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Global Manual Revised 121020 WHO Library Cataloguing-in-Publication Data Global manual on surveillance of adverse events following immunization. 1.Immunization Programs. 2.Adverse Drug Reaction Reporting Systems. 3.Vaccination – adverse effects. I.World Health Organization. ISBN 978 92 4 150776 9 (NLM classification: WA 115) © World Health Organization 2014 (Revised March 2016) All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The named authors [or editors as appropriate] alone are responsible for the views expressed in this publication. Printed by the WHO Document Production Services, Geneva, Switzerland. Cover by Denis Meissner-WHO - Layout by Jean-Claude Fattier ACKNOWLEDGEMENTS This manual has been developed by WHO under the guidance of the Global Advisory Committee on Vaccine Safety (GACVS). The GACVS members included Ananda Amarasinghe (lead author), Michael Gold, Robert Pless, Xavier Kurz, Gagandeep Kang, Ambrose Isah and Brigitte Keller-Stanislawski. Significant inputs were provided by the CIOMS Working Group on Vaccine Safety, the Brighton Collaboration and WHO regional and country offices. The WHO secretariat in Geneva supporting the work included Madhava Ram Balakrishnan and Patrick Zuber. This manual has been developed on the basis of the Guidelines for immunization programme managers on surveillance of adverse events following immunization (second edition) published by the WHO Western Pacific Regional Office in 2012. CONTENTS Glossary ................................................................................................................v Abbreviations ........................................................................................................... viii 1. Purpose .............................................................................................................. 1 2. Principles of immunization and understanding vaccines .............................. 3 2.1 Immunity ....................................................................................................... 3 2.1.1 Active immunity ................................................................................... 4 2.1.2 Passive immunity .................................................................................. 4 2.1.3 Herd immunity ..................................................................................... 4 2.1.4 How does immunization work? ............................................................ 4 2.2 Vaccines ........................................................................................................ 5 2.2.1 Classification of vaccines ...................................................................... 6 2.2.2 Other components of vaccines (excipients) ............................................ 9 2.3 Contraindications and precautions ............................................................... 10 3. Adverse events following immunization ...................................................... 13 3.1 Vaccine reactions ......................................................................................... 14 3.1.1 Cause-specific vaccine reactions ......................................................... 14 3.1.2 Vaccine reactions by seriousness and frequency .................................. 15 3.1.3 Prevention and treatment of vaccine reactions .................................... 16 3.2 Immunization error-related reactions ............................................................ 17 3.3 Immunization anxiety-related reactions ........................................................ 20 3.4 Coincidental events ..................................................................................... 21 4. Immunization safety surveillance system ..................................................... 25 4.1 Objectives .................................................................................................... 25 4.2 Types of immunization safety surveillance .................................................... 26 4.3 Steps for establishing an immunization safety surveillance system ................ 27 4.4 Roles and responsibilities of the NRA in immunization safety surveillance ..... 29 4.5 Roles and responsibilities of the immunization programme in immunization safety surveillance ........................................................................................ 30 4.5.1 Roles and responsibilities at the level of the immunization service provider ............................................................................................. 30 4.5.2 Roles and responsibilities at the subnational level of immunization services .............................................................................................. 31 4.5 3 Roles and responsibilities at the national level of immunization services .............................................................................................. 33 4.5.4 Roles and responsibilities of immunization providers in the private sector ..................................................................................... 34 4.6 Terms of reference of the National Immunization Safety Expert Committee .. 35 4.7 Monitoring and evaluating the immunization safety surveillance system ...... 37 4.8 Differences between surveillance of AEFI and adverse events linked to other medical products ................................................................................ 38 5. Reporting AEFI ................................................................................................ 43 5.1 Which events should be reported? ............................................................... 43 5.2 When to report? .......................................................................................... 45 5.3 How to report? ............................................................................................ 45 5.4 Reporting AEFI during immunization campaigns .......................................... 47 5.5 Barriers to reporting ..................................................................................... 47 5.6 Private-sector reporting ................................................................................ 48 5.7 Vaccine Adverse Events Information Management System (VAEIMS) ............ 48 6. Investigating AEFI ........................................................................................... 51 6.1 Why AEFI reports should be investigated ...................................................... 51 6.2 Which AEFI reports should be investigated? ................................................. 51 6.3 Who should investigate AEFI? ...................................................................... 52 6.4 When to investigate AEFI ............................................................................. 52 6.5 How to investigate AEFI ............................................................................... 53 6.6 Laboratory testing: vaccine .......................................................................... 54 6.7 Laboratory testing: human specimens .......................................................... 55 6.8 Investigating AEFI clusters ............................................................................ 57 6.9 Investigation of deaths ................................................................................. 58 7. Analysis of AEFI data ...................................................................................... 63 7.1 Who should analyse the data? ..................................................................... 64 7.2 How should the data be analysed and interpreted? ...................................... 65 7.3 How should a cause be determined? ........................................................... 68 8. Causality assessment of an AEFI .................................................................... 71 8.1 Levels of AEFI
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