Drugs / mRNA-1010
mRNA-1010
Drug InvestigationalInvestigational mRNA seasonal influenza vaccine
- Registered trials
- 12
- Ongoing
- 0/ 0%
- Completed
- 12
- Indications
- 1
Approved indications
| Indication |
|---|
| Seasonal influenza prevention in adults (regulatory path seeking full approval ages 50-64 and accelerated approval ages 65+)† |
† Added under accelerated approval. The indication may be withdrawn if confirmatory trials fail to verify clinical benefit.
Clinical trial landscape
12 registered studies reference this molecule or one of its brands. The split below shows how many are ongoing versus completed per phase.
| Phase | Total | Ongoing | Completed | Split |
|---|---|---|---|---|
| Phase 1/2 | 4 | 0 | 4 | |
| Phase 3 | 4 | 0 | 4 | |
| Phase 1 | 2 | 0 | 2 | |
| Phase 2 | 2 | 0 | 2 | |
| All phases | 12 | 0 | 12 |
Ongoing Completed Balance withdrawn, terminated, or status unreported.
Study records: ClinicalTrials.gov →
Mechanism of action
mRNA vaccine encoding HA antigens of recommended influenza strains to induce protective immune responses.
Recent developments
| FDA Advisory Panel Unanimously Backs Moderna's mRNA Flu Vaccine mFlusiva | kffhealthnews.org ↗ | |
| FDA Refuses to File Moderna’s mRNA Flu Vaccine, Company Shifts Focus Ex-US | insights.citeline.com ↗ | |
| Moderna Shares Fall 11%, Eye Worst Week Since August 2025 After June Surge | bioworld.com ↗ | |
| Moderna's Combination Covid-Flu Vaccine Receives Positive CHMP Opinion in Europe | medicalxpress.com ↗ | |
| FDA Accepts Moderna's Flu Vaccine for Review After Revised Regulatory Strategy | raps.org ↗ | |
| FDA Reverses Decision, Agrees to Review Moderna's Seasonal Flu Vaccine Application | theglobeandmail.com ↗ | |
| FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine mRNA-1010 | kffhealthnews.org ↗ | |
| FDA Accepts Revised Application for Moderna's mRNA-1010 Flu Vaccine with August 2026 Decision Date | theglobeandmail.com ↗ | |
| FDA Issues Refusal-to-File Letter for Moderna's mRNA Flu Vaccine Over Trial Design Dispute | firstwordpharma.com ↗ | |
| FDA Reverses Course, Accepts Moderna mRNA Flu Vaccine Application for Review | science.org ↗ |
Headlines link to the original publisher. Sources limited to a reviewed list of journals, regulators, and medical press.