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

Reuters
21 May
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.

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