The U.S. Food and Drug Administration (FDA) has authorized the first mRNA-based influenza vaccine, mFLUSIVA, by the Biotech firm Moderna. Moderna’s vaccine, branded as mFLUSIVA® (mRNA-1010), is approved for adults aged 50 years and older. FDA approval for Moderna’s mRNA flu vaccine was declined in the initial stages by the agency but later endorsed by the panel.
The FDA approval for Moderna’s mRNA flu vaccine marks a major milestone, offering a new approach to protecting people against influenza using messenger RNA (mRNA) technology. It expands the use of mRNA technology beyond COVID-19 and respiratory syncytial virus (RSV) vaccines.
FDA Approval for Moderna’s mRNA Flu Vaccine Accelerates Influenza Prevention
Moderna’s mFLUSIVA FDA approval covers two age groups through different regulatory pathways. Adults aged 50 to 64 years received traditional FDA approval, while adults 65 years and older received accelerated approval.
For adults aged 65 years and older, a mFLUSIVA clinical trial was conducted involving 2,992 participants to compare with a high-dose influenza vaccine. The findings showed strong immune responses.
One international Phase 3 trial for Moderna’s mRNA vaccine enrolled 40,805 adults aged 50 years and older across 11 countries, evaluating the vaccine compared with a licensed standard-dose influenza vaccine. The study demonstrated higher relative vaccine effectiveness while maintaining an acceptable safety profile.
Moderna will conduct a post-marketing study to further confirm the mRNA flu vaccine’s clinical benefit in the older population.
The FDA approval for Moderna’s mRNA flu vaccine follows a unanimous recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which concluded that the vaccine’s benefits outweigh its risks for eligible adults.
Moderna expects mFLUSIVA to become available in select U.S. retailers during the 2026–2027 respiratory virus season.
Moderna mRNA Flu Vaccine Differs from Traditional Flu Shots
Unlike conventional influenza vaccines, which are commonly produced using fertilized chicken eggs over several months, the Moderna mRNA flu vaccine uses messenger RNA technology.
Messenger RNA, or mRNA, carries genetic instructions that prompt the body’s cells to temporarily produce a harmless viral protein. This trains the immune system to recognize and fight influenza viruses if exposure occurs later.
Experts say this mRNA manufacturing approach offers several advantages, including:
- Faster vaccine development and production
- Greater flexibility to update vaccines when circulating flu strains change
- Reduced reliance on traditional egg-based manufacturing
- Potentially closer matching of vaccines to seasonal influenza viruses
These advantages due to FDA approval for Moderna’s mRNA flu vaccine could become especially valuable during severe influenza seasons or future influenza outbreaks, where rapid vaccine updates may improve protection.
Commenting on the approval, Moderna Chief Executive Officer Stéphane Bancel said in a statement, “The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform.”
He added that influenza remains a significant public health challenge and that the new vaccine provides “an important new option for America’s seniors.”
Safety Profile of the First mRNA Flu Vaccine
The FDA approval for Moderna’s mRNA flu vaccine was supported by clinical trials that showed an acceptable safety profile, with no new safety concerns identified. The most commonly reported side effects were similar to those seen with other vaccines and were generally mild to moderate.
Common side effects of Moderna’s mRNA vaccine included:
- Injection-site pain or tenderness
- Swelling or redness at the injection site
- Headache
- Muscle and joint pain
- Chills
- Fever
- Nausea or vomiting
Severe allergic reactions are considered rare but can occur after vaccination. People with a history of severe allergic reactions to vaccine ingredients or certain medical conditions should consult their healthcare provider before receiving Moderna mRNA flu vaccine.
Moderna’s mFLUSIVA FDA Approval Strengthens Vaccine Market Presence
The influenza vaccine, mFLUSIVA, is now Moderna’s fourth FDA-approved product and its fifth approved product globally, further expanding its mRNA vaccine portfolio beyond COVID-19 and RSV.
Moderna also confirmed that regulatory reviews for mFLUSIVA are underway in the European Union, Canada, and Australia, with additional international submissions planned during 2026.
Although commercial adoption may build gradually because much of the current U.S. flu vaccine supply has already been contracted, the FDA approval for Moderna’s mRNA flu vaccine positions the pharma giant to compete in one of the world’s largest seasonal vaccine markets.
