Moderna announced that the U.S. Food and Drug Administration (FDA) is refusing to review its application for the company’s first influenza vaccine developed using mRNA technology. The decision represents a potential setback for the biotech firm as it seeks to expand its mRNA platform beyond COVID-19.According to Moderna, the submission was intended to secure regulatory approval for a next-generation flu shot designed using the same messenger RNA technology that powered its widely used COVID-19 vaccine. The company has positioned mRNA as a flexible and rapid-response platform capable of addressing multiple infectious diseases, including influenza.The FDA’s refusal to review the application does not necessarily constitute a final rejection but may indicate that regulators require additional data, documentation, or procedural steps before formally accepting the filing. Specific details regarding the agency’s reasoning have not yet been publicly disclosed.

Seasonal influenza remains a major public health concern, causing significant hospitalizations and deaths each year worldwide. Traditional flu vaccines are typically developed using egg-based or cell-based production methods, which can take months to manufacture. Moderna’s mRNA approach aims to streamline production timelines and potentially improve vaccine effectiveness by better matching circulating strains.The development of an mRNA flu vaccine is considered a key strategic objective for Moderna as it works to diversify revenue streams following declining COVID-19 vaccine demand.

Market analysts note that regulatory uncertainty could impact investor sentiment in the short term. However, the long-term outlook for mRNA technology in infectious disease prevention remains a focal point for both the biotech industry and public health officials.

Further updates are expected as discussions between Moderna and the FDA continue.