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People aged 50 and over in the US will be able to receive Moderna’s mRNA vaccine against flu starting the 2026-2027 respiratory virus season, following approval by the US Food and Drug Administration (FDA). It is the first mRNA-based influenza vaccine to be authorised in the United States, extending the technology first deployed during the Covid-19 pandemic.
“mFLUSIVA provides an important new option for America’s seniors,” Stéphane Bancel, Chief Executive Officer of Moderna, said. He added that the approval “reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”
The positive decision was based on results from phase 3 clinical trial which incloved newalry 41,000 adults aged 50 years and older across 11 countries, as well as a separate study of almost 3,000 adults aged 65 and older in the United States.
In Europe the vaccine is still undergoing evaluation by the European Medicines Agency (EMA), which earlier this year approved combined mRNA vaccine – mCombriax – for protecting people aged 50 years and older against COVID-19 and flu. This vaccine has not been approved in the US.