The Technical Network for Strengthening Immunization Services
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Improving immunization coverage and equity - technical resources
Comparing Resources
| Resource | Global Manual on Surveillance of Adverse Events Following Immunization |
|---|---|
| Purpose | Setting-up AEFI surveillance systems with standardized methodologies and tools. |
| Content | The manual provides guidance on investigation of AEFI, how to analyze surveillance data, causality assessment and how to respond to serious AEFI, including communication. It also includes a description of the most common vaccine reactions and provides references to the most recent references in vaccine pharmacovigilance. |
| Expected outcomes | Established AEFI / pharmacovigilance systems according to international standards, improved vaccine safety, reduced vaccine refusals. |
| Strengths | Systematic steps in reporting, responding, investigating, analysing, causality assessment, and follow up actions and communication clearly outlined, with attached annexes for reporting and investigating. |
| Contraints/Limitations | (a) Passive surveillance has many limitations, including underreporting. Passive surveillance is often not useful for determining whether the rate of an adverse event has increased. For this reason, some forms of active surveillance should be considered when introducing new vaccines. (b) With causality assessment, it is not always possible to quantify likelihood of a causal relationship between vaccination and an adverse event. |
| Why use it | (a) Community concerns regarding vaccine safety are a main cause of vaccine refusals. (b) To improve systems for ensuring the quality of vaccines and delivery, and to establish or improve AEFI systems including reporting, investigation, causality assessment and classification of cause-specific AEFI. (c) Zero dose and under immunised: Improved systems for AEFI surveillance may result in better understanding of reasons for non-acceptance of vaccination by some populations |
| Who should use it | National immunization programme managers, staff of the national regulatory authority (NRA) at national and subnational levels, immunization service providers at institutions and in the field, staff of pharmacovigilance centres and other stakeholders in immunization services. |
| Additional Links | |
| Link to access the resource | /en/resources/guidance/global-manual-on-surveillance-of-adverse-events-following-immunization |
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