FDA review advances for Moderna flu shot

Moderna is pursuing U.S. approval for its investigational mRNA seasonal influenza vaccine, known as mFlusiva (mRNA-1010). The application under review covers adult populations and represents an effort to bring mRNA technology, already used in COVID-19 vaccines, into the seasonal flu market.

As part of the current regulatory process, external advisory input has been gathered to inform the U.S. Food and Drug Administration’s evaluation. This step is one element of the broader biologics license application review and precedes the agency’s final decision on whether the product can be marketed.

Moderna’s filing uses a differentiated approach for two adult age brackets. For adults aged 50 to 64, the company is seeking traditional approval, which is based on a more complete package of efficacy and safety data at the time of authorization.

For adults 65 and older, Moderna is seeking accelerated approval for mFlusiva. The accelerated pathway allows earlier authorization based on surrogate or intermediate endpoints considered reasonably likely to predict clinical benefit, subject to further confirmatory evidence.

If accelerated approval is granted in the 65-and-older group, Moderna has committed to conduct a post-marketing Phase IV confirmatory study. The objective of that study would be to verify and describe the clinical benefit of the vaccine in this higher-risk population after it is made available.

The FDA has set a target action date of August 5, 2026 to complete its review of Moderna’s mRNA influenza vaccine application. This Prescription Drug User Fee Act (PDUFA) date marks the agency’s goal for issuing a decision on the biologics license request.

Until that date, regulators will continue evaluating the totality of evidence submitted in support of mFlusiva, including clinical data and any commitments such as the planned Phase IV study. The outcome will determine whether the vaccine is approved, under what conditions, and for which adult age groups.

The decision will also clarify how the different approval pathways are applied in practice for this product, particularly the use of accelerated approval in older adults alongside traditional approval in younger seniors. This structure may influence how future mRNA-based respiratory vaccines are developed and reviewed.