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. 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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