FDA Approves mRNA-1010 (mFLUSIVA) as mRNA Flu Vaccine for Adults 50 and Older

The US Food and Drug Administration (FDA) has approved mRNA-1010 (mFLUSIVA), Moderna's messenger RNA-based seasonal influenza vaccine, for active immunization against influenza A and B in adults 50 years of age and older.¹

The approval follows unanimous recommendations from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) supporting mRNA-1010 in this population.¹ mRNA-1010 is Moderna's fourth FDA-approved product and the first mRNA-based flu vaccine licensed in the United States.¹

Moderna expects mRNA-1010 to be available for eligible populations in the US for the 2026-2027 respiratory virus season, alongside Spikevax, mRESVIA, and mNEXSPIKE.¹ For primary care clinicians, mRNA-1010 adds a new option to discuss with patients ahead of fall vaccination visits, particularly for adults 65 and older who carry the highest burden of severe influenza.

"The FDA approval of [mRNA-1010], 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," said Stéphane Bancel, Chief Executive Officer of Moderna.¹ "Flu remains a significant public health challenge, and [mRNA-1010] provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible."

mFLUSIVA Trial Design and Efficacy in Adults 50 and Older

Approval in adults 50 through 64 years is based on a randomized, observer-blind, active-controlled phase 3 trial enrolling 40,805 adults 50 years and older across 11 countries.² The trial's primary objectives were to evaluate safety and reactogenicity of mRNA-1010 and to assess relative vaccine efficacy (rVE) against RT-PCR-confirmed, protocol-defined influenza-like illness caused by influenza A or B strains, compared with a standard-dose active comparator.²

Use in adults 65 and older was granted accelerated approval, based on an immunogenicity trial enrolling 2992 US adults comparing mRNA-1010 with a high-dose inactivated comparator.³ Effectiveness in this older cohort is further supported by a descriptive rVE analysis from the same phase 3 trial used to support approval in the younger age group.³ Confirmation of clinical benefit in adults 65 and older will be assessed in a postmarketing trial.³

mFLUSIVA Safety Profile in the Phase 3 Program

Moderna reports an acceptable safety profile across the phase 3 program, with no new safety concerns identified and results consistent with previously reported mRNA-1010 studies.¹ Reported adverse events include injection site pain, tenderness, and swelling; ipsilateral lymphadenopathy; and systemic effects such as fatigue, headache, myalgia, arthralgia, chills, nausea or vomiting, and fever.¹ Severe allergic reactions are rare, and when they occur, typically present within minutes to one hour of vaccination.¹ mFLUSIVA is contraindicated in patients with a history of severe allergic reaction to any vaccine component.¹

mRNA-1010 has also been accepted for regulatory review in the European Union, Canada, and Australia, with additional country submissions planned during 2026.¹ Moderna expects mRNA-1010 supply in select US retailers within the coming weeks.¹

References

1. Moderna, Inc. Moderna receives U.S. FDA approval for influenza vaccine mFLUSIVA. Published August 5, 2026. Accessed August 6, 2026. https://www.newswire.com/news/moderna-receives-u-s-fda-approval-for-influenza-vaccine-mflusiva

2. ClinicalTrials.gov. A study to evaluate the safety, reactogenicity, and efficacy of mRNA-1010 in adults 50 years of age and older. Identifier NCT06602024.

3. ClinicalTrials.gov. A study to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1010 in older adults. Identifier NCT05827978.