The Food and Drug Administration has approved Moderna’s mFLUSIVA, the first mRNA flu vaccine, allowing the company to use the technology to more rapidly target widely circulating or especially dangerous strains of the virus, The New York Times reports.

The vaccine was authorized for adults between the ages of 50 and 64. The FDA also granted accelerated approval for adults 65 and older, allowing broader use while Moderna conducts a follow-up study to confirm the results.

Moderna said it expects the vaccine to be ready for the 2026-2027 respiratory virus season. Unlike traditional flu vaccines, which can require months of preparation using decades-old production methods, the mRNA approach is designed to allow manufacturers to adjust more quickly to emerging strains and select the best option for each flu season.

The FDA had initially refused to review Moderna’s application earlier this year, but reversed course following a public outcry. The agency subsequently began reviewing the application, which was based on a major clinical trial involving nearly 41,000 people between the ages of 50 and 64.

The study found that the Moderna vaccine was more effective than a flu vaccine manufactured using older technology, translating to a relative efficacy of approximately 27%. Participants receiving Moderna’s vaccine reported higher rates of injection-site pain, fatigue and headaches, while serious medical incidents recorded during the trial were determined to be unrelated to the vaccine.

(YWN World Headquarters – NYC)