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Indication
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Associated Conditions
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Research Report
A Comprehensive Clinical Monograph on the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23)
Executive Summary
The 23-valent pneumococcal polysaccharide vaccine (PPSV23), marketed principally as Pneumovax 23, represents a cornerstone of adult immunization strategies against disease caused by the bacterium Streptococcus pneumoniae. For decades, it has been the primary tool for preventing pneumococcal infections in older adults and those with high-risk medical conditions. This monograph provides a comprehensive clinical review of PPSV23, synthesizing evidence on its pharmacology, immunology, clinical effectiveness, and its evolving role within contemporary vaccination guidelines.
The vaccine's mechanism of action is predicated on a T-cell independent immune response, which effectively stimulates the production of opsonizing antibodies against the 23 capsular polysaccharide serotypes contained within its formulation. This mechanism underpins both its primary strength and its key limitations. Clinical evidence robustly supports the effectiveness of PPSV23 in preventing invasive pneumococcal disease (IPD), including life-threatening conditions such as bacteremia and meningitis. Meta-analyses confirm a pooled effectiveness of approximately 45% against vaccine-type IPD in adults. However, its efficacy in preventing non-bacteremic pneumococcal pneumonia (NBPP) is inconsistent and, according to recent meta-analyses, not statistically significant. This crucial distinction reframes the vaccine's primary value proposition as a targeted intervention against severe, invasive disease rather than a general "pneumonia vaccine."
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/17 | N/A | Completed | |||
2024/11/25 | Phase 1 | ENROLLING_BY_INVITATION | |||
2024/11/07 | Phase 2 | Recruiting | Shanghai Reinovax Biologics Co.,LTD | ||
2024/11/07 | Phase 1 | Completed | Shanghai Reinovax Biologics Co.,LTD | ||
2023/12/20 | Phase 3 | Completed | |||
2023/08/08 | Phase 1 | Completed | GPN Vaccines | ||
2023/04/25 | Phase 1 | Completed | |||
2023/04/18 | Phase 1 | Completed | Ab&b Biotechnology Co., Ltd.JS | ||
2023/01/25 | Phase 3 | Completed | |||
2022/12/29 | Phase 1 | Recruiting | GPN Vaccines |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PNEUMOVAX 23 -(5-DOSE) | Merck Canada Inc | 02240632 | Solution - Intramuscular
,
Subcutaneous | 25 MCG / 0.5 ML | 10/18/1999 |
PNU-IMUNE 23 | lederle labs, division of american cyanamid co | 02230175 | Liquid - Intramuscular
,
Subcutaneous | 25 MCG / 0.5 ML | 9/10/1997 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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