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Introduction <p>This phase&#xa0;IV study aimed to evaluate the safety of the 23-valent pneumococcal polysaccharide vaccine (PPV23) in individuals aged 2&#xa0;years and older through active and passive surveillance.</p> Methods <p>Safety data were collected from May&#xa0;2022 to March 2024 through 28-day post-vaccination active surveillance via active follow-up and 1-year passive surveillance via the Chinese National Adverse Events Following Immunization (AEFI) Information System (CNAEFIS). Adverse drug reactions (ADRs) via active follow-up and AEFIs via CNAEFIS were analyzed by age, health status, and co-administration status.</p> Results <p>A total of 19,267 participants received a single dose of PPV23, including 2977 under active surveillance and 16,290 under passive surveillance. In active surveillance, the overall incidence of ADRs was 1.81%, mostly mild and self-limiting, with rates of 1.76% in children (2–17&#xa0;years), 2.28% in adults (18–59&#xa0;years), and 1.67% in older adults (60&#xa0;years and older). The incidence was 1.79% among healthy participants and 1.92% among participants with underlying medical conditions, and the incidence was 1.01% following PPV23 alone and 4.96% after co-administration with influenza vaccines. Passive surveillance identified 60 AEFI case reports (368 per 100000 doses), all occurring within 7&#xa0;days of vaccination. No serious adverse event or serious AEFI were reported.</p> Conclusion <p>The PPV23 showed a favorable safety profile in all age groups, regardless of health status or co-administration with influenza vaccines. These findings support the use of PPV23 and provide evidence for its co-administration with influenza vaccines.</p> ClinicalTrials.gov Identifier <p>NCT07071701. Retrospectively registered.</p>

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Post-marketing Safety Surveillance of 23-Valent Pneumococcal Polysaccharide Vaccine Administered Alone and Concomitantly with Influenza Vaccine in Individuals Aged 2 Years and Older in China

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月23日

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  • Yun-feng Shi,
  • Lin-hang Ju,
  • Kang-ning Wang,
  • Yu Pan,
  • Yu-ying Zou,
  • Xi Lu,
  • Ling Tuo,
  • Wen-tao Zou,
  • Ming-wei Wei,
  • Yan-wei Zhao,
  • Hong-xing Pan

摘要

Introduction

This phase IV study aimed to evaluate the safety of the 23-valent pneumococcal polysaccharide vaccine (PPV23) in individuals aged 2 years and older through active and passive surveillance.

Methods

Safety data were collected from May 2022 to March 2024 through 28-day post-vaccination active surveillance via active follow-up and 1-year passive surveillance via the Chinese National Adverse Events Following Immunization (AEFI) Information System (CNAEFIS). Adverse drug reactions (ADRs) via active follow-up and AEFIs via CNAEFIS were analyzed by age, health status, and co-administration status.

Results

A total of 19,267 participants received a single dose of PPV23, including 2977 under active surveillance and 16,290 under passive surveillance. In active surveillance, the overall incidence of ADRs was 1.81%, mostly mild and self-limiting, with rates of 1.76% in children (2–17 years), 2.28% in adults (18–59 years), and 1.67% in older adults (60 years and older). The incidence was 1.79% among healthy participants and 1.92% among participants with underlying medical conditions, and the incidence was 1.01% following PPV23 alone and 4.96% after co-administration with influenza vaccines. Passive surveillance identified 60 AEFI case reports (368 per 100000 doses), all occurring within 7 days of vaccination. No serious adverse event or serious AEFI were reported.

Conclusion

The PPV23 showed a favorable safety profile in all age groups, regardless of health status or co-administration with influenza vaccines. These findings support the use of PPV23 and provide evidence for its co-administration with influenza vaccines.

ClinicalTrials.gov Identifier

NCT07071701. Retrospectively registered.