FDA grants approval for Moderna's mRNA flu vaccine for adults 50 and older

The U.S. Food and Drug Administration approved Moderna's mRNA-based influenza vaccine for adults 50 and older, marking the first such product in the United States. The agency’s decision follows a study of more than 40,000 participants that found the vaccine to be about 27% more effective during the 2024-25 respiratory virus season than standard flu shots.

"Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors," Moderna CEO Stephane Bancel said in a statement. "This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation."

Reported side effects include injection-site reactions such as pain and tenderness, swollen lymph nodes, fatigue, headache, muscle or joint pain, nausea or vomiting, and fever. The mRNA platform allows a shorter interval between strain selection and vaccine distribution, potentially enabling a closer match to circulating influenza strains.

Moderna expects to make the vaccine available this fall. The FDA’s independent vaccine advisory panel unanimously concluded that the benefits outweigh the risks and endorsed traditional approval for adults 50-64 and accelerated approval for those 65 and older, pending further trials.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to consider a recommendation on the vaccine at its October meeting.