Точка Синхронізації

The U.S. Food and Drug Administration (FDA) formally declined to review Moderna’s marketing application for its standalone mRNA seasonal influenza vaccine, known as mRNA-1010, on June 26, 2024, citing a technical refusal to file due to missing data. The regulatory body informed the Massachusetts-based biotechnology firm that the current submission lacked sufficient clinical evidence to move forward into the formal evaluation phase. This decision marks a significant, albeit temporary, setback for Moderna as it attempts to expand its portfolio beyond COVID-19 and prove the efficacy of messenger RNA technology in the highly competitive annual flu shot market. According to company statements, the FDA's refusal to file (RTF) was not based on safety concerns but rather on specific documentation gaps regarding the vaccine's performance and manufacturing consistency. Moderna had hoped the vaccine would show superior antibody responses compared to traditional shots, particularly against the influenza A and B strains that dominate each season. However, regulatory experts suggest that the high bar for traditional flu vaccine efficacy and the complexities of mRNA delivery in non-pandemic settings require more robust longitudinal datasets than what was initially provided. Despite this administrative hurdle, Moderna executives expressed confidence in the eventual approval of their respiratory pipeline. The company is currently working to address the specific data requests from the FDA and plans to resubmit the application later this year or in early 2025. This delay comes at a critical time for the company, which is also seeking to launch a combination vaccine that targets both COVID-19 and the flu in a single injection—a product seen as vital for the firm's long-term commercial viability as pandemic-related revenue continues to fluctuate. The broader pharmaceutical industry is closely watching this development, as it represents one of the first major regulatory tests for mRNA technology in a well-established therapeutic area like seasonal influenza. Traditional vaccines, which are produced using chicken eggs or cell cultures, have been the standard of care for decades. If Moderna eventually succeeds, it could revolutionize the speed at which flu vaccines are produced each year, allowing scientists to more accurately match the vaccine to the specific strains circulating during any given winter season.