The FDA approved the first mRNA flu vaccine in the United States for people aged 50 and older
Kyiv • UNN
The FDA approved Moderna’s seasonal mRNA flu vaccine for people aged 50 and older. The vaccine showed 27% fewer cases of flu compared with the standard vaccine.
On Wednesday, the U.S. Food and Drug Administration (FDA) approved Moderna’s seasonal mRNA flu vaccine. ABC News reports, writes UNN.
Details
The mFLUSIVA vaccine is expected to be available for people aged 50 and older during the 2026–2027 respiratory disease season.
Flu remains a serious public health issue, and mFLUSIVA provides an important new option for older Americans. This approval also reflects the continued potential of our mRNA platform to address important public health challenges through ongoing scientific innovation
In a clinical trial involving people aged 50 to 64, the mRNA vaccine showed 27% fewer confirmed cases of flu compared with the current standard vaccine. The safety profile of Moderna’s vaccine and the standard vaccine was approximately the same, although more people who received the mRNA vaccine reported side effects. They were mostly mild and lasted two days or less.
For people aged 65 and older, a high-dose vaccine is currently recommended. Moderna said it would continue collecting data this winter on how mFLUSIVA compares with the current high-dose vaccine and submit it to the FDA to determine whether the product will remain approved for this age group.
Earlier this year, the FDA said it would not review Moderna’s application for this vaccine. However, the agency later reversed its decision and agreed to review the product after Moderna promised to conduct an additional post-marketing study.
U.S. Health Secretary Robert F. Kennedy Jr. has openly expressed opposition to the use of the mRNA platform for vaccines. Last year, the U.S. Department of Health and Human Services canceled at least $500 million in federal funding for the development of mRNA vaccines.
In a statement announcing the cancellation of funding for mRNA vaccines, Kennedy said that the money should be directed toward "safer and broader vaccine platforms that remain effective even when viruses mutate." At the same time, infectious disease and vaccinology experts say that the mRNA platform is safe. Kennedy has also falsely claimed that mRNA vaccines can prolong pandemics.
Vaccine experts emphasize that using the mRNA platform can speed up vaccine production and allow vaccines to be better adapted to currently circulating virus strains, since such vaccines can be manufactured faster than those made using traditional methods.
The U.S. Centers for Disease Control and Prevention (CDC) currently recommend flu vaccination for everyone aged 6 months and older.
Vaccination is generally recommended by the end of October. The vaccine helps reduce the risk of severe illness, including hospitalization and death.