mRNA-1083

Moderna voluntarily withdrew its biologics license application for mRNA-1083, a combination COVID-19/influenza vaccine for adults 50 and older, after the FDA requested additional phase 3 influenza efficacy data.

Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.

Moderna's combination flu-COVID vaccine faces FDA delay until 2026, as regulators now require Phase 3 flu efficacy data before approval, signaling potentially heightened scrutiny for vaccine developers.

Moderna reported $3.2 billion in total revenue for fiscal year 2024, with a net loss of $3.6 billion as the company transitions from pandemic to seasonal COVID-19 vaccine market.

Pfizer and BioNTech are advancing an mRNA influenza vaccine, PF-07252220, demonstrating superiority over existing flu vaccines in Phase III trials.