Moderna, Inc. announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. FDA in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.

Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. 

mRNA-1010 is also under review in Europe, Canada and Australia with further submissions planned in 2026. Moderna expects the first potential approvals for mRNA-1010 in 2026, subject to various ongoing regulatory reviews. 

The vaccine is designed to target seasonal influenza using Moderna’s mRNA platform, which is now being applied across respiratory and combination vaccines.

Patent Infringement Case

Meanwhile, a Court recently rejected two Moderna defenses in a patent infringement case filed by Arbutus Biopharma concerning Moderna’s mRNA COVID-19 vaccine. Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.

Arbutus sued Moderna in February 2022, saying Moderna first accessed Arbutus’ vaccine delivery technology in 2015 by sublicensing it from another company. Moderna claims it “never entered a license agreement that covered the use of the technology for the coronavirus that causes COVID-19.”