FDA Approves First mRNA Based Flu Vaccine for Seniors
Qwenews.com – The FDA approves first mRNA based flu vaccine, marking a significant milestone in respiratory disease prevention. The US Food and Drug Administration on Wednesday granted approval for the United States’ first mRNA-based flu vaccine, specifically designed for adults aged 50 and older, according to pharmaceutical company Moderna. “Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” Moderna CEO Stephane Bancel stated in an official announcement. “This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”
The newly approved vaccine demonstrated approximately 27% greater effectiveness during the 2024–25 respiratory virus season compared to conventional flu shots in Moderna’s comprehensive clinical study. This research enrolled more than 40,000 adults aged 50 and older, providing robust evidence for the vaccine’s efficacy. Common side effects included injection-site reactions such as pain, tenderness, and swollen lymph nodes, alongside fatigue, headache, muscle or joint pain, nausea or vomiting, and fever.
Accelerated Timeline for Strain Selection
For flu vaccines previously available on the market, experts select flu strains for each fall’s seasonal vaccines during the preceding February. Moderna’s mRNA flu vaccine requires less time between strain selection and public circulation, which could allow for a closer match between the immunity conferred by vaccines and the season’s circulating influenza strains. This technological advancement represents a meaningful improvement over traditional vaccine development processes.
Moderna says it expects to have the vaccine available this fall. In February, the FDA initially declined Moderna’s request for review of the new flu vaccine, citing inadequate trials despite previous conflicting feedback within the agency. However, the FDA switched course about two weeks later and agreed to review the shot, ultimately leading to this historic approval.
Moderna utilizes mRNA technology in its Covid-19 vaccines, as does drugmaker Pfizer, which also has mRNA-based flu vaccines in development. An mRNA-based vaccine from Moderna targeting both Covid-19 and the flu was approved in Europe earlier this year. Although the record-speed development of mRNA-based Covid-19 vaccines during the pandemic was a chief accomplishment of President Donald Trump’s first term, his second administration has withdrawn support for mRNA technology in infectious diseases.
The US Department of Health and Human Services canceled 22 projects worth about $500 million focused on mRNA vaccine development in August 2025, with HHS Secretary Robert F. Kennedy Jr. claiming against evidence that “these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.” After a year of turmoil, cancer researchers see promising signs for mRNA vaccines. But in June, the FDA’s independent vaccine advisory panel — made up of nine physicians and vaccine scientists — unanimously voted that the benefits of the new Moderna vaccine outweigh the risks.
The panel endorsed the drugmaker’s request for traditional approval for the vaccine in adults ages 50 to 64 and accelerated approval for adults 65 and older, which requires further trials to prove clinical benefit. Typically, after a new vaccine is approved, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will review data and weigh in on whether the agency should recommend it. However, a federal judge ruled in March that Kennedy did not follow federal legal procedures when he replaced all the committee’s members, and it hasn’t met since. The committee’s next meeting is currently scheduled for October.
Frequently Asked Questions
Who can receive the new mRNA flu vaccine?
The FDA approves first mRNA based flu vaccine for two age groups with different approval pathways. Adults ages 50 to 64 receive traditional approval, while adults 65 and older receive accelerated approval that requires additional trials to confirm clinical benefit.
How effective is the mRNA flu vaccine compared to traditional shots?
According to Moderna’s study involving over 40,000 adults, the mRNA flu vaccine showed approximately 27% greater effectiveness during the 2024–25 respiratory virus season compared to standard flu vaccines.
When will the vaccine be available to the public?
Moderna expects to have the vaccine available this fall, following the FDA’s approval and subsequent scheduling of the Advisory Committee on Immunization Practices meeting in October.
What are the common side effects?
Side effects include injection-site reactions such as pain, tenderness, and swollen lymph nodes, as well as fatigue, headache, muscle or joint pain, nausea or vomiting, and fever.
