MAY 24, 2025

Moderna Withdraws BLA for Combination Influenza and COVID-19 Vaccine

By IDSE News Staff

After consulting with the FDA, Moderna voluntarily withdrew its pending Biologics License Application (BLA) for mRNA-1083, an influenzaCOVID-19 combination vaccine candidate. The company was seeking an indication for adults ages 50 years and older.

The company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available, which are expected this summer.
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