The immunisation was approved for adults aged 50 and over. It received a traditional approval for patients between the ages of 50 and 64, and an accelerated approval for those 65 and older, Moderna said in a statement.

The immunisation, called mFlusiva, is a key component of Moderna’s effort to generate growth as demand fades for the Covid-19 vaccines that made it a household name during the pandemic. The plan ran into trouble when the FDA unexpectedly refused to consider Moderna’s application in February, before abruptly reversing course shortly afterward.

In a statement, the company said it expected supply to be available in select retailers in the coming weeks. A post-marketing clinical trial will be required to confirm the vaccine’s benefit in people 65 and over.

The unusual public spat between the company and regulators underscored the high degree of politicisation around mRNA technology and vaccination in the US. Moderna pulled its application for a combination Covid-flu shot from the US in May 2025 after the FDA asked for more data on the standalone influenza vaccine. While the combo immunisation got the green light from European regulators in February, the company said on July 31 that it is still waiting for FDA guidance on refiling in the US.

A panel of FDA advisers voted unanimously to recommend approval of the standalone flu vaccine in June.

Uploaded by Liza Shireen Koshy