FDA Advisory Committee Supports Moderna mRNA Flu Vaccine Review

A prospective influenza vaccine passed an FDA advisory committee meeting last month with a Prescription Drug User Fee Act goal date of August 5, 2026, after the committee initially refused to review the vaccine application in early February.¹

The FDA’s Vaccines and Related Biological Products Advisory Committee determined the benefits outweighed the risk for mRNA-1010 (mFlusiva; Moderna) in adults aged 50 to 64 years and those 65 years and older. The vote was 9-0 in favor of the vaccine’s safety and efficacy, and the committee will forward its recommendation to the FDA’s review team.¹ The recommendation was based on data from the most recent phase 3 trial (NCT06602024) update that demonstrated a relative vaccine efficacy of 26.6% (95% CI, 16.7%-35.4%) compared with a licensed standard dose of the vaccine.² The mFlusiva vaccine can potentially expand prevention options for those 50 years and older who are at a higher risk of severe influenza and associated complications as the first mRNA-based seasonal influenza vaccine candidate to reach late-stage regulatory review.¹

“We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform,” Stéphane Bancel, Moderna CEO, said in a news release.³

Influenza Burden in Adults 65-Plus Underscores Need for Improved Vaccine Effectiveness

Adults 65 years and older are at a higher risk of developing severe influenza due to a decrease in immune defense that declines with age, according to the CDC. As of 2024, it’s estimated that between 70% and 85% of flu-related deaths occurred in adults aged 65 and older.⁴

The most recent national virology surveillance of influenza reported 122 of 25,697 respiratory specimens tested positive for the influenza virus as of June 27, 2026, and a cumulative 322,080 of 2,723,042 since September 28, 2025.⁴ The rate of influenza infections has significantly decreased from its peak in mid-December of 2025, aligned with historical trends in seasonal influenza spikes.

The target PDUFA date for mRNA-1010 would be beneficial as it allows time for distribution and potentially broader access before the next influenza season associated with late-fall and winter seasons.

“This would be a great advancement for the seasonal influenza vaccines market, as the utilization of mRNA technology in influenza vaccines will improve vaccine effectiveness,” Stephanie Kurdach, GlobalData infectious disease analyst, said, according to Pharmaceutical Technology.¹

Safety Profile and Reactogenicity Remain Consistent With mRNA Vaccine Class Effects

The clinical trial included 40,703 participants randomly assigned to receive mRNA-1010 or the standard dose comparator with a median follow-up of 181 days.² RT-PCR-confirmed, protocol-defined influenza-like illnesses were documented among the per-protocol efficacy analysis population, of whom 20,179 and 20,124 received mRNA-1010 and the comparator, respectively. Of them, only 411 (2.0%) in the mRNA group experienced influenza-like illness when compared with the 557 (2.8%) in the comparator group.²

Adverse events occurred more frequently in the mRNA-1010 group, although the majority were mild to moderate with a median duration of 1 to 2 days. The most common solicited local adverse reaction in both subject groups was injection-site pain (65.8% vs 29.8%). The most frequently solicited systemic adverse reactions were fatigue (45.1% vs 20.3%), headache (37.8% vs 18.0%), and myalgia (35.4% vs 11.6%).²

For managed care professionals, the mFlusiva vaccine, should it be approved, could broaden effective vaccine prevention in vulnerable, high-risk populations. As the first mRNA vaccine targeting influenza, it has the potential to inform future combination therapies.

Moderna recently received marketing authorization from the European Commission for its combination vaccine targeting SARS-CoV-2 and influenza, combining mRNA-1010 with its COVID-19 mRNA vaccine, mNEXSPIKE.⁵

The vaccine is not approved in the US because the pharmaceutical company withdrew its application to the FDA for the combination vaccine mRNA1038 (mCOMBRIAX) and has not yet indicated when it may seek FDA approval again.

As regulatory review continues, mRNA-1010 represents a broader shift toward mRNA-based vaccines that continue to reshape the growing landscape and evolve alongside infectious diseases.

References

1. Barrie R. Moderna’s mRNA flu vaccine passes FDA ADCOM, review underway - pharmaceutical technology. Pharmaceutical Technology. June 22, 2026. Accessed July 6, 2026. https://www.pharmaceutical-technology.com/news/modernas-mrna-flu-vaccine-passes-fda-adcom-review-underway/

2. Roels IL, Huang G, Ferguson M, et al. Efficacy and safety of an mRNA seasonal influenza vaccine in adults. New Eng J Med. 2026;394:1803-1813. doi:10.1056/NEJMoa2516491

3. Moderna announces FDA advisory committee votes unanimously in favor of the benefit-risk profile of mRNA-1010, an investigational seasonal influenza vaccine. News release. Moderna. June 18, 2026. Accessed July 6, 2026. https://feeds.issuerdirect.com/news-release.html?newsid=5170330895753287

4. Flu and people 65 years and older. CDC. September 5, 2024. Accessed July 6, 2026. https://www.cdc.gov/flu/highrisk/65over.htm

5. European Medicines Agency's Committee for Medicinal Products for Human Use adopts positive opinion recommending marketing authorization of mCOMBRIAX, Moderna's mRNA combination vaccine against influenza and COVID-19. News release. Moderna. February 27, 2026. Accessed July 6, 2026. https://feeds.issuerdirect.com/news-release.html?newsid=8245752892462590