Washington: The Food and Drug Administration (FDA) has approved Moderna's mFlusiva vaccine, marking it as the first seasonal influenza vaccine in the United States based on messenger RNA (mRNA) technology. This approval is specifically for adults aged 50 and older, offering a new option in the fight against seasonal flu.
According to Anadolu Agency, the vaccine has received traditional approval for adults between 50 and 64 and accelerated approval for those 65 and older. The accelerated approval for the older age group is supported by evidence showing that mFlusiva generates a strong immune response. However, Moderna is required to conduct an additional study to confirm the clinical benefits for individuals aged 65 and older, with continued approval possibly depending on the outcomes of this study.
Moderna's Chief Executive Officer Stephane Bancel emphasized the significance of this development, stating, "Flu remains a significant public health challenge, and mFlusiva provides an important new option for America's seniors." The approval was bolstered by a late-stage clinical trial involving over 40,000 adults aged 50 and older, which found that mFlusiva was 26.6% more effective at preventing laboratory-confirmed influenza-like illness compared to a licensed standard-dose flu vaccine.
A separate study with approximately 3,000 adults aged 65 and older revealed that mFlusiva produced stronger antibody responses against tested influenza strains than a high-dose flu vaccine. Despite the positive findings, reactions such as pain at the injection site, fatigue, headaches, and muscle pain were more common among mFlusiva recipients compared to those who received other vaccines. Most of these reactions were mild or moderate, lasting about two days.
The FDA's review noted that serious adverse events and deaths occurred at similar rates in both the vaccine and comparison groups, with no cases of myocarditis or pericarditis identified within 42 days of vaccination. Unlike traditional flu vaccines produced using eggs, mFlusiva employs mRNA technology to instruct the body to produce influenza antigens, triggering an immune response. This technology could potentially enable faster updates to flu shots, ensuring a better match with circulating strains.
Moderna anticipates that mFlusiva will be available to eligible adults in the US during the 2026-2027 respiratory virus season. Additionally, applications for the vaccine are currently under review in the European Union, Canada, and Australia.