Data updated: May 26, 2026
Prevnar 20 (pneumococcal 20-valent conjugate vaccine)
Approved 2021-06-07
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Prescription
- First Approved
- 2021-06-07
- Patent Cliff
- 2033
- Routes
- Intramuscular
- Dosage Forms
- Injection
Prevnar 20 Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
Jun 2021 ORIGINAL
Update · CBER biologic (Purple Book)
What Prevnar 20 Treats
1 FDA approvalsOriginally approved for its first indication in 2021 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2021)
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Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07160244 | C1091009 2022-503070-36-00 | Ph 3 | recruiting | BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies |
| NCT05183854 | HCI145280 NCI-2021-13373, HCI145280 | Ph 2 | recruiting | Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial |
| NCT03621670 results posted | 205239 2016-003268-37, V72_57 | Ph 3 | completed | Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants |
| NCT05170399 | 10000444 000444-H | Ph 4 | recruiting | Vaccine Responses in Patients With B Cell Malignancies |
| NCT05417165 | OSU-21289 NCI-2022-01763 | Ph 2 | recruiting | Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia |
| NCT05412030 | 219651 2023-000423-36 | Ph 2 | completed | A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants |
| NCT05297578 results posted | VAX24-102 | Ph 2 | completed | Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults |
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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.
Prevnar 20 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.