Moderna has pulled the filing for FDA approval of its flu/COVID combination vaccine. The biotech plans to resubmit later this year with the phase 3 flu vaccine efficacy data the agency wants to see.
Moderna filed for FDA approval of its mRNA-1083 combination shot last year. The submission put the biotech on track to win approval in adults aged 50 and older in November 2025. However, at the start of May, Moderna pushed back the expected approval date to 2026 after the FDA asked to see phase 3 efficacy before making a decision on authorization.
The company said Wednesday that it has voluntarily withdrawn the pending approval application. Moderna plans to resubmit the application later this year, once efficacy data from a phase 3 trial of its flu vaccine mRNA-1010 are available. Moderna expects to have interim mRNA-1010 data this summer.
Stephen Hoge, M.D., Moderna’s president, discussed the FDA’s request for efficacy data on an earnings call at the start of May. With Moderna closing in on data from a 40,000-person study of its standalone flu vaccine, Hoge said “it makes good scientific sense that that would be a part of the review that's going on for our flu-COVID combination.” At the time, Moderna was unsure whether it would opt to resubmit the filing.
“It is totally appropriate to submit that data as an amendment to the BLA. It could also be, from a pragmatic perspective, it makes sense to update more broadly the BLA submission with it, which could result in a resubmission,” Hoge said. “We'll just go forward with whatever feels like the most pragmatic approach and, ultimately, the one that the FDA guides us to do.”
Hoge said it had been “business as usual” in terms of Moderna’s interactions with the FDA, adding that the company continues to have “productive exchanges” across all of its ongoing file reviews.