FDA approval of Moderna mRNA influenza vaccine

The U.S. Food and Drug Administration (FDA) has approved Moderna’s mFLUSIVA, the first mRNA-powered influenza vaccine. This technology utilizes a genetic blueprint to produce viral proteins, offering a faster production method compared to traditional egg-based manufacturing and allowing for better alignment with circulating virus strains.

Clinical studies involving over 40,000 adults indicated the vaccine demonstrated approximately 27% greater efficacy than standard influenza vaccines during the 2024-2025 respiratory virus season. Reported side effects included fatigue, headache, muscle aches, nausea, fever, and injection site pain or swelling.

The FDA has authorized the vaccine for adults aged 50 to 64, with fast-track approval processes underway for those aged 65 and older. Moderna expects the vaccine to be available by the fall of 2026. This development occurs alongside shifts in research funding, specifically the cancellation of 22 government-backed mRNA projects by Health Secretary Robert F. Kennedy Jr. through the Biomedical Advanced Research and Development Authority (BARDA).

In a separate regional development, the Hong Kong Department of Health announced its 2026/27 influenza vaccination program will commence on September 17. The government has procured 1.6 million doses and expanded the ‘Doctor Vaccine Procurement Pilot Scheme’ from 100,000 to 300,000 doses. While vaccination rates for some groups in Hong Kong have risen, officials noted that rates for children aged 6 months to 2 years remain low at 27.5%, and rates for seniors over 65 have seen a slight decline.