FDA APPROVES MODERNA MRNA FLU VACCINE FOR ADULTS OVER 50

The Food and Drug Administration has approved mFlusiva, a new flu vaccine manufactured by Moderna using messenger RNA technology, for adults aged 50 and older. The agency granted full approval for use in people aged 50 to 64 based on a clinical trial of 40,000 people, which found the vaccine reduced flu cases by approximately 27 per cent compared with another routinely used flu vaccine brand. For people aged 65 or older, the FDA granted accelerated approval pending an additional postmarketing study, based on a smaller trial demonstrating a strong immune response compared with an existing high-dose vaccine for seniors. Moderna, based in Cambridge, Massachusetts, stated that mFlusiva is expected to become available at select retailers soon.

The mRNA platform behind mFlusiva is the same technology used in Moderna's Covid-19 vaccine. Experts note that vaccines manufactured using mRNA technology can be produced faster than other vaccine types, potentially offering an advantage if the influenza virus mutates in ways requiring rapid vaccine reformulation. Flu vaccines must be updated annually to match circulating virus strains. Tens of thousands of Americans die from influenza each year, with older adults among the most vulnerable populations.

Moderna's trial data indicated no major safety concerns, though the vaccine did produce temporary side-effects including injection site pain, fever, headache, fatigue and muscle aches at rates somewhat higher than existing flu vaccines. The FDA approval follows a public dispute earlier in the year when a senior FDA official initially blocked the company's application amid heightened vaccine scrutiny under health secretary Robert F Kennedy Jr. Multiple flu vaccine options already exist for older adults, including three specifically recommended for people aged 65 or older.