Moderna CEO Stéphane Bancel conveyed cautious optimism about the impending FDA approval of the company's mRNA influenza vaccine, mRNA-1010, which passed a crucial hurdle by receiving unanimous backing from a US Food and Drug Administration (FDA) advisory committee. This positive sentiment follows earlier regulatory challenges where the FDA initially refused to accept Moderna's application, citing issues with the Phase III trial's control group. However, a subsequent reversal by the FDA, following discussions with Moderna, allowed the review to proceed.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended the vaccine, also known as mFlusiva, for adults aged 50 to 64 and supported accelerated approval for those aged 65 and older. This recommendation is based on data from a Phase III trial involving nearly 41,000 adults, which demonstrated mRNA-1010's significantly higher relative effectiveness, showing a 26.6% to 27% improved protection against flu-like illness compared to a licensed standard-dose seasonal influenza vaccine. The FDA's decision is anticipated by August 5, 2026, according to the Prescription Drug User Fee Act (PDUFA) goal date.
Moderna CEO Bancel emphasized that mRNA-1010 has the potential to offer a significant new option for seasonal flu prevention and highlights the versatility of their mRNA platform. While the advisory committee vote marks a major victory and a turnaround for Moderna's US vaccine prospects, concerns were raised during the committee review about the trial's length (covering only one flu season) and the lack of data in immunocompromised and very frail older adults. Moderna has agreed to conduct a confirmatory Phase IV post-marketing study to address these gaps, particularly for the older age group and immunocompromised individuals, which will involve up to 800,000 participants over two flu seasons.
