Moderna Pulls FDA Application for Flu-Covid Combo Vaccine

Dow Jones

2025/05/21

By Dean Seal

Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data.

The maker of the Spikevax Covid-19 vaccine and Mresvia RSV vaccine said Wednesday that the withdrawal of mRNA-1083, which was developed for adults aged 50 years and older, was done in consultation with the U.S. Food and Drug Administration.

The company plans to submit a new biologics license application later this year after it has vaccine efficacy data from an ongoing Phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010. Interim data from that trail should be available this summer.

Shares ticked down 1.7% to $27.52 in premarket trading.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

May 21, 2025 07:36 ET (11:36 GMT)

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