What's Happening?
The U.S. Food and Drug Administration (FDA) has reversed its previous decision and agreed to review Moderna's seasonal flu vaccine, mRNA-1010, following a meeting with the company. Initially, the FDA had declined to review the vaccine due to concerns about the control arm used in the study. The agency will now assess the vaccine through a two-pronged approach, evaluating its use in adults aged 50-64 and those 65 and older separately. Moderna will need to conduct a post-marketing study for the older age group to gain full regulatory approval. The Prescription Drug User Fee Act (PDUFA) goal date for the vaccine is set for August 5, 2026, potentially allowing it to be available for the 2026/2027 flu season.
Why It's Important?
This development is significant as it
marks a potential advancement in the seasonal influenza vaccines market. mRNA-based vaccines like mRNA-1010 offer a shorter production time compared to traditional egg-based vaccines, allowing for a better match to circulating influenza strains. The FDA's decision to review the vaccine could restore a revenue stream for Moderna, which had been uncertain following the initial refusal. The approval of mRNA-1010 would also solidify Moderna's position in the seasonal influenza vaccines market, potentially impacting the competitive landscape and influencing future vaccine development strategies.
What's Next?
Moderna will proceed with the necessary post-marketing study for the older age group to secure full approval. The company is also seeking regulatory approval in Europe, Canada, and Australia, with further submissions planned for 2026. The outcome of the FDA's review and subsequent approval could influence other pharmaceutical companies to pursue mRNA technology for vaccine development, potentially leading to more efficient and effective vaccines in the future.
