First mRNA Influenza Vaccine Approved in USA Despite Political Headwinds

The US Food and Drug Administration has approved Moderna’s mFlusiva mRNA influenza vaccine for adults, marking a major milestone amid skepticism from the current administration.

Approval Details for mFlusiva

The mFlusiva vaccine has received standard approval for individuals aged 50 to 64 and accelerated approval for those aged 65 and older. Moderna has agreed to conduct additional studies and provide more data regarding individuals aged 65 and older to confirm the benefits of using the vaccine in this age group.

Clinical Trial Results and Side Effects

The FDA based its decision on the results of a phase three study involving over 40,000 adults aged 50 and older from 11 countries. The results showed that the mRNA vaccine was 26.6 percent more effective than the standard influenza vaccine. Adverse reactions such as fatigue and headaches occurred more frequently with mFlusiva than with the traditional vaccine, though they were moderate in severity.

The vaccine will be available within the next few weeks, as assured by Moderna.

Statements from Moderna Leadership

The approval of mFLUSIVA by the FDA demonstrates the capability and versatility of our mRNA platform, said Stéphane Bancel, CEO of Moderna, in a statement.

Influenza remains a serious public health challenge, and mFLUSIVA offers an important new option for American seniors, Bancel added, noting that this approval also reflects the ongoing potential of their mRNA platform to address major public health problems through continuous scientific innovation.

Skepticism and Political Pressure

The Trump administration was hostile to mRNA technology.

According to the American portal NPR, the US healthcare industry closely monitored the FDA’s decisions regarding Moderna’s vaccine due to the hostility toward mRNA technology declared by some members of the current US administration.

US Department of Health and Human Services Secretary Robert F. Kennedy Jr. announced in August 2025 the suspension of nearly 500 million dollars in federal funds for 22 mRNA vaccine development projects. Initially, the FDA even refused to consider approving mFLUSIVA, but the agency changed its mind under pressure from the negative reaction of the pharmaceutical industry and public health experts.

Global and National Impact of Influenza

Influenza kills more than 300,000 people worldwide every year. It is estimated that 45,000 people died as a result of influenza in the United States during the 2024-2025 season, and at least 297 cases were recorded in children, according to data from the US Centers for Disease Control and Prevention.