Moderna voluntarily withdraws BLA for Flu/COVID combination vaccine, plans resubmission later in 2025

On May 21, 2025, Moderna, announced a significant update regarding its flu/COVID combination vaccine candidate, mRNA-1083. In consultation with the U.S. Food and Drug Administration (FDA), Moderna has voluntarily withdrawn its pending Biologics License Application (BLA) for mRNA-1083, a combination of mRNA-1010 (seasonal influenza) plus m-RNA-1283 (next generation COVID19 vaccine; NTD + RBD), which is intended for adults aged 50 years and older. It appears that this decision is a strategic move rather than a response to safety or efficacy concerns: Reason for the withdrawal According to Moderna’s announcement, the withdrawal is primarily procedural. The company stated that it intends to resubmit the BLA later in 2025, after obtaining additional vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010. Moderna expects interim data from this trial to become available during the summer. The company’s decision to wait for these results suggests a commitment to providing...