VACCINE SAFETY AND FALSE CONTRAINDICATIONS …

1 VACCINE SAFETY AND FALSE CONTRAINDICATIONS TO VACCINATIONT raining manualVACCINE SAFETY AND FALSE CONTRAINDICATIONS TO VACCINATIONT raining manualAbstractHealth 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 IMMUNIZATIONVACCINE SAFETYVACCINE SIDE EFFECTSA ddress requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe UN City, Marmorvej 51 DK-2100 Copenhagen , DenmarkAlternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office website ( ).

2 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 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 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.

3 Errors and omissions excepted, the names of proprietary products are distinguished by initial capital 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 express 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 views expressed by authors, editors, or expert groups do not necessarily represent the decisions or the stated policy of the World Health ..viAbbreviations ..vii1 . Scope and purpose ..12 . SAFETY of vaccines .. Introduction .. Pre-licensure testing .. Post-licensure testing .. Manufacture of Addition of a VACCINE to a recommended immunization Continuous monitoring of the SAFETY of Role of clinicians in VACCINE Predictable pattern of behaviour when a new VACCINE is introduced.

4 VACCINE SAFETY institutions and mechanisms .. National regulatory authorities .. Immunization SAFETY surveillance Adverse events after VACCINE reactions .. Reactions associated with defective VACCINE Reactions due to vaccination Reactions due to anxiety about vaccination .. Coincidental events .. Case definitions and treatment of adverse events after Reporting of adverse events after Events to be Timing of Mode of Reporting adverse events during immunization Barriers to reporting .. VACCINE Adverse Events Information Management System (VAEIMS)..213 . Valid and FALSE CONTRAINDICATIONS to vaccination .. When to vaccinate CONTRAINDICATIONS to commonly used vaccines and precautions to be Precautions for administration of rotavirus Misperceptions about . Facts and myths about vaccination.

5 Introduction .. Reasons given for refusing Barriers to vaccination .. Objections to vaccines based on religious beliefs ..30 Table of Responding to concerns .. VACCINE manufacture and testing .. The immune system and the host Are vaccines really necessary? .. Relations between vaccination and neurological disease .. Relation with other diseases .. Conservation .. The cold VACCINE VACCINE vial VACCINE administration .. Which, when, where and Simultaneous administration of several Vaccination records .. Records of health care providers .. Patient records .. Vaccination information systems .. Advice on Before vaccination .. At the doctor s office .. After vaccination ..536 . Vaccination in special situations .. Altered immunocompetence .. Immunodeficiency.

6 Vaccination of contacts .. Conditions that might cause HIV Congenital immunodeficiency in Recipients of haematopoietic cell transplants .. Recipients of solid organ transplants .. Anatomical or functional asplenia .. Bleeding Chronic illnesses in children .. Drugs that might cause Corticosteroids .. Other immunosuppressive drugs .. Antibody-containing products .. Concurrent administration of antimicrobial agents and vaccines .. Vaccination of preterm Vaccination during breastfeeding .. Vaccination during pregnancy .. Vaccination of patients with tuberculosis .. Tuberculosis skin test reactivity .. Screening of people vaccinated with bacille Calmette-Gu rin (BCG) .. Efficacy of BCG .. Revaccination with Screening for severe combined immunodeficiency disease in countries with universal BCG vaccination.

7 Vaccination of people with lapsed or unknown immunity .. Interchangeability of Catch-up vaccination .. Vaccination for travellers ..717 . Conclusion ..728 . Clinical cases .. Case 1 .. Case 2 .. Frequency of adverse reactions to commonly used vaccines ..99 vAcknowledgementsThe authors of the training manual are listed below. They received guidance from WHO Regional Office for Federico Martin n-Torres, the Head of Translational Paediatrics and Infectious Diseases Service of Hospital Cl nico of the University of Santiago, the Associate Professor of Paediatrics of the University of Santiago, and the Coordinator of Genetics, Vaccines, Infections and Paediatrics Research Group of the Health Care Research Institute of Santiago, Irene Rivero Calle, the Consultant in Paediatrics of Translational Paediatrics and Infectious Diseases Service of the Hospital Cl nico of the University of Santiago.

8 SAFETY and FALSE CONTRAINDICATIONS to Vaccination Training manualviAbbreviationsAEFI Adverse effects after vaccination AIDS Acquired ImmunoDeficiency SyndromeBCG bacille Calmette-Gu rinCIOMS Council for International Organizations of Medical Sciences DT diphtheria and tetanus toxoids DTP diphtheria, tetanus and pertussis DTaP diphtheria and tetanus toxoids and acellular pertussis DTwP diphtheria and tetanus toxoids and whole-cell pertussis GACVS Global Advisory Committee on VACCINE SAFETY GBS Guillian-Barr syndrome HBsAg hepatitis B surface antigen Hib Haemophilus influenzae type b HIV human immunodeficiency virus HPV human papillomavirus Ig immunoglobulin IL interleukin IPV inactivated poliovirus VACCINE Men meningococcusNK cells natural killer cellsNRA National Regulatory AuthorityOPV oral poliovirus vaccinePCV pneumococcal conjugate VACCINE PIDM Programme for International Drug Monitoring PS23 23-valent pneumococcal polysaccharide VACCINE RV1 rotavirus VACCINE RotaTeq RV5 rotavirus VACCINE Rotarix SCID severe combined immunodeficiency SIV Simian

9 Immunodeficiency VirusTB TuberculosisTd tetanus and diphtheria toxoids Tdap tetanus toxoid, reduced diphtheria toxoid and acellular pertussis Tdwp tetanus toxoid, reduced diphtheria toxoid and whole-cell pertussis TIV trivalent inactivated vaccineTST tuberculin skin testTT tetanus toxoid USA United States of AmericaVAEIMS VACCINE Adverse Event Information Management System VAERS VACCINE Adverse Event Reporting SystemVi typhoid capsular polysaccharide typhoid VACCINE VVM VACCINE vial monitorWHO World Health Organizationvii1 . Scope and purpose Vaccination has been demonstrated repeatedly to be one of the most effective interventions for preventing disease worldwide. Ironically, the fact that vaccines are administered to healthy people to prevent diseases that have become rare, largely thanks to vaccination, contributes to concern about VACCINE SAFETY .

10 Because the devastating effects of the diseases are no longer prominent, public attention is focused on side-effects of vaccination. This influences how people weigh up the risks and benefits of vaccination, leading in some instances to reduced vaccination rates and outbreaks of disease; however, the minimal risks associated with vaccination are totally overshadowed by the health risks associated with 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.