Moderna withdraws combo vaccine filing

USA – Moderna has decided to voluntarily withdraw its FDA application for mRNA-1083, a combination influenza and COVID-19 vaccine intended for adults aged 50 and above.

The company made the announcement on Wednesday, citing the need for more data to meet regulatory requirements.

Although the initial submission had a target review date set for November, the FDA requested Phase III efficacy results specifically for the flu component of the vaccine.

In response, Moderna will wait for data from its ongoing late-stage trial of mRNA-1010, a seasonal flu vaccine, which is expected this summer. The company plans to resubmit the application later in 2025.

The combo vaccine, mRNA-1083, merges two of Moderna’s key candidates: the flu shot mRNA-1010 and the next-generation COVID-19 booster mRNA-1283.

Early Phase III results showed that mRNA-1083 generated stronger immune responses than either Sanofi’s Fluzone (for flu) or Moderna’s Spikevax (for COVID-19) on their own.

Additionally, the COVID-19 portion of the vaccine has already demonstrated efficacy in a separate Phase III program.

Despite this promising data, the regulatory path for combination vaccines remains uncertain. Moderna’s move reflects this complexity and highlights the evolving standards the FDA uses to evaluate new mRNA-based products.

A recent commentary in the New England Journal of Medicine by FDA officials offered some guidance on booster expectations, but the agency’s stance on combination vaccines is still developing.

Moderna is now aiming for a potential launch of mRNA-1083 in time for the 2025 or 2026 respiratory illness season, pending successful resubmission and review.