Highlights From TD Cowen's 2026 US Corporate Access Day With Moderna Management

Research evidence excerpt

Highlights From TD Cowen's 2026 US Corporate Access Day With Moderna Management

ender markets could drive a meaningful

step-up in revenue.

Management Remains Confident In mFLUSIVA's Benefit-Risk Profile

Recall that the BLA for Moderna's standalone flu vaccine, mFLUSIVA (formerly mRNA-1010), is

under regulatory review following an initial RTF (discussed here), with a PDUFA date of August

5, 2026. On June 18th, the FDA conducted a VRBPAC (AdCom) meeting to discuss and vote

on the favorability of mFLUSIVA's benefit-risk profile in older adults ages 50-64 and 65+ (link

here). The committee voted 9-0, with no abstentions, on both voting questions:

■(1) whether the benefits of mFLUSIVA outweigh its risks for the prevention of influenza

disease in adults ages 50 through 64 years old, and;

■(2) whether the benefits of mFLUSIVA outweigh its risks for the prevention of influenza

disease in adults 65 years of age and older.

During our discussion, management expressed confidence that mFLUSIVA's benefit-risk profile

remains favorable, emphasizing the strength of immunogenicity data, particularly in older

populations, and the broader rationale for improved vaccine effectiveness relative to egg-

based approaches. Management also pointed out that strongly supportive data are now

broadly available, including (1) a recent NEJM publication (link here); and (2) VRBPAC briefing

materials describing no major concerns issues or deficiencies related to efficacy or safety (link

here).

The Flu Platform's Differentiation Is Supported By Structural mRNA Advantages

Management highlighted a favorable backdrop for demonstrating differentiation in flu, driven

by persistent limitations of egg-based manufacturing, which still accounts for the majority

of global supply.