immune system is working, a point emphasized by an FDA adviser who said it’s important to explain this to people receiving the shot. Moderna is also testing the vaccine in younger adults and will run a separate study for kids aged 9 to 17 this fall.