The U.S. Food and Drug Administration (FDA) has granted approval for mFlusiva, a new influenza vaccine developed by Moderna specifically for adults aged 50 and older. This marks the first time mRNA technology, which played a pivotal role in the COVID-19 pandemic response, has been applied to a seasonal flu vaccine.
Moderna announced that the vaccine will be available soon at select retailers as the fall vaccination season approaches. The FDA’s approval process involved distinct pathways for different age groups. For individuals aged 50 to 64, the agency granted full approval following a 40,000-person study that demonstrated a 27% reduction in flu cases compared to existing traditional vaccines. For those 65 and older, the FDA utilized an accelerated approval process based on clinical data showing a robust immune response, with a confirmatory study currently underway.
The path to approval faced significant regulatory hurdles earlier this year. According to reports, a high-level FDA official initially blocked the application amid heightened agency scrutiny under Health Secretary Robert F. Kennedy Jr. However, following a public challenge by Moderna and a unanimous recommendation from an independent panel of FDA advisors in June, the agency reversed its position.
While the vaccine offers a new defense against the virus, Moderna noted that clinical data indicated a slightly higher incidence of temporary side effects compared to current flu shots, including injection site pain, fever, headache, and fatigue. Health officials emphasize that because mRNA technology allows for faster manufacturing, this vaccine could prove vital if the influenza virus undergoes rapid mutations requiring updated doses on short notice.