Moderna Shares Fall as Company Withdraws Flu/COVID-19 Combination Vaccine Application

On May 21, 2025, Moderna announced it has voluntarily withdrawn its Biologics License Application (BLA) for its flu/COVID-19 combination vaccine candidate, mRNA-1083, following consultation with the U.S. Food and Drug Administration (FDA)245.

The decision to pull the application was driven by a need to submit additional vaccine efficacy data from the ongoing Phase 3 clinical trial of Moderna's investigational seasonal influenza vaccine, mRNA-101012.

Moderna plans to resubmit the application later in 2025 after interim efficacy data from the mRNA-1010 trial become available, expected this summer12.

The combination vaccine was targeted for adults aged 50 and older12.

The announcement came shortly after the FDA updated its guidelines, recommending COVID-19 boosters mainly for adults aged 65 and older or others at high risk13.

Following the announcement of the withdrawn application, Moderna's share price slipped in premarket trading4.

Sources:

1. https://www.cidrap.umn.edu/covid-19/moderna-pulls-licensing-submission-combo-flu-covid-vaccine

2. https://investors.modernatx.com/news/news-details/2025/Moderna-Provides-Update-on-BLA-Submission-for-Combination-Vaccine-Against-Influenza-and-COVID-19/default.aspx

3. https://www.biopharmadive.com/news/moderna-withdraw-fda-covid-flu-vaccine-application/748709/

4. https://seekingalpha.com/news/4450863-moderna-pulls-marketing-application-flucovid-shot

5. https://www.empr.com/news/moderna-withdraws-bla-for-flu-covid-19-combo-vaccine-candidate/