Moderna Withdraws FDA Filing for Flu/COVID Combination Vaccine, Plans Resubmission with Efficacy Data

Moderna, the biotechnology company at the forefront of mRNA vaccine development, has voluntarily withdrawn its filing for FDA approval of its flu/COVID combination vaccine, mRNA-1083. The company plans to resubmit the application later this year, incorporating phase 3 efficacy data from its standalone flu vaccine trial.

Regulatory Setback and Strategic Pivot

Initially on track for potential approval in adults aged 50 and older by November 2025, Moderna's combination shot faced a delay earlier this month when the FDA requested additional phase 3 efficacy data before making an authorization decision. This request pushed the expected approval timeline to 2026.

Stephen Hoge, M.D., Moderna's president, explained the rationale behind the FDA's request during a recent earnings call. "It makes good scientific sense that [the flu vaccine efficacy data] would be a part of the review that's going on for our flu-COVID combination," Hoge stated.

Upcoming Clinical Data and Resubmission Plans

Moderna anticipates receiving interim data from its mRNA-1010 flu vaccine phase 3 trial this summer. The study, involving 40,000 participants, is expected to provide crucial efficacy information that will bolster the company's resubmission to the FDA.

"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 commented, highlighting the company's flexible strategy in response to regulatory requirements.

Implications for Moderna's Product Pipeline

The withdrawal and planned resubmission of mRNA-1083 underscore the complex landscape of vaccine development and approval processes. Despite this setback, Moderna maintains that its interactions with the FDA remain "business as usual," with "productive exchanges" continuing across all ongoing file reviews.

This development comes amidst a broader context of Moderna's efforts to diversify its product pipeline beyond its successful COVID-19 vaccine. The company's pursuit of a combination flu/COVID vaccine represents a significant step in this direction, potentially offering a more convenient immunization option for consumers and healthcare providers alike.

As the pharmaceutical industry continues to evolve in response to global health challenges, Moderna's strategic decisions and ongoing clinical trials will likely play a crucial role in shaping the future of vaccine development and distribution.