FDA Committee Votes Unanimously to Recommend mRNA Flu Vaccine

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 in favor of the benefit-risk profile for mRNA-1010, an investigational seasonal influenza vaccine. The committee’s unanimous recommendation covers adults aged 50 through 64 years as well as those 65 years and older, marking the first time the panel reviewed a new vaccine application since 2023. With a Prescription Drug User Fee Act (PDUFA) goal date set for August 5, 2026, pharmacists and health care providers may need to prepare for the potential availability of this new immunization option in time for the 2026-2027 flu season.^1-3

"We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010," Stéphane Bancel, MD, CEO of Moderna, said in a news release.¹ "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. We look forward to continuing to work with the FDA as it completes its review."

For the pharmacy profession, mRNA-1010 represents a differentiated, nonegg-based option that leverages the same messenger-RNA technology used successfully during the COVID-19 pandemic. The path to this recommendation was marked by a rare regulatory hurdle when the FDA initially issued a refusal-to-file letter regarding the design of Moderna’s clinical trials.^1-3

Agency officials originally argued that the trials used a standard-dose comparator for older adults, which did not reflect the current standard of care that prioritizes high-dose or adjuvanted vaccines for that demographic. To resolve these concerns, Moderna adopted a bifurcated regulatory strategy, seeking full approval for the 50-to-64-year age bracket and accelerated approval for those 65 years and older, with a commitment to conduct post-marketing studies against high-dose alternatives.³

The potential clinical impact of this vaccine is significant, as research indicates it may offer greater efficacy in preventing severe influenza-associated illness compared with standard-dose comparators. One of the advantages for pharmacists managing inventory and public health outreach is the speed of production, according to NPR. Although traditional flu vaccines require a 6-month window, the mRNA platform can shorten this to 2 or 3 months. This agility allows for more accurate strain selection and a faster response if a new flu strain suddenly emerges during the season. Furthermore, data from the CDC presented during the committee meeting highlighted the ongoing burden of the disease, noting at least 32 million cases and 24,000 deaths in the most recent season, with 85% of those eligible remaining unvaccinated.²

Detailed scientific evidence further supports the use of this platform, with studies published in Nature Immunology showing that mRNA-1010 induces sustained germinal center reactions in draining lymph nodes for up to 26 weeks. This persistent immune response is not typically observed with conventional split-virion vaccines and appears to broaden the B-cell response, allowing the body to produce antibodies that recognize a wider variety of flu strains. Such repertoire remodeling could be essential in overcoming the perennial challenge of antigenic drift, providing patients with a more durable protective shield against evolving viruses.⁴

During the review, the FDA found no major safety issues, and experts emphasized that mRNA vaccines do not interact with the cellular nucleus or integrate into human DNA. Despite the vaccine’s politicization, committee members expressed high confidence in the vaccine’s safety profile, which has been bolstered by the administration of over 6 billion doses of mRNA technology globally since 2020, according to NPR.²

As the August PDUFA date approaches, the pharmacy profession will be watching closely to see how this technology integrates into the annual immunization fold and helps mitigate the disproportionate share of severe influenza outcomes in older adults.

REFERENCES

1. 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 June 19, 2026.

2. Kim J. Key FDA committee unanimously recommends its first vaccine since 2023. NPR. June 18, 2026. Accessed June 19, 2026. https://www.npr.org/2026/06/18/nx-s1-5863570/flu-vaccine-mrna-moderna-fda

3. Nowosielski B. FDA reverses stance, initiates formal review for moderna flu vaccine. Drug Topics. February 19, 2026. Accessed June 19, 2026. https://www.drugtopics.com/view/fda-reverses-stance-initiates-formal-review-for-moderna-flu-vaccine

4. Matz HC, Yu TG, Zhou JQ, et al. mRNA-based influenza vaccine expands breadth of B cell response in humans. Preprint. bioRxiv. 2024;2024.10.10.617255. Published 2024 Oct 13. doi:10.1101/2024.10.10.617255