The U.S. Food and Drug Administration (FDA) has granted approval for a novel seasonal influenza vaccine developed by Moderna that employs mRNA technology, as the company announced on Wednesday.
Named mFLUSIVA, this vaccine is specifically designed for individuals aged 50 and above and marks the first instance of an influenza vaccine utilizing mRNA technology to gain FDA endorsement.
Moderna stated, “This approval underscores the ongoing promise of our mRNA platform in addressing significant public health issues through persistent scientific advancement.” The company expressed gratitude towards the clinical trial participants, investigators, regulators, and its own teams whose efforts contributed to achieving this significant milestone.
The FDA operates under the U.S. Department of Health and Human Services, and this approval comes in the face of ongoing criticism regarding mRNA technology from Health and Human Services Secretary Robert F. Kennedy Jr. Notably, he had previously halted 22 vaccine development initiatives that incorporated mRNA technology last year.
Earlier this year, the FDA indicated it would not entertain Moderna’s application. However, approximately one week later, it reversed its decision, allowing the vaccine to proceed to review following discussions that resulted in a revised regulatory strategy and an amended application, which was subsequently accepted by the FDA.
The contention primarily revolved around a clinical trial involving 40,000 participants, which demonstrated that Moderna’s new vaccine was more effective in adults aged 50 and older compared to one of the currently administered standard flu vaccines. In a letter denying the initial submission, FDA vaccine director Dr. Vinay Prasad criticized the trial for its exclusion of another vaccine that is specifically recommended for individuals aged 65 and older.
In response, Moderna modified its application, seeking comprehensive approval for individuals aged 50 to 64 and expedited approval for those aged 65 and older. The company also committed to conducting an additional study regarding the vaccine’s efficacy in older adults.
Moderna anticipates that mFLUSIVA will be available for use during the 2026-27 flu season.
