FDA approves Moderna's first mRNA flu vaccine for seniors

The U.S. Food and Drug Administration has granted approval to Moderna’s influenza vaccine for older adults, marking the first licensed flu shot that uses messenger RNA technology.

The product, to be sold under the name mFlusiva, joins three other Moderna vaccines already on the U.S. market and is aimed at seniors, a group at high risk from seasonal flu.

The approval follows a brief dispute earlier this year when the FDA’s biologics chief issued a refusal-to-file notice, saying the data were insufficient. The decision was reversed a week later and the official left the agency in April.

Officials said the new vaccine adds an important option for protecting America’s seniors and demonstrates the broader potential of mRNA platforms for infectious disease prevention.