Moderna's mRNA-based influenza vaccine, mRNA-1010, which will be marketed as mFlusiva, has moved significantly closer to FDA approval after receiving unanimous recommendations from the agency's Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee voted 9-0 in favor of approving the shot for adults aged 50 to 64 and also recommended accelerated approval for those 65 and older. This positive development positions Moderna to potentially launch the vaccine later this year, with a final FDA decision expected by August 5.
The unanimous support from the FDA advisers marks a substantial turnaround after earlier regulatory challenges. In February, the FDA initially declined to review Moderna's application, with former official Vinay Prasad citing concerns about insufficient comparative data. However, the agency reversed course shortly after a public outcry and a revised regulatory proposal from Moderna. The company's application was largely supported by Phase 3 trial data involving over 40,000 adults aged 50 and older, which indicated a 27% higher effectiveness against seasonal flu compared to a standard flu shot. A smaller trial also showed stronger immune responses in the 65 and older age group when compared to high-dose flu vaccines.
Despite concerns raised by a few panel members regarding the study's duration (one flu season), lack of data in immunocompromised and frail older adults, and slightly more reactogenicity events (primarily fever), the committee's unanimous vote underscored the perceived benefits outweighing the risks. Moderna has committed to conducting a confirmatory post-marketing study involving up to 800,000 participants over two flu seasons to further evaluate effectiveness in the elderly and immunocompromised groups. CEO Stéphane Bancel expressed confidence that mRNA-1010 could be a crucial new option for seasonal flu prevention and demonstrate the versatility of Moderna's mRNA platform.
This positive recommendation is considered a significant victory for Moderna, aligning with its revenue growth goals, particularly targeting a potential $1 billion in revenue from mFlusiva. This revenue boost could help the company, which has reported losses, including a $2.8 billion loss last year, toward its goal of breaking even by 2028. While the FDA is not obligated to follow advisory committee recommendations, it historically does so in 84% of cases. Following FDA approval, the vaccine would also need a recommendation from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) before broader distribution.
