Moderna Delays Flu-COVID Combo Vaccine Filing Amid FDA Request

Moderna has announced that it is withdrawing its application for approval from the U.S. Food and Drug Administration (FDA) for its combination flu and COVID-19 vaccine, identified as mRNA-1083.
According to the company, it intends to submit the application again later in the year. The decision to resubmit will be timed to follow the availability of efficacy data from a phase 3 clinical trial of Moderna’s standalone flu vaccine, mRNA-1010.
The original application for mRNA-1083 had been filed last year. Based on that submission, the company had been on track to potentially secure FDA approval for the vaccine for adults aged 50 and above by November 2025. However, at the beginning of May, Moderna revised its expectations, shifting the anticipated timeline for approval to 2026. This adjustment followed a request from the FDA, in which the agency asked to review phase 3 efficacy data prior to making any decision on whether to authorize the vaccine.
The company has stated that the decision to withdraw the application was made voluntarily. Moderna now plans to refile the application once interim data from its ongoing phase 3 trial of mRNA-1010 are available. The trial is currently in progress, and the company expects to have preliminary results this summer.

Stephen Hoge, M.D., who serves as the president of Moderna, addressed the FDA’s request and the company’s response during an earnings call held at the beginning of May. He noted that Moderna is approaching the point at which data will become available from a 40,000-participant study evaluating the mRNA-1010 flu vaccine. In that context, Hoge remarked, “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 of the call, Moderna had not yet decided whether it would include the data in an amendment to the existing biologics license application (BLA) or submit a new application altogether. “It is totally appropriate to submit that data as an amendment to the BLA,” Hoge said. “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.” He added that Moderna would proceed with whichever option appears most practical and aligns with the direction provided by the FDA.

Hoge further explained that Moderna’s interactions with the FDA have remained consistent. Describing the situation, he said it had been “business as usual” with regard to communications, and he stated that the company continues to maintain “productive exchanges” with the agency concerning all of its current file reviews.
Although the company has not specified an exact date for when it intends to resubmit the application, it has confirmed that the filing will follow the release of the phase 3 efficacy data from mRNA-1010 later this year.