Moderna Delays Flu-COVID Vaccine, Cites FDA Scrutiny

Moderna has voluntarily withdrawn its application for FDA approval of its combination influenza and COVID-19 vaccine, mRNA-1083, intended for adults aged 50 and older, after discussions with the agency. The company now plans to resubmit the application later in 2025, once interim efficacy data from its ongoing Phase 3 trial of a standalone influenza vaccine become available this summer. This move aims to strengthen the application with more robust clinical evidence. The withdrawal comes as the FDA has announced it will require new clinical trials for annual COVID-19 boosters in healthy individuals under 65. Moderna continues to face revenue declines and revised earnings expectations, while stating its future plans are subject to risks and uncertainties as disclosed in regulatory filings. Investors have responded cautiously to the announcement.