Data updated: May 26, 2026
Comirnaty (covid-19 vaccine, mrna)
Approved 2021-08-22
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Disc
- First Approved
- 2021-08-22
- Revenue
- $2.2B (Q4-2025)
- Routes
- Intramuscular
- Dosage Forms
- For Injection
Companies
Active Ingredient: COVID-19 Vaccine, mRNA , COVID-19 Vaccine, mRNA , COVID-19 Vaccine, mRNA , COVID-19 Vaccine, mRNA
Website: ↗
Comirnaty Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
Aug 2021 ORIGINAL
Update · CBER biologic (Purple Book)
What Comirnaty Treats
1 FDA approvalsOriginally approved for its first indication in 2021 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 2021)
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Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05329220 results posted | ABNCoV2-03 | Ph 3 | completed | ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 |
| NCT05977127 HVaNa | 2023-503800-99-00 | Ph 2 | terminated | Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly |
| NCT05239975 | SCTV01C-01-In-LAO-1 | Ph 2 | withdrawn | A Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine |
| NCT05075538 I-SPARC | IJB-COVID-001 2021-003710-39 | Ph 4 | terminated | COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 |
| NCT04569383 | UKE-DZIF-SARS-CoV-2 | Ph 1 | completed | Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Comirnaty FDA Label Details
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Revenue Insights
- • Q4-2025: $2.2B
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.