TheraRadar
Data updated: May 26, 2026

Pneumovax 23 (pneumococcal vaccine, polyvalent)

Approved 1977-11-20
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
48
Years on Market

Details

Status
Prescription
First Approved
1977-11-20
Routes
Intramuscular, Subcutaneous
Dosage Forms
Injection

Companies

Merck
Active Ingredient: Pneumococcal Vaccine, Polyvalent , Pneumococcal Vaccine, Polyvalent

Pneumovax 23 Approval History

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Original
New Indication
New Form
Label Update
1 FDA actions from 1977 to 1977
Nov 1977 ORIGINAL
Update · CBER biologic (Purple Book)

What Pneumovax 23 Treats

1 FDA approvals

Originally approved for its first indication in 1977 .

  • Other (1)
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT05170399 10000444 000444-H Ph 4 recruiting Vaccine Responses in Patients With B Cell Malignancies
NCT05163834 ARGX-113-2102 2021-004878-53 Ph 1 completed Immune Response to PNEUMOVAX 23 in Healthy Adults Receiving Efgartigimod IV
NCT02308540 results posted VAC-017 Ph 1, Ph 2 completed Safety and Immunogenicity of a 10 Valent Pneumococcal Conjugate Vaccine (SIILPCV10) in Healthy Adults, Toddlers, Infants
NCT02097589 StatVax IRB201400208 Ph 1 completed The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

Pneumovax 23 FDA Label Details

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Data Sources

FDA Approval: BLA101094 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.