Ahead of the June 18 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), the Alliance for mRNA Medicines (AMM) submitted a letter encouraging committee members to conduct a thorough, evidence-based review of mRNA influenza vaccines. The letter highlights the continued burden of seasonal influenza among older adults, the advantages of mRNA technology for flu prevention, and the broader public health importance of maintaining a science-based pathway for innovation. Key excerpts from the AMM letter are below.
Influenza continues to pose a serious risk
“During the 2024 to 2025 [flu] season, adults aged 65 and older accounted for an estimated 71 percent of influenza-related deaths and 57 percent of hospitalizations, consistent with the pattern seen across prior seasons. While today’s vaccines have delivered real benefits, meaningful gaps in protection remain for the populations most at risk.”
Gaps in existing vaccine protection
“Most seasonal influenza vaccines are produced in eggs, a process that can introduce egg-adaptive mutations and reduce how closely the vaccine matches circulating strains. … mRNA technology does not rely on egg-based production and therefore avoids this source of mismatch entirely.”
mRNA enables faster flu strain selection
“Because mRNA vaccines can be manufactured on a shorter timeline, strain selection can occur closer to the start of the season when predictions about circulating viruses are more reliable. Modeling studies have found that the later strain selection made possible by faster production could improve vaccine match in some seasons.”
FDA should consider “full body of evidence”
“AMM encourages the Committee to conduct a thorough and independent review. We respectfully encourage members to consider the full body of evidence, the benefits of expanding the options available to patients and providers, and the broader public health value of continued progress in mRNA innovation.”
The broader value of mRNA innovation
“The questions before the Committee reach beyond a single vaccine or a single season. How emerging RNA technologies are evaluated sends a signal to the scientists, companies, and investors building the next generation of medicines… A predictable, science-based pathway that weighs each product on its own evidence is what allows this field to advance …”
You can read the full AMM letter here.
If you have any questions or would like to learn more about mRNA, please don’t hesitate to reach out to contact@mrnamedicines.org. We are happy to be a resource. Thank you.