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CIOMS Guide to Active Vaccine Safety Surveillance

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CIOMS Guide to Active Vaccine Safety Surveillance

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ISBN: 978 92 9036 087 2
Year of publication: 2017
Number of pages: 88
SKU: 321 Category:
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The Council for International Organizations of Medical Sciences (CIOMS) announces the publication of the CIOMS Guide to Active Vaccine Safety Surveillance.

This Guide addresses the situation facing many resource-limited countries’ national immunization programmes and regulatory authorities around the globe when a new vaccine is being introduced into a country for the first time ever and vaccine safety needs to be assured.

The latest CIOMS Working Group on Vaccine Safety (WG) was created to continue addressing unmet needs in the area of vaccine pharmacovigilance and specifically address Objective #8 of WHO’s Global Vaccine Safety Initiative regarding public-private information exchange.

The earlier CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2012) focused on supporting surveillance of vaccine safety globally and the evolving need for a harmonized view on terminology and case definitions; and published, Definitions and Application of Terms for Vaccine Pharmacovigilance: Report of the CIOMS/WHO Working Group (2012).

With more vaccine solutions available and opportunities for earlier availability of new vaccine products in resource-limited countries (e.g.  vaccines against rotavirus, human papillomavirus or pneumococci) as well as new products that address diseases endemic in those countries only
(e.g. malaria, dengue among others), generating reliable data about specific safety concerns is becoming a priority for all countries.

The Guide offers a practical step-by-step approach and algorithm to aid immunization professionals and decision-makers in determining the best course of action if additional vaccine safety data is needed. The Guide provides a structured process for evaluating whether significant knowledge gaps exist, whether passive safety surveillance is adequate, and if not, methods for and practical aspects of conducting active vaccine safety surveillance.

The Guide also includes an essential vaccine information source list for evaluating the extent of data resources and several case studies for review. This CIOMS publication more than any other in recent history focuses on the special needs of the country level organizations responsible for developing vaccines safety surveillance strategies and implementing new vaccination programmes into resource-limited environments.


Contents of CIOMS Guide to Active Vaccine Safety Surveillance

  1. Key background concepts and introduction, including:-
  • Collaborating at regional and international levels
  • Stakeholders and responsibilities for active vaccine safety surveillance (AVSS)
  • A six-step algorithm for determining the need for AVSS


  1. Identification of significant knowledge gaps and choosing the appropriate tools to close them, including:-
  • Examples of potential gaps related to the vaccine or usage in a resource limited country
    • Related to the vaccine itself
    • Related to the population
    • Related to the targeted disease or differences in local serotypes, mutations or virulence factors
    • Related to the use of the vaccine
  • Approaches for performing post-marketing pharmacovigilance


  1. Active vaccine safety surveillance principles and methods, including:-
  • Type of data needed and methodological approaches


  1. Practical aspects of conducting AVSS studies, including:-
  • Communication for the conduct of AVSS
  • Study protocol
  • Study implementation
  • Data analysis


  1. Essential Vaccine Information (EVI)
  • Vaccine approval – local registration
  • Vaccine approval – WHO prequalification
  • Background on the development of the EVI source list
  • The EVI source list.


Examples and Case Studies

Example:        Meningitis vaccine in West Africa

Case study 1:  Enhanced passive surveillance/active case finding for AEFI in multi-country vaccination campaigns in Africa

Case study 2:  A large linked database approach for active surveillance in Viet Nam

Case study 3:  A cohort study utilizing health and demographic surveillance sites (HDSS) in Ethiopia

Case study 4:  A case-control study of a rare AEFI in Mexico and Brazil

Case study 5:  Active vaccine safety surveillance using a self-control analysis in Guatemala

Case study 6:  Background rates from active hospital-based surveillance in Tunisia