Immunization Safety Surveillance Guidelines for immunization programme managers on surveillance of adverse events following immunization Third Edition Immunization Safety Surveillance Guidelines for immunization programme managers on surveillance of adverse events following immunization Third Edition Immunization Safety Surveillance Guidelines for immunization programme managers on surveillance of adverse events following immunization Third Edition WHO Library Cataloguing in Publication Data Immunization safety surveillance: guidelines for immunization programme managers on surveillance of adverse events following immunization. Third edition. 1. Immunization. 2. Immunization programs – organization and administration. 3. Safety management – standards. I. World Health Organization Regional Office for the Western Pacific. ISBN 978 92 9061 745 7 (NLM Classification: WA 115) © World Health Organization 2015 All rights reserved. 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Photographs: ©WHO Contents Preface vii Glossary viii Abbreviations xi Purpose 1 Principles of immunization and vaccine 3 Immunity .............................................................................................................................................................................................................3 Vaccine ...................................................................................................................................................................................................................4 Classification of vaccines .........................................................................................................................................................................5 Other components in vaccines (excipients) .............................................................................................................................6 Contraindication and precaution ......................................................................................................................................................7 Adverse events following immunization (AEFIs) 9 Vaccine reactions .........................................................................................................................................................................................10 Immunization error–related reactions........................................................................................................................................17 Immunization anxiety-related reactions ...................................................................................................................................20 Coincidental events ..................................................................................................................................................................................21 Establishing an immunization safety surveillance system 25 Objectives .........................................................................................................................................................................................................25 Steps for establishing a system .........................................................................................................................................................26 Roles and responsibilities of National Regulatory Authorities in immunization safety surveillance ............................................................................................................................................27 Roles and responsibilities of immunization programmes in immunization safety surveillance.........28 Private sector ..................................................................................................................................................................................................33 National immunization safety expert committee ..............................................................................................................34 Differences between surveillance of AEFIs and of adverse drug reactions ....................................................35 Evaluation of the immunization safety surveillance system .....................................................................................36 Reporting AEFIs 39 Which events should be reported? ...............................................................................................................................................39 When to report? ..........................................................................................................................................................................................41 How to report?..............................................................................................................................................................................................41 Reporting AEFIs during immunization campaigns .........................................................................................................42 Barriers to reporting .................................................................................................................................................................................43 Private sector reporting ..........................................................................................................................................................................43 Vaccine Adverse Events Information Management System (VAEIMS) .............................................................43 Immunization Safety Surveillance iii InvestigatingAEFIs 45 Why should AEFI reports be investigated? ............................................................................................................................45 Which AEFI reports should be investigated? .......................................................................................................................45 Who should investigate AEFI? .........................................................................................................................................................46 When to investigate AEFI ....................................................................................................................................................................46 How to investigate AEFI .......................................................................................................................................................................46 Laboratory testing: vaccine .................................................................................................................................................................48 Laboratory testing: human specimens .......................................................................................................................................48 Investigating AEFI clusters .................................................................................................................................................................50 Investigation of deaths ...........................................................................................................................................................................51 Analysis of AEFI data 53 Who should analyse the data? ..........................................................................................................................................................53 Purpose of analysis at different levels .........................................................................................................................................53