Moderna Withdraws BLA for Flu/COVID Combination Vaccine, Plans Resubmission Following Phase 3 Trial Results

Reuters
2025/05/21
Moderna Withdraws BLA for Flu/COVID Combination Vaccine, Plans Resubmission Following Phase 3 Trial Results

Moderna Inc. has announced the voluntary withdrawal of its Biologics License Application $(BLA.AU)$ for its combination vaccine against influenza and COVID-19, mRNA-1083, in consultation with the U.S. Food and Drug Administration (FDA). The company plans to resubmit the application later this year, once efficacy data from the ongoing Phase 3 trial of its seasonal influenza vaccine, mRNA-1010, become available. This decision reflects an ongoing regulatory review process, with interim data expected this summer. No grant or funding information was specified in the announcement.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moderna Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1030190) on May 21, 2025, and is solely responsible for the information contained therein.

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