Vaccine Update: What Is New in mRNA Vaccines

The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research announced Feb. 18 that it will review Moderna’s biologics license application for mRNA-1010, a seasonal influenza mRNA vaccine. A week prior, the FDA declined to review the application. After a meeting between Moderna and the FDA and agreement on a revised regulatory approach, the FDA made the determination to proceed to review. The revised regulatory pathway will be based on age and will seek full approval for adults aged 50-64 years, with accelerated approval for those >65. The hope is to have approval to use this product for the 2026-2027 influenza season. mRNA-1010 has also been accepted for review in Europe, Canada and Australia.

Traditional vaccine technology uses either a weakened version of the target pathogen, an inactivated version (which is the case for most influenza vaccines), or an actual part of the pathogen to trigger an immune response in the recipient. These vaccines are slow to produce, can take up to 10 years to become available, and are often expensive. mRNA vaccines are faster to develop and less expensive to bring to market, as was seen during the SARS-CoV-2 pandemic.¹  Currently, mRNA vaccines are commercially available for COVID-19 in all ages >6 months² and respiratory syncytial virus (RSV) for adults.³ There are now mRNA vaccines in varying stages of clinical trials for influenza, human metapneumovirus, pediatric RSV, norovirus, cytomegalovirus, Epstein-Barr virus, HIV, Lyme disease, mpox and Nipah virus.⁴ However, the momentum of mRNA vaccine development may be at risk with recent changes in funding and research.

The U.S. Department of Health and Human Services under the Biomedical Advanced Research and Development Authority announced Aug. 5, 2025 that it would be winding down mRNA vaccine development, canceling $500 million dollars in funding for mRNA vaccines.⁵ The global scientific community has expressed concern over these changes and the impact on the future ability to expedite vaccines in the setting of the next pandemic and for preventing and treating diseases such as cancer and HIV.⁶ Other countries outside of the United States are now calling for a concerted effort to close the gap left by these funding cuts to ensure the world is not left more vulnerable to pandemics and threats from infectious diseases. However, the concern remains that these funding changes could lead to a global disincentive for research and development in mRNA technology in the future.

News around changes in vaccine research, development and approval, as well as mixed messages regarding vaccine recommendations, leads to confusion and worry for patients and families. The American Academy of Pediatrics (AAP) now diverges from the Centers for Disease Control’s Advisory Committee on Immunization Practices on the recommended immunization schedule for children. The AAP is using evidence-based recommendations for children’s health in its childhood immunization guidance and remains steadfast in its commitment to a vaccine schedule that is thoroughly researched and rooted in science. The AAP vaccine schedule can be found at https://bit.ly/4pyyV5C.

References:

1. Gote V, Bolla PK, Kommineni N, et al. A comprehensive review of mRNA vaccines. Int J Mol Sci. 2023;24(3):2700.
2. Staying up to date with COVID-19 vaccines. Centers for Disease Control and Prevention. November 19, 2025. Accessed February 19, 2026. https://www.cdc.gov/covid/vaccines/stay-up-to-date.html
3. RSV vaccines. Centers for Disease Control and Prevention. August 18, 2025. Accessed February 19, 2026. https://www.cdc.gov/rsv/vaccines/index.html
4. mRNA pipeline. Moderna. Updated January 12, 2025. Accessed February 19, 2026. https://www.modernatx.com/en-US/research/product-pipeline
5. S. Department of Health and Human Services. HHS winds down mRNA vaccine development under BARDA. News release. August 5, 2025. Accessed February 24, 2026. https://www.hhs.gov/press-room/hhs-winds-down-mrna-development-under-barda.html
6. Nuzzo JB. Defunding mRNA vaccine research leaves us all more vulnerable to future health emergencies. BMJ. 2025;391:r2183. doi:10.1136/bmj.r2183