FDA approves Moderna’s mFLUSIVA for adults 50+ ahead of 2026-2027 flu season

Aug. 7, 2026

Key Highlights

mFLUSIVA is the first seasonal flu vaccine made from mRNA technology approved for adults 50+.
The vaccine was approved after two clinical trials involving over 43,000 participants demonstrated safety and effectiveness.
Common side effects include fatigue, headache, muscle pain, chills, and injection site reactions.
The FDA’s VRBPAC unanimously supported the vaccine, citing its favorable risk-benefit profile.
Moderna plans to have mFLUSIVA ready for the 2026-2027 flu season to enhance protection for older adults.

6a75f9fe7eef68b527222386 Adobestock 464005773

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.