US FDA approves first mRNA flu vaccine for seniors
The US Food and Drug Administration has approved the nation’s first mRNA-based flu vaccine for adults aged 50 and older, according to drugmaker Moderna, reports BritPanorama.
Moderna’s CEO, Stephane Bancel, emphasized the importance of this development, stating, “Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”
Clinical trials involving over 40,000 adults indicated that the new vaccine was approximately 27% more effective during the 2024–25 respiratory virus season compared to traditional flu shots. Side effects reported included injection-site reactions, fatigue, and headaches among others.
Importantly, the mRNA flu vaccine allows for a reduced timeframe between strain selection and public distribution, potentially offering better alignment with the prevalent influenza strains of the season. Moderna anticipates making the vaccine available this autumn.
Despite an initial rejection of Moderna’s request for review back in February due to concerns over trial adequacy, the FDA reversed its decision two weeks later, permitting the review to proceed. The FDA’s independent vaccine advisory panel later unanimously determined that the vaccine’s benefits outweigh its risks, endowing Moderna with a traditional approval for adults aged 50 to 64 and accelerated approval for those 65 and older, contingent upon additional clinical trials.
Previous flu vaccines typically require forensic strain selection months in advance, while this mRNA technology allows for a more responsive approach to vaccine production. In addition to Moderna, Pfizer is also developing mRNA-based flu vaccines.
Interestingly, the rapid advancement of mRNA technology during the Covid-19 pandemic was largely viewed as a significant achievement during President Trump’s tenure. However, in August 2025, the Department of Health and Human Services announced the cancellation of 22 projects related to mRNA vaccine development, amounting to approximately $500 million, with Secretary Robert F. Kennedy Jr. claiming that “these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.”
The CDC’s Advisory Committee on Immunization Practices is expected to assess the new vaccine further, although their review has been hampered by legal issues concerning committee appointments. Their next meeting is set for October.
The approval of Moderna’s mRNA flu vaccine not only marks a significant advancement in public health but also reflects the potential for continued innovation within vaccine development, a landscape that remains critical as respiratory illnesses evolve.
