VACCINE SAFETY AND FALSE CONTRAINDICATIONS TO VACCINATION Training manual VACCINE SAFETY AND FALSE CONTRAINDICATIONS TO VACCINATION Training manual Abstract Health professionals are the single most important influence on whether individuals decide to have themselves or their children vaccinated; therefore, information and education for health professionals are essential. The aim of this training manual is to present “state-of-the-art”, authoritative, scientifically valid advice to counter common misperceptions of vaccination. Keywords IMMUNIZATION VACCINE SAFETY VACCINE SIDE EFFECTS Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe UN City, Marmorvej 51 DK-2100 Copenhagen Ø, Denmark Alternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office website (http://www.euro.who.int/pubrequest). © World Health Organization 2017 All rights reserved. The Regional Office for Europe of the World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. 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. 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The views expressed by authors, editors, or expert groups do not necessarily represent the decisions or the stated policy of the World Health Organization. Table of contents Acknowledgements . vi Abbreviations . vii 1 . Scope and purpose . 1 2 . Safety of vaccines . 1. 2.1. Introduction ............................................................. 1 2.1.1. Pre-licensure testing . 1 2.1.2. Post-licensure testing ..................................................2 2.1.3. Manufacture of vaccines ................................................2 2.1.4. Addition of a vaccine to a recommended immunization schedule............4 2.1.5. Continuous monitoring of the safety of vaccines ...........................5 2.1.6. Role of clinicians in vaccine safety .......................................5 2.1.7. Predictable pattern of behaviour when a new vaccine is introduced .........5 2.2. Vaccine safety institutions and mechanisms ................................ 7 2.2.1. National regulatory authorities ..........................................7 2.2.2. Immunization safety surveillance system.................................9 2.3. Adverse events after vaccination........................................... 9 2.3.1. Vaccine reactions .....................................................10 2.3.2. Reactions associated with defective vaccine quality.......................12 2.3.3. Reactions due to vaccination errors .....................................12 2.3.4. Reactions due to anxiety about vaccination ..............................13 2.3.5. Coincidental events ...................................................13 2.4. Case definitions and treatment of adverse events after vaccination ...........14 2.5. Reporting of adverse events after vaccination ..............................16 2.5.1. Events to be reported..................................................17 2.5.2. Timing of reporting....................................................19 2.5.3. Mode of reporting .....................................................19 2.5.4. Reporting adverse events during immunization campaigns................20 2.5.5. Barriers to reporting ..................................................20 2.5.6. Vaccine Adverse Events Information Management System (VAEIMS)........21 3 .Valid and false contraindications to vaccination . 21 3.1. When to vaccinate safely.................................................21 3.1.1. Contraindications to commonly used vaccines and precautions to be taken..22 3.1.2. Precautions for administration of rotavirus vaccine .......................25 3.2. Misperceptions about vaccination .........................................26 4 .Facts and myths about vaccination . 28 4.1. Introduction ............................................................28 4.2. Reasons given for refusing vaccination ....................................29 4.2.1. Barriers to vaccination ................................................29 4.2.2. Objections to vaccines based on religious beliefs .........................30 iii 4.3. Responding to concerns .................................................31 4.3.1. Vaccine manufacture and testing .......................................31 4.3.2. The immune system and the host response..............................32 4.3.3. Are vaccines really necessary? . 34 4.3.4. Relations between vaccination and neurological disease ..................38 4.3.5. Relation with other diseases ...........................................42 5.1. Conservation ...........................................................46 5.1.1. The cold chain ........................................................46 5.1.2. Vaccine storage.......................................................47 5.1.3. Vaccine vial monitors..................................................47 5.2. Vaccine administration ..................................................48 5.2.1. Which, when, where and how...........................................49 5.2.2. Simultaneous administration of several vaccines.........................50 5.3. Vaccination records .....................................................51 5.3.1. Records of health care providers .......................................51 5.3.2. Patient records .......................................................51 5.3.3. Vaccination information systems .......................................51 5.4. Advice on vaccination....................................................52 5.4.1. Before vaccination ....................................................52 5.4.2. At the doctor’s office ..................................................52 5.4.3. After vaccination .....................................................53 6 . Vaccination in special situations . 53 6.1. Altered immunocompetence .............................................53 6.1.1. Immunodeficiency ....................................................54 6.1.2. Vaccination of contacts ................................................54 6.2. Conditions that might cause immunodeficiency.............................54 6.2.1. HIV infection..........................................................54 6.2.2. Congenital immunodeficiency in children ................................55 6.2.3. Recipients of haematopoietic cell transplants ............................56 6.2.4. Recipients of solid organ transplants ...................................57 6.2.5. Anatomical or functional asplenia ......................................57 6.2.6. Bleeding disorders ....................................................57 6.2.7. Chronic illnesses in children ...........................................58 6.3. Drugs that might cause immunodeficiency.................................60 6.3.1. Corticosteroids .......................................................60 6.3.2. Other immunosuppressive drugs .......................................60 6.3.3. Antibody-containing products ..........................................61 6.3.4. Concurrent administration of antimicrobial agents and vaccines ...........62 6.4. Vaccination of preterm infants............................................63 6.5. Vaccination during breastfeeding .........................................64 6.6. Vaccination during pregnancy ............................................64 6.7. Vaccination of patients with tuberculosis ..................................66 6.7.1. Tuberculosis skin test reactivity ........................................66 6.7.2. Screening of people vaccinated with bacille Calmette-Guérin (BCG) ........67 iv 6.7.3. Efficacy of BCG .......................................................68 6.7.4. Revaccination with BCG................................................68 6.7.5. Screening for severe combined immunodeficiency disease in countries with universal BCG vaccination .....................................68 6.8. Vaccination of people with lapsed or unknown immunity ....................69 6.8.1. Interchangeability of brands............................................69 6.8.2. Catch-up vaccination . 69 6.10 Vaccination for travellers ................................................71 7 .Conclusion . 72 8 . Clinical cases . 72 8.1. Case 1 .................................................................72