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23-valent pneumococcal polysaccharide vaccine

Generic Name
23-valent pneumococcal polysaccharide vaccine

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Aug 25, 2025

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."

Continue reading the full research report

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
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
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
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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