The US Food and Drug Administration (FDA) has approved mFLUSIVA, the first mRNA influenza vaccine ever licensed in the United States. This approval comes after the Department of Health and Human Services canceled 22 mRNA vaccine projects worth roughly $500 million in August 2025.
The decision to approve mFLUSIVA was made by a panel of nine experts who voted unanimously that the vaccine’s benefits outweigh its risks. This is significant, as the experts were appointed by the same secretary who had previously expressed skepticism about mRNA technology.
The Limitations of Traditional Flu Vaccines
Traditional flu vaccines have been grown inside fertilized chicken eggs since the 1940s. This process is laborious and can take around six months, which means that the flu strains in the vaccine may not match the dominant strain of the flu virus during the flu season. The egg-based process also forces the flu virus to adapt to egg cells, which can alter the surface protein that the vaccine is meant to teach the immune system to recognize.
In contrast, mRNA vaccines like mFLUSIVA do not require the use of eggs and can be produced more quickly. Moderna, the manufacturer of mFLUSIVA, claims that it can go from strain selection to finished vaccine in just two to three months.
The Potential of mRNA Technology
mFLUSIVA is not a universal flu vaccine, but it is a step in the right direction. The mRNA platform has shown promise in other areas, such as cancer treatment. In June, a study showed that an individualized mRNA therapy given after surgery alongside pembrolizumab cut the risk of recurrence or death by 49 percent in melanoma patients.
Despite the potential of mRNA technology, the US is falling behind in its development and adoption. Moderna’s combined Covid-and-flu shot is already licensed in Europe, while patients in the US wait for a resubmission. The Phase 3 trial of its H5 bird flu vaccine is being funded by the Coalition for Epidemic Preparedness Innovations and the British government, after the US administration killed a $760 million contract.
Challenges Ahead
While mFLUSIVA has shown to be more effective than traditional flu vaccines, it is not without its challenges. The vaccine has been shown to cause injection-site pain in two-thirds of recipients, which could be a significant issue in a country where a quarter of people who skip the flu shot cite side effects as the reason.
Additionally, the approval of mFLUSIVA does not guarantee access to the vaccine. The CDC’s vaccine advisory committee has been frozen by a federal court since March, which means that there is no clinical recommendation and insurers are not required to cover the vaccine at no cost.
Despite these challenges, the approval of mFLUSIVA is a significant step forward in the development of more effective flu vaccines. As one expert noted, the fact that nine independent experts appointed by the government could not produce a single vote against the vaccine is a promising sign for the future of mRNA technology.
Helene Elliott is the senior reporter for News Raise. She covers Science news. She also has a keen interest in photojournalism. Helene holds a nomination for the prestigious Red Smith Award. She is married to author Dennis D’Agostino, a former publicist with the New York Mets.
