Data updated: May 26, 2026
Spikevax (covid-19 vaccine, mrna)
Approved 2022-01-30
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Disc
- First Approved
- 2022-01-30
- Routes
- Intramuscular
- Dosage Forms
- Injection
Companies
Active Ingredient: COVID-19 Vaccine, mRNA , COVID-19 Vaccine, mRNA , COVID-19 Vaccine, mRNA , COVID-19 Vaccine, mRNA , COVID-19 Vaccine, mRNA
Website: ↗
Spikevax Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2022 to 2022
Jan 2022 ORIGINAL
Update · CBER biologic (Purple Book)
What Spikevax Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Jan 2022)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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 |
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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.
Spikevax FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.