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News|Articles|June 19, 2026

FDA Advisory Committee Votes Unanimously in Favor of the Benefit-Risk Profile of mRNA-1010

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Key Takeaways

  • VRBPAC voted 9-0 in both adults 50–64 and ≥65 years that mRNA-1010’s benefit–risk profile is favorable, despite FDA staff noting evidence gaps in select subpopulations.
  • Phase III efficacy data showed 26.6% relative vaccine efficacy versus standard-dose comparator for RT-PCR–confirmed influenza-like illness and 47.9% for ER visits, hospitalizations, and urgent care use.
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FDA advisory panel voted 9-0 to recommend approval of Moderna's mRNA flu vaccine mRNA-1010 across both the 50-to-64 and 65-and-older age groups, a unanimous outcome that validates the underlying clinical data.

An FDA advisory panel voted unanimously to recommend approval of Moderna's mRNA-based influenza vaccine mRNA-1010.

The vote clears a milestone for a vaccine that has had one of the more turbulent regulatory paths in recent memory, while also setting the stage for a potential approval decision by August 5.

What was the committee’s decision?

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 that the benefits of mRNA-1010 outweigh its risks in adults aged 50 through 64, and 9-0 in adults aged 65 and older.1 The unanimous outcome across both age groups exceeded many expectations due to the skepticism FDA scientists had expressed in their pre-meeting briefing documents about the strength of evidence in certain patient populations.

What data supported the committee's vote?

The committee’s discussion centered on data from Moderna's Phase III clinical program, including results from the pivotal Phase III trial, which enrolled 40,805 adults across 301 sites in 11 countries, published earlier this year in The New England Journal of Medicine.2 In that study, mRNA-1010 demonstrated a relative vaccine efficacy of 26.6% against RT-PCR-confirmed influenza-like illness compared with a standard-dose comparator vaccine, while against higher-level healthcare outcomes including emergency room visits, hospitalizations, and urgent care use, efficacy rose to 47.9%.2 The safety profile observed in the Phase III program remained consistent with previously reported studies of the vaccine candidate.

For adults 65 and older Moderna pursued an accelerated approval pathway based on immunogenicity data from a separate trial comparing mRNA-1010 with Fluzone High-Dose. In that study, mRNA-1010 met prespecified noninferiority and superiority criteria against the high-dose comparator across all four vaccine-matched influenza strains, with immune responses remaining higher through the six-month follow-up endpoint.2 As a condition of accelerated approval in that age group, Moderna has agreed to conduct a post-marketing confirmatory study.

"We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010," said Stéphane Bancel, chief executive officer of Moderna. "Influenza continues to cause substantial illness and hospitalizations among older adults each year. 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."

Why does this vote matter?

The unanimous vote carries particular weight given the context surrounding this application. Earlier this year, FDA issued a refuse-to-file letter for mRNA-1010, declining to accept the application for review on the basis that Moderna's trial used an inadequate comparator. Moderna disputed the decision, arguing it contradicted prior agency guidance and that it had been blindsided by the rejection. FDA reversed course days later amid public backlash, one of several controversial regulatory decisions that preceded the departure of both then-acting CBER director Vinay Prasad and former commissioner Marty Makary as part of a broader White House-directed agency overhaul.

Thursday's 9-0 vote from an independent panel of scientific experts effectively validates the strength of the underlying data, even amid a pre-meeting briefing from FDA staff that flagged meaningful evidence gaps, including the absence of efficacy data in immunocompromised patients, very frail elderly adults, and those receiving other respiratory vaccines concurrently.

What is the broader significance of mRNA-1010?

mRNA-1010 uses the same manufacturing technology Moderna deployed in its Covid-19 vaccine, encoding hemagglutinin proteins in lipid nanoparticles rather than using the egg-based production methods that underpin most existing influenza vaccines.3 An mRNA-based flu vaccine would also support faster strain reformulation in response to antigenic drift or pandemic-level antigenic shift, a meaningful operational advantage.3

mRNA-1010 has been accepted for regulatory review in the United States, European Union, Canada, and Australia, with additional country submissions planned through 2026.1 FDA's advisory panel recommendations are non-binding, and the agency retains full authority over the final approval determination expected by August 5.

Sources

  1. Moderna Announces FDA Advisory Committee Votes Unanimously in Favor of the Benefit-Risk Profile of mRNA-1010, an Investigational Seasonal Influenza Vaccine Moderna June 18, 2026 https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/moderna-announces-fda-advisory-committee-votes-unanimously-in-favor-o-1179265
  2. A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age National Library of Medicine September 10, 2025https://clinicaltrials.gov/study/NCT06602024
  3. Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults The New England Journal of Medicine May 6, 2026 https://www.nejm.org/doi/full/10.1056/NEJMoa2516491

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