The Food and Drug Administration (FDA) has approved Moderna's messenger RNA (mRNA) seasonal flu vaccine, named mFLUSIVA. The vaccine is slated for availability for individuals aged 50 and older for the 2026-2027 respiratory illness season. Stéphane Bancel, CEO of Moderna, stated that mFLUSIVA provides "an important new option for America's seniors" and reflects the potential of the mRNA platform to address public health challenges through scientific innovation.
During a clinical trial involving participants aged 50 to 64, the mRNA vaccine demonstrated a 27% reduction in confirmed flu cases compared to the current standard flu vaccine. While the safety profiles of both the mRNA vaccine and the standard vaccine were comparable, participants receiving the mRNA vaccine reported a higher incidence of side effects. These side effects were predominantly mild and resolved within two days.
Moderna plans to gather data on mFLUSIVA's performance against the current high-dose flu vaccine in individuals aged 65 and older throughout the upcoming winter. This data will be submitted to the FDA to determine if the vaccine's approval will extend to this demographic.
Earlier this year, the FDA initially indicated it would not review Moderna's application for the vaccine. However, the agency reversed this decision after Moderna committed to conducting an additional study post-market.
Despite the approval, Health Secretary Robert F. Kennedy Jr. has previously expressed reservations about the mRNA vaccine platform. Last year, the Department of Health and Human Services canceled approximately $500 million in federally funded mRNA vaccine development. Kennedy cited a focus on "safer, broader vaccine platforms that remain effective even as viruses mutate," although infectious disease experts and vaccinologists maintain that the mRNA platform is safe. He has also made unsubstantiated claims that mRNA vaccines can prolong pandemics.
Vaccine specialists, conversely, emphasize that the mRNA vaccine technology allows for expedited production of vaccines, enabling them to more effectively match currently circulating viral strains due to their rapid development capabilities compared to traditional methods.
The Centers for Disease Control and Prevention (CDC) recommends the flu vaccine for everyone over the age of 6 months. The CDC typically advises receiving the vaccination before the end of October to help mitigate the risk of severe illness, including hospitalization and death.