FDA Accepts Revised Application for Moderna's mRNA-1010 Flu Vaccine with August 2026 Decision Date
Moderna's seasonal influenza vaccine candidate mRNA-1010 receives FDA acceptance after initial refusal, with a PDUFA date set for August 5, 2026. The revised application proposes full approval for adults 50-64 and accelerated approval for those 65 and older.
The FDA has accepted Moderna's revised application for its seasonal influenza vaccine candidate, mRNA-1010, and assigned a Prescription Drug User Fee Act (PDUFA) date of August 5, 2026. The revised application proposes full approval for adults aged 50–64, accelerated approval for those 65 and older, and a post-marketing study.
The agency's Center for Biologics Evaluation and Research (CBER) had previously issued a Refusal-to-File (RTF) letter, citing concerns over the comparator vaccine used in Phase III trials. The RTF highlighted the use of a standard-dose vaccine rather than one tailored for older adults, such as high-dose or adjuvanted formulations.
Moderna demonstrated statistical superiority of mRNA-1010 over comparator vaccines in Phase III trials, including data from a study against a high-dose vaccine. The revised regulatory strategy positions mRNA-1010 as a viable candidate for commercialization by the 2026/2027 flu season.
On February 25, 2026, Moderna's stock closed with a 1.68% increase, reflecting positive investor sentiment. The stock recorded a trading volume of $0.41 billion, ranking it 334th in daily trading activity across the market.
Current vaccines produced via egg-based, cell-based, or recombinant methods face limitations in production timelines and strain-matching accuracy. In contrast, mRNA vaccines like mRNA-1010 can be manufactured closer to the flu season, enabling better alignment with circulating strains.
Regulatory acceptance in the EU, Canada, and Australia further amplifies the vaccine's commercial potential. These approvals, alongside the FDA's revised timeline, suggest a broader global rollout if the U.S. application is successful. Rivals such as Pfizer and GSK are advancing mRNA-based influenza candidates in Phase II trials.
Moderna's full-year 2025 revenue stood at $1.9 billion, a 40% decline from 2024 as the world moved toward a seasonal, private-market model for COVID vaccinations. The company reported a net loss of $2.8 billion for 2025, an improvement over the $3.6 billion loss in 2024, aided by a $2.2 billion reduction in operating expenses. Moderna ended 2025 with $8.1 billion in cash and investments.
The company's current portfolio includes mRESVIA, its RSV vaccine for older adults, which has secured roughly a 34% share in the 65+ segment, largely due to its pre-filled syringe format. Management anticipates returning to cash-flow breakeven by 2028 as the respiratory portfolio and oncology products scale.