mRNA-1010 is Moderna's investigational seasonal influenza mRNA vaccine candidate encoding hemagglutinin proteins of WHO-recommended strains. Phase 3 efficacy and immunogenicity data have been reported, and regulatory filings are under review in multiple regions. In the U.S., after a prior Refusal-to-File letter, FDA accepted an amended BLA and assigned a PDUFA goal date of August 5, 2026.
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Moderna's mCOMBRIAX, the world's first combination Covid-19 and influenza vaccine, for individuals 50 years and older.
Moderna's mRNA-1010 seasonal influenza vaccine enters FDA review following a revised approach that splits approval pathways by age group, with a decision expected by August 2026.
The FDA reversed an earlier refusal and agreed to review Moderna's seasonal flu vaccine application after the company revised its approach based on age groups, setting a decision date of August 5, 2026.
The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.
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's Center for Biologics Evaluation and Research issued a refusal-to-file letter to Moderna for its investigational influenza vaccine mRNA-1010, citing concerns over the Phase 3 trial control arm and whether it reflected the best-available standard of care.
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-1010 seasonal influenza vaccine application, setting an August 5, 2026 review deadline after the company proposed a revised regulatory approach based on age groups.
Moderna announced the FDA will consider approving its mRNA-based flu vaccine for older adults after resolving a dispute over clinical trial design. The vaccine showed 34.5% higher efficacy than standard flu shots in trials.
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-based flu vaccine application, with a decision expected by August 5. The company modified its regulatory approach to address concerns about older adults.
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06602024 |
A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age |
COMPLETED | PHASE3 |
| NCT05868382 |
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults |
COMPLETED | PHASE2 |
| NCT05827978 |
Study of mRNA-1010 Seasonal Influenza Vaccine in Adults |
COMPLETED | PHASE3 |
| NCT05827068 |
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults |
COMPLETED | PHASE1/PHASE2 |
| NCT05606965 |
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults |
COMPLETED | PHASE2 |
| NCT05585632 |
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old |
COMPLETED | PHASE1 |
| NCT05566639 |
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older |
COMPLETED | PHASE3 |
| NCT05415462 |
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults |
COMPLETED | PHASE3 |
| NCT05397223 |
A Study of Modified mRNA Vaccines in Healthy Adults |
COMPLETED | PHASE1 |
| NCT05375838 |
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old |
COMPLETED | PHASE1/PHASE2 |
