Moderna Withdraws BLA Submission for Combo Vaccine

Moderna, Inc. announced the withdrawal of its Biologics License Application (BLA) for mRNA-1083, a combination vaccine targeting influenza and COVID-19 for adults over 50. This decision followed consultations with the U.S. Food and Drug Administration (FDA). The company plans to resubmit after obtaining vaccine efficacy data from its ongoing Phase 3 trial of the mRNA-1010 flu vaccine, expected this summer.

The withdrawal is a strategic move, with Moderna aiming to ensure comprehensive data accompany its submission. The timing of this decision aligns with the company's broader mission to leverage mRNA technology efficiently for global health solutions.