mCOMBRIAX

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Moderna
Moderna

Overview

Moderna's combination COVID-19 and influenza vaccine (mRNA-1083), the world's first authorized flu-plus-COVID combination vaccine, delivered as a single shot.

Approved by the European Commission on April 20, 2026 for adults 50 and older, valid across the EU plus Iceland, Liechtenstein, and Norway. Moderna withdrew its original 2024 US application in May 2025 after the FDA requested additional Phase 3 influenza-efficacy data; with that data now delivered via mFlusiva's August 2026 approval, Moderna plans to resubmit the US application, though it has not announced a timeline.

Key Specs

EU Approval

April 20, 2026 (adults 50+)

US Status

Application withdrawn May 2025; resubmission planned, no date set