FDA approves Moderna's mRNA flu vaccine after initial pushback

The U.S. Food and Drug Administration has given the green light to a new seasonal flu vaccine from Moderna, called mFLUSIVA, which utilizes mRNA technology. This vaccine is designated for adults aged 50 and above and represents the first influenza vaccine to use mRNA technology to receive FDA approval. Moderna highlighted the potential of its mRNA platform to address significant public health concerns through continuous scientific advancements.

The FDA's decision to approve the vaccine came after initial skepticism from Health and Human Services Secretary Robert F. Kennedy Jr., who canceled 22 vaccine development projects that utilize mRNA technology, including Moderna's. Despite this, the FDA reversed its stance a week later and agreed to review the vaccine following discussions with Moderna, which led to a revised regulatory approach and an amended application.

The approval was based on a 40,000-person clinical trial that demonstrated mFLUSIVA's higher efficacy in adults aged 50 to 64 compared to standard flu shots, with additional studies planned for older adults. Common side effects of the vaccine include pain at the injection site, fatigue, and headache. Moderna anticipates the vaccine's availability for the 2026-27 flu season.