Data updated: Nov 8, 2026
Prevnar 13 (pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)) · Pfizer
Approved 2010-02-24
1
Indication
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Disc
- First Approved
- 2010-02-24
- Revenue
- $1.6B (Q3-2026) combined: Prevnar 13 + Prevnar 20
- Routes
- Intramuscular
- Dosage Forms
- Injection
Companies
Active Ingredient: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Website: ↗
Prevnar 13 Approval History
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2010 to 2010
Feb 2010 ORIGINAL
Update · CBER biologic (Purple Book)
What Prevnar 13 Treats
1 FDA approvalsOriginally approved for its first indication in 2010 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2010)
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
HYMPAVZI
2024 MARSTACIMAB-HNCQ
2 designations
ZAVZPRET
2023 ZAVEGEPANT HYDROCHLORIDE
NGENLA
2023 SOMATROGON-GHLA
1 designation
VELSIPITY
2023 ETRASIMOD ARGININE
PAXLOVID (COPACKAGED)
2023 NIRMATRELVIR
3 designations
LITFULO
2023 RITLECITINIB TOSYLATE
ELREXFIO
2023 ELRANATAMAB
5 designations
CIBINQO
2022 ABROCITINIB
2 designations
NURTEC ODT
2020 RIMEGEPANT SULFATE
VIZIMPRO
2018 DACOMITINIB
2 designations
DAURISMO
2018 GLASDEGIB MALEATE
2 designations
TALZENNA
2018 TALAZOPARIB TOSYLATE
1 designation
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Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03819049 results posted | CR108580 VAC52416BAC1001, 2020-000657-27 | Ph 1, Ph 2 | completed | A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health |
| NCT07017777 | CTP-PCV-002 | Ph 3 | active not recruiting | A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks) |
| NCT05170399 | 10000444 000444-H | Ph 4 | recruiting | Vaccine Responses in Patients With B Cell Malignancies |
| NCT06183216 | PRO-PCV-1002 | Ph 1 | completed | A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine |
| NCT05412030 results posted | 219651 2023-000423-36, 2023 | Ph 2 | completed | A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants |
| NCT01049035 results posted | MET39 UTN: U1111-1112-2593 | Ph 2 | completed | A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers |
| NCT03550313 results posted | C3571002 2020-005039-59 | Ph 2 | terminated | Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants |
| NCT02370069 | RP-232-08262014 | Ph 4 | completed | The Effect of Previous Pneumococcal Immunization on the Immune Response of Patients With Severe CKD to Prevnar 13 |
| NCT01681992 results posted | 115649 2011-004905-26 | Ph 3 | completed | Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life |
| NCT02184572 results posted | 115650 2011-006161-18 | Ph 3 | completed | Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age |
| NCT02494999 | JSVCT022 | Ph 3 | completed | A Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants |
| NCT03313037 results posted | B7471002 | Ph 2 | completed | Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age |
| NCT01702428 results posted | 115648 2011-004891-12 | Ph 3 | completed | Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age |
| NCT03642847 | B7471005 | Ph 1 | completed | Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age |
| NCT02141009 CAPolista | NL44924.100.13 2013-002166-39 | Ph 4 | completed | Community Acquired Pneumonia: Outcome, Quality of Life and Immune Status |
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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 13 FDA Label Details
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Deep insights for Prevnar 13
Revenue Insights
- • Q3-2026: $1.6B (combined: Prevnar 13 + Prevnar 20)
- • 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.