Moderna says US FDA approved flu vaccine for adults 50+

Moderna said the US Food and Drug Administration has approved its new mRNA-based influenza vaccine for adults aged 50 and older in the United States.

The vaccine manufacturer said the shot, called mFLUSIVA, is its first mRNA-based flu vaccine. Moderna said it expects to have the vaccine available for eligible populations in the US during the 2026-2027 respiratory virus season.

The approval follows a brief setback earlier in 2026. Moderna said in February that federal vaccine regulators had described its clinical trials as inadequate and rejected its application for review. The FDA reversed that position a week later after what Moderna called a constructive meeting.

The vaccine uses mRNA technology, which US health chief Robert F. Kennedy Jr has criticised. Under Kennedy and President Donald Trump, the FDA has called for a reconsideration of approval procedures for some vaccines, including influenza vaccines, alongside proposed federal policy changes that have alarmed public health and medical professionals.