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Vaccine Safety Basics Learning Manual

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Vaccine Safety Basics Learning Manual VACCINE SAFETY BASICS learning manual The content of this course has been compiled by leading international vaccine experts who are committed to the promo- tion of best practice in the implementation of immunization programmes across the world. CONTRIBUTORS Molly Mort (project coordinator and writer of a pilot course, which served as basis of this course). Adele Baleta (South Africa), Frank Destefano (US CDC), Jane G. Nsubuga (US CDC), Claudia Vellozzi (US CDC), Ushma Mehta (Medicines Control Council, South Africa), Robert Pless (Public Health Agency of Canada), Siti Asfijah Abdoellah (NADFC Indonesia), Prima Yosephine (EPI-MOH, Indonesia), Sherli Karolina (EPI-MOH, Indonesia). PHOTO CREDITS Barbara Pahud (Children’s Mercy Hospitals and Clinics, UMKC), WHO Photo Library, CDC Photo Library. OVERALL COORDINATION (WHO) Patrick Zuber, Philipp Lambach. DESIGN AND TECHNICAL IMPLEMENTATION Oksana Fillmann, Munich. SEND US FEEDBACK Please let us know how you liked the course. Send us an email with your suggestions to: [email protected]. © World Health Organization 2013 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 3264; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). 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 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 interpreta- tion 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. Table of Contents Introduction ...................................................................................................................................... 7 Getting starting ................................................................................................................................ 8 MODULE 1: Introduction to vaccine safety ................................................................................ 9 Overview ............................................................................................................................... 10 Importance of immunization programmes ...................................................................... 10 History of vaccine development ....................................................................................... 11 Expectations towards safety of vaccines ...................................................................... 13 How the immune system works ....................................................................................... 14 How vaccines work ............................................................................................................. 16 Vaccine-preventable diseases ......................................................................................... 17 Types of vaccine .................................................................................................................. 18 Adverse events .................................................................................................................... 19 Classification ..........................................................................................................................19 Causes .....................................................................................................................................20 Frequency and severity ........................................................................................................21 Vaccine safety in immunization programmes ................................................................23 Vaccine regulations ............................................................................................................25 Pre-licensure vaccine safety ............................................................................................25 Post licensure surveillance options ...................................................................................27 Balancing efficacy and safety ..........................................................................................29 Summary ...............................................................................................................................31 ASSESSMENT 1 .............................................................................................................................32 Assessment solutions ........................................................................................................36 MODULE 2: Types of vaccine and adverse reactions .............................................................38 Overview ...............................................................................................................................39 Types of vaccine ..................................................................................................................40 Live attenuated vaccines .....................................................................................................41 Inactivated whole-cell vaccines .........................................................................................44 Subunit vaccines ...................................................................................................................45 Toxoid vaccines .....................................................................................................................49 Combination vaccines ........................................................................................................50 3 Components of a vaccine .................................................................................................. 51 Route of administration ......................................................................................................53 Contraindications ................................................................................................................55 Anaphylaxis ..........................................................................................................................56 Immunizing the immunocompromised .............................................................................57 Immunization and pregnancy ............................................................................................58 Influenza ..................................................................................................................................58 Tetanus ....................................................................................................................................59 Vaccination associations and public concern ...............................................................60 Summary ...............................................................................................................................60 ASSESSMENT 2 .............................................................................................................................61 Assessment solutions ........................................................................................................65 MODULE 3: Adverse events following immunization .............................................................67 Overview ...............................................................................................................................68 Classification of AEFIs .......................................................................................................69 Vaccine reactions ..................................................................................................................71 Immunization error-related reaction ..................................................................................74 Immunization anxiety-related reactions ............................................................................76 Coincidental events ...............................................................................................................76 Mass vaccination campaigns ...........................................................................................78 Rates of adverse vaccine reactions ................................................................................79 Summary ...............................................................................................................................82
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