The U.S. Food and Drug Administration has approved the nation’s first mRNA-based influenza vaccine for adults age 50 and older, marking a major milestone for Moderna as the company expands the use of its mRNA technology beyond COVID-19 vaccines.
Announcing the approval on Wednesday, Moderna CEO Stephane Bancel hailed the decision as an important step forward for older Americans. “Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” Moderna CEO Stephane Bancel said in a statement. “This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”
According to Moderna, clinical trial data involving more than 40,000 participants ages 50 and older showed the vaccine was approximately 27% more effective than conventional flu shots during the 2024–25 respiratory virus season.
The company reported that the most common side effects included pain and tenderness at the injection site, swollen lymph nodes, fatigue, headaches, muscle and joint pain, nausea, vomiting, and fever.
Unlike traditional flu vaccines, which require experts to select virus strains months in advance each February for the following flu season, Moderna’s mRNA platform can be updated more quickly. That shorter production timeline could allow vaccines to more closely match the influenza strains circulating each season.
Moderna said it expects the newly approved vaccine to be available for patients this fall.
The approval follows an unusual regulatory process. In February, the FDA initially declined to review Moderna’s application, citing concerns over the adequacy of its clinical trials despite earlier feedback within the agency that appeared to point in a different direction. Roughly two weeks later, however, the agency reversed course and agreed to evaluate the vaccine.
Moderna already employs mRNA technology in its COVID-19 vaccine, while Pfizer is also developing mRNA-based influenza vaccines. Earlier this year, European regulators approved Moderna’s combination vaccine designed to protect against both COVID-19 and influenza.
Although the rapid development of mRNA COVID-19 vaccines was widely viewed as one of the major scientific achievements of President Donald Trump’s first administration, the current administration has taken a different approach toward the technology for infectious diseases. In August 2025, the Department of Health and Human Services canceled 22 mRNA vaccine development projects worth approximately $500 million. HHS Secretary Robert F. Kennedy Jr. argued, without presenting supporting evidence, that “these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.”
Despite that policy shift, the FDA’s independent vaccine advisory committee unanimously concluded in June that the benefits of Moderna’s new flu vaccine outweighed its risks. The panel recommended full approval for adults ages 50 to 64 and accelerated approval for those 65 and older, with additional studies required to confirm long-term clinical benefits for the older age group.
Ordinarily, a newly approved vaccine would next be reviewed by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices before any national recommendation is issued. However, that process has been delayed after a federal judge ruled in March that Health Secretary Robert F. Kennedy Jr. failed to follow proper legal procedures when replacing the committee’s members. The advisory panel has not convened since that ruling, though its next meeting is currently scheduled for October.
{Matzav.com}