REGULATORY · COMPETITIVE · USA
FDA agrees to review Moderna mRNA flu vaccine
Change
The FDA reversed its prior refusal and will now review Moderna’s mRNA flu vaccine application under a revised regulatory pathway.
Why it matters
FDA’s agreement to proceed with review follows a formal Type A meeting and Moderna’s proposed change to the regulatory pathway used in its submission. The agency’s expected decision date of August 5, 2026 creates a defined timeline for whether an mRNA-based flu option can enter the US market later in 2026. The episode also signals that internal FDA review outcomes can be altered after escalation, affecting predictability of review gating decisions for vaccine sponsors. Moderna also indicated it will provide additional analysis involving high-dose comparators in older participants, which can shape labeling, positioning, and payer/provider uptake if approved.
Implications
- • Defined FDA decision timeline: expected by Aug 5, 2026
- • Regulatory pathway choice becomes a binding constraint for review access
- • Potential additional analysis requirements for older-adult comparator data
- • Review reversals add uncertainty to vaccine submission gating decisions
Who is affected
- • Moderna (mRNA-1010 flu vaccine program)
- • FDA vaccine review leadership and career review teams
- • Influenza vaccine manufacturers competing in the US market
- • Providers and payers focused on vaccination for adults 65+
Source
Topics
World & Politics Policy & Regulation Law & Public Safety Regulatory Actions Health & Medicine Pharma & Biotech