Moderna’s new seasonal influenza vaccine, mFLUSIVA, has received U.S. Food and Drug Administration (FDA) approval for adults aged 50 and older, according to an announcement from Moderna. The company anticipates having the vaccine ready for the upcoming 2026-2027 flu season.

Results from two clinical trials led to the FDA’s decision. Between the two, more than 43,000 adults over the age of 50 participated. One of the trials, a Phase 3 clinical trial, “demonstrated an acceptable safety profile for mFLUSIVA, with no new safety concerns identified, consistent with previously reported studies of mFLUSIVA.”

mFLUSIVA is the first approved flu vaccine made from mRNA. Known side effects include fatigue, headache, muscle and joint pain, chills, nausea, vomiting, and fever. Patients may also experience pain, tenderness, swelling, and redness around the injection site. However, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously (9-0) in favor of the vaccine, leading to the FDA’s approval. They agreed that the vaccine’s benefits outweigh its risk, Moderna said.