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Background <p>Functional active safety surveillance is essential for post-authorization assessment and life-cycle safety evidence generation of vaccines and medicines. Data collected through active surveillance methods are routinely used for post-approval surveillance of novel vaccines and medicines. Implementing these methods in low- and middle-income countries remains challenging.</p> Objective <p>This systematic review identified and assessed existing active safety surveillance in low- and middle-income countries, including key features, strengths, and limitations.</p> Methods <p>A search of EMBASE and PubMed Google Scholar databases was conducted. The protocol was registered with PROSPERO and adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Findings were synthesized narratively and categorized by surveillance systems characteristics.</p> Results <p>Of 13,027 records identified, 423 publications met inclusion criteria. Articles spanned 96 low- and middle-income countries, with India (96), China (57), Brazil (30), Iran (26), Ethiopia (21), Indonesia (20), Uganda (18), Kenya (17), and Ghana (16), most represented. The majority focused on vaccines (211). A total of 127 articles utilized mobile technologies for follow-up, online data collection, and/or adverse event reporting. Fifteen percent of vaccine surveillance systems described in articles demonstrated flexibility to incorporate new vaccines, 34% reported multi-sectoral collaborations, and 10% involved multiple countries. Gaps identified include small sample sizes, lack of sustainability, limited flexible surveillance, staffing challenges, and limited use of standard case definitions and digital technologies.</p> Conclusions <p>Active safety surveillance in low- and middle-income countries has made progress but still faces challenges. The capture and management of safety data through harmonized digital tools that promote consistency in recording and reporting and cross-country collaborations are crucial in further strengthening active safety surveillance in low- and middle-income countries.</p>

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Systematic Review of Active Safety Surveillance of Vaccines and Medicines in Low- and Middle-Income Countries

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年11月27日

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  • Andy Stergachis,
  • Esperança Sevene,
  • Mohammad Gazi Shah Alam,
  • Rebecca E. Chandler,
  • Alexander Precioso,
  • Samatha Mudigonda,
  • Dale Nordenberg,
  • Robert T. Chen

摘要

Background

Functional active safety surveillance is essential for post-authorization assessment and life-cycle safety evidence generation of vaccines and medicines. Data collected through active surveillance methods are routinely used for post-approval surveillance of novel vaccines and medicines. Implementing these methods in low- and middle-income countries remains challenging.

Objective

This systematic review identified and assessed existing active safety surveillance in low- and middle-income countries, including key features, strengths, and limitations.

Methods

A search of EMBASE and PubMed Google Scholar databases was conducted. The protocol was registered with PROSPERO and adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Findings were synthesized narratively and categorized by surveillance systems characteristics.

Results

Of 13,027 records identified, 423 publications met inclusion criteria. Articles spanned 96 low- and middle-income countries, with India (96), China (57), Brazil (30), Iran (26), Ethiopia (21), Indonesia (20), Uganda (18), Kenya (17), and Ghana (16), most represented. The majority focused on vaccines (211). A total of 127 articles utilized mobile technologies for follow-up, online data collection, and/or adverse event reporting. Fifteen percent of vaccine surveillance systems described in articles demonstrated flexibility to incorporate new vaccines, 34% reported multi-sectoral collaborations, and 10% involved multiple countries. Gaps identified include small sample sizes, lack of sustainability, limited flexible surveillance, staffing challenges, and limited use of standard case definitions and digital technologies.

Conclusions

Active safety surveillance in low- and middle-income countries has made progress but still faces challenges. The capture and management of safety data through harmonized digital tools that promote consistency in recording and reporting and cross-country collaborations are crucial in further strengthening active safety surveillance in low- and middle-income countries.