Immunization Essentials
A Practical Field Guide

Immunization Essentials: A Practical Field Guide has been produced and funded by the Office of Health, Infectious Diseases, and Nutrition, Bureau for
Global Health, U.S. Agency for International Development (USAID).
Production of this document has been coordinated and facilitated by the
Monitoring, Evaluation and Design Support (MEDS) Project, and thePopulation, Health and Nutrition Information (PHNI) Project.
The MEDS Project is funded by USAID under Contract No. HRN-I-02-99-000200, Task Order No. 02, and is implemented by LTG Associates, Inc. and TvT
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Systems, Inc. The PHNI Project is funded by USAID under contract no. HRN-C00-00-00004-00, and is managed by Jorge Scientific Corporation with
Futures Group International and John Snow, Inc.
USAID would also like to thank the CHANGE Project and the BASICS II
Project for contributing expert technical staff to the preparation of this Guide.
CHANGE is a cooperative agreement (No. HRN-A-00-98-00044-00) between
USAID and the Academy for Educational Development with its subcontractor,
The Manoff Group, Inc., to provide leadership for behavior change innovationand state-of-the-art tools and strategies.
BASICS II is a global child survival project funded by the Office of Health,Infectious Diseases, and Nutrition, Bureau for Global Health, USAID. BASICS
II is conducted by The Partnership for Child Health Care, Inc., under contract
no. HRN-C-00-99-00007-00. Partners are the Academy for Educational
Development, John Snow, Inc., and Management Sciences for Health.
Subcontractors include Emory University, The Johns Hopkins University, The
Manoff Group, Inc., the Program for Appropriate Technology in Health, Save
the Children Federation, Inc., and TSL.
This document may be freely reviewed, abstracted, reproduced and translated, in part or in whole, but not for sale and not for use in conjunction withcommercial purposes.
The opinions expressed herein are those of the Technical Writing Group anddo not necessarily reflect the views of USAID.
ISBN 0-9742991-2-X
October 2003

Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

1 Introduction

15

2 Immunization Program Management27

3 Delivery of Immunization Services

43

Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Types of Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Disease Transmission and the Impact of Immunization . . . . . . . . . . . . . . . . . . . .18
The Global Effort to Immunize All Children . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Overview of Immunization Essentials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

The Public and Private Health Sectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Public Sector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Private Sector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Non-Governmental Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
For-Profit Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
The Organization of Immunization Services . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Immunization Service Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Coordination of Immunization Activities – Inter-agency Coordinating Committees . .33
Global Partnerships – Global Alliance for Vaccines and Immunization . . . . . . . . . 36
Community Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
The Impact of Health System Changes on Immunization Services . . . . . . . . . . . .38
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

Immunization Schedules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Provision of Routine Immunization Services . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Why People Use Routine Immunization Services . . . . . . . . . . . . . . . . . . . . . . . .45
Strategies for Increasing the Use of Routine Services . . . . . . . . . . . . . . . . . . . . .47
Reaching the Unreached . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Reducing Drop-Outs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Limiting Missed Opportunities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Supplemental Immunization Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Accelerated Disease Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Outbreak Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Special Populations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

Immunization Essentials

1

4 Monitoring, Evaluation, and Information Management61

5 Vaccine Supply and Quality

87

6 The Cold Chain and Logistics

99

Health Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Basic Monitoring Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Patient Registers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Vaccination Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Tickler Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Tally Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Immunization Monitoring Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Analysis and Use of Routine Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Immunization Coverage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Drop-Out Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Other Uses of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Routine Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Monitoring the Information System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Interpreting Coverage from Different Sources . . . . . . . . . . . . . . . . . . . . . . . . . .80
Tools for Assessment and Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Immunization Services Assessment Guide . . . . . . . . . . . . . . . . . . . . . . . . .82
Immunization Coverage Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Seventy-Five-Household Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Missed Opportunity Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Lot Quality Assurance Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Large-Scale Population-Based Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Computerized Information Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

Forecasting Vaccine Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Vaccine Vial Size and Session Frequency . . . . . . . . . . . . . . . . . . . . . . . . .87
Size of the Target Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Stock on Hand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Supply Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Storage Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Reserve Stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
Vaccine Use and Wastage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
Calculating How Much Vaccine to Order . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Vaccine Procurement and Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . .94
Global Vaccine Shortages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97

Vaccine Stock Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
Vaccine Arrival . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100

2

Immunization Essentials

Vaccine Stock Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Temperature Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Freezing Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
“Shake Test” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
Temperature Monitoring Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
Vaccine Vial Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
Selection of Storage Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Cold Rooms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Freezers and Refrigerators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Cold Boxes and Vaccine Carriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111
Icepacks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Management of Storage Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Equipment Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113
Equipment Maintenance and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . .113
Replacement Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
Planning for Emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Vaccine Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Packing Vaccines in Cold Boxes and Vaccine Carriers . . . . . . . . . . . . . . .115
Storing Diluent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
Reconstitution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
Transportation Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118

7 Injection Safety

121

8 Disease Surveillance

135

Assessing Injection Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Safe Injection Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
Injection Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124
Injection Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Auto-Disable Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Conventional Disposable Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Pre-Filled, Single-Dose, Non-Reusable Syringes . . . . . . . . . . . . . . . . . . . . .128
Sterilizables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
Sterilization of Injection Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Management of Sharps Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Safety Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .130
Waste Disposal and Destruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
Incineration Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132

Types of Disease Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .136
Facility-Based Routine Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .136
Community-Based Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137
Sentinel Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138

Immunization Essentials

3

Surveillance Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138
Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
Analysis and Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140
Presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142
Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143
Laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .144
Adverse Events Following Immunization . . . . . . . . . . . . . . . . . . . . . . . . . . . .144
Dealing with Rumors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .146
Integrated Disease Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .147
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .148

9 The Role of Behavior Change

151

Identifying Barriers to Desired Behaviors . . . . . . . . . . . . . . . . . . . . . . . . . . . .153
Behavioral Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155
Behavior Change Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157
Training to Improve Knowledge and Skills . . . . . . . . . . . . . . . . . . . . . . .160
Supervision and other Strategies to Support Positive Behavior . . . . . . . . . . .161
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165

10 Costs and Financing

167

11 New Vaccines and Technologies

191

What Does It Cost to Provide Vaccination Services? . . . . . . . . . . . . . . . . . . . .168
What Costs Need to Be Included in an Immunization Budget? . . . . . . . . . . . . .170
Commonly Overlooked Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .172
Costs in Transition: Vaccine and Waste Management . . . . . . . . . . . . . . . .173
How Can Different Service Delivery Strategies Affect Cost? . . . . . . . . . . . . . . .174
How Can Resources Be Used Efficiently and Effectively? . . . . . . . . . . . . . . . . .175
What Does It Cost to Reach New Targets? . . . . . . . . . . . . . . . . . . . . . . . . . .176
How Can Vaccination Services Be Financed? . . . . . . . . . . . . . . . . . . . . . . . .180
What Needs to Be Done to Obtain Funding? . . . . . . . . . . . . . . . . . . . . . . . .184
Sustainability of Immunization Financing . . . . . . . . . . . . . . . . . . . . . . . . . . . .186
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .188

Introducing New Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .191
Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .191
Service Delivery Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .192
Target Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .192
Vaccine Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .193
Cold Chain and Logistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .194
Disease Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .194
Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .194
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195
Financing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195

4

Immunization Essentials

Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195
Monitoring and the Information System . . . . . . . . . . . . . . . . . . . . . . . . . .198
Vaccines in Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .198
New Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201
Needle-Free (or Jet) Injectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201
Needle Removal and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201
Vaccine Preservation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .202
Auto-Reconstitution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .202
Improved Rapid Field Diagnostic Tests . . . . . . . . . . . . . . . . . . . . . . . . . .202
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .203

12 Vaccines and Vaccine-Preventable Diseases

205

Vaccine-Preventable Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .206
Vaccines Used in National Immunization Programs in Developing Countries . . . .208
Diphtheria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210
Hib Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .215
Hepatitis B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219
Measles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .224
Pertussis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .234
Polio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .238
Tetanus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .243
Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .251
Yellow Fever . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .255
Vitamin A Deficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .259
Available Vaccines Not Widely Used in Developing Countries . . . . . . . . . . . . .265

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .269

Immunization Essentials

5

6

Immunization Essentials

Preface“The best way to escape from a problem is to solve it.”– Alan Saporta
Like its predecessor, EPI Essentials (1988), this manual has been written
for immunization program managers at national and sub-national levels
in developing countries and for people who support these managers, particularly field staff of donor agencies. Our intention is to provide information thatis practical as well as technically and operationally sound. For readers who
would like to explore topics in greater depth, we have provided additionalreferences.
In revising EPI Essentials, we have tried to listen to readers’ feedback, which
was generally very positive. Users very much appreciated having such avariety of practical information in one compact volume; the user-friendly
format with many photos, forms, tables, and quotations; the accessible writing
style; and, at times, the authors’ provocative attitude.
USAID decided to revise the earlier volume because it had long been outof print and because, over the past 15 years, immunization programs haveundergone a number of significant changes. These include new objectives(e.g., accelerated disease control for polio, measles, and neonatal tetanus),
new vaccines (e.g., hepatitis B and Hib), new procedures to solve old problems (e.g., injection safety), new technologies for vaccine delivery and cold
chain, and health sector reforms. Such changes underscore the need for constant attention, sharing of experience, creativity, and flexibility in responding
to problems.
A central theme is that there is not just one way of doing things. We provide
managers and other decision-makers with scientifically based principles, policies, and standards; technical specifications for vaccines and equipment; andoperational considerations that they must weigh to devise the best solutions fortheir circumstances. We have drawn on real life experiences to illustrate howtechnical and operational issues can be addressed in the field.
In addition to technical changes, immunization has been subject to boom andbust funding cycles, which are mirrored in fluctuations in coverage rates anddisease transmission. We see a need to use the boom times to build strong
managerial capacity, stable funding commitments, and a wide base of support for the task required to be done year after year for the foreseeable future
to protect every child in every country.

Immunization Essentials

7

We view the provision of a primary series of vaccines in the first year of life
(often called “routine immunization”) as the cornerstone of all immunization
efforts and other primary health care efforts as well. The fact that immunization gives each child five contacts with the health system before the age of
one year is a tremendous opportunity that is often underutilized. While thenecessity for “routine immunization” for every birth cohort remains constant,immunization programs are anything but static. Decentralization, integration,and other changes in primary health service delivery pose a continual challenge, and public health personnel must be ever vigilant to make sure that thetremendous promise of immunization is sustained.
While the impact of immunization on childhood morbidity and mortality has
been great, its full potential has yet to be reached. Millions of children still die
from vaccine-preventable diseases each year. It is our fervent hope that thismanual will assist those responsible for immunization programs to meet thischallenge. The protection of children, a task every immunization worker takes
on every day, is a high calling. If this manual can make that task a little easier, then the effort to prepare it has been worthwhile.

8

Immunization Essentials

Acknowledgements
Technical Writing Group:

Murray Trostle (USAID)
Robert Steinglass (BASICS II)
Rebecca Fields (CHANGE Project)
Michael Favin (CHANGE Project)
Stacey Ballou (USAID)

Writing Consultant:

Kristina Engstrom

Graphic Designers:

Matthew J. Baek, Craig Manning

Editorial Consultant:

Linda Kean

MEDS Project Support:

Daniele Avila
Julie Klement
Karen Lombardi
Muthoni Njage

PHNI Project Support:

Matthew J. Baek, Kristin Kilbane
Marcia MacNeil, Sarah Melendez

Technical Reviewers:
Caroline Akim
John Barenzi
Kristine Bisgard
Lyndon Brown
James Cheyne
Pierre Claquin
Andrew Clements
Margaret Cortese
Frances Davidson
Carter Diggs
Rachel Feilden
Paul Fife
Stan Foster
David Gittelman
Richard Greene
Steve Hadler

Mary Harvey
Yvan Hutin
Jessica Kafuko
Lidija Kamara
Umit Kartoglu
Maureen Kolasa
Ulla Kou
Steve Landry
Gordon Larsen
Jennifer Luna
Patrick Lydon
Rose Macauley
Marty Makinen
Tony Marfin
Eric Mast
Julie Milstien

Khadija Msambichaka
Evariste Mutabaruka
Joe Naimoli
Carib Nelson
Deo Nshimirimana
Ellyn Ogden
Nancy Pielemeier
Bryn Sakagawa
Tina Sanghvi
Fred Shaw
Lora Shimp
Diana SilimperiPeter Strebel
Tej Tiwari
Mark Weeks

Reviewers were sought for the breadth and scope of their technical expertise and awide range of perspectives. USAID would like to acknowledge and thank all those
involved for their contributions. They included staff from BASICS II, CDC, Emory
University, FBA, MSH, Ministry of Health (Tanzania), National Council for Children(Uganda), PATH/CVP, PHRplus, QAP, World Bank, WHO, UNICEF, USAID, and otherindependent immunization experts.

Immunization Essentials

910

Immunization Essentials

Selected Acronyms
A-D

Auto-disable (syringe)

AEFI

Adverse events following immunization

AFP

Acute flaccid paralysis

BCG

Bacillus Calmette-Guerin vaccine

CDC

U.S. Centers for Disease Control and Prevention

cVDPV

Circulating vaccine-derived polio virus

DHMT

District health management teamDT

Diphtheria-tetanus vaccine

DTP

Diphtheria-tetanus-pertussis vaccine

EPI

Expanded Program on Immunization

FIC

Fully immunized child

GAVI

Global Alliance for Vaccines and Immunization

Hep B

Hepatitis B vaccine

Hib
HIPC II
HIV/AIDS

Haemophilus influenzae type b
Highly Indebted Poor Countries II
Human Immunodeficiency Virus/Acquired Immune Deficiency
Syndrome

ICC

Inter-agency Coordinating Committee

IIP

Immunization in Practice

IMCIIntegrated Management of Childhood Illness

IPV

Inactivated polio vaccine

MLM

Mid-level management

Immunization Essentials

11

MMR

Measles-mumps-rubella vaccine

MOH

Ministry of HealthMR
NGO

Non-governmental organization

NID

National immunization day

NRA

National Regulatory Authority

OPV

Oral polio vaccine

PEI

Polio Eradication Initiative

SIGN

Safe Injection Global Network

SNID

Sub-national immunization day

SWAp

Sector-wide approach

Td

Tetanus-diphtheria vaccine

TT

Tetanus toxoid vaccine

UCI

Universal Childhood Immunization

UNFPA

United Nations Fund for Population Activities

UNICEF

United Nations Children's Fund

USAID

United States Agency for International Development

VAD(D)

Vitamin A deficiency (disorder)

VAPP

Vaccine-associated paralytic polio

VVM

Vaccine vial monitor

WHO

World Health Organization

WinCOSAS
YF

12

Measles-rubella vaccine

Coverage Survey Analysis System
Yellow fever vaccine

Immunization Essentials

Immunization Essentials

13Chapter 1:
Introduction“The health of the people is really the foundation upon which
all their happiness and all their powers as a state depend.”

On May 14, 1796, Edward Jenner, aBritish physician, performed an experiment that would revolutionize publichealth. He made two small cuts on thearm of an eight-year-old boy, James
Phipps, and inserted material takenfrom a sore on a woman infected withcowpox, a mild disease common todairy workers. Six weeks later, Jenner
injected the boy with fluid from asmallpox lesion, and James did notcontract smallpox. With this experiment, Jenner discovered that inoculation ofa person with relatively harmless disease material could protect the personfrom a more dangerous disease. He called this process “vaccination”, derived
from the Latin name for cowpox, vaccinia.

Courtesy of Thomas Cooper Library,
University of South Carolina– Benjamin Disraeli

Milestones in Vaccine Development
1885

First use of live attenuated viral vaccine (rabies) in humans

1909

First live attenuated bacterial vaccine (Bacillus Calmette-Guerin, or BCG)
created for use against tuberculosis

1921

Diphtheria toxoid developed

1924

Tetanus toxoid produced

1930s

Pertussis vaccine developed

1932

Yellow fever vaccine developed

1940sDiphtheria-tetanus-pertussis (DTP) combination introduced

1955

Inactivated polio vaccine introduced

1963Live attenuated oral polio vaccine introduced

1963

Measles vaccine introduced

1986

First recombinant vaccine (hepatitis B) introduced

1990

First polysaccharide conjugate vaccine (Haemophilus influenzae type b)
introduced

Immunization Essentials
Chapter 1: Introduction

15

By the time the World Health Assembly declared in 1980 that smallpox had
been eradicated, scientists had developed vaccines for many other diseases.
Today, there are many vaccines available to prevent illness. Indeed, vaccination has become one of the most important preventive health care interventions of all time. Every year millions of children and adults receive
vaccinations that protect them from a host of infectious diseases; meanwhile,
the arsenal of vaccines is growing rapidly through bio-medical research.

Immunity
Immunity is the ability of the body to tolerate material that is indigenous to it
and eliminate material that is foreign. The immune system is comprised oforgans and specialized cells that protect the body by identifying harmful substances, known as antigens, and by destroying them by using antibodies andother specialized substances and cells. There are two basic ways to acquire
this protection – active immunity and passive immunity.
• Active immunity is provided by a person’s own immune system. This typeof immunity can come from exposure to a disease or from vaccination.
Active immunity usually lasts for many years and often is permanent.
• Passive immunity results when antibodies are transferred from one person
or animal to another. The most common form of passive immunity occurs
when a fetus receives antibodies from his or her mother across the placenta during pregnancy. Other sources of passive immunity include bloodand blood products, immune or hyper-immune globulin, and animal antitoxins. Passive immunity disappears over time, usually within weeks
or months.
Live microorganisms or antigens bring about the most effective immune
responses, but an antigen does not need to be alive for the body to respond.

Types of Vaccine
Live attenuated vaccines are derived from disease-causing viruses or bacteria that have been weakened under laboratory conditions. They will grow ina vaccinated individual, but because they are weak, they will cause either nodisease or only a mild form. Usually, only one dose of this type of vaccine
provides life-long immunity, with the exception of oral polio vaccine, which
requires multiple doses.
Inactivated vaccines are produced by growing viruses or bacteria andthen inactivating them with heat or chemicals. Because they are not alive, theycannot grow in a vaccinated individual and therefore cannot cause the disease. They are not as effective as live vaccines, and multiple doses are

16

Immunization Essentials
Chapter 1: Introduction

Types of Vaccine• Live attenuated– Virus, e.g., oral polio vaccine (OPV), measles, yellow fever– Bacteria, e.g., BCG• InactivatedWhole– Virus, e.g., inactivated polio vaccine (IPV)– Bacteria, e.g., whole-cell pertussis
Fractional– Protein-based– Subunit, e.g., acellular pertussis– Toxoid, e.g., diphtheria and tetanus– Polysaccharide-based– Pure, e.g. meningococcal– Conjugate, e.g., Haemophilus influenzae type b (Hib)• Recombinant, e.g., hepatitis B

required for full protection. Booster doses are needed to maintain immunity
because protection by these vaccines diminishes over time.
Inactivated vaccines may be whole-cell or
fractional. Whole-cell vaccines are made ofan entire bacterial or viral cell. Fractional
vaccines, composed of only part of a cell,are either protein- or polysaccharide-based.

Credit: Aventis Pasteur

Polysaccharide-based vaccines are composed of long chains of sugar molecules
taken from the surface capsule of thebacteria. Unless coupled with a protein,pure polysaccharide vaccines are generally
not effective in children under the age of
two years. This coupling process is known
as “conjugation.”
Recombinant vaccines are produced byinserting genetic material from a disease-causing organism into a harmless
cell, which replicates the proteins of the disease-causing organism. The proteins are then purified and used as vaccine.
Vaccines used in national immunization programs in developing countries aredescribed in detail in Chapter 12.

Immunization Essentials
Chapter 1: Introduction

17

Disease Transmission and the Impact of
Immunization
An infectious disease is an illness that occurs when an infectious agent istransmitted from an infected person, animal, or reservoir to a susceptible host.
Some of the factors that influence transmission include:• Contagiousness of the infective agent• Duration of infectivity• Disease fatality and attack rate
• Route of transmission(e.g. person-to-person, vector-borne, water or food-borne)• Nature of the vector• Population density and size
• Nutritional status• Hygiene and sanitation• Access to clean water• Poverty• Population immunity

Credit: WHO

A basic concept of public health is that every individual who is protected froma disease as a result of an immunization is one less individual capable oftransmitting the disease to others. Individuals who have been immunized serve
as a protective barrier for other individuals who have not been immunized,
provided that the number immunized has reached a certain level. Reaching
and maintaining that level, which varies by communicable disease, provides“herd immunity” to unimmunized individuals.

18

Immunization Essentials
Chapter 1: IntroductionAdopted from: Fine, 1994

Good immunization coverage can also protect the unvaccinated

CONCLUSIONCONCLUSION

In this hypothetical population consistingof only susceptible individuals, the diseasecan spread through the population exponentially, eventually infecting everyone
because everyone will come in contact
with an infected individual.

In this hypothetical population where
75% of the population has been immunized, some non-immunized and susceptible individuals (as shown by the green
circles) will not become infected becauseof the fact that they will not come in contact with an infected individual.
Therefore, the growth rate of the infectionis held in check with only a 75% immunization coverage rate.

The figure above illustrates the concept of herd immunity. It shows two hypothetical populations in which each individual comes in contact with four othermembers of the population. Both populations have been exposed to a hypothetical disease that is 100% contagious. The first group has no immunity to
the disease and, therefore, the disease spreads to everyone.
The second population is partially immune due to vaccination services thathave protected 75% of the population. Even though only 75% are immune
because of vaccination, the disease does not spread to all of the remaining
25% of susceptible individuals. This is because some of the remaining susceptibles are protected by the fact that they do not come in contact with aninfected individual. This is how herd immunity can protect more people thanthose who actually receive vaccinations and thus inhibit the spread of disease. Note that if the susceptible individuals are unevenly distributed, e.g., ifthey cluster in urban slums, the level of protection in that population will need
to be higher to prevent transmission.

Immunization Essentials
Chapter 1: Introduction

19

In the 1970s, at the end stage of the global campaign to eradicate smallpox,
the World Health Organization (WHO) launched the Expanded Programmeon Immunization (EPI). Coverage for basic
vaccines was an estimated 5% in developing
countries at that time. The EPI goals were toensure that every child received protection
against childhood tuberculosis, polio, diphtheria, pertussis, tetanus, and measles by the time
he or she was one year of age and to givetetanus toxoid vaccinations to women to protect them and their newborns against tetanus.
During the 1980s, national immunization
programs in developing countries made substantial progress in meeting the EPI goal, with the support of WHO, theUnited Nations Children’s Fund (UNICEF), the U.S. Agency for International
Development (USAID), the Italian government, and other partners. EPI and theprogram to control diarrheal diseases were the “twin engines” that poweredchild survival programs worldwide. As immunization coverage in developing
countries soared, EPI was helping lay the foundation for other primary healthcare services. By 1990, average reported coverage for the six antigens wasover 70%. As a result of the increase in coverage, the incidence of vaccinepreventable diseases began to fall dramatically.
Reported DTP3 Coverage by WHO Region, 1980 - 1999

20

Immunization Essentials
Chapter 1: Introduction

EPI Logo. Credit: WHO

The Global Effort to Immunize All Children

In the 1990s, coverage leveled off and even declined in some countries.
There were a number of reasons why it proved difficult to maintain the
momentum of the early EPI years. When coverage peaked in 1990,
many believed that the job was finished and turned their attention to otherimmunization activities such as vertical disease eradication programs. Somedonors became fatigued with immunization altogether and, noting the declining incidence of vaccine-preventable diseases, shifted their resources to other
health priorities. Another factor was that the remaining unimmunized children
were primarily the hard-to-reach children with whom routine health services
generally had little or no contact.
Furthermore, health sector reform and structural adjustments diverted attention
away from maintaining effective preventive services in many countries and,in some cases, created confusion regarding where the responsibility for immunization resided within the health sector. Whatever the reasons, the result wasa declining investment in training, equipment, logistics, and communications.
Global Estimated Deaths Occurring and Prevented, 2000:
Measles, Neonatal Tetanus and Pertussis

Despite the slowdown of progress in the 1990s, over two million deaths were prevented in the year 2000 as the result of measles, pertussis, and tetanus immunizations
alone (see graph). Clearly, however, the job is far from complete: approximately
800,000 children die each year from measles, 400,000 from pertussis, and 200,000
from tetanus.

Immunization Essentials
Chapter 1: Introduction

21

The deteriorating situation in the 1990s sounded alarms in the public healthcommunity, and at the turn of the century, governments and their partners
began to renew their commitment to routine immunization services. New
coordination and funding mechanisms were set up. Most noteworthy was theformation of the Global Alliance for Vaccines and Immunization (GAVI), which
supports immunization efforts worldwide. GAVI is a coalition of governments
and international, bilateral, and private-sector partners with the purpose ofhelping countries strengthen immunization services and introduce new andunderutilized vaccines.
The lessons of the 1980s and 1990s and the new opportunities put forthat the turn of the century have set the stage for great strides in national
immunization programs. Realizing the potential of immunization requires acommitment from a broad coalition of partners. That coalition involves everyone from the village health worker to the research scientist, from the national
EPI manager to the global policy maker, from the donor agency health officer
to the Minister of Health. If these partners can work together in coordinatedstrategies that give appropriate attention to all the essentials of immunization,then the world’s children will face a much safer and brighter future.

Overview of Immunization Essentials
This guide describes what is necessary to administer potent vaccines to children and women in a safe and effective manner on a continual basis.
Immunization services must be provided and used throughout the year, every
year, to enable each new cohort of newborns and women of childbearing
age to become adequately protected. Developing and managing systems todo this requires attention to many program details, which are described in thechapters that follow:

Chapter 2: Immunization Program Management
Roles of the public and private sectors, organization of immunization services,personnel required, donor coordination, global partnerships, community
participation, and the impact of health sector reform

Chapter 3: Delivery of Immunization Services
Immunization schedules, organizing routine services, why people use
these services, strategies for increasing use, and supplemental
immunization strategies

22

Immunization Essentials
Chapter 1: Introduction

Chapter 4: Monitoring, Evaluation, and Information
Management
Using information to record, monitor, and evaluate services, to raisecoverage, and to reduce drop-out rates; tools to support these objectives

Chapter 5: Vaccine Supply and Quality
Forecasting vaccine needs, vaccine wastage, procurement, andquality assurance

Chapter 6: Cold Chain and Logistics
Storing, handling, and distributing vaccines and other commodities; essential
equipment and procedures; and transportation management

Chapter 7: Injection Safety
Assessing safety, developing the policies and practices to promote injection
safety, managing waste, and selecting appropriate equipment

Chapter 8: Disease Surveillance
Planning and implementing surveillance activities for disease control andadverse events

Chapter 9: The Role of Behavior Change
Determining feasible actions for parents, health staff, and others to enhance
immunization programs; developing comprehensive strategies to promote andfacilitate those behaviors

Chapter 10: Costs and Financing
Mobilizing resources, options for financing, costing and budgeting, and using
resources efficiently and effectively

Chapter 11: New Vaccines and Technologies
Introducing new vaccines and technologies into existing programs; new vaccines and technologies in the pipeline

Chapter 12: Vaccines and Vaccine-Preventable Diseases
Details on vaccines used in developing country programs, the diseases they
prevent, and disease-specific strategies for their control

Immunization Essentials
Chapter 1: Introduction23

References
Epidemiology and Prevention of Vaccine-Preventable Diseases. Seventh
Edition. January 2002. Atlanta, GA: U.S. Centers for Disease Control
and Prevention.
Fine, Paul E.M. “The Contribution of Modelling to Vaccination Policy.”
Vaccination & World Health. John Wiley & Sons, 1994. Cutt, Felicity T. andPeter G. Smith, editors.
National Institutes of Health, National Institute of Allergy and Infectious
Diseases. Understanding Vaccines. 1998. Washington, DC: U.S. Department
of Health and Human Services. NIH Publication No. 98-4219.
Steinglass, Robert and Rebecca Fields. May-June 2000. “Immunization:
Challenges and Opportunities.” Global Health Link. White River Junction, VT:
Global Health Council, p. 15.
WHO. 2003. Increasing Immunization Coverage at the Health Facility Level.
Geneva: World Health Organization. WHO/V&B/02.27.
WHO and UNICEF. 2002. State of the World’s Vaccines and Immunization.
Geneva: World Health Organization.
WHO. 1999. The World Health Report 1999: Making a Difference. Geneva:
World Health Organization.
Full page photo credit: Kelley Sams, BASICS II

24

Immunization Essentials
Chapter 1: Introduction

Immunization Essentials
Chapter 1: Introduction25

Chapter 2:
Immunization Program Management“Tis skill, not strength, that governs a ship.”– Thomas Fuller, 1732
Immunization program managers operate within the context of the overall
health system. Consequently, whether they think in terms of “systems” or not,their decisions and activities can strengthen the system or weaken it. This happens because most functions in the health system are shared among programs
and services — personnel, budgets, facilities, equipment, supplies, transportation, logistics, supervision, and more. Changes in one activity ripple throughthe whole system.
Priorities, organization, and resources differ among health systems. In recent
years, many health systems have faced pressure to improve efficiency, raise
quality, and increase access to services, while simultaneously reducing costs.
The experience of health sector reform has underscored the extent to which
the health system affects, and is affected by, the political, economic, andsocial environment, as shown below. Clients, health workers, and health officials interact in numerous ways among themselves and with the political structure. As voters or members of the community, clients can provide the criticallink between the health system and the political environment.

Good health is good politics

Immunization Essentials
Chapter 2: Immunization Program Management

27

The Public and Private Health Sectors
Public Sector
The public health sector includes ministries of health, public hospitals, andgovernment health facilities at the local, district, other sub-national, andnational levels. Public health officials formulate policies, standards, and guidelines for national immunization programs. They monitor immunization coverage and disease incidence. They are responsible for ensuring that all
immunization service providers, including those in the private sector, comply
with the national immunization schedule, maintain the vaccine cold chain,practice injection safety, and follow other policies governing equity and quality. Health personnel from the public sector provide the majority of vaccination
services in most developing countries.

Private Sector
The private sector includes non-governmental and for-profit components.
Non-governmental organizations (NGOs) are nonprofit groups thatprovide curative and preventive health services directly and/or support government-provided services. They range in size and scope from small religious
or community-based organizations to large international groups with hundreds
and even thousands of employees.
A traditional strength of NGOs is their ability to reach people that lack accessto public-sector services. Many NGOs have good relationships with people inthe communities they serve and involve community members in planning andsupporting activities. People often regard health services provided by NGOs
as being of higher quality than those provided by the public sector.
In some countries, involvement of health-focused NGOs in immunization programs is limited, largely because they do not have access to vaccines andimmunization equipment. On the other hand, their extensive involvement inprograms like Integrated Management of Childhood Illness (IMCI), in which
they manage drugs and supplies and provide services, indicates that given
adequate support, NGOs can contribute to immunization.

28

Immunization Essentials
Chapter 2: Immunization Program Management

Credit: Hari Krishna Shah, BASICS II

An outpatient center.

National immunization programs can take advantage of NGOs’ experienceand appeal by encouraging their participation in:• Organizing and providing immunization services directly, although thegovernment should always be responsible for ensuring that NGO services
adhere to government policies, norms, and standards.
• Supporting public-sector services with in-kind assistance (e.g., transportation, lodging, and meals), financial support, or technical support (e.g.,
cold chain equipment, maintenance, and repair).
• Mobilizing the community to demand and preparing the community toreceive immunization services.
• Reporting cases of vaccine-preventable diseases and tallies of vaccinations that NGOs provide.
For-profit providers consist of individuals and organizations that provide
services or products for monetary gain. For-profit service providers include
professionally-trained health workers, traditional practitioners, private hospitals, and clinics. This sector also includes manufacturers and sellers of pharmaceuticals, health products, and equipment, as well as companies that provide
laboratory services, fleet management, equipment repair and maintenance,
training, and other services.
Vaccination services offered by these private providers are available to those
who pay for them. People who are unable to pay and who are often most at
risk of vaccine-preventable diseases must be reached by the public sector, if
they are reached at all.

Immunization Essentials
Chapter 2: Immunization Program Management

29

The Organization of Immunization Services
In recent years, ministries of health have been increasingly faced with thechallenge of balancing the potential benefits of local decision-making with theefficiencies of centralized policymaking and procurement. Setting policies andstandards at the central level helps to ensure technical reliability and consistent practices throughout their countries. Central-level procurement of somecommodities, particularly vaccines, makes it easier to negotiate lower prices
and to control quality. Staff in local health facilities and district health officesneed to continue to plan and monitor the services that they are responsiblefor delivering.
In 1998, Feilden and Nielsen studied the impact of health sector reform on
immunization in two African countries. Based on this analysis, they developed
a matrix to help decentralization planners distinguish the immunization service
functions that should be retained at the national level from those that, althoughtraditionally a national responsibility, could effectively be located at more
peripheral levels.

30

Immunization Essentials
Chapter 2: Immunization Program Management

Distribution of Immunization Service Functions Among Levels
Function

National level only

Formulating national policies,
standards, and guidelines

Yes

Planning international coordination (e.g., for NIDs)

Yes

Planning service delivery
strategies

National coordinates with otherlevels and disseminates news ofcreative and successful local
solutions.

Advocacy for allocation offunds from central government;
coordinating donor support

Preferable to ensure
equitable distribution

Procurement: preparation oftender documents, monitoring
quality of products bought
under the tender (vaccines,
equipment, and supplies)

Yes

Purchase, customs clearances,storage, stock management,
distribution
Forecasting, quantification

National and/or other levels

These functions may bedelegated (as in South Africa).
Monitor the quantities
forecast

With bottom-up forecasting,national level can aggregate
totals from lower levels, but total
quantity ordered may be others’
responsibility.

Monitoring, surveillance, andAggregate data from
reporting; design of formats for lower levels; key roleuse nationwide
for AFP (acute flaccid
paralysis) surveillance. Forward data
to WHO Regional
OfficeLocal staff, close to point ofservice, can act promptly, before
data reach the national level.

Focal point for research pertaining to immunization

Organizing reviews
In-service training; updatingskillsSupervision

Yes: choice of topics,
priority setting andcoordination areneeded for best useof resources
Yes
Skill requirements
defined as perpolicies, standards
and guidelines

Lower levels participate.
National participates incurriculum development; training
itself can be delegated anddecentralized.
Yes

Immunization Essentials
Chapter 2: Immunization Program Management

31Immunization Service Personnel
Typical assignments of immunization functions of government personnel atvarious levels of the system are shown in the table below. It is important forgovernment planners and partners to recognize that most of these people
have responsibilities in addition to immunization services, so their workloads
may be heavy.
The table excludes personnel who are less directly involved in immunization
services, such as health planners, human resource managers, and financial
managers. The list also excludes members of the community who participate
voluntarily.
Government Personnel Directly Involved in Immunization Services
National

District

Health Facility*

National Manager

District HealthManagement
Team

Officer-in-charge
Usually a nurse who plans,Disease surveillance officers
manages, and monitors
immunization services,
Information management
Day-to-day immunizaamong other responsibilispecialist
tion operations may
ties. In small facilities, thisbe the responsibility of
National vaccine store
may be the only person
a public health nurse
manager and storekeepers
who is authorized to giveor district cold chain
injections.
National cold chain andofficer on the team.
logistics manager
Nurse assistantDisease surveilUsually prohibited by law
Workshop managers andlance officer or
techniciansfrom giving injections but
focal point
can give OPV, register,For repairs of cold chain equipment
and advise parents.
that cannot be made at more periph- Cold chain andlogistics officereral levels
Custodial staff
Responsible for mainteTransport officer
Transport officer
nance and repair of cold
In some districts
Training officer and training
chain equipment and vehiAccounting andstaffcles. In some facilities, theyclerical workers
may take on some of the
May be a private-sector organization
nurse assistant roles.
Communication and social
Clerical workers
mobilization staff
May be volunteers
Often part of a health education orsocial mobilization unit that assists
multiple health services
Laboratory technicians
Accounting and clerical
workers* In many small dispensaries and health posts, the staff consists of one person who is amanager, medical professional, technician, administrator, and custodian, all in one.
Source: Adapted from Feilden and Nielsen, 2001

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In addition to the three levels shown in the table, many countries also havesub-national levels (provincial, regional, or state), but few staff members atthese levels are dedicated solely to immunization services. Even surveillance
officers who were initially appointed solely to monitor acute flaccid paralysis(AFP) for the polio eradication initiative now are responsible for finding andinvestigating other communicable diseases.

Coordination of Immunization Activities—
Inter-agency Coordinating Committees
The public- and private-sector individuals and groups involved in immunization
service provision or support need to coordinate their activities at all levels.
Inter-agency Coordinating Committees (ICCs) have been formed in many countries to respond to this need at the national and, sometimes, other levels.
These committees usually include:

Credit: Kelley Sams, BASICS II• Ministry of Health staff (e.g., thenational immunization program
manager and the director of preventive services)• Staff from related ministries (e.g.,
the Ministry of Finance andMinistry of Planning)• Multilateral donors (WHO and
UNICEF)“Many hands make light the work.”• International development banks• Bilateral agencies (e.g., USAID, Department for International Development[DFID], Japan International Cooperation Agency [JICA])• Non-governmental organizations
ICCs work with national and sub-national immunization personnel to assist
with multi-year and annual planning and reviews; coordinate financial andother resource needs; and analyze, design, implement, monitor, and supervise
immunization services. One of their most important tasks is to ensure that adequate funding is available for immunization services (see Chapter 10). ICC
sub-committees are often formed to focus on specific technical issues, such as
vaccine supply, logistics, or social mobilization.
WHO has developed generic terms of reference for ICCs, which include
suggestions for their roles, as shown in the box.

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The Role of ICCs
Technical• Development of a national policy framework for vaccines and immunization thatgives priority to immunization activities, sets targets, and provides guidelines• Sponsorship of periodic in-depth assessments of national immunization programs• Advisory body for national strategic plans of action• Support for the implementation of strategies• Monitoring of service performance; tracking of disease surveillance data
• Monitoring quality control and adherence to international standards• Development of proposals for program support

Financial• Evaluation of the use of resources• Financial planning• Mobilization of additional resources when necessary

Political• Advocacy for increased commitment to immunization at all levels• Social mobilization

Capacity Building• Development of government capacity for managing and delivering immunization
services

ICCs work most effectively when a national representative, such as a highranking Ministry of Health official, directs them, when roles and responsibilities are clearly defined, when opportunities for in-depth technical discussions
are provided, and when all members agree to terms of reference that outline
these roles and responsibilities. All members should have decision-making
authority from their own organizations, and the structure should allow for the
frank discussion of even sensitive issues.
The structure of the ICC in the Democratic Republic of Congo (DRC),
described on the following page, has worked well in that country.

34

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Credit: Nelson and Shimp,2002

Enhancing the Effectiveness of an ICC
The ICC for immunization in the DRC was formed in the late 1990s as a unit of ahealth sector-wide ICC, which has seven sub-committees to address interventions thathave been designated by the DRC government as high priority. Members include various branches of the Ministry of Health, WHO, UNICEF, foreign government donors(e.g., USAID, Government of Japan, and the European Union), technical subcontractors of foreign governments, NGOs, and missionary groups. The immunization subcommittee is divided further between two subgroups, as shown in the diagram.

The experience of the DRC Ministry of Health has shown that a number of
elements are needed in order for an ICC to be effective:• Harmonizing different objectives, priorities, agendas, work plans, andbudgeting cycles of different institutions• Building an open, inclusive, and collegial partnership among membersthat resolves conflicts transparently and avoids favoritism• Designating a single focal organization to call meetings, draft documents,
monitor progress, etc.
• Fostering continuity in membership by making assignments for two years
or longer• Communicating frequently• Conducting meetings with clear objectives, agendas, time management,
meeting minutes, and follow-up• Establishing systems of checks and balances• Focusing on the long-term development of immunization services (including financing)

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Global Partnerships — Global Alliance for
Vaccines and Immunization
Created in 1999, the Global Alliance for Vaccines
and Immunization (GAVI) is a public-private partnership to strengthen immunization services andintroduce new and underutilized vaccines. GAVI
provides a forum for partners to agree upon goals,
share strategies, and coordinate activities. As of2003, the financial arm of GAVI, the Vaccine
Fund, provides financing to over 70 countries tohelp them reach national and GAVI objectives (seeChapter 10). The box below summarizes GAVI’s organizational structure.
Organizational Structure of GAVIGAVI Board – includes the highest-level

representatives ofAlliance members to set policy.

Renewable members:
WHO
UNICEF
The World BankBill & Melinda Gates Foundation
The Vaccine Fund
Rotating members:
One foundation
Two developing country governments
Three industrialized country governments
One NGO
Pharmaceutical industry – industrializedcountry
Pharmaceutical industry – developing
country
Research instituteTechnical health institute

GAVI Working Group – comprises
managers from GAVI partner institutions, some on a rotating basis.

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Supports the Board in policy development and implementation. Members
make sure that GAVI priorities arereflected in their institutions’ work
plans.
GAVI Secretariat – facilitates coordination among partners and manages thereview of country proposals to the
Vaccine Fund.
GAVI Task Forces – time-limited. They
address specific issues of concern to
the Board, including:
Advocacy and Communication
Implementation
FinancingRegional Working Groups (RWGs)– includes partners with a technicalpresence in regions. These groups
coordinate technical assistance activities between national and international
levels.
Source: Global Alliance for Vaccines and
Immunization, 2002

Community Participation
Community participation in immunization programs has been shown to resultin higher coverage and, ultimately, reduce the numbers of cases of vaccinepreventable diseases. Managers at all levels should seek the participation of
local politicians, religious leaders, community group leaders, and parents inscheduling the days and hours for immunization sessions, organizing outreach activities, promoting immunization, and monitoring performance.
Community members also can help solve specific service delivery problems,as described below.

The Primary Health Care Center (PHC) in Abba,
Nepal, had a refrigerator but no kerosene torun it. The lack of refrigeration for vaccines
meant that every day a member of the PHC
staff would have to go to the district healthoffice to collect vaccines for the catchment area.
In turn, village health workers (VHWs) would
come to the PHC every day to collect vaccines
for use that day in their villages. When vaccines
were not brought from the district to the healthcenter or when VHWs were not able to collectvaccine from the center, fixed sessions were cancelled. Outreach sessions were difficult to schedule. The availability of frozen icepacks was also
a problem.

Credit: Mizan Siddiqi

Village Development Councils
Improve Immunization Services!

The Ministry of Health could not provide funds for the purchase of kerosene, so
Village Development Councils (VDCs) met with PHC and district officials and eventuallyagreed to cover that cost. The PHC now has kerosene for its refrigerator and stores
adequate stocks of vaccines. Fixed sessions are held as scheduled, and more outreachsessions are offered. The VDCs participate more actively in planning and monitoring
immunization activities in their areas, and there are indications that coverage isincreasing and the drop-out rate is decreasing.
Community participation made the difference.
Source: Siddiqi and Weeks, 2002

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The Impact of Health Sector Reform on
Immunization Services
Immunization services everywhere are continually in transition, as governments try to meet political pressures, improve efficiency, reduce costs, identify
reliable funding sources, and increase access to and quality of services. These
never-ending changes affect all aspects of government, including the healthsector. It is imperative that immunization program managers participate in any
national level discussions on the organization and financing of the overall
health sector.
Common Elements of Health Sector Reform
There is no single formula for health sector reform. Therefore, reforms should be
adapted to address the situation in a particular country, taking into account health,economic, administrative, and political factors. Some common elements of healthsector reform that are most likely to affect the management and delivery of vaccination
services include:

Decentralization: moving decision-making authority and resources (financial andhuman) from the central level to more peripheral levels

Integration: not just of services at the peripheral level, but also of management
functions (for example, logistics or information management) at central, regional, or
district levels

Public-private mix and changes in financing: alternative strategies for service delivery or financing that are intended to increase the funding base for services

One of the many lessons ofhealth sector reform has beenthat health priorities are not
the same at the national andlocal levels. Indeed, one resultof decentralization in many
countries has been a reduction in support for immunization and other preventive
services. District health management teams tend to givehigher priority to curative careand services, such as ambulances, that are visible to the
public and to politicians.

38

Credit: Kelley Sams, BASICS II

Source: WHO, 2002

Members of the community share their concernswith local health officials.

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Another lesson of health reform is that when responsibility for the delivery ofhealth services is shifted from one level of the system (e.g., national) to another (e.g., district), resources must follow. To ensure that continuous funding isavailable for immunization, some national governments are providing grants
to districts for immunization or primary health care services.
Staff resources are as critical as financial resources. Over the coming years,
as district health management team members get training and work experience in public health and preventive care, their skills and knowledge should
begin to reach the level of their national counterparts. Because these teammembers make budget decisions, they also need to be skilled in assessing themerits of competing demands, setting priorities for allocating and disbursing
limited resources, strategic planning, and dealing with the public.
A third lesson of health sector reform is that the same individuals who are
given explicit responsibility and authority for managing immunization services
should be involved in planning, budget development, monitoring, and evaluation, not only for immunization services but also for the overall health sector.
Although the adaptation of program management and services to fit local circumstances is necessary, it must be counterbalanced with the need to adhere
to technical standards set at the national level. For example, the vaccination
schedule and the appropriate temperatures for vaccine storage should notvary from place to place within a country.

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References
Alwan, Ala’ and Peter Hornby. The Implications of Health Sector Reform for
Human Resources Development. Bulletin of the World Health Organization
2002, 80(1), pages 56-60.
BASICS II, UNICEF, Zdrav Reform, MOH, and WHO Office for the European
Region. 2000. Immunization and Health Sector Reform in the Kyrgyz
Republic: Report of a WHO-led mission, 1-12 March 1999. Geneva: World
Health Organization. WHO/V&B/99.33.
Feilden, Rachel and O. F. Nielsen. 2001. Immunization and Health Reform:
Making Reforms Work for Immunization. A Reference Guide. Geneva: World
Health Organization. WHO/V&B/01.44.
Nelson, Dan and Lora Shimp. 2002. The Immunization Inter-agency
Coordination Committee Model — Example from Democratic Republic ofCongo. Arlington, VA: BASICS II.
Siddiqi, Mizan and Mark Weeks. 2002. Notes from an Experience in Parsa
District, Nepal. Arlington, VA: BASICS II.
WHO. 2002. “What is the impact of health sector development on immunization services?” Fact Sheet 1 of 3. Geneva: World Health Organization.
Full page photo credit: WHO

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Immunization Essentials
Chapter 2: Immunization Program Management

41Chapter 3:
Delivery of Immunization Services“Every journey begins with a single step.”– Lao Tsu
In order to reduce mortality, morbidity, and disability, immunization
programs must safely administer potent vaccines to susceptible children
and women before they are exposed to vaccine-preventable diseases.
This chapter describes some of the barriers that prevent people from using
immunization services and then outlines delivery strategies for overcomingsome of these problems.

Immunization Schedules
The schedule recommended by WHO for delivering the primary series ofvaccines to children below the age of one year reflects a balance between
epidemiology and practicality. Although the approximate ages and intervals
WHO’s Recommended Schedule for Primary Series ofChildhood Vaccinations in Developing Countries
Age

Vaccines

Birth

BCG
OPV0
Hep B*

6 weeks

DTP1
OPV1
Hep B*
Hib1**

10 weeks

DTP2
OPV2
Hep B*
Hib2**

14 weeks

DTP3
OPV3
Hep B*
Hib3**

9 months

MeaslesHep B*
Yellow fever****Only three doses of hepatitis B vaccine are needed for full protection.
Hepatitis B vaccination schedules vary by country. See Chapter 12.
**Hib stands for Haemophilus influenzae type b. See Chapter 12.
***In countries where indicated.

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between doses in country schedules should not deviate from those that WHO
recommends, there is no single schedule that is appropriate for all countries.
An understanding of local epidemiology and national policy is needed toadapt the recommended schedule to a given country’s needs. In so doing,
local experts should keep in mind the importance of limiting the number ofcontacts and reaching children as soon as their immune systems are able torespond to the vaccine.

Provision of Routine Immunization Services
There are several strategies for the routine delivery of immunization services inor from health facilities.

Outreach: Outreach is the delivery of services to people who
cannot get to health facilities or
who can do so only with difficulty.
Trips to outreach sites are usuallycompleted within a day and aremade by health facility staff onfoot or using motorized vehicles,
bicycles, or pack animals.
Monthly visits provide the mosttimely protection for children,
although less frequent visits may
be necessary where distances are far, travel is difficult, or staff resources
are limited. Rainy seasons or snowy winters may make it necessary toschedule a pre-season and a post-season outreach visit with a gap of several
months in between.
In some countries, such as India, outreach visits for primary vaccinations
that are conducted once, twice, or three times a year are called “pulse
immunization.”
Mobile strategy: This usually describes trips of more than one day by
district or regional health workers for the purpose of delivering services topeople living in remote areas. Mobile teams may spend several days travelingto reach the people. In Nepal, it can take up to ten days of walking from the
district center to reach some villages.

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Credit: Veronique Leger

Fixed facility: This refers to the regular delivery of vaccinations in a healthfacility on specified days of the week and hours of the day. Larger facilities
may give vaccinations whenever eligible clients come.

In general, the cost per vaccination is higher when services are provided
through outreach and mobile strategies than through fixed services, because
health workers spend more time to reach each child and because there aretransportation and per diem costs involved. However, some people cannot bereached in any other way.

Why People Use Routine Immunization Services
Studies in many developing countries show that the great majority of parents
view immunization as a worthwhile and relatively easy health practice.
Childhood immunization only requires parents to take action about five times
in the first year of a child’s life and is generally accepted by families andcommunities. This contrasts with other practices, such as exclusive breastfeeding, which require repeated and frequent actions on the part of mothers andwhich are sometimes contrary to cultural norms and beliefs.
Scheduling immunization sessions to be accessible is only half the battle –people must actually use the services. Research from many countries indicates that people will use immunization services at least once if they knowwhat services are offered and where and when they are available. They will
return if:• They know when to come back.
• They have been treatedrespectfully.

We also know why families do notuse immunization services. Focus
group discussions, interviews, andknowledge-attitude-practice surveys ina wide range of countries have consistently found that a majority of parents
wish to immunize their children butthat many encounter obstacles, suchas those described below. These areoften due to perceived and actual
deficiencies within the health services.

Credit: Kelley Sams, BASICS II• They have confidence that they
will receive the vaccinations thatthey come for.

Health workers should be sure mothers
know when and where to return for the
next vaccination.

Lack of information. Many families lack accurate information about immunizations and immunization services. In fact, this is often the primary obstacle
to achieving full immunization of children and women who have good access

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Poor services. Some people
receive one or more immunizations,but are unwilling to return because
they are dissatisfied with the services they have received for such reasons as:• Long waits• Rudeness or insensitivity on the part of health workers• Poor vaccination techniques that cause abscesses or other discomfort• Unauthorized fees charged by health care providers• Unscheduled facility closures• Shortages of personnel, vaccines, drugs, or other supplies
Time constraints. Making a trip to a health facility with a healthy child
may not be the first priority for people with other important things to do. For
many parents, particularly women, collecting and preparing food for daily
meals requires working from dawn to dusk. Others have agricultural work thattakes them far from home, inflexible working hours, other family obligations,or they lack child care.
Social, cultural, or political barriers. Many people who live within geographic reach of health facilities do not use them because of social, cultural,or political barriers. Migrants, people from minority ethnic groups, urban
squatters, and illegal residents often try to avoid contact with any publicauthority. People will not return to health facilities where they feel unwelcome.
Misinformation. False beliefs or malicious rumors also keep people fromusing services. Common misconceptions include the following:• Children are safe from vaccine-preventable diseases because a religious
or supernatural being protects them.
• Children are fully protected because they have received someimmunizations.
• Sick children cannot be vaccinated.
• Immunizations commonly cause sterilization, disease, or dangerous
side effects.

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Credit: Kelley Sams, BASICS II

to services. They do not know when and where immunizations are available
or when their next vaccination is due. They often are unaware that if they missa scheduled immunization date,they can still be immunized; so theyshould come as soon as they can.

• Vaccinators would come to their homes or communities if the vaccinations
were truly important because they have done so before during immunization campaigns.
Distance. Some people simply do not live within reach of health services.
Some of these people live in permanent communities, and others are on themove (e.g., nomads and seasonal migrants).

Strategies for Increasing the Use of Routine
Services
The reasons why people never use immunization services or stop using themafter one or two encounters differ from place to place, but most strategies
focus on one or more of the following goals:• Reaching the unreached• Reducing drop-outs• Limiting missed opportunities

Reaching the UnreachedImprovements in scheduling.
Immunization sessions should bescheduled to be convenient forparents. Health facility managers
should assess their facilities’ immunization schedules at least once a
year and change them if necessary
to reflect the current needs of thecommunity. Both epidemiologicaland practical considerations areimportant. For example, holding
sessions less often than once permonth may delay protection, but
A clear schedule of vaccination sessions canoverly ambitious schedules mayhelp parents avoid wasted trips.
keep health workers from performing other responsibilities or result in cancelled sessions. For outreach, scheduling visits to individual villages every two months instead of every monthpermits health workers to reach twice as many villages.

Credit: Kelley Sams, BASICS II

In many countries, geographical barriers are not the only — or even the
primary — reason why people are not vaccinated. Access is also impeded
by inconvenient scheduling, lack of information, and lack of opportunities —problems that can be solved relatively simply by improving scheduling, raisingawareness, or expanding outreach.

One indicator of good management is the number of vaccination sessions that are actually
held compared to the number planned.

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Raising awareness. Families need to know about immunization services
before they can use them. Local health workers play a particularly importantrole in increasing awareness and providing information to the target population. Individual volunteers and community-based groups can assist in thiseffort, as described in Chapter 9.

Several strategies can be employed
to maximize limited resources andassure continuity of outreach services. Village health days can be used
to reach remote populations threetimes per year with vaccinations,vitamin A supplementation, andother health services. Communities
can also support visiting teams byproviding work sites, furniture,
food, and lodging. These strategies can broaden the appeal of outreach,share costs with other programs, and help avoid overdependence on externalfunding sources.
Targeting services to meet urban needs. Although vaccination coverage rates often appear higher in cities than in rural areas, these figures may
mask pockets of much lower coverage in high-risk areas such as urban slums.
Reaching unreached populations in urban areas is particularly important epidemiologically because:• Population density increases the intensity of disease transmission.
Epidemics occur more frequently in urban than rural areas, resulting in
infection of younger children, more severe illness, and higher mortality.
• Chains of transmission, particularly of measles and pertussis, often begin
in cities and towns and then spread to rural areas.
• The poor sanitation and poor nutrition found in densely populated slumareas weakens residents’ resistance to disease and increases their risk ofsevere illness and death.

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Credit: WHO

Improving and expanding outreach. Effective outreach must be wellplanned, organized, and supported. Vehicles must have fuel and must be ingood condition. Vaccines, sterile syringes and needles, vaccine carriers,
icepacks, and other supplies must be available in the right amount, in the rightplace, and at the right time. In
addition, outreach workers often
need per diems.

Credit: Richard Pollard

Improving immunization coverage inurban areas can be complex. In somesituations, the ministry of health,municipal governments, ministry of
local governments, and NGOs all
share responsibility for managing andproviding vaccination services.
Ongoing coordination is needed toensure that policies and standards areapplied uniformly, trained healthworkers are available, and marginalized populations that may fall outsideof established jurisdictions, such astransient slum-dwellers, have access toservices. Data on vaccination coverage and disease surveillance should
be collected from all service
providers, private as well as public.

Pockets in urban areas are likely tohave low coverage and high disease
Urban health facilities, like their ruraltransmission.
counterparts, can marshal the help ofcommunity members and local healthteams to identify who is not being reached and to find out why. For example,
people who live within walking distance of a health facility may not use its
services because of lack of information, cultural or physical barriers, orprevious negative experience. Different communication and service delivery
strategies may be needed to reach populations with diverse language, cultural, and socioeconomic backgrounds. Planners should take advantage of themany events that are available in urban areas, such as public concerts, sports
matches, fairs, and religious gatherings, to promote immunization.

Reducing Drop-Outs
Drop-outs are people who begin the vaccination schedule but do notcomplete it. They have at least periodic access and motivation to use
immunization services, but they stop using them for one or more of the reasons described above. With the increased use of expensive vaccines like Hep
B, Hib, and combination vaccines against multiple diseases, monitoring dropouts and devising strategies to prevent them merit greater attention. If a childdoes not receive all of the doses required for full protection, the resources thathave been used to partially vaccinate that child are mostly wasted.
Many health districts have problems with never-reached segments of the population and with drop-outs. Because resources are limited, planners have to

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49

Understand the Problem — Never-Reached or Drop-Outs?

District A. 50% of children have access to immunization services using DTP1
coverage as an indicator. 42% complete the three-dose series of DTP. The
drop-out rate therefore is 16% :( 50% – 42% ) x 100 = 16%50%
In District A, planners should give priority to raising DTP1 coverage by reaching the
50% of children who have never been reached. Reducing drop-outs would, at best,
result only in a gain in DTP3 coverage from 42 to 50% .
District B. 85% of children have received DTP1. 58% complete the three-dose DTP
series. The drop-out rate is 32% :( 85% – 58% ) x 100 = 32%
85%
In District B, reaching the last 15% of the population that has never been reached islikely to be labor-intensive and expensive. On the other hand, following up on dropouts and persuading them to complete the series could raise coverage of DTP3 from
58% to 85%. Unless additional information indicates otherwise, District B should givepriority to reducing drop-outs.

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decide where their efforts will result in the greatest benefit, as shown in theexample on the previous page. Drop-out rates can be calculated using either
absolute numbers or percentages.
Formulas for calculating and monitoring drop-out rates are discussed in
Chapter 4. System failures that cause drop-outs, such as vaccine stock-outs orlack of other essential supplies, are discussed in Chapters 5 and 6.
Techniques for increasing public knowledge and improving the communication
skills of health workers are described in Chapter 9.

Limiting Missed
Opportunities

Failure to Screen
Can Be Fatal

A missed opportunity occurs when
While on a visit to a health center ina client, present in a situation in which
her district, the supervisor talked withvaccinations should be available,
a woman whose baby had recently
does not receive all of the vaccinesdied of neonatal tetanus. She wasfor which he or she is eligible. Missed
receiving weekly treatment for tubercuopportunities delay protection andlosis from a health facility a few hundred meters from her home, but notprolong the risk of getting the disease.
once during her pregnancy had she
The missed opportunity and 30-cluster
been screened for tetanus toxoid. Thissurveys are good tools for identifying
was the second baby she had lost towhether potential vaccination clients
neonatal tetanus.
are being missed and for what
reasons. (See pages 82-83.) Thosereasons are sometimes system related, i.e. health workers do not have sufficient quantities of vaccine or the appropriate equipment. More commonly,
missed opportunities can be corrected by health workers themselves, as
described below.

Credit: Kelley Sams, BASICS II

Improve screening. Health workers
should check children’s and women’svaccination status every time a client
visits a health facility or outreach site,
regardless of the reason for the visit.
Sick children should always be
screened for vaccination, as recommended in protocols like those forIntegrated Management of Childhood
Illness (IMCI). Girls and women receiving antenatal and postnatal careshould be screened and, if eligible,
vaccinated with tetanus toxoid.

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Give all vaccines due. Some studies have found that health workers failto give from 30 to 40% of the vaccinations that are due at the time of clients’visits. For example, a ninemonth-old child may be given
DTP and OPV but not measles
vaccine, despite being eligible
for all three vaccines. This often
reflects a belief on the part ofhealth workers or parents thatgiving too many vaccines atonce will harm a child, when,
in fact, vaccines are as safeand effective in combination as
they are individually. Somehealth workers mistakenly delay
the measles vaccination
because they believe that it must
be the last vaccination given to
Job aids can help remind health workers how to
the child.
administer vaccines correctly.
Sometimes, missed opportunities reflect an organizational problem. For example, a mother arrives at a busy session, and a health worker or volunteer
checks her child’s card and determines that the child is eligible for DTP3,
OPV3, and measles vaccine. The health worker gives the child DTP3 andreturns the card to the mother, assuming that the mother will go to a nearby
table for the next vaccination. Instead, the mother leaves the facility thinking
that she is finished. The child’s card shows that three vaccines have been
Contraindications and Precautions
While vaccines offer significant benefits for most individuals, there are rare situations
where vaccination is not recommended. Contraindications and precautions identify circumstances when vaccines should not be given. Contraindications are conditions in
the recipient that greatly increase the chance of a serious adverse reaction.
Precautions are conditions in the recipient that may increase the chance of an adverse
reaction or may impair the ability of the vaccine to produce immunity. Most contraindications and precautions are temporary, so the vaccine may still be given once the condition passes. Since contraindications and precautions vary by vaccine, health workers
are strongly advised to understand the appropriate restrictions for each vaccine and toscreen recipients carefully.

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Credit: Kelley Sams, BASICS II

Vaccination cards are of primary importance in determining eligibility for
vaccination and in avoiding missed opportunities. Health workers should
advise the mother to bring vaccination cards every time she visits the healthfacility for any reason. Health facility registers also can be used to identify
children who are due for a vaccination. Vaccination cards, registers, andother methods of record-keeping are described further in Chapter 4.

given that day, but the child has received only one.
Eliminate false contraindications. There are few true contraindications
to vaccination. Children with low-grade fever, a cold, diarrhea, vomiting, orother mild illness can safely and effectively be vaccinated. Prematurity, lowbirth weight, and breastfeeding are not reasons to withhold a vaccination. It isparticularly important that malnourished children be immunized because they
are much more likely to die from a vaccine-preventable disease than well-nourished ones.
Over the past several years the need for clear policies regarding vaccinationof children with HIV infection has been recognized. WHO recommendations
for vaccinating children with HIV infection are summarized in the box below.

Vaccinating in the Presence of HIV
Policy makers and program staff must address the difficult question of vaccinating
children with compromised immune systems. Live attenuated vaccines are a particularrisk because the vaccines can cause a form of the disease, and children with weakened immune systems may not be able to fight off even a mild infection. This risk,
however, must be balanced against the threat of the disease that the vaccine isintended to prevent. Such diseases can be very severe in HIV-infected children.
The problem is that most infants who have been infected with the HIV virus do notshow symptoms, and it is difficult to know if they should be excluded from vaccination.
With respect to the vaccines that may present the greatest threat to HIV-infected children, WHO recommends the following:
BCG – BCG should be given to all infants, even if their mothers have HIV, unless theinfant shows HIV/AIDS symptoms, which is highly unlikely. Since testing infants for HIV
before they are vaccinated is generally not feasible, virtually all newborns should
receive BCG.
This practice will protect HIV-positive and -negative children who are at high risk of
exposure to tuberculosis because their mothers are HIV-infected.
OPV – In highly HIV-endemic countries, as in other countries, individuals without
HIV/AIDS symptoms should be immunized with OPV according to standard schedules.
Measles – Measles can be very severe in HIV-infected children. WHO currently recommends that an early dose be given at six months followed by the scheduled dose atnine months to children who are known to be infected with HIV. For children with AIDS
disease, the potential risks and benefits must be evaluated on an individual basis. The
overall risk of adverse events from the vaccine is relatively low compared with the riskof measles infection in HIV-infected children.
Children should not be screened for HIV antibody status before receiving measles
vaccine.
Yellow fever – Yellow fever vaccinations should not be given to patients with symptomatic HIV infection nor to pregnant women.
These are WHO policies concerning vaccination and HIV at the time of the preparation of this field guide. The reader is strongly advised to check the most current policy
through WHO.

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Because both health workers and parents may hesitate before vaccinating asick child, some countries have issued policies on contraindications, such as
the one shown below.
Policy on

Immunizing Sick Children
1.

Recent studies in Kenya have shown that one of the biggest obstacles to achieving fullimmunization in children is the failure to immunize sick children.

2.

Controlled, scientific studies have shown that vaccination of sick and malnourished children
in Africa is both SAFE and EFFECTIVE.

3.

Babies of low birth weight should be immunized according to the standard KEPI schedule as long as
their weight at the time of immunization exceeds 2000 grammes.

4.

MOH and KEPI policy advocates the administration of vaccines to all eligible children, including
those who are ill. This policy is included in KEPI training materials.

5.

There are no contraindications to immunization. All children admitted to hospital must be
screened and if they are eligible for immunization, should receive it upon admission. *6.

No child should be discharged from hospital without receiving all the vaccines for which heor she is eligible, based on age and vaccination status.

Sick children should not be denied their right to protection against
vaccine-preventable diseases. They are in greatest need of thisprotection.
7.

The immunization status of every child coming for health services should be checked,
regardless of the service being sought, and immunization should be provided to all eligible
children.

8.

Many diseases may have similar presentation. Therefore, the child should be immunized
regardless of whether the mother says the child has already had the disease. This is especiallytrue for measles.

9.

All children should be properly screened to ensure that they receive every vaccine for which
they are eligible, based upon their age.

Parents should be encouraged to bring their children for
immunization despite illness.
Health workers should not deny immunization to sick or
malnourished children.

Director of Medical services

If you have any questions or concerns about the attached policies, please contact the District Medical Officer of Health.

Source: KEPI, Ministry of Health, Kenya. 1993

*This policy predates clear guidance from WHO about immunization of children with
HIV/AIDS.

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Clarify policy on multi-dose vials. Health workers often hesitate before
opening vaccine vials for one or a few clients for fear of running out of vaccines before the next delivery. Governments need to set policies on when to
open multi-dose vials and whether opened vials can be used in subsequentsessions (see page 92). Health workers, in turn, need guidance on applying
the policy, taking into account such factors as:• The size of vaccine vials available• The frequency of immunization sessions• The likelihood that the parent will return for the vaccination another time

Supplemental Immunization Strategies
Supplemental strategies are used to reach children who have not been vaccinated or have not developed sufficient immunity after previous vaccinations.
Strategies differ according to the epidemiology of the disease. Some of thecommon features are: the target age group is expanded, all children are vaccinated regardless of their immunization status, immunizations do not need tobe marked on vaccination cards, volunteers are used, and civil society ismobilized. Examples include polio national immunization days (NIDs) andmeasles campaigns. Supplemental immunization strategies should not replaceroutine services.

Accelerated disease control strategies
differ by disease. For polio, population immunity levels must be increased
quickly in order to interrupt chains ofpoliovirus transmission. In the few
remaining polio-endemic countries,
NIDs are held two or more times
Using local transport to move vaccine.
annually to vaccinate everyone in thetarget population (usually children under five years of age) in a one- to- threeday period. In non-endemic countries with low population immunity, NIDs areneeded approximately every three years.

Credit: Ellyn W. Ogden/USAID

Accelerated Disease Control

In addition to NIDs, polio eradication planners use sub-national immunization
days (SNIDs) and even local immunization days (LIDs) to reach children who
were missed in previous campaigns and are not reached by routine services.
With respect to tetanus, supplemental immunization activities also focus on
high-risk areas; however, they cannot interrupt transmission because tetanus is
not a contagious disease. (See Chapter 12.)

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Measles catch-up and follow-up strategies provide a“second opportunity”
because all children in thetarget population are includ- Children receiving vitamin A during measles campaign.
ed, regardless of immunization status. For those who were missed before, such strategies provide asecond opportunity to be vaccinated. For those who were vaccinated earlier
but failed to develop immunity, these strategies provide a second opportunity to
be immunized. (See the measles section in Chapter 12 for more information.)

Door-to-Door Vaccinations

At least two visits to the same
area may be necessary: the firstto map residences, enumerate thetarget population, and publicize
the approaching visit, and the second to provide vaccinations andperhaps other services. Even
when going door to door, healthworkers must make a special
effort not to miss sick children,
sleeping children, very young infants, children who are visiting, and children on upper
floors of apartment buildings.
The door-to-door strategy can be effective, but it is also expensive in terms of humanresources, transport, and other costs.

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Immunization Essentials
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Credit: Daniel Cima, American Red Cross

The door-to-door, or child-to-child,strategy is sometimes used as asupplemental immunization strategy to reach families that are notserved at health facilities andother collection points.

Credit: WHO

Catch-up campaigns foraccelerated measles control
are conducted during aperiod of several days or aweek over wide geographic
areas. Follow-up campaigns
are held after catch-up campaigns to reach children ina narrower age range.

Mop-up strategies are used occasionally when control activities have succeeded in reducing the incidence of disease and in containing the diseasegeographically, but some children still remain unreached. These activities often
target high-risk children who live in poor urban areas, hard-to-reach rural
areas, and areas with transient populations. Mopping-up requires intensive
vaccination efforts, including door-to-door visits. As in other supplemental
immunization activities, screening is not required.

Outbreak Response
When an outbreak of a vaccine-preventable disease occurs or is suspected,
managers must decide whether an immediate vaccination campaign is warranted and, if so, which populations to target. Target populations for suchcampaigns are people who are at risk in terms of both age and location.
Decisions about target groups, age range, geographic scope, and type andduration of response activities should be based on local epidemiological data.
Outbreak control must be timely to be effective. Although vaccination campaigns during outbreaks are almost always appropriate for yellow fever andother diseases with relatively slow transmission, many countries cannot
respond in time to halt faster-moving diseases like measles. Nevertheless, governments can provide information, treatment, rehabilitative care, and inmeasles outbreaks, vitamin A supplementation. If the response includes vaccination campaigns, health and other public officials should explain that people
might already be incubating the disease when they are vaccinated and therefore may get the disease despite being vaccinated.
To respond quickly, staff from local facilities and district, regional, and evennational offices often have to participate. Local health workers may offer vaccinations at their own facilities or through outreach visits, and mobile teams
may go to remote areas. To be effective, outbreak control must be timely.

Special Populations
Refugees and people in other emergency situations are often more susceptible
to infection because of unsettled conditions, lack of services, population movements, and crowded living conditions. Measles poses a particular risk in emergencies because measles case fatality can be as high as 50%. Therefore, theminimum immunization target should be to rapidly reach all children up to 15
years of age with measles vaccine and vitamin A supplementation.
Campaigns to vaccinate people in emergencies can prevent outbreaks andmay also supplement routine immunization services, as shown in the example
on the following page.

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57

Protecting Refugees against Disease
All children in refugee camps in Macedonia who were younger than 48 months ofage were targeted for immunization against eight vaccine-preventable diseases. Threemass campaigns were carried out in three consecutive months in seven camps, achieving coverage ranging from 73% to 91%. After the first campaign, weekly immunization clinics were established in every camp. These achieved an average of 93%
coverage.
Although many individuals were vaccinated, planners were disappointed because:• The campaigns did not begin until weeks after the refugees arrived, which could
have resulted in outbreaks.
• The constant turnover meant that many children did not complete the schedule for
vaccines requiring more than one dose.

Credit: Tim Healing, Merlin

Source: Koop, Darryl G. B.M. Jackson, and G. Nestel. October 2001

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References
Koop, Darryl G., B.M. Jackson, and G. Nestel. October 2001. Results of the
Expanded Program of Immunization in the Macedonian Refugee Camps.
American Journal of Public Health, 91 (10); 1656-1659.
WHO. 2003. Increasing Immunization Coverage at the Health Facility Level.
Geneva: World Health Organization. WHO/V&B/02.27.
WHO. 2002. Core Information for the Development of Immunization Policy:
2002 update. Vaccines and Biologicals/02.28.
WHO. 2000. Key Elements for Improving Supplementary Immunization
Activities for Polio Eradication. Geneva: World Health Organization.
WHO/V&B/00.22.
WHO. 2000. Sustainable Outreach Services (SOS): A Strategy for Reaching
the Unreached with Immunization and Other Services. Geneva: World HealthOrganization. WHO/V&B/00.37.
WHO. 1996. Field Guide for Supplementary Activities Aimed at Achieving
Polio Eradication. Geneva: World Health Organization.
WHO/EPI/GEN/95.01 Rev. 1.
WHO. 1991. Identify Missed Opportunities. Training for Mid-level Managers.
Revised. Geneva: World Health Organization. WHO/EPI/MLM/91.7.
WHO. 1991. Plan to Provide Immunization Services. Training for Mid-level
Managers. Revised. Geneva: World Health Organization.
WHO/EPI/MLM/91.3.
Full page photo credit: WHO

Immunization Essentials
Chapter 3: Delivery of Immunization Services

59Chapter 4:
Monitoring, Evaluation, andInformation Management“Not everything that counts can be counted,
and not everthing that can be counted, counts.”– Albert Einstein
Immunization program managers and service providers need a continuous
flow of information that tells them:• Whether immunization services are accessible to the target population.
• How many individuals in the target population are being vaccinated,
who is not being vaccinated, and why.
• Whether the quality of services meets program standards.
• Whether resources are used efficiently.
• Whether service strategies are meeting objectives.
• Whether mortality and morbidity from vaccine-preventable diseases arebeing reduced.
Policy makers, political leaders, health planners, donors, providers of technical assistance, and members of the general public also need information. This
chapter describes systems, methods, and tools for the collection, analysis, anddissemination of information on coverage, drop-outs, and quality of services.
(Collection and use of data for disease surveillance are discussed in Chapter 8.)

Health Information
A good information system avoids
over-burdening health-care workers bylimiting the information they need tocollect and record to that which ismost essential for program management and assessment. The following
questions can help information systemdevelopers distinguish “need toknow” from “nice to know” data:

Time To Tally?
A nurse in East Africa reported:“ You have mothers waiting for you.
You have children waiting for you.
You have curative waiting for you.
You have antenatal waiting for you.
You have family planning waiting
for you. It is very difficult to rushback and tally.”
Source: GAVI, 2001

Immunization Essentials
Chapter 4: Monitoring, Evaluation, and Information Management61• What do we (all of the interested parties) need to know? Why?
• How will people at various levels of the system use the data, including
health workers, supervisors, community members, and managers?
• Does the use of the data justify the work and expense involved in theircollection, collation, and analysis?
• Which indicators are most likely to tell us that we are progressing or having
problems?
• How will we collect, collate, and analyze data?
• How, when, and to whom will data be reported?
• How will we monitor the timeliness, completeness, and accuracy ofreports?
• How will we provide feedback to interested parties?
Health information systems generally focus on collecting patient names,
recording treatment or visit dates, and counting the number of events. These
data are not sufficient, however, to allow managers to evaluate services andmonitor changes over time, for example, disease incidence, patient characteristics, or the impact of health interventions. To do this, managers need information that is:• Relevant• Specific and quantitative• Understandable

To limit the time, effort, and cost
involved in collecting, collating,and analyzing data, planners
have to restrain the common
impulse to add information
items. At the same time, theymust ensure that the items thatthey choose provide the information they need to make program decisions.
For immunization programs, coverage and drop-out rates are used as indicators of the availability, accessibility, and use of services, as well as of otherprogram characteristics. As the name implies, an indicator describes one ormore aspects of services and shows only that there may be a problem. A mix
of indicators, as shown in the table, should be used to get a more complete
picture of services and to identify problems that should be investigated.

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Credit: Kelley Sams, BASICS II• Sensitive to changes andtrendsImmunization Coverage and Drop-Out Indicators
Indicator

What It May Indicate

Limitations

DTP1 coverage

Availability of, access to, andinitial use of immunization
services by children.

Measures only the first in a three-doseseries.

DTP3 coverage

Continuity of use by parents,
client satisfaction withservices, and capability of thesystem to deliver a series ofvaccinations.

Shows only completion of DTP series
and not other antigens.

Measles coverage

Protection against a disease of Does not indicate the capability of the
major public health imporsystem to deliver a series of vaccines.
tance.
Supplementary doses may be confusedwith routine doses.

DTP1 to DTP3

Quality of service as perceived by parents and thequality of communication
between parents and healthworkers — this is the classic
drop-out indicator.

Does not stand on its own; must be
interpreted in light of actual coveragelevels.

TT1 coverage

Availability of, access to, anduse of immunization services
by pregnant women.

Measures only the first dose in a
multi-dose series.

TT2+(TT2, TT3, TT4,
and/or TT5
coverage)Continuity of use, client
satisfaction, and capability ofthe system to deliver a seriesof vaccinations to women.

The series of five TT doses is given at
different intervals over the course ofmany years.

Fully immunized child Capability of the system to(FIC)
provide all vaccines in thechildhood schedule at theappropriate age and theappropriate interval between
doses in the first year of life;
also measures public demandand perceived quality ofservices.

Generally not available from routine
service statistics.

(Difference in thenumber of children
who receive DTP1
and the number who
receive DTP3,
expressed as a rate)

BCG, although the first vaccination in
the schedule, is not an effective indicator where births take place at home andno BCG is given. When BCG is given
to babies born in hospitals, it may berecorded in a different information
system, if at all.

Does not give a complete picture ofdrop-outs that may be occurring
between other antigens.

Once a woman has received five doses,
she should no longer be counted in the
denominator as a member of the target
population.

Information can usually be derived from
population-based surveys analyzed by
WinCOSAS or other software.
Absence of vaccination cards limits thereliability of this indicator.
The definition of FIC may vary among
countries.

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Chapter 4: Monitoring, Evaluation, and Information Management63

Governments, organizations that provide technical assistance, donors, andcommunity leaders use indicators such as those listed above to measure
whether they are achieving their objectives and to make strategic decisions
on resource allocation. For example, some community-based health committees use DTP3 coverage as an indicator of the performance of all publichealth services in their communities. GAVI uses DTP3 coverage by district as
an indicator of progress toward its goals.
Managers also use indicators to assess quality, efficiency, effort, and impact.
Some examples are given below.
Quality and Other Indicators

64

Indicator

What It May Indicate

Number of immunization sessions that are actually held compared to the number planned

Quality of program management

Chapter 3

Supply of unexpired vaccines

Effectiveness of vaccine procurement, delivery, and management

Chapter 5

Vaccine usage

Effectiveness of fixed and outreachsession scheduling, vaccination
administration, and vaccine
handling

Chapter 5

Temperature monitoring of cold
chain equipment

Quality of cold chain management

Chapter 6

Updated inventory (models,
location, and age) of refrigeration equipment at national, subnational, and district levels;
monthly reporting at districtlevel on status of equipment

Quality of cold chain management

Chapter 6

Use of a sterile syringe and needle for each injection

Quality of injection practices

Chapter 7

Disease incidence

Impact of immunization services

Chapter 8

Parents’ knowledge of commonside effects and when to returnfor additional vaccinations

Quality of communication between
parents and health workers

Chapter 9

Immunization Essentials
Chapter 4: Monitoring, Evaluation, and Information Management

For More
Information,
Refer to:Basic Monitoring Tools
Many of the basic monitoring tools that could benefit health workers, theirsupervisors, and managers throughout the system are neglected because people don’t know how to use them. This is true despite the fact that many havebeen available for years. The most important of these are maps, patient registers, vaccination cards, tickler files, tally sheets, and immunization monitoring
charts, each of which is described below.

In addition to geographical distributionof cases (see Chapter 8), maps canshow access to services, particularly inrural areas. For example, local maps
can show population distribution in
relation to the location of healthfacilities. Maps should indicate
geographical features (e.g., mountains
and rivers) and infrastructure (e.g.,roads and bridges), because these
are important considerations for
improving access.

Credit: Kelley Sams, BASICS II

Maps

Hand-drawn maps posted where they are
to be used can be helpful in planning.

Patient Registers
Most health facilities use a patient register to record information about every
person who comes to the facility for any health-related reason – preventive or
curative, outpatient or inpatient. For immunization, registers are used to identify children who are due for a vaccination, to monitor missed opportunities, tocheck the accuracy of reporting, and to target case investigations.
At a minimum, a patient register should include: the day, month, and year ofvisit; the patient’s name; the patient’s address; the patient’s date of birth; and asummary of services provided, including vaccinations given and dose number.
Another way to organize the immunization register is to set aside one or morepages for each month of the year. When a child comes to the facility, a healthworker records the child’s name on the page for the month of his or her date ofbirth. As vaccinations are given to that child, they are recorded on the sameline in the register.
Some health facilities keep special immunization registers. At the end of every
month, health workers review the register to identify the children who have notreceived the vaccination or vaccinations for which they are eligible and thenfollow up with these children. For example, children should have a measles

Immunization Essentials
Chapter 4: Monitoring, Evaluation, and Information Management

65Credit: WHO, 2003

vaccination at age nine months. At the end of each month, health workers
should make a list and follow up on children born more than nine months earlier who did not yet get their measles vaccinations.

Vaccination Cards

A vaccination record may be a separate document or part of a generalchild health card. Regardless, it should include the child’s name, date of birth,address, a parent’s name, and the date of each vaccination by dose. A
general health card reinforces the importance oftaking advantage of allhealth contacts and missing
no opportunities to provide
preventive services; thisapplies whether a childhas come for an immunization and needs growthmonitoring or a woman
has come for antenatal
care and needs a tetanus
toxoid vaccination.
Home record and reminder materials from Madagascar.

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Credit: Jereo Salama Isika, JSI/Madagascar

Vaccination cards and other home-based records enable parents and healthworkers to monitor an individual child’s progress toward full immunization.
Families keep these records of childhood and tetanus toxoid vaccinations toremind them which vaccinations and doses have been given, which have not,and when vaccinations are due. These cards may be the only records healthworkers have of vaccination history and status if patient registers are not wellmaintained or for clients who have moved from another health facility.

There is reliable evidence that clients
generally value and retain their cards
and that, if reminded, they will bringthe cards to the health facility at each
visit. However, the cards’ meaningand possible utility is not always recognized. Before any new card isintroduced, health workers and representative families should be asked toassess how well they can read andunderstand everything on it.
Managers should make sure that
health workers have adequate supplies of cards; many health facilities
fail to issue them because there arenone available.
It can be difficult to interpret the information on vaccination cards without
assistance. Oral reminders may beneeded to communicate information,
particularly to people with poor
reading skills.

Do They Understandthe Card?
A recent study of 600 mothers in one
country revealed that many could notunderstand basic information on theirvaccination card.
A reading test was first given to allmothers. Those who could read (490
of 600) were asked to look at a “typical” card filled out by researchers.
• Only 49% of the literate mothers
could say how many immunizations
the child received during the lastvisit.
• Only 45% could tell when the next
immunization was due.
• Only 44% could identify which vaccines the child had alreadyreceived.
Source: CHANGE Project, 2002

Credit: Kelley Sams, BASICS II

When new vaccines are added tonational immunization programs,
changes to the old cards may berequired. To avoid the expense andeffort of revising the card, programs
may leave a space in which towrite additional vaccines as they
are introduced.

Credit: Craig Manning

Tickler Files
Tickler files are boxes in which copies
of children’s vaccination cards or similar records are filed according to themonth when each child’s next vaccination is due. For example, when achild comes to a health facility andreceives a vaccination card, a health

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67

worker writes on the card the vaccine, dose, and date of each vaccination thechild receives that day. The health worker makes a copy of the card and files
it in the box behind the divider for the month when the child’s next vaccination is due. The cards behind each month-divider are alphabetized by last
name. As children come for vaccinations during the month, their cards arepulled, updated, and moved to the divider for the month when the next vaccination is due.
At the end of each month, cards remaining behind the divider for that month
represent drop-outs. Health workers then plan strategies to ensure that each ofthese children receives the vaccinations that are now overdue.

Tally Sheets
Tally sheets are forms on which health workers make a mark every time theyadminister a vaccination. These are used as a basis for reporting to the districtlevel. Supervisors use them to monitor the accuracy of reporting from healthfacilities to districts.

Daily Tally SheetFor recording immunization and children protected at birth against neonatal tetanus
Health center:____________________________________ Date:____________________
Childrenunder one year of age

TOTAL

Childrenover one year of age

TOTAL

BCG
OPV 0
OPV 1
OPV 2
OPV 3
DPT 1
DPT 2
DPT 3
Measles
Hib 1
Hib 2
Hib 3
Hep 1
Hep 2
Hep 3

Women of childbearing age
Pregnant

Total

Non-pregnant

Total

TT1
TT2
TT3
TT4
TT5

Children protected at birth against neonatal tetanus
All children who receive DPT 1 should be assessed for protection at birth against neonatal tetanus.
Child IS protected against neonatal tetanus at birth

Total

Child is NOT protected against
neonatal tetanus at birth

Total

Source: WHO, Immunization in Practice (2002 draft)

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The tally sheet shown has a space to record every vaccine and every dose of
vaccine offered by the national immunization program. Children under one
year and over one year of age are recorded separately in order to accurately
calculate coverage in children under one. This tally sheet also enables healthworkers to specify which dose of tetanus toxoid was given and whether the
woman to whom it was given was pregnant at the time. (In most developing
countries, pregnant women are the target population for tetanus toxoid.) A
space is provided to record whether children receiving DTP1 were protected
at birth from neonatal tetanus.
Determining Tetanus Protection at Birth
If the number ofvalid doses alreadyreceived is:

And the last dose received was:0

Last born childmust be considered as:

Not protected

1

At any time

Not protected2

Less than three years before last birthProtected

3Less than five years before last birthProtected

4Less than ten years before last birthProtected

5 or more

At any time

Protected

Immunization Monitoring Charts
Every health facility that offers immunization services needs to monitor progress
toward coverage objectives. Providing tools such as monitoring charts andensuring that health workers have the skills to use them can motivate healthworkers, enhance performance, and improve the quality of data.

Immunization monitoring chartsshould be posted in every healthfacility for inspection by health facility
staff, clients, and supervisors. The
charts can be shared with politicaland community leaders.

Immunization Essentials
Chapter 4: Monitoring, Evaluation, and Information Management

Credit: Kelley Sams, BASICS II

The information on the following
page explains how to complete andinterpret a monitoring chart.

69

Example of Completing and Interpreting a Monitoring Chart

STEP 1: Estimate size of target population
The target population for childhood immunizations is all children under one year of age. The target population for tetanus toxoid is pregnant women. If the actual number of pregnant women is not available, thenumber is assumed to be the same as, or slightly higher than, the number of children under one year.
In some places, health workers can ask community leaders for help in counting children under one yearof age and pregnant women in their catchment area.
STEP 2: Enter yearly and monthly coverage objectives
In the monitoring chart, a printed diagonal line goes straightfrom the lower left corner to the upper right corner. This represents regular progress over a 12-month period toward a coverage objective of 100%. In this example, the objective has been
divided evenly across 12 months, and each monthly objective isshown as a percent on the left side of the table and as a number on the right.

STEP 3: Record vaccine doses
per monthTwo vaccines given at different
ages are selected, such as DTP1
and DTP3. The number of vaccinations recorded on the tally
sheet is written in the box for thatmonth under the graph.

STEP 4: Calculate the cumulative and annual totals and drop-out rates
Every month, the total for that month is added to the previous month’s cumulative total and recorded in
the monitoring chart, in the box labeled Total. At the same time, the monitoring chart is marked with a
dot that represents the cumulative total, and the dots are connected.
STEP 5: Interpret and use the information
When the drawn line is on or above the printed line, the facility is on track to meeting the coverage
objective. When the drawn line is below the printed line, the facility is not on track.
After several months, the monitoring chart will begin to show whether progress is being made toward
the objective, and any slippage below the target can be corrected in the following months by exceeding the target. The difference between the printed and drawn line for DTP1 in the example above may
be used as an indicator of the unreached population.
The space between the two drawn lines for DTP1 and DTP3 is the visual equivalent of drop-out. As of
September in the example above, the facility is experiencing approximately 30% drop-out. It is not on
track to reach the coverage target, but it can still take action in the next three months to catch up.

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Sample Self-Monitoring Chart for a Health Post
It has been shown that if
service providers understand such information,
they can use it to guideaction to improve immunization coverage. In
order to accomplish this,data should be presented in a way that is useful to health workers andunderstandable by community members. This isan example of a combined tally sheet andmonitoring chart thatmight be used byperipheral health workers with limited arithmetic skills. In thisexample, the healthworker did an annual
head count in the community and identified
340 children less than
12 months of age. Dotsare filled in to represent
doses of vaccine given.
They are counted andcompared against quarterly targets as shown in
the glasses of water(cylinders).

The level of water is hand-drawn
each quarter. Based upon thetally sheet below the glass, thehealth worker and the community
can clearly see that only 90 children have been vaccinated with
DTP1. Despite 6 months of activity, the glass is only one-quarter
full. Children are being missed.

Each darkened circle represents one
person vaccinatedwith DTP1. In thisexample, 90 children have been
vaccinated during
the first six monthsof the year.

Such charts provide a visual reminder of both the overall immunization objective and a gauge of the facility’s progress in achieving it. If all goes well, thechart could also foster a sense of accomplishment.

Analysis and Use of Routine Data
The data that health workers collect should be used by the health workers
themselves and by their supervisors, managers at all levels, and community
leaders to monitor performance in general and, specifically, to monitor immunization coverage and the drop-out rate.

Immunization Coverage
Immunization coverage is the proportion of the target population that has
been vaccinated. The difficulty of calculating and interpreting immunization
coverage rates often stems from problems related to estimating the size of thetarget population. These, in turn, are the result of inaccurate or outdated

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Chapter 4: Monitoring, Evaluation, and Information Management71

At the end of the month, health staff
add the daily tallies of vaccinations
and convert them into a percentage
called coverage. The box below
shows three examples of the annual
coverage rate by vaccine. The second
box shows how to estimate the number of surviving infants for use in calculating coverage rates.

Credit: Lauren Goodsmith

census counts, population migrations,and unforeseen changes in birth rates
or infant mortality.

Immunization chart in Morocco.

Calculating Annual Coverage for DTP1, DTP3, andMeasles Vaccines for 2003
DTP1 coverage:
number immunized by 12 months with DTP1 in 2003 x 100
number of surviving infants <12 mos. of age in 2003
DTP3 coverage:
number immunized by 12 months with DTP3 in 2003 x 100
number of surviving infants <12 mos. of age in 2003
Measles coverage:
number immunized by 12 months with measles vaccine in 2003
x 100
number of surviving infants <12 mos. of age in 2003

Example of Estimating the Number of Surviving Infants
Total population: 5,500,000
Crude birth rate (CBR): 30/1000
Infant mortality rate (IMR): 80/1000
Number of surviving infants = Total population x CBR x (1–IMR)= 5,500,000 x 30/1000 x (1–0.080)= 5,500,000 x 0.030 x 0.920= 151,800

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If coverage rates indicate that people are not using immunization services,
health workers and their supervisors need to find the causes and take appropriate action. Comparing coverage rates for different vaccines sometimes points
toward the likely problem as well as possible solutions, as shown below.
Examples of Using Coverage Data to
Improve Vaccination Services
Coverage
Data

Issue

Example 1:

Why thedecrease
BCG 80%
between BCG
DTP1 60%
and DTP1
DTP3 55%
vaccinations?
Measles 55%

Possible
Reasons

Suggested Remedy

Missed opportunities to give
vaccination cardand information
at place of birth

When mothers give birth in maternity
centers, give their babies BCG
vaccine and:-A vaccination card for the baby
-Information on where and when tobring the baby for other vaccinations-Encouragement to get the baby
immunized again as soon as he or
she reaches 6 weeks of age

Example 2:

Why thedecrease
BCG 80%
between DTP3
DTP1 75%
and measles?
DTP3 70%
Measles 45%

The long interval
between vaccination with DTP3 at
14 weeks andmeasles at ninemonthsInform parents about preventing
measles by means of vaccination.

Example 3:

Difficult and/or
infrequent accessto vaccinations

Remind health workers that if a childhas reached nine months of age
without completing DTP vaccinations,a DTP vaccination can be given at thesame time as measles vaccine.

BCG 70%
DTP1 70%
DTP3 40%
Measles 60%

Why ismeasles coverage higher
than DTP3?

Health workers
may be (incorrectly) re-starting
DTP series after
long intervals
between doses.

Remind parents when and where to
bring the child in for measles vaccine.

After DTP1 vaccination, remindparents that three doses are needed
and when to bring child for DTP2
and DTP3.

Drop-Out Rates
High drop-out rates may reflect problems in demand for vaccinations, client
satisfaction with services, and the ability of the immunization program to provide those services. To calculate drop-out rates, the number of doses of any
two antigens administered at different ages are needed, for example, BCG
and measles, DTP1 and DTP3, DTP1 and measles, or TT1 and TT2+. Under
most circumstances, a drop-out rate of 10% or less is considered acceptable,
although full immunization is always the goal.

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Chapter 4: Monitoring, Evaluation, and Information Management73

Health workers should investigate the reasons, determine the solutions, andtake action when drop-out data indicate a problem. Supervisors, community
leaders or other interested community members should also be involved.
To facilitate monitoring and use of drop-out information, health facility staff
can use and post a chart to monitor drop-outs.
Drop-Out Rate Monitoring Chart, 2004
Sub Health District:

Health Facility:

J
DTP1

F

M

A

M

District:

Month
J
J

A

S

O

N

D

A. Month
B. Cumulative
C. Month
D. Cumulative

DTP3
E. Cumulative Drop-Out
DTP1–DTP3 (B–D)
F. Cumulative Drop-Out Rate %G. Bar Chart

60%
55%
50%
45%
40%
35%
30%
25%
20%
15%
Good Performance 10%
Drop-Out Rate
5%
10% or less
0%
-5%
-10%
-15%
-20%
-30%

INSTRUCTIONS:
A. Enter the monthly total of DTP1 immunizations given to children below the ageof one year.
B. Enter the cumulative total of DTP1 immunizations given. Cumulative includes
the current monthly total plus the monthly totals for all of the previous months
during the year.
C. Enter the monthly total of DTP3 immunizations given to children below the ageof one year.
D. Enter the cumulative total of DTP3 immunizations given.
E. Subtract the cumulative total for DTP1 from the cumulative total for DTP3. This is
the cumulative total number of drop-outs for DTP1 to DTP3 for the year.
F. Calculate the Cumulative Drop-Out Rate as follows:
DTP1 Cumulative Total - DTP3 Cumulative Total

DTP1 Cumulative Total

x 100

G. Chart the Cumulative Drop-Out Rate by shading in the area up to the drop-out
rate on the chart.
PLACE THIS CHART WHERE IT CAN BE SEEN BY YOUR STAFF, EVERY DAY !

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Credit: Mark Weeks, BASICS II

Example of Monitoring Drop–Out Rates

A drop-out chart used in a health facility in Uganda helps health workers track theirprogress in reducing drop-outs. In this example, drop-out rates between DTP1 andmeasles were monitored.
Because their drop-out rate is higher than the 10% national target, health workers
should try to determine the causes for the drop-out so that they can correct the problem
in the months remaining in the year.

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Chapter 4: Monitoring, Evaluation, and Information Management

75

Other Uses of Data
In addition to their use in monitoring performance and progress toward objectives, routine immunization data may be used to track the implementation ofpolicies and to justify budget requests.
Monitoring the implementation of policies. In Kyrgyzstan, managers
used data on contraindications to identify a problem and then used the samedata to track the impact of a new policy. Monitoring and feedback provided
evidence of improvements in the application of the policy and a resulting
increase in coverage.
Monitoring the Use of Contraindications
Health workers throughout Kyrgyzstan keep immunization records on every child.
Included in these records is the number of times that children were denied vaccinations
because of contraindications. For years, these data were ignored, but when they were
finally examined, managers realized that health workers were applying unnecessarycontraindications that left many children unprotected.
The Ministry of Health issued a policy to clarify the use of contraindications, but healthworkers continued to use invalid contraindications.
Then supervisors in one district were specifically asked to monitor the percentage of
eligible children who were denied a DTP vaccination because of contraindications. As
the study began, a very high proportion (28%) of children was being denied vaccinations because of contraindications. When staff at all levels became aware of the magnitude of the problem, they took action. Twelve months later, failure to immunize
because of contraindications had declined to less than 5%.
Expanded throughout Kyrgyzstan, the monitoring approach succeeded in reducing
contraindications nationwide to less than 5% annually.
Source: Weeks et al., 2000

Justifying budget requests.
Health reform and decentralization
have increased the need to advocate for immunization services atthe district level, where budgetarydecisions are increasingly being
made. Active monitoring andsharing of a few indicators oncoverage, drop-outs, and otherdata can be used to mobilize
communities, determine strengths
and weaknesses in health services, attract political support, andjustify funding requests.

76

Constellation of Activities

Immunization Essentials
Chapter 4: Monitoring, Evaluation, and Information Management

Routine Reporting
By a specified date at the end of every month, designated staff members at
each health facility should report to the district level. These reports should provide a summary and analysis, not simply a collation of all of the data thatfacilities collected during the month.
District healthmanagement teams
usually need coveragedata for all vaccines
by dose. They may
also ask for data onother aspects ofimmunization services,such as amount ofvaccine used anddisease incidence.
A team at WHO’s
Africa Regional Office developed the monthly reporting form shown here,
initially for use in West Africa. The form is designed for the national level, but
managers have found that it can be adapted easily for district use.
District health management teams aggregate the data from all health facilities
in their district, then send the aggregated figures to the next administrative
level, and so on, until the data reach the national level, where they are collated into a national coverage report. The Joint Reporting Form is submitted by
15 April of each year to WHO Regional Offices and to WHO and UNICEF
headquarters, which publish the information in a joint annual report.

Monitoring the Information System
Supervisors and managers can monitor a health facility’s information
system by:• Checking the patient register: Is it complete and up to date?
• Checking vaccination cards: Are there enough in stock? Are they completed properly and up to date? Do the holders of the cards understand their
purpose?
• Reviewing the immunization monitoring chart: Is it on the wall of thehealth facility? Is it up to date? Can health workers in the facility explain
what it means?

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Chapter 4: Monitoring, Evaluation, and Information Management

77Completeness and timeliness of reporting can be tracked on a chart that lists
the units from which monthly reports are expected and the dates when thereports are actually received.
Accuracy of reporting, as well as completeness and timeliness, should bemonitored. Inflating or deflating performance levels in reports can be tempting
when benefits seem to be associated with certain outcomes. Innocent mistakes
can also occur. To make sure that data are accurate, users should rely on theirknowledge of the area, their experience, and even their intuitions about“funny numbers,” i.e., numbers that are unexpected, that stand out in someway, or that otherwise don’t make sense. Some true examples of funny numbers from the field are described in the box.
“Funny Numbers” for Immunization Coverage
Coverage over 100%?
Example 1: For six months in a row, one health center recorded immunization coverage that exceeded expectations. Upon investigation, health workers realized thatclients were coming to their center from another catchment area where vaccine shortages were common. These individuals had not been included in the denominator used
to calculate coverage.
Example 2: Health workers included children over 12 months of age in calculating
coverage for their routine reports. This inflated the numerator for the coverage equation, and since the denominator included only children under 12 months of age, thehealth facility’s coverage often appeared to be above 100%.

Higher DTP3 than DTP1?
Last year 51 of the 110 districts in the country reported higher figures for DTP3 than
DTP1. National staff found that, during a catch-up campaign, health workers classified
all DTP vaccinations as DTP3 without checking whether individuals had received DTP1
or DTP2.

Variations among Health Facilities
As of May, most health facilities in the country were reporting 30% to 40% cumulative
measles coverage, which is approximately what one would expect. One center, however, reported 100% coverage. This center had conducted a measles vaccination campaign in their catchment area to prevent a predicted outbreak and had inappropriately
included the vaccinations given during the campaign in its routine reports.
(Vaccinations given during campaigns should be reported separately and not included
in routine reporting.)

Giving health workers the tools and skills to use data to assess their own performance can improve staff motivation, strengthen performance, and improvedata quality. Self-assessment through a process of active, continuous monitoring at each level should always be encouraged.

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Credit: Anne B. Keiser

The final step in monitoring information systems is to provide feedback to
the data collectors. Such feedback
can include assessments of data quality, data from other facilities, andreports of actions taken at district andhigher levels, as well as guidance for
local action.

Evaluation
An evaluation can be a comprehensive study of the whole health system, aservice or program within the system, or a single function, such as the cold
chain, disease surveillance, or training. Like monitoring, evaluation should
lead to action. Unlike monitoring, which is carried out continually, evaluationis periodic.
Evaluations should answer the following kinds of questions:• What do clients, health workers, managers, and/or other stakeholders
think about the service or specific aspects of it? What do they like? What
do they dislike?
• Were stated objectives achieved? How?
• Which inputs led to improvements and which did not?
• Were there any unintended, positive outcomes? What were they? How
can they be replicated?
• How efficiently were activities implemented?
• Were the outcomes worth the cost?
• Which strategies should be continued? How can they be improved?
Health service evaluations usually focus on outcomes (e.g., changes in immunization coverage), processes (e.g.,
vaccine delivery), and/or client satisfaction. Impact evaluations, which
examine the effect of activities on
goals such as reduction of morbidity and mortality, are less common
because of the difficulty in sortingout variables and determining
cause and effect relationships.
Measuring impact is time-consuming
and requires significant resourcesand epidemiological expertise.
Nevertheless, impact evaluations

Immunization Essentials
Chapter 4: Monitoring, Evaluation, and Information Management

Credit: Kelley Sams, BASICS II• What was the impact of the service on organizational or national goals?

79are needed periodically to show whether activities have made a difference inthe health status of the population.
Unfortunately, the results of evaluations are often not used to the extent they
could be to improve programs. One solution is participatory evaluation, whichenables key stakeholders to participate in designing, planning, and executing
the evaluation.
Participatory Evaluation
A participatory evaluation is a collaborative process that involves the people who will
be affected by decisions based on the evaluation findings. These stakeholders should
participate in planning when and how to evaluate and what methods to use, collecting
and analyzing information, and making recommendations. Their participation meansthat the issues that are important to them will be examined, they will learn more about
the issues, and they will feel more committed to use the results.
Source: Feuerstein, 1986

Interpreting Coverage from Different Sources
Immunization coverage rates are usually estimated based on routine (administrative) figures that are derived from tally sheets filled in at the health facility.
In addition, population-based surveys conducted periodically for special
purposes also serve as a source of data for estimating coverage. Survey data
may tell a different story from routine data, so managers and other users need
Comparing Immunization Coverage Rates
from Different Sources

In this instance, the two sources of data that cover approximately the same time period
are the routine EPI data and the Multi-Indicator Cluster Survey (MICS). Dramatic differences can be seen between these two sets of figures. A careful analysis revealed thatat least one reason for the high coverage rates from routine EPI data is that children
over 12 months of age were included in the numerator but not the denominator ofthese coverage estimates. The population-based MICS included estimated coverage by
12 months of age, and excluded doses given to children over 12 months.

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to be able to figure out which data are most suitable to use in a given situation. The data in the box on the previous page from one African country highlight the complexities of coming up with clear figures for estimating coverage.
As seen from the example, coverage estimates can vary greatly by the sourceof data. To make sense of any data, users need to be aware that:• The age group and geographic scope can differ among studies or data
sources.
• Some surveys report coverage based only on what is documented by vaccination cards, while others include data from caretakers’ recall. Parents’recall of what vaccines were given to which of their children on whatdates is not always reliable.
• Some surveys of children 12-23 months of age include the vaccinations
that these children received only up to 12 months of age. This is the recommended survey methodology for immunization coverage. However,other surveys include the vaccinations that children received up to the timeof the survey, which means that vaccinations given to children when they
were older than 12 months of age will be included and thereby inflate
coverage estimates.
• Different data can be used for different purposes. For example, valid,
population-based data should be used for estimating the proportion of the
population protected against vaccine-preventable diseases. But cruder estimates, including those based on routine data, can be used to detect
trends from year to year or to estimate drop-out rates.
• Not all coverage data can be compared in a constructive way. In the example, it would be meaningless to compare the Demographic and Health
Survey (DHS) data from 1997 with 1999 routine EPI data because both thesources of data and the time periods covered are different.
• Population-based surveys will detect vaccinations provided by the private
sector that may be missed by the facility-based tallies used to estimate routine coverage.
• Indicators are only markers of possible problems. Further investigation isneeded to confirm that there is a problem and to clarify its causes so that
good planning can be done.
The Inter-agency Coordinating Committee (ICC), or a technical sub-committee,
is an appropriate forum for discussions of such issues. In the example above,
the analysis of coverage data was done to prepare the ICC for a multi-yearplanning exercise.

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Chapter 4: Monitoring, Evaluation, and Information Management81

Tools for Assessment and Evaluation
Many tools are now available for identifying immunization service delivery
problems and determining how best to fix them. National-level healthmanagers, academicians, donors, and international development organizations use these for assessments, evaluations, reviews, coverage surveys, andother purposes.

Immunization Services Assessment Guide
This guide (sometimes called “the common assessment tool”) is used toanalyze current services in order to plan program improvements and calculate
resource needs. It was prepared by WHO/EPI for adaptation by partners of
GAVI, national immunization programs, and other users. It can be used at
the beginning of a planning cycle or when a change, such as introduction ofa new vaccine, is under consideration. The guide enables users to conduct
a comprehensive assessment of all levels of immunization services and to
examine their relationship to the health system as a whole.

Immunization Coverage Surveys
A standard WHO methodology for determining immunization coverage isbased on a survey of small numbers of individuals (210 in 30 clusters of 7
individuals each). Homes are visited and immunization records examined to
calculate immunization coverage in children 12 to 23 months of age andtetanus toxoid immunization coverage for mothers of infants. Respondents
are asked to describe their perceptions of immunization services and any
problems they have had.
The surveys use a cluster sampling technique to ensure that data from a small
sample of homes can be generalized to a larger population, but these data
can be used only in the aggregate.
They say nothing about individual
Coverage Surveys Can
clusters or specific health facilities.
Make a Difference!
A Coverage Survey Analysis System(WinCOSAS) is available for the compilation and analysis of data fromcluster sampling surveys. The software
can be used to identify:• Coverage by 12 months ofage and coverage from 12 to
23 months of age for eachvaccine dose82

A country in South America refrained
from making additional investments in
its immunization program because
government officials had accepted
reports from national staff that immunization coverage was approximately
80%. The government renewed its support when coverage survey data
revealed that coverage was closer to
40%.

Immunization Essentials
Chapter 4: Monitoring, Evaluation, and Information Management

Source: GAO, 1999

• Percentage of children who are fully vaccinated• Average age when each vaccine and dose is received• Percentage of newborns protected against neonatal tetanus• Number of vaccination sessions in which attending children and women
did not receive all of the vaccinations for which they were eligible• Percentage of vaccines and doses given by type of facility — hospitals,
health centers, maternal and child health centers, or outreach posts• Whether DTP, OPV, Hib, and Hep B doses have been given at appropriate ages and intervals• Number of measles vaccine doses given before the recommended age ofnine months
For more information, refer to Training for Mid-level Managers: The EPI
Coverage Survey (WHO).
WinCOSAS software isavailable on the WHO/EPI
website.

This method focuses onhouseholds that have easy
access to health facilities.
The theory is that if people
in the 75 to 100 households that are closest to
health facilities are notreceiving services, then useof services in the wider
catchment area must bepoor indeed. This type of survey is valuable because it encourages interaction
between community members and the health workers who collect the datafrom people at home. It is most useful in areas where the population is stable
and coverage unknown. For more information refer to Training for Mid-level
Managers: Increase Immunization Coverage, Annex C (WHO).

Credit: Richard Pollard

Seventy-FiveHousehold Survey

Missed Opportunity Survey
A missed opportunity survey assesses whether all clients who were present ina facility offering vaccinations for which they were eligible that day received
them. Available from WHO/EPI, the survey includes reviews of coverage dataand patient registers and interviews with clients as they leave health facilities.

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Chapter 4: Monitoring, Evaluation, and Information Management

83Lot Quality Assurance SamplingThis technique is used to assess the quality of service, coverage, or both forthe purpose of directing attention and support to the facilities or areas thatneed it most. It is often used in areas that do not correspond to official reporting sites, such as urban slums. This type of survey addresses a limitation in the
immunization coverage survey technique that does not allow analysis of datafrom individual clusters. For more information, refer to Monitoring
Immunization Services Using the Lot Quality Technique (WHO).

Large-Scale Population-Based Surveys
DHS and UNICEF’s Multi-Indicator Cluster Surveys (MICS) are periodic, largescale, population-based surveys that are good sources of data on national
health sectors and target populations. More information on these methodologies is available from USAID and UNICEF.

Computerized Information Systems
Computers are used increasingly to track the number of vaccinations administered and to compute coverage, vaccine in stock, vaccine wastage, disease
incidence, age of vehicles in use, and other data. Although computerization
can solve arithmetic errors and perform additional analyses, it does not guarantee the production of high-quality data or its use. Skilled health workers areneeded in the first instance to collect data and report them accurately, completely, and on time.
When considering using computers for immunization data, managers anddonors should keep in mind the:• Reliability of power supply• Adequacy of telephone, Internet, and computer networks• Availability and applicability of software• Ability to attract and retain competent information system staff• Availability of budget for training, maintenance, support, and paper, ink,
and other consumables• Direct access that trained staff have to computers

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References
Feuerstein, Marie-Therese. 1986. Partners in Evaluation: Evaluating
Development and Community Programmes with Participants. London:
MacMillan Education Ltd.
GAO. 1999. Global Health: Factors Contributing to Low Vaccination Rates in
Developing Countries.
MSF Publications. Winter 1999/2000. Guide to Computerizing Your
Accounting System, A supplement to The Manager, Volume VIII, Number 4.
Boston: Management Sciences for Health.
Patton, Michael Quinn. 1982. Practical Evaluation. Beverly Hills, CA: SAGE
Publications, Inc.
Weeks, Mark R., Svetlana Firsova, Noorgul Seitkazieva, and Valentina
Gaidamako. 2000. Improving the Monitoring of Immunization Services in
Kyrgyzstan. Health Policy and Planning 15(3): 279-286.
WHO. 2003. Increasing Immunization Coverage at the Health Facility Level.
Geneva: World Health Organization. WHO/V&B/02.27.
WHO. 1998. Immunization in Practice. Module 6: During a session: registering and assessing clients. Geneva: World Health Organization.
WHO/EPI/TRAM/98.06.
WHO. 1996. Monitoring Immunization Services Using the Lot Quality
Technique. Geneva: World Health Organization. WHO/VRD/TRAM/96.01.
WHO. 1991. Training for Mid-level Managers: The EPI Coverage Survey.
Geneva: World Health Organization. WHO/EPI/MLM/91.10.
WHO. 1991. Training for Mid-level Managers: Evaluate Immunization
Services. Geneva: World Health Organization. WHO/EPI/MLM/91.9.
WHO. 1991. Training for Mid-level Managers: Identify Missed Opportunities.
Geneva: World Health Organization. WHO/EPI/MLM/91.7.
WHO. 1991. Training for Mid-level Managers: Monitor Immunization
Coverage. Geneva: World Health Organization. WHO/EPI/MLM/91.6.
Full page photo credit: CCP

Immunization Essentials
Chapter 4: Monitoring, Evaluation, and Information Management

85Chapter 5:
Vaccine Supply and Quality“He who would do good to another must do it in Minute Particulars.”– William Blake
The potential of vaccination to protect millions of mothers and children eachyear cannot be fulfilled unless potent vaccine is available when and where itis needed. To ensure an adequate vaccine supply, managers must competently
estimate supply needs. Also, regulatory mechanisms are needed to monitor
vaccine quality.

Forecasting Vaccine Needs
Whether the source of vaccine is local or international, managers need toforecast vaccine needs accurately. This involves assessing the impact ofpolicies and plans on vaccine needs, determining the size of the target
population, knowing the amount of stock on hand, setting supply intervals,
and calculating reserve requirements. Vaccine use and wastage are also
critical factors.

Vaccine Vial Size and Session Frequency

Vaccines come in a variety
of presentations, depending on the particular vaccine, including vials
containing one, two, five,six, 10, or 20 doses.
Managers and suppliers
need to work together toensure that the best vial
size is procured, given
availability, demand, storage space, transportation capabilities, and cost.

Immunization Essentials
Chapter 5: Vaccine Supply and Quality

Credit: Harvey Nelson

Policies, coverage objectives, and service delivery strategies all have an
impact on vaccine needs. For example, increased promotion of routine
immunization services should increase demand, and an adequate supplyof vaccines must thenbe available to meetthat demand.

87Another factor is session size. If only a few children typically attend sessions
in a health facility, use of single-dose vials might mean that less vaccine would
be discarded at the end of a day. However, single-dose presentations (which
are available for measles, Hib, and Hep B vaccines) are considerably more
expensive per dose than multi-dose presentations.

Size of the Target Population
The accuracy with which the target population is measured or estimated is as
critical in vaccine forecasting as it is in calculating coverage (see Chapter 4).
To increase accuracy, target population figures should be adjusted annually,
especially in urban areas where populations constantly change and in rural
areas subject to high migration.
Overestimating the Target
Population for Campaigns
May Result in Oversupply
In preparing for high-visibility campaigns, planners forecast vaccine
requirements based on the desire tohave an adequate supply of vaccines.
At every level, they tend to calculate
target population size, coverage objectives, and vaccine wastage on the highside to avoid shortages. Sometimes
existing stock balance is not considered, so vaccines are ordered as if
none were already in the system. The
result is that after campaigns, there
can be a sizable stock of vaccines atthe district and health facility levels.
After campaigns, managers should collect excess vaccine, move it to higher
and safer levels of the cold chain forstorage, and make adjustments infuture vaccine orders to account for thepresence of these stocks. In addition,
campaign planners should use thenumber of children immunized in previous campaign rounds to estimate thetarget for the next.

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Inaccurate or outdated census counts,
population migrations, and unforeseenchanges in birth rates contribute todifficulties in determining the size ofa target population. Local healthmanagers may try to overcome suchproblems by working with community
leaders to count people in their catchment areas (“head counts”), but thisis not easy, as any demographer
can attest.
In addition to problems in counting
people, some managers inflate thesize of the target population to makesure that they receive an adequate
supply of vaccines. In other cases, as
discussed in Chapter 4, they may
deflate the size to make coverage
rates look high!
Estimates should begin to improve as
supply systems become more reliable
and staff are better supported in solving problems, rather than punished for
low coverage rates. As health workers
begin to collect and use vaccine datain which they have confidence, usage,
rather than population size, is likely to
become the preferred basis for calculating vaccine needs.

Stock on Hand
The amount of stock on hand should always be counted at each vaccine storage point before new stock is ordered. Stock should be kept within designated minimum and maximum levels toensure that:• Adequate amounts are available• Space is available to store thestock• The duration of storage is consistent with recommendations (seeChapter 6)

Supply Intervals

Credit: WHO• Vaccine is used before the expiry
date

It is good stock management practiceto organize vaccines by type andexpiry date.

Another variable in calculating vaccine needs is frequency of supply. Typicalsupply intervals, which should be adapted by each level to account for transport availability, cold chain storage capacity and quality, and continuity ofenergy supply, are listed below.
Typical Supply Intervals for Vaccines at Different Levels
Level

Interval

National store

Six months

Regional storesThree months

District stores

One month

Health centers

One month

Health posts

One week

An additional consideration in
forecasting vaccine needs is theamount of cold chain storage space
available at each level for vaccines.
A vaccine volume calculator has beendeveloped by WHO to help national
immunization programs determine
their space requirements when introducing new vaccines. With this tool,
managers can use the national

Credit: Craig Manning

Storage Capacity

A vaccine volume calculator spreadsheet
is available from WHO.

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Chapter 5: Vaccine Supply and Quality

89immunization schedule and the vaccine vial sizes to estimate net storage
requirements per fully immunized child and woman of childbearing age.

Reserve StockReserve, or buffer, stock is a quantity of vaccine that can be used if new supplies are delayed or if there is a sudden increase in demand. Facilities should
always maintain a reserve stock, which is typically calculated at 25% of theamount expected to be used during a given supply period. Experience may
justify a higher or lower amount. To avoid overstocking, the figure should be
reviewed and adjusted every time an order is placed.
Note that reserve stock is not the same as a wastage allowance. Both areneeded in forecasting vaccine needs.

Vaccine Use and Wastage
Vaccine use and wastage, two sides of the same coin, are also factors in forecasting vaccine needs. Vaccine use is defined as the proportion of the vaccine
supply that is actually administered to a child or mother. Vaccine wastage isthe proportion of vaccine that is supplied but never administered, calculated
as shown below.
Calculating Vaccine Wastage
Formula:doses supplied* - doses administered x 100 = wastage rate
doses supplied
Example:Doses supplied: 200
Doses administered: 150
200 -150
x 100 = 25% wastage
200* “Doses supplied” is calculated from stock records by adding the starting balance ofusable vaccine doses at the beginning of a designated period to the new doses
received during that period and subtracting the balance remaining at the end of theperiod: Starting balance + doses received - balance remaining = doses suppliedSome so-called “wastage” is not wastage at all but rather a predictable andacceptable cost of providing immunization services. Common causes ofunavoidable loss of vaccine include the following:• It is impossible to get all vaccine out of a multi-dose vial. A 20-dose vial
does not yield 20 doses, only 17 or 18.

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Credit: WHO• Any immunization session may attract fewer eligible people than anticipated. For example, based on experience, a health worker expects seven oreight children to show up for measles vaccinations in the weekly immunization session. The first child arrives and the health worker appropriately reconstitutes the vaccine in a 10-dose vial. By the end of the day, she
has administered measles vaccine to only four other children. The remaining vaccine must be discarded.

Unlike the messy refrigerator on the left, the tidy refrigerator on the right permits better
management of vaccine stocks.

On the other hand, wastage rates higher than 20% can be an indicator of
problems that might be avoided, such as:• Repeated instances of lower-than-planned attendance at sessions.
• Poor stock management• Cold chain failure that exposes vaccines to unacceptably high or low
extremes of temperature• Incorrect mixing of freeze-dried vaccine• Incorrect dosage, e.g., the administration of three drops of OPV insteadof two, or the injection of 0.6 ml of vaccine instead of 0.5 ml• Inappropriately large vial sizes. BCG, however, is only available in 20
dose vials.
• Failure to comply with a multi-dose vial policy

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WHO’s policy on multi-dose vials is intended to reduce wastage.
WHO Multi-Dose Vial Policy Recommendation
1.2.1 The revised policy applies only to OPV, DTP, TT, DT, hepatitis B, and liquid
formulations of Hib vaccines that:• Meet WHO requirements for potency and temperature stability• Are packaged according to ISO [International Organisation for Standardisation]
standards• Contain an appropriate concentration of preservative

1.2.2 For these vaccines, the revised policy states:
Multi-dose vials of OPV, DTP, TT, DT, hepatitis B, and liquid formulations of Hib vaccines from which one or more doses have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 4
weeks, provided that all of the following conditions are met:
• The expiry date has not passed.
• The vaccines are stored under appropriate cold chain conditions.
• The vaccine vial septum has not been submerged in water.
• Aseptic technique has been used to withdraw all doses.
• The vaccine vial monitor (VVM), if attached, has not reached the discard point.

1.2.3 The revised policy does not change recommended procedures for handling vaccines that must be reconstituted, that is, BCG, measles, yellow fever, and some formulations of Hib vaccines. Once they are reconstituted, vials of the vaccines must be
discarded at the end of each immunization session or at the end of six hours, whichever comes first.

Credit: Anne B. Keiser

Source: WHO, 2000

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Managers should carefully interpret data that indicate wastage and avoid
taking actions to reduce it that could result in a decrease in the number of
immunizations administered.
Three Ways to Reduce Vaccine Wastage
In the early 1990s, approximately half of all vaccines supplied to immunization programs
worldwide were never used and eventually had to be discarded. In addition to better stock
management and improvements in service delivery, three steps have proven successful in
reducing vaccine wastage:
1) The strategic use of smaller-dose vials, when funds and storage space are available.
2) Implementation of opened multi-dose vial policies, when training and monitoring are
included to ensure compliance.
3) The use of vaccine vial monitors (VVMs), when training and monitoring are provided(see Chapter 6).

Calculating How Much Vaccine to OrderAs discussed above, to calculate the amount of vaccine to order, managers
need to know the size of the target population, number of doses in the primary series, expected coverage given the strategies to be used, supply
interval, and wastage rate. The basic formula for calculating the order size
for any vaccine is:target population x expected coverage x number of dosesof the particular vaccine required x wastage factor

The calculation is then adjusted based on the amount of stock on hand andthe reserve stock needed, as shown below.
An Example of Calculating Order Size for DTP
Number of doses required
Wastage rate
Target population = 1000
Wastage rate in this district is 25%.
Expected coverage = 70%
Wastage factor or multiplier: 100/(100–25) = 1.33
Number of doses per child required = 31000 x 0.70 x 3 = 2100 doses
2100 doses x 1.33 = 2800 doses
Number of doses required per supply period
Supply period in district is every 3 months (0.25 of a year).
2800 x 0.25 = 700 doses
Vaccine in stock
The amount of DTP that is needed in the district for this three-month supply period is 700
doses. If the district already has 400 doses in stock, the amount of vaccine to be ordered is
300 doses, not 700 doses. It is a common and costly mistake to order vaccine without
adjusting for the amount in stock.
Reserve stock required
A percentage should be added for reserve stock. If 25% reserve stock is used, then an additional 175 doses are needed (25% of 700).
Amount to order: 300 + 175 = 475 doses

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93Forecasting the requirements for tetanus toxoid (TT) is more difficult than forchildhood vaccines because the target population for TT is girls and women,
who have approximately 30 years of eligibility, usually between ages 15 to
44 years. Furthermore, the intervals between each of the five doses vary. The
previous year’s TT usage will usually provide the best estimate of the current
year’s need, but that figure should be adjusted to the situation. For example, aTT campaign in high-risk areas may increase the demand for TT, while thedemand will begin to decrease when several years of good TT coverage
results in a build-up of protected women.

Vaccine Procurement and Quality Assurance
Some countries procure vaccines themselves, while others rely on internationalorganizations, particularly UNICEF, that specialize in vaccine procurement
and supply. If a country program is directly procuring vaccines, the activity
should be managed at the national level to ensure that standards are maintained. Procurement is not a simple task, as suggested in the box. Specialized
procurement units should performthese tasks, as described in detail in
Steps for Procuring
the WHO manual Procurement of
Vaccines at the
Vaccines for Public-Sector Programs.
National Level
WHO’s Ensuring Quality of Vaccinesat Country Level–Guidelines for
Health Staff describes international
requirements that national immunization programs need to follow forshipping, verifying vaccine quality,
assessing production, and monitoring
the National Regulatory Authority(NRA). These guidelines also provide
instructions on how to protect vaccines against dangers like those listedon the following page.
A vaccine arrival procedure has beendeveloped to monitor and record thecondition of vaccines upon arrival.
This is described in Chapter 6.

• Pre-qualify vaccines and suppliers• Prepare for procurement• Prepare bid documents• Prepare for bid evaluation• Solicit and receive bids
• Evaluate and compare bids
• Select a supplier• Make an award• Write a contract• Make financial arrangements• Set up a contract monitoring system• Arrange for and monitor shipment• Accept delivery and clear customs

All countries need National Regulatory Authorities, or control authorities, tomonitor the quality of vaccines. NRAs in countries that purchase their vaccines
directly from manufacturers are also responsible for:94

Immunization Essentials
Chapter 5: Vaccine Supply and Quality• Licensing all vaccines used in the country• Establishing procedures for releasing each lot of vaccines used in the
country• Monitoring adverse events following immunization (AEFI) (see Chapter 8).
Access to a laboratory is needed to monitor vaccine quality, whether
countries are procuring vaccines from external sources or producing thevaccine themselves.
A Short List of Threats to Vaccine Quality• During shipment: Inadequate notice of arrival, scheduling arrival during longholidays, route deviations, en route delays, cold chain breaks• Upon receipt: Vaccine quality not checked• Central storage: Cold chain breaks, inadequate recording, inadequate stock
control system, power failure• Release for use: Release certificates from the NRA in the producing country not
checked, no formal release system• Distribution: Freeze-dried vaccines not distributed with diluents in matching quantities, cold chain breaks, freezing of DTP, TT, DT, Td, Hep B, liquid Hib• Point of use: Inadequate storage, reconstitution, administration, and disposal

International organizations, particularly WHO and UNICEF, also provide
vaccine quality assurance and financing services. Once WHO is satisfied thata producer meets its standards, UNICEF and other United Nations purchasing
agencies are advised that they may purchase from this producer. Many
countries also benefit from UNICEF donor funds and procurement service
agreements.
UNICEF also finances the purchase of vaccines – directly or with funds contributed by donors. Payment usually is required in advance and must be
made in a convertible currency, unless the government has made otherarrangements. The PAHO Revolving Fund and the Vaccine Independence
Initiative (VII) both function as payment guarantees in lieu of prepayment for
vaccines (see Chapter 10).

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Global Vaccine Shortages
The supply of the six traditional vaccines was more than adequate to meetdemand until the late 1990s. Some manufacturers then stopped producing
these vaccines, and as their availability decreased, prices began to risesignificantly.
By 2002, most vaccines given to children and women in developing countries, including the newer vaccines, were in short supply. Reduction in theavailability of some of the traditional vaccines is shown in the graph below.

Source: UNICEF, 2002

Availability Versus Demand for Traditional Vaccines Procured
Through UNICEF

Supplies can be jeopardized if there are significant variations in vaccine
production, sizable batch failures during manufacturing, or changes invaccine formulations that requireapprovals and increased manufacturing
capacity. Poor forecasting, inefficientuse, and sudden increases in demand
can add to shortages. Global responses
to shortages include:• Providing manufacturers with sufficient guarantees that the vaccinesthat they produce will be purchased• Improving the accuracy of forecasting, especially long-term

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Credit: BASICS• Making long-term funding available
to cover vaccine costsReferences
Schnur, Alan. 2001. Vaccine Wastage and Monitoring the EPI. Technet
Meeting, New Delhi.
UNICEF. 2002. UNICEF Supply Division.
WHO. 2003. Ensuring the Quality of Vaccines at Country Level. Guidelines
for Health Staff. Geneva: World Health Organization. WHO/V&B/02.16.
WHO. 2001. Guidelines on the International Packaging and Shipping of
Vaccines. Geneva: World Health Organization. WHO/V&B/01.05.
WHO. 2001. Vaccine Volume Calculator: An Aid to the Introduction of New
Vaccines. Geneva: World Health Organization. WHO/V&B/01.27.
WHO. 2000. WHO Policy Statement: The Use of Opened Multi-Dose Vials of
Vaccine in Subsequent Immunization Sessions. Geneva: World HealthOrganization. WHO/V&B/00.09.
WHO. 1999. Procurement of Vaccines for Public-Sector Programmes: A
Reference Manual. Geneva: World Health Organization. WHO/V&B/99.12.
WHO. 1991. Training for Mid-level Managers: Manage the Cold Chain.
Geneva: World Health Organization. WHO/EPI/MLM/91.5.
Credit full page photo: WHO

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97Chapter 6:
Cold Chain and Logistics“A desk is a dangerous place from which to view the world.”– John LeCarré
An immunization program’s ability to provide vaccination services to all members of the target population depends on attention to detail, and nowhere is
this more necessary than in cold chain and logistics. Ensuring that vaccines,
supplies, and staff arrive on time and where they are needed requires an integrated system of equipment, people, policies, and procedures. This integrated
system is called the cold chain, and information links its parts.

National and sub-national program managers, district health management
teams, cold chain technicians, logisticians, drivers, and health facility staff
all play a role in getting vaccines from the manufacturer to the point of use.
These individuals deal with vaccine stock management, temperaturemonitoring, equipment selection and maintenance, vaccine handling, andtransporting people and vaccines.

Vaccine Stock Management
Having too much vaccine for too long in one part of the cold chain increases
the risk of some vaccine reaching its expiration date and having to be
destroyed. In contrast, when too little vaccine is available, not all the children
and women in the target population can be vaccinated. Too much vaccine in
one part of the cold chain may mean too little in another.
To be sure that the appropriate amount of vaccine is available, vaccine stocks
must be checked continuously, and records kept of all movements of stock inand out of storage areas.

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99Credit: REACH Project/JSI

Staff should be ready to collect the vaccines upon arrival.

Vaccine Arrival
The successful arrival of vaccines from international sources requires that
programs avoid such problems as:• Shipment of vaccines by way of airports that lack cold rooms• Consignments to the wrong party• Shipment of the wrong vial sizes• Shipment of the wrong quantity of vaccines and diluents• Shipment of vaccines that are due to expire soon
• Arrival of vaccines on weekends or holidays• Shipment of vaccines without:– Advance notification– Sufficient icepacks– Cold chain monitors– Documentation needed for customs clearance
Every international shipment of vaccines from a manufacturer should include a
blank vaccine arrival report (VAR) form, as shown on the following page.
When the shipment arrives, the individual responsible for monitoring vaccine
arrivals and storage fills in the VAR and gives a copy to the local office of the
procuring agency. The report documents the condition of the shipment and thequantities received, and it confirms that all other necessary documentation is
included. If problems occur, the VAR can be the basis for initiating corrective
action or making claims.

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Source: WHO, 2001

Vaccine Arrival Report

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Use of this WHO-recommended VAR form helps logisticians to identify anddocument problems at the highest link of the cold chain through which allimported vaccines pass. Problems identified at this level are usually more easily and inexpensively solved. For more information, see WHO’s Guidelines on
the International Packaging and Shipping of Vaccines (WHO, 2001).

Vaccine Stock Records

Source: WHO, 2003

Accurate vaccine forecasting and ordering depends on knowing the quantityof vaccines in stock at all times. Whenever vaccines and diluents enter orleave a storage area, they should be counted. Ordering should be based ona physical count of vaccine stocks rather than on stock records alone.

To ensure that no vaccine remains toolong in storage, stocks should bearranged in order of “earliest expiration date — first out” (EEFO) at every

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Credit: WHO

Vaccine stock records, like the one
shown above, are used to record thename of the manufacturer of each lotof vaccine, the vial size, the lot number, expiry date, vaccine vial monitor
status (see pages 106-109), doses ofvaccine received, doses issued, andthe balance remaining in stock. This
type of card can be used in a stock
book or ledger or as a stock card at
any level of the system.

level. This helps ensure that old vaccine stocks are distributed before newer
ones and limits wastage caused by expiration.

Temperature Monitoring
Keeping vaccines at the right temperature is not an easy task, but the consequences of not doing so can be disastrous. Once vaccine potency is lost, itcannot be regained. Damaged vaccines must be destroyed, which can leave acountry without adequate vaccine stocks and can cause serious budget problems when the losses involve large lots and/or expensive vaccines. Children
and women who receive a vaccine that is not potent are not protected.
Beer and Vaccines
Whenever there is a discussion on immunization service logistics, someone asks why
cold beer is available in remote areas but vaccines at the required temperature are not.
Of course, beer is a profitable commodity, but more to the point, it does not require continuous cold. In contrast, vaccines can lose their potency if they are exposed to heat, or,in the case of some vaccines, freezing temperatures.

Source: WHO, 2003

Vaccines have different cold storage requirements, which change at different
levels of the cold chain, as shown below.

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Freezing Vaccines
Some vaccines spoil if they are frozen, including DTP, TT, DT, Td, Hep B,
and liquid formulations of Hib. The risk is real and the costs may be high.
In Indonesia, logisticians used continuous temperature monitoring devices totrack 16 shipments of vaccine from the national manufacturer to the point ofuse. Vaccine in 12 of the 16 shipments froze at various points in the cold
chain. The biggest risk for freezing occurred during transport from province todistrict with vaccine in 10 shipments affected. Freezing episodes at such ahigh level of the cold chain affect several month’s worth of vaccine supplied tomany districts and health centers. In the Indonesian study, vaccine was alsofrozen at district levels within ice-lined refrigerators and in some health center
refrigerators. The temperature is shown below for one vaccine shipment froma province to a district to a health center. Freezing occurred during storage atboth district and health center levels.
New methods to keep vaccines cold without freezing them are being developed and some old practices challenged. For example, using cardboard or
paper partitions in a cold box or carrier to keep freeze-sensitive vaccines from

Source: Nelson, 2001

Freezing Study Results, Indonesia

Extra care and precautions to prevent freezing should be emphasized in training,supervision, and monitoring.

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touching icepacks has proven to be ineffective against freezing. During immunization sessions, vaccines can be kept cool but should be protected fromfreezing by standing opened vials in a foam pad above the ice packs in thevaccine carrier.

“Shake Test”
The shake test is designed to determine whether adsorbed vaccines such as
DTP, DT, Td, TT or hepatitis B have been frozen. Adsorbed vaccines are manufactured in such a way that one substance attaches to the surface of anotherTo perform the shake test, take a vaccine vial of the same type, manufacturer andbatch number as the vaccine vial you want to test. Freeze the vial for at least 10
hours at -10°C until the contents are solid, and then let it thaw. This vial is the “control” sample and should be labeled as “frozen” to avoid its use for vaccination.
Then take a vaccine vial from the batch that you suspect has been frozen. This is the“test” sample. Vigorously shake the control and test samples for 10 seconds, place
both vials on a flat surface to rest, and continuously observe them over the following
20 minutes.
View both vials against the light to compare the rate of sedimentation. If the test
sample shows a much slower sedimentation rate than the control sample, the test
sample has probably not been frozen and may be used.
However, if the sedimentation rate is similar and the test sample contains flakes,
the test sample has probably been damaged by freezing and should be withdrawn
from use. The health worker must notify the supervisor immediately to ensure thatany other damaged vials are also identified and withdrawn from use.

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material. After freezing, the vaccine is no longer a uniform cloudy liquid, but
tends to form flakes that gradually settle to the bottom after the vial has been
shaken. Sedimentation occurs faster in a vaccine vial that has been frozen
than in a vaccine vial from the same manufacturer that has never been frozen.

Temperature Monitoring Devices
Keeping a record of temperature changes is critically important. Health workers should record the temperature of their vaccine refrigerator twice a day on

a chart like the one above. The shaded area on the chart represents the temperature range that is acceptable, from +2° to +8°C. When they visit healthfacilities, district- and higher-level managers and supervisors should review
these charts to emphasize the importance of maintaining appropriate vaccine
temperatures. Recording thermometers that automatically make such recordings also are available.
The numbers in the top row are calendar days. The columns in the second
row are divided into morning (M) and evening (E) for recording temperatures
twice a day.
Different types of thermometers, thermo-recorders, and chemical indicators areused to monitor vaccine temperatures, as described on the following page.

Vaccine Vial Monitors
A vaccine vial monitor (VVM) is a small colored disk printed on a vial labelor, for freeze-dried vaccines, placed on the vial cap. A square inside the diskdarkens irreversibly when exposed to heat over time. By comparing the colorof the inner square to that of the outer ring, users can determine the extent towhich the vaccine inside has been exposed to heat.

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Credit: WHOSome Tools Used for Monitoring Temperature

Vaccine Cold Chain Monitor Card (CCM)

This is used to monitor temperatureduring transport and in storage. It
irreversibly records cumulative heat
exposures above +10°C and any
exposure over +34°C.

Manufacturers should pack a CCM
card or manufacturer-validated monitor in each carton of vaccine shipped. When thesecartons are opened and vials put into smaller boxes for distribution to lower levels of
the cold chain, the value of the monitor is diminished. The CCM card shown above
indicates that substantial exposure to heat has occurred.

Credit: WHO

Freeze indicator(FreezeWatchTM)

Thermometer

Manufacturers pack thesedevices with DTP, TT, DT,
Td, liquid Hib, and hepatitis B vaccines. They canalso serve as “silent supervisors” in refrigerators.
However, they do notindicate whether vaccine
in individual vials has
been frozen.

Different
types ofthermometers areused fortransport
and forstorage at
different
levels ofthe coldchain.

HO

CARTE DE CONTRÔLERÉFRIGÉRATION

Cr

ed

it:

W

REFRIGERATORMONITOR CARD

Cold Chain Monitor and Freeze
Watch (STOP!WatchTM)
A combination of a Cold
Chain Monitor and Freeze
Watch™ indicator is used tocontinuously monitor temperature range in vaccine refrigerators. The heat indicatorirreversibly records cumulative
heat exposures of +10°C or
any exposure over +34°C. The
freeze component bursts at
temperatures below freezing.

This functions as a“reusable cold chain
monitor” for use in vaccine
refrigerators, shipments,
and cold chain studies.
It stores data that can be
downloaded by special
cable to the serial port ofa computer with MS
Windows-supported
software.

Credit: WHO

Credit: WHO

This is an irreversible
temperature indicator thatbursts when a shipment is
exposed to freezing temperatures. The most recent
model (Product Information
Sheet code E6/45) releases blue liquid and stains
the white backing card
when the indicator is
exposed to temperatures
below 0°C for more thanan hour.

Temperature
data logger(Tiny TTMTM)

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107Credit: WHO

Different VVM models correspond to the heat stability ofdifferent vaccines and, therefore, react at different rates.
For example, a VVM on a vial of OPV, which is themost heat-sensitive of all vaccines used in national
immunization programs, will reach its end
point within two days of
exposure to+37°C. At theother extreme, a
VVM on a vial
containing TT,
which is very stable, will reach its
end point only
Always check the VVM before using the vial. The vaccines in theseafter 30 days ofvials can be used because the inner square is still lighter than the+37°C exposure.
outer ring.
VVMs have been
available on all vials of OPV procured through UNICEF since 1996 and are
becoming available for all other UNICEF-procured vaccines, as well as vaccines from other sources. Countries that purchase their own vaccines directlyfrom manufacturers should include VVMs in their procurement specifications.

When health workers use VVMs correctly, they can:• Identify heat-damaged vaccine and discard it• Avoid unnecessarily discarding vaccine because of suspected heat
exposure• Extend accessibility to vaccinations in remote areas beyond the reach of
the cold chain

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• Monitor the amount of vaccine discarded due to excessive heat exposure• Identify cold chain problems
For these benefits to be realized, national immunization programs have foundthat they must issue policies authorizing staff to use VVMs; disseminate clear
instructions to public and private health facilities; provide hands-on training inreading and interpreting the monitors; and monitor and provide feedback on
VVM use.

Selection of Storage Equipment
People who are responsible for procuring cold chain storage equipment generally use Product Information Sheets to find out about different types of equipment, costs, ordering details, and how to select products. Items in the Product
Information Sheets are independently tested and must meet product specifications defined by WHO.
To simplify maintenance and repair, cold
chain equipment managers and donors
are advised to procure the same types
and models of equipment. The costs ofspare parts, tools, repairs, and fuel to
run the equipment must not be
overlooked during budget
preparation. As the pie chartshows, these costs are much
more significant over a 10-year
period than the initial cost topurchase cold chain equipment.

Cold Rooms
Cold rooms are large, speciallyconstructed rooms or self-containedbuildings located at the national,
and in some cases regional, levelfor storage of large quantities ofvaccines. They have a 24-hour temperature monitoring system with analarm, a recorder, and a back-up

Cost of Cold Chain Equipment over a
10-year Period

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generator that will turnon automatically when
the regular power isinterrupted.

Storage of Vaccines andIce packs in the Refrigerator

Freezers andRefrigerators

Credit: WHO

Freezers and refrigerators are used in
district, regional, andcentral stores. Freezers
are used for freezing
icepacks and storingcertain vaccines, particularly OPV, thatneed to be kept at

CFC-Free Equipment
The Montreal Protocol banned the manufacturing and use of chlorofluorocarbons(CFCs) in industrialized countries on January 1, 1996 and in developing countries
beginning on January 1, 2010. These chemicals have been widely used as refrigerants in compression refrigeration circuits and as foaming agents for insulating cold
storage equipment. UNICEF, WHO, and equipment manufacturers are working to
make a gradual transition to CFC-free equipment for all vaccine storage and transport
purposes in all countries by 2010.
How to dispose of equipment in the course of this transition is a question that has yet
to be completely resolved.

temperatures below 0°C. Other vaccines are stored in refrigerators, which arealso used for chilling diluent before it is mixed with freeze-dried vaccine. Icelined refrigerators, which are used at the central and sub-national levels, arecapable of maintaining temperatures below +8°C even when electricity fails
for as many as 16 of every 24 hours, day after day.
Factors in addition to price should be considered when selecting cold chain
refrigerators and freezers, including:Service delivery strategies. The freezing compartment of refrigerators inhealth facilities should be large enough to freeze and store icepacks neededfor outreach and fixed sessions.
Source of power. Electric appliances are the least expensive to buy and

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the easiest to maintain, but reliable electric power is not available in manyrural areas.Voltage stabilizers are usually needed to avoid damage to compressors caused by fluctuations in power. Where electricity is unreliable, gasor kerosene appliances may be the best choice, despite their high costs,
maintenance demands, and ongoing need for fuel.
Where gas or kerosene delivery is unreliable, solar power may be used,
despite the high cost of installation and need for maintenance.
Storage capacity. Space needs vary at different levels of the system,
depending on the amount and type of vaccine expected to be stored. In a typical health center, a refrigerator should be expected to hold a one-month supplyof vaccines and diluent, and one to two weeks of reserve stock. Half the total
space in a refrigerator should be left empty so that air can circulate, and there
should be room in the bottom for frozen icepacks or sealed bottles of cold
water to keep the interior cool if the power fails.
Supply interval. The supply interval also must be considered in calculating
the amount of space needed to store vaccines. For example, where roads are
impassable during parts of the year, health facilities may need to have athree-month supply of vaccines and other supplies delivered just before roads
close and sufficient refrigerator space
to store all of this vaccine.

Cold Boxes and Vaccine
Carriers

Managers should consider a numberof technical questions in selecting acold box or vaccine carrier, including:Credit: Kelley Sams, BASICS II

Cold boxes and vaccine carriers are
insulated containers that are linedwith icepacks to keep vaccines anddiluent cold.

At this health facility, a cold box is used tostore vaccines on a temporary basis.

• How much vaccine, ice, and diluent must be carried• How much the equipment weighs – especially if it is to be carried on abicycle or by a person on foot• How long the equipment is supposed to last
• How much “cold life” they need
Cold life is the interval between the time that the coldest point in the load
stored in a piece of equipment passes -3°C until the temperature reaches

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+10°C at a given ambient temperature, usually +32°C and +43°C. Cold life
is measured “without openings.” At +43°C (a temperature easily reached in aclosed vehicle in the tropics), cold life can range from eight hours for NID carriers to 120 hours for large long-range cold boxes.

Vaccine carriers, which are more
portable, are commonly used to transport vaccine from district stores tosmaller health facilities and to outreachsessions. Special “NID carriers” arebags or boxes that have the benefit of Icepacks inside vaccine carrier.
being lightweight; however, they havea short cold life and are not durable.

Credit: WHO

Cold boxes are normally used to transport vaccine from the central level tothe provinces, from provinces to districts, and sometimes from districts to theservice delivery level. (Refrigerated vehicles are rarely used for vaccines indeveloping countries because they are costly and subject to frequent breakdowns: a good cold box works as wellor better.) Cold boxes also are used
for temporary storage when a refrigerator is out of order or being defrosted.

Icepacks
An icepack is a flat rectangular plastic container designed to be filled withwater, frozen, and then used to keep
vaccines cold. Icepacks must beplaced in a cold box or vaccine
carrier in a precise way, so their size
is important. When buying a cold box
or vaccine carrier, purchasers areadvised to order at least one extra
set of icepacks so that while one set
is being used, the other is being
frozen, a process that usually takes atleast 24 hours.

Obtaining the best available and mostappropriate equipment at the lowest
cost is only one aspect of keeping the112

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Credit: WHO

Management of Storage
Equipment
Placing icepacks inside a cold box.

cold chain in operation. A second, and perhaps even more important, task is
to manage the equipment, which requires:• Keeping an equipment inventory• Planning and budgeting for maintenance and repair• Planning and budgeting for replacements• Preparation for emergencies
These tasks are described in detail in the documents cited in the reference section at the end of the chapter.

Equipment Inventory
Equipment management includes setting up and updating records about theequipment, tools, and spare parts that are being used or in stock. A goodequipment inventory will provide the information that is needed to track thelocation of larger pieces of equipment, schedule maintenance and replacement, and evaluate the adequacy of stock. Records for each piece of equipment should include:• Technical information (brand, model, serial number, year of manufacture,
date of entry into service, projected replacement date, and date of final
removal from service)• Specific location• Current condition (working, in repair, out of commission)

Equipment Maintenance and Repair
Maintenance is performed to reduce the likelihood of equipment failure, andrepair is performed to fix equipment when it fails. Planning for maintenanceincludes identifying what needs to be done on a regular basis to clean theequipment and keep it running, ensuring that appropriate tools and spareparts are available, and scheduling these activities. Some types of equipment,e.g., vaccine refrigerators, need daily, weekly, and monthly attention; others
need maintenance after use, e.g., coldboxes and vaccine carriers.

Credit: WHO

Equipment manufacturers usuallydescribe maintenance requirements inthe manuals and other documents that
accompany their products. Healthworkers and others who use or are
responsible for maintaining cold chain
equipment need training.

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Since any equipment can break down, repair workshops are needed withappropriate tools, spare parts, and skilled technicians.
The availability of tools, spare parts, fuel, training, and labor for maintenanceand repair can be major problems. Planners and donors tend to fund the purchase of new equipment
and vehicles without alsoplanning and budgeting for
fuel, spare parts, maintenance, and repair.

Even with the best of care,equipment will eventuallywear out or become obsolete. To avoid interruptions
Regular maintenance and repair can extend the lifeof immunization services,long-term and annual plans of vehicles.
are needed for replacing
equipment. Most manufacturers provide estimates of the life expectancy of
their equipment, and the Product Information Sheets, a reference publishedevery few years by WHO and UNICEF, include life-expectancy norms.
“It is sometimes easier to get a donor to provide a new vehicle than a setof new tires for a vehicle that we already have.”– An African health worker
Some governments have established policies, based on WHO recommendations, that call for the replacement of all refrigerators and freezers after ten
years of use. WHO also recommends that refrigerators for storing vaccines be
installed in all new health centers.
As equipment is inventoried and installed, a replacement date should bedetermined and recorded in the inventory. Schedules can be set for selecting
and ordering equipment, which may take a number of months to be delivered;and plans made for financing the purchase.
Technicians at national, provincial, and district levels need training in equipment installation, especially when new types, such as CFC-free and solar
equipment, are introduced.

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Credit: TRANSAID

Replacement
PlanningMany things can interrupt
immunization services,
including equipment breakdown, loss of electric power,
and shortage of spare partsor fuel. Planning for theseemergencies can minimize
damage to vaccines and disruptions in immunization
services. In every place thathas vaccine storage equipment, staff should set up
warning systems for identifyContinuous monitoring of vaccine stocks is needed, as
ing an equipment failure and shown in this national cold room.
make arrangements inadvance for moving vaccines
to the nearest location that has appropriate substitute equipment. In provincial
and district stores, standby equipment and power generators should be available on the premises. In health facilities at the peripheral level, equipment for
emergency use may be found in businesses or private homes.

Credit: Anne B. Keiser

Planning for
Emergencies

Equipment outages caused by shortages of spare parts and fuel should notoccur. They should be avoided if there is regular monitoring of stocks andordering of new supplies.

Vaccine Handling
Proper handling of vaccines requires correct packing and storing of vaccinesand diluents, and correct reconstitution of freeze-dried vaccines.

Packing Vaccines in Cold
Boxes and Vaccine Carriers

Credit: Anne B. Keiser

Freeze-sensitive vaccines may bedamaged if they are placed in close
contact with icepacks. This can be
an expensive loss, especially when
new vaccines are involved. Healthworkers are therefore advised toremove icepacks from the freezer
and keep them at room temperature
before putting them in cold boxes or
carriers. This “conditioning” process

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115

takes several hours at an ambient temperature of +20°C and less time at higher temperatures. The ice is conditioned when it begins to move around inside
the icepack and makes a rattling sound when shaken next to the ear.

Storing Diluent
Diluent is a liquid that is used to reconstitute BCG, yellow fever, measles, andfreeze-dried formulations of monovalent Hib vaccines. Combination vaccinesthat include freeze-dried Hib are reconstituted with DTP or with a DTP-Hep B
combination. The manufacturers of freeze-dried vaccines also manufacture thediluents needed for reconstituting their vaccines. The vaccine should always
be reconstituted with the diluent provided by the manufacturer for thatsame vaccine.
Diluent can be stored at +2°C to +8°C or at room temperature but should not
be frozen, as diluent ampoules are fragile and may crack in freezing temperatures. If stored at room temperature, they should be cooled to below +8°C
before use to avoid thermal shock to the vaccine.

Reconstitution
A sterile needle and sterile syringe are needed to remove diluent from its
ampoule and add it to freeze-dried vaccine in its vial. Again, only the diluent
supplied by the vaccine’s manufacturer should be used, and care should betaken to use the whole amount of diluent for reconstitution. Once reconstituted,
the vaccine vial should be wrapped in the foam pad from a vaccine carrier, in
paper, or in foil to protect it from direct sunlight. The wrapped vial should be
kept on ice.
After six hours or at the end of a session, whichever comes first, reconstituted
vaccines must be discarded.

Transportation Management
For immunization services to function properly, vaccine, fuel, spare parts, andhealth workers have to be at the right place at the right time. Transportation
management has a critical role to play. It consists of five components, as
described by TRANSAID in its Transport Management Manual.

Cable from country to headquarters: “The trucks don’t keep vaccine cool.”
Headquarters’ response: “Park in the shade.”
Return cable from country: “Send trees.”

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The Five Components of Transportation Management
Fleet management
This consists of the selection, purchase,record keeping, maintenance, and repairof the vehicles operated under a single
authority, such as a program or district
health management team. It includes:• Setting up and maintaining a vehicle
inventory that records for each vehicle:
year, make and model, physical location, major use, total kilometers, average kilometers per month, averagedays used per month, and condition• Identifying vehicle replacement
needs for a given period oftime, for example five years

mation. Transportation experts recommendthat information on the following performance indicators be compiled and analyzed
on every vehicle every month:• Kilometers traveled• Fuel utilization: Number of kilometers
traveled for each liter of fuel used
• Running cost per kilometer, including
fuel, maintenance, and tire costs• Availability: Amount of time during
the period that the vehicle was readyfor use as compared to the time it
was broken down or undergoing
maintenance• Utilization: Amount oftime that a vehicle was actually used

• Defining technical specifications for the purchase of vehicles;
selecting and procuring vehicles• Needs satisfaction:
Percentage of authorized requests for vehicle use that were met• Providing preventive• Safety record
maintenance that
Source: TRANSAID, 2001
includes driver trainHuman Resources
ing, daily vehicle defect reporting,
All staff members contribute to the effectivevehicle inspection, vehicle servicing at
ness of the transport system, but specialists
regular intervals, and correction of
defects; maintenance may be performed are needed to manage and operate it. The
specialists for whom training and superviby an organization’s own staff or ansion are required include transport officers,
outside contractor
service managers, vehicle operators,• Arranging for disposal of vehicles at themechanics, vehicle inspectors, and vehicle
end of their useful lives
operator trainers.

Operational management
This involves planning, scheduling, andcontrolling the use of vehicles and definingroles and responsibilities of managers,
transport officers, drivers, and users. Whendone correctly, it can increase the numberof kilometers traveled per vehicle by 20%
per month and increase the total length oftime that vehicles can be used for service
delivery. Such savings can mean that fewer
vehicles are needed or that available
vehicles can be used to extend services tounreached populations or meet otherservice objectives.

Management Information

Policies
Policies are needed to guide or give direction to transport systems, which is why they
are shown as handlebars on the motorcycle above. Policies should address:• Authorized vehicle operators and passengers• Roles and responsibilities of managers,
transport specialists, operators, andpassengers• Selection, procurement, replacement,
and disposal of vehicles• Vehicle planning at national, subnational, district, and local levels.

Transportation management relies on infor-

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117References
Family Planning Logistics Management. 2000. Programs That Deliver:
Logistics’ Contributions to Better Health in Developing Countries. Published for
the U.S. Agency for International Development (USAID). Arlington, VA: Family
Planning Logistics Management/John Snow, Inc.
Management Sciences for Health in collaboration with WHO. 1997.
Managing Drug Supply. West Hartford, CT: Kumarian Press.
Nelson, C. 2001. Flexible Cold Chain. Technet Meeting Presentation, Delhi.
TRANSAID. 2001. Transport Management Manual: Delivering Transport
Solutions for a Developing World. London: TRANSAID Worldwide.
UNICEF and WHO/UNICEF. 2000. Product Information Sheets. Geneva:
World Health Organization. WHO/V&B/00.13.
Weekly Epidemiological Record 58(31). 237-240, 1986.
WHO/AFRO. [in press]. EPI Cold Chain Management for Health Workers.
WHO. 2003. Ensuring the Quality of Vaccines at Country Level – Guidelines
for Health Staff. Geneva: World Health Organization.
WHO. 2002. Guidelines for Establishing or Improving National, Regional,
and District Stores. Geneva: World Health Organization. WHO/V+B/02.34.
WHO. 2002. Getting Started with Vaccine Vial Monitors: Questions andAnswers on Field Operations. Geneva: World Health Organization.
WHO. 2001. Guidelines on the International Packaging and Shipping of
Vaccines. Geneva: World Health Organization. WHO/V&B/01.05.
WHO. 2000. Making Use of Vaccine Vial Monitors – Flexible Vaccine
Management for Polio Supplementary Immunization Services. Geneva: World
Health Organization. WHO/V&B/00.14.
WHO and UNICEF. 1999. Quality for the Cold Chain: WHO-UNICEF Policy
Statement on the Use of Vaccine Vial Monitors in Immunization Services.
Geneva: World Health Organization. WHO/V&B/99.18.
WHO. 1999. Temperature Monitors for Vaccines and the Cold Chain.
Geneva: World Health Organization. WHO/V&B/99.15.

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WHO. 1998. Immunization in Practice: Manage the Cold Chain. Geneva:
World Health Organization. WHO/EPI/TRAM/98.03.
WHO. 1998. Safe Vaccine Handling, Cold Chain and Immunization: A
Manual Developed by WHO/EPI and BASICS, U.S.A., for the Newly
Independent States. Geneva: World Health Organization.
WHO/EPI/LHIS/98.02.
WHO. 1997. Equipment Performance Specifications and Test Procedures.
Geneva: World Health Organization.
WHO. 1996. Managing Cold Chain Equipment: A Guide for National
Logistics Officers. Geneva: World Health Organization.
WHO/EPI/LHIS/96.02.
WHO. 1991. Training for Mid-Level Managers: Manage the Cold Chain.
Geneva: World Health Organization. WHO/EPI/MLM/91/5.
Full page photo credit: WHO

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119Chapter 7:
Injection Safety“First do no harm.”– from the Hippocratic Oath
Vaccination is one of the most effective and safe health interventions—when
vaccines are good quality, appropriately stored and handled, and when injections are given safely. Chapters 5 and 6 address the vaccine quality, storage,
and handling aspects of immunization safety. This chapter discusses safe injection practices, selection of injection and other equipment, and waste disposal.
A safe injection is defined by the World Health Organization as an injectionthat:• Does not harm the recipient• Does not expose the health care worker to any avoidable risks• Does not result in waste that is dangerous to the community
Over 16 billion injections are given every year in developing countries for
immunizations, therapeutic purposes, transfusion of blood and blood products,
and as injectable contraceptives. Any of these injections, if unsafe, can transmit hepatitis B, hepatitis C, HIV, hemorrhagic fevers, malaria, tetanus, andother diseases. Poor injection techniques can cause abscesses and infected
lymph nodes as well.
Global Estimates of Infections Attributable toUnsafe Injections from Any Type of Injection
Hepatitis B cases

20 million (39% of all new hepatitis B
infections per year)

Hepatitis C cases

2 million (40% of all hepatitis C cases
per year)

HIV infections

250,000 (5.4% of all HIV infections
per year)
Source: Hauri, 2003

Only 5% of the 16 billion injections given annually are for immunizations,and studies have shown that immunization injections are among the safest.
However, most vaccines currently available are given by injection, and global
concern about unsafe injections has compelled immunization managers and

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121providers to address safety issues more seriously than ever. Improved equipment, such as auto-disable (A-D) syringes and safety boxes, has helped, butchanges are required in human behavior and in the health system, too. The firststep is to identify the primary causes of unsafe injections. Programs can thenplan and implement training, supervision, provision of injection equipment,
waste disposal, information campaigns and other activities as appropriate.
Safe Injection Global Network (SIGN)SIGN is an association of stakeholders sharing a common interest in the safe and appropriate use of injections. SIGN associates include internationalorganizations such as WHO and UNICEF, NGOs,
developing country governments, donor organizations,
universities, health care worker organizations, industries, and others. SIGN exchanges information, ideas,
and experience from diverse groups and fosters thedevelopment and use of innovative, cost-effective
approaches to promote safe and appropriate use of
injections for all health care applications.

Assessing Injection Safety
Unsafe injection practices may not always be obvious nor the causes andmagnitude of problems clear. To help national immunization programs andothers evaluate injection safety, WHO has made a number of assessment tools
available through SIGN and the Expanded Programme on Immunization.
These tools enable managers to assess policies, plans, and standards; healthworker practices and reasons for them; and issues related to equipment. They
include the Rapid Assessment and Response Guide, the EPI tool to assess thesafety of injection practices, and a WHO tool to assess health care waste
management.
As with any generic assessment instrument, these tools should be adapted toreflect local needs and conditions. Most importantly, an effort should be madeto ensure that the information generated by any assessment is actually used to
improve injection safety. This requires engaging stakeholders at the outset in
the decision to conduct an assessment, and later in design, planning, datacollection, analysis, and formulation of recommendations.

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Safe Injection Policies
Governments have the primary responsibility for ensuring that injections aresafe. At a minimum, policies are needed to address the following key issues:• Reduction of the total number of unnecessary injections• Promotion of safe injection practices• Provision of sufficient quantities of appropriate injection equipment andinfection control supplies• Management of sharps waste
A policy that addresses only immunization injections is insufficient. Safe injection policies should apply to all public and private health care services, including maternal and child health, dentistry, familyplanning, curative care (including HIV/AIDS),
blood collection, and laboratory services. The
policies should be introduced to all stakeholders, including donors, clients, and their families.
Health care budgets should include adequate
resources to cover the costs of:
Credit: Daniel Cima, American Red Cross• Needles and syringes• Safety boxes• Training• Incinerator equipment and spare parts• Fuel for incinerators• Sterilizing equipment, spare parts, and fuelin places where sterilizable injection equipment continues to be used
An Integrated Approach to Policy Making and Planning
Integrated policies should take into account the following programs and concerns:• HIV/AIDS prevention programs should raise awareness about the risks of unsafe
injections.
• National drug policies should address injection overuse.
• Essential drugs programs should budget for sterile syringes and needles, safety
boxes, and other equipment.
• Governments and partners should provide matching quantities of sterile syringes
and needles and safety boxes.
• Health systems should include sharps waste management as a required“duty of care.”

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To assist countries with planning for injection safety, SIGN has published anaide-memoire on developing a national strategy for the safe and appropriate
use of injections. This document provides both a checklist and more detailed
guidance on steps that countries can take in developing and implementing
injection safety policies.

Credit: WHO

Setting, communicating, and adhering to clear national policies is especially
important in mass vaccination campaigns, when a large number of immunization injections are given in a short time, often by personnel who do not routinely give injections. Such campaigns also involve temporary distribution
systems for vaccine, supplies, and equipment and arrangements for waste
management. To help governments conduct safe campaigns, in 2002,
WHO/EPI issued another aide-memoire that outlines the actions needed toreduce the risk of unsafe injections.

Injection Practices
Changing the behavior of health workers and clients may be the most important step required to make injections safe. SIGN and WHO have identified
critical issues and made recommendations for addressing them, as outlined on
the next page. Training and supervision are discussed further in Chapter 9.

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Chapter 7: Injection SafetyInjection Practice Problems and Recommendations
Problems

Recommendations

1. Use of unsterile injection equipment.

To assure that health workers use a sterile
syringe and needle for each injection, managers should forecast, order, and assure
reliable delivery of adequate quantities.

Auto-disable syringes and needles, which
are recommended by WHO for immunizations, may be unavailable.
Sterilization equipment or fuel may not be
available for sterilizable syringes andneedles, which are still commonly used fortherapeutic purposes.

Health workers should alert supervisors ofshortages.
Managers should ensure that equipment,
fuel and spare parts are included in thebudget and provided as planned.

2. Unsafe collection of sharps.

The health system should promote safe handling of injection equipment through poliHealth workers are unaware of the danger
cies, training, supervision, andto themselves and others caused by their not informational campaigns.
placing disposable syringes and needles inTrainers should require that health workers
safety boxes.
demonstrate mastery of safe injection
Health workers are unaware of the dangers techniques.
of recapping needles.
Supervisors should monitor handling of
injection equipment, use of safety boxes,
Health workers do not have or do not use
and management of supplies.
safety boxes.
3. Unsafe management of waste.
Health workers do not know how to handle
waste or lack the appropriate equipment todestroy it.

Trainers and supervisors should require that
health workers demonstrate the ability tohandle and destroy waste.
Supervisors should monitor waste
management.

Used equipment is dumped into public areas
The health system should provide informawhere children and others scavenge it.
tion to the public about the risks of handling
medical waste.
4. Overuse of therapeutic injections.
Because it is the norm to use injections,injections are over-prescribed.
Some health workers believe that injections
work faster and better than oral
medications.

Health workers should prescribe oral medication whenever possible.
The health system should educate the public
on the effectiveness of oral medication.

Patients may prefer injections to oral
medication.

Another response to injection safety problems is public information, but thiscan be a double-edged sword. While information campaigns can increase thedemand for injection safety, they can also discourage people from getting
those injections that are needed, such as vaccinations. To inform people about
injection safety without frightening them, health officials should communicate
what is being done to solve the problem whenever a situation involving unsafe
injections occurs. People also should be told what they can do themselves toreduce the risks.

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Chapter 7: Injection Safety125

Of course, the most important factor in maintaining public confidence in immunization services is
to ensure the safety of injections.

Credit: SIGN

Local circumstances and awarenessof the problem should be used togauge how best to share information with the public. For example,
in a country with high rates of
HIV/AIDS and awareness that dirty
needles and syringes can transmit
HIV, publicizing the introduction of
A-D syringes for immunization
could reassure people that something is being done to address a
problem they recognize. In othersettings, publicity about A-D
syringes may create needless anxiety and do more harm than good.

Improper disposal of syringes and othermedical waste behind a clinic.

Injection Equipment
Injection equipment that can be used to administer injectablevaccines includes:• Auto-disable syringes• Standard disposable syringes• Pre-filled, single dose, non-reusable devices (e.g., Uniject™)• Sterilizable syringes and needles

A-D syringes are disposable injection devices that are speciallymade to prevent reuse and are
therefore less likely than standard
disposable syringes or sterilizables
to cause person-to-person transmission of blood-borne pathogens.
Auto-disable (A-D) syringe.
Many health workers prefer A-D
syringes because they save the timethat they would otherwise spend on sterilization. Although these syringes are
more costly than other types, the cost is decreasing as demand increases.

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Credit: Becton-Dickinson

Auto-Disable Syringes

The use of A-D syringes, however, generates a large volume of potentially
dangerous waste. As with any equipment, there is no guarantee against
improper use; therefore policies, training, supervision, and other measures areneeded to support correct use and disposal of A-D syringes. The use of A-D
syringes greatly increased in 2001, when GAVI advised the Vaccine Fund toprovide them in sufficient quantity to cover both newly-introduced and “traditional” vaccines for at least three years, based on acceptable country proposals for immunization injection safety.
WHO-UNICEF-UNFPA Statement on the Use of Auto-Disable
Syringes in Immunization Services
In a joint statement issued in December 1999, WHO, UNICEF, and the United
Nations Fund for Population Activities (UNFPA) said:
The auto-disable syringe, which is now widely available at low cost, presents the lowest risk of person-to-person transmission of blood-borne pathogens (such as hepatitis B
or HIV) because it cannot be reused. The auto-disable syringe is the equipment ofchoice for administering vaccines, both in routine immunization and mass campaigns.
• WHO, UNICEF and United Nations Fund for Population Activities (UNFPA) urge
that, by the end of 2001, all countries should use auto-disable or sterilizablesyringes only. Standard disposable syringes should no longer be used for immunization.
• WHO, UNICEF and UNFPA urge that, by the end of 2003, all countries should use
only auto-disable syringes for immunization.
Source: WHO, 1999

Conventional Disposable Syringes
Conventional disposable syringes are plastic syringes with steel needles that areprovided by the manufacturer in a sterile package. The needle may either be
fixed to the syringe when it is produced or attached by the health worker justbefore use. These syringes are intended to be used only once, but they are, infact, quite easy to use multiple times. Since they cannot be properly sterilized,
their re-use places the public at high risk of disease and death, and WHO and
UNICEF recommend that they not be used for immunization purposes.

Immunization Essentials
Chapter 7: Injection Safety127Some injection devices (e.g. Uniject™)
package vaccine, needle, and syringe
together in a sealed foil pouch. They
are designed to ensure that clients get
the correct amount of vaccine and thatthe injection is safe. In some settings,
they have been used to take moreheat-stable vaccines like tetanus toxoid
and hepatitis B vaccine to hard-toreach areas beyond the cold chain.
Pre-filled, single-dose, non-reusable devices.
Their relatively higher cost, greater storage requirements, and more limited
availability suggest that they are appropriate for use in selected circumstances.

Sterilizables
Sterilizable injection equipment consists of plastic syringes and steel needles
that are designed for re-use after cleaning and sterilization in a steam sterilizer
or autoclave.
Sterilizables are the least expensive per injection and have the lowest volume
for re-supply and waste disposal. However, they require more handling byhealth workers for cleaning and sterilizing the equipment, which may increase
the risk of needle-stick injury. Health personnel must also order supplies suchas fuel and spare parts for the sterilizers. Supervisors need to monitor the useof this equipment constantly.
Sterilizable syringes and needles are being phased out for immunization injections but continue to be used for reconstituting freeze-dried vaccines. They arestill used extensively for injections other than immunization.
Reconstituting Freeze-Dried Vaccines with
Syringes and Needles
Even if A-D syringes are adopted for use with all vaccines, there will still be a need toorder and distribute mixing syringes to reconstitute lyophilized vaccines such as
measles, BCG, and some Hib vaccines. To ensure safety, one sterile mixing syringe
and needle should be used for each new vial of vaccine that is reconstituted. If
small vial sizes are introduced, for example, two-dose vials of pentavalent vaccine, thequantity of mixing syringes required will increase substantially compared to needs for
10-dose or 20-dose vials.
Where A-D syringes are used for all vaccine administration and steam sterilizers are
no longer required for immunization equipment, managers will have to decide whether
to dispose of mixing syringes after each vial is reconstituted or to sterilize them alongwith other non-immunization equipment.

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Credit: San Francisco Chronicle

Pre-Filled, Single-Dose,
Non-Reusable Devices

Wherever health workers use
sterilizable needles and syringes,
they must sterilize them after
each use. They should use
appropriate sterilization equipment and carefully adhere to
manufacturers’ directions.
Sterilizers made for vaccinationequipment have one, two, or
three racks, each of which holds approximately 40 syringes and 50 needles.
In addition to the sterilizer itself, thefollowing items are needed for the
These Practices Are Unsafe!
cleaning and sterilizing procedure: a•Recapping needles (can result inbasin for washing used syringes andneedle sticks for health workers)
needles, forceps, a timer, stove, and• Changing the needle after an injecfuel. Time, steam, and temperaturetion but using the same syringe
indicators (TST) are required for every• Reusing the needle and syringe forsterilization cycle. These strips or
multiple patientsspots change color irreversibly when
• Boiling needles and syringes
the contents of a sterilizer have been
• Flaming the needle
sterilized. Health workers must keep
• Reusing mixing syringes
records of their use to document thatsterilization has been done.

Credit: Veronique Leger

Sterilization of Injection
Equipment

In compliance with a joint statement issued by WHO, UNICEF, UNFPA, andthe International Federation of Red Cross and Red Crescent Societies, steam
sterilizers made for vaccination equipment will not be available from UNICEF
Supply Division after 2003. Spare parts and sterilizable syringes will continue
to be available for a limited time until national immunization programs makethe full transition to A-D syringes.

Management of Sharps
Waste

Credit: San Francisco Chronicle

As the use of A-D syringes has
increased, so has the urgency of
ensuring that all injection supplies aredisposed of properly. Careless disposal places health workers and the public at high risk of needle-stick injuries.
Used syringes and needles should
never be dumped in open areas

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129where people might pick them up, step on them, or come in contact with themin any other way.
The need to better manage contaminated sharps has prompted the development of tools to assist countries with planning and policy development.
Available from WHO and SIGN, these tools include an assessment tool for
health care waste management that examines current practices, level ofawareness of risks, and the country’s regulatory framework in order to provide essential information for designing an action plan. Also available is an
aide-memoire for developing a national strategy for safe health care waste
management.

Safety Boxes

The volume of used syringes and needles that safety boxes must accommodate can be significant, as describedin the box.

Credit: WHO

Safety boxes, or sharps containers,
are puncture-resistant containers into
which A-D syringes and needles areplaced immediately after use and temporarily stored until they can be
destroyed. They should be supplied in
sufficient quantity such that a safety
box is always within reach of a vaccinator, even during outreach sessions.
A safety box should be available withinreach of every health worker who gives aninjection.

Wastage Volume of Used Needles and Syringes

For a health facility with a catchment population of 30,000, a birth rate of 30 per
1000, and 100% childhood immunization
coverage, eight five-liter safety boxes will
be filled every month with used syringes
and needles.
In addition to the eight boxes per month forchildren’s immunizations, the health facility will need additional boxes for TT and curative care injection equipment. The volume of waste produced in immunization campaigns, which may cover children up to five or more years of age, is also significant.

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Credit: SIGN

Approximately 100 2ml syringes and needles (used for most childhood vaccinations)fill a five-liter safety box. Five and 10ml
syringes take up more space.

Waste Disposal and Destruction• Location of disposal facilities:
Ideally, every health facility would havean incinerator. Because cost and demand
limit the practicality of this solution, districts may install incinerators at strategic
locations, such as hospitals.

Credit: D. Marchand/IDRC

Once nearly full, safety boxes should be incinerated. If an incinerator is not available, amuch less desirable and effective alternative isto douse them with kerosene and burn them.
In planning waste disposal, managers should
consult medical waste disposal policies andenvironmental regulations for the national andlocal levels. They should make plans for the:Improper disposal poses risks to• Disposal of filled safety boxes:
the community.
Properly functioning incinerators, operated
by trained personnel, ensure the most complete destruction of syringes
and needles. They also produce less air pollution than burning by othermeans at lower temperatures. Burning in a metal drum is considered thenext best option after incineration but may not destroy the waste completely and may result in heavy smoke. Open burning and burying are muchless effective and not recommended.
• Schedule and budget for destruction of safety boxes: A regularschedule should be developed and maintained, and funds should be provided for sufficient quantities of fuel.
• Logistics: What arrangements are needed to ensure transport of wastefrom health facilities to incineration sites, a reliable supply of fuel for incinerators, provision of spare parts, and tools for maintenance and repair?
• Training: Training is needed for health workers, incinerator operators,
and others, for example, those who transport waste. Such considerations
should be included in training curricula.

Incineration Equipment
Auto-combustion incinerators that reach temperatures of over 800°C destroy
contaminated sharps and syringes most effectively. Work is now under way inmany countries to equip district hospitals and large health centers with thiskind of incinerator. However, means of disposing of waste from small facilities, like dispensaries and health posts, and at the end of outreach visits arestill under study.
While improvements in waste management continue, work is under way todevelop new disposal technologies. Some of the technologies that soon may
be available are described in Chapter 11.

Immunization Essentials
Chapter 7: Injection Safety131References
Battersby, Anthony, Rachel Feilden, and Barbara Stilwell. 1998. Vital to
Health: A Briefing Document for Senior Decision-Makers. Arlington, VA:
BASICS II.
Children’s Vaccine Program at PATH. 2002. Proper Handling and Disposal of
Auto-Disable Syringes and Safety Boxes: A Training Module for Clinic
Managers and Immunization Providers. Seattle, WA: Children’s Vaccine
Program at PATH.
Children’s Vaccine Program at PATH. 2000. Giving Safe Injections: Using
Auto-destruct Syringes for Immunization. Seattle, WA: PATH.
Dicko, M., A.-Q.O. Oni, S. Ganivet, S. Kone, L. Pierre, and B. Jaquet. 2000.
Safety of Immunization Injections in Africa: Not Simply a Problem of Logistics.
Bulletin of the World Health Organization 78(2), pp. 163-69.
Expanded Programme on Immunisation in South Africa. 1997. Cold Chain
and Immunisation Operations Manual.
Hauri, A.M., G.L. Armstrong, and Y.J.F. Hutin. “Contaminated Injections in
Health Care Settings.” Comparative Quantification of Health Risks: Global
and Regional Burden of Disease Attributable to Selected Major Risk Factors.
Geneva: World Health Organization . 2003.
WHO. 2003. Managing an Injection Safety Policy. WHO/BCT/03.01.
WHO. 2002. Aide-Memoire for a National Strategy for the Safe andAppropriate Use of Injections. Geneva: World Health Organization.
WHO. 2002. The Injection Safety Policy Planner (Draft 5, October 2002).
Geneva: World Health organization. Department of Blood Safety and ClinicalTechnology.
WHO and UNICEF. 2000. Product Information Sheets. Geneva: WHO,
WHO/V&B/00.13.
WHO. 2001a. Aide-Memoire for a National Strategy for Safe Health Care
Waste Management. Geneva: World Health Organization. Department ofProtection of the Human Environment.
WHO. 2001b. Injection Safety: First Do No Harm. Geneva: World HealthOrganization. WHO/BCT/DCT/01.3.
WHO. 2001c. The Tool for the Assessment of Injection Safety. Geneva: World
Health Organization. WHO/V&B/01.30 and WHO/BCT/01.02.

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Chapter 7: Injection SafetyWHO. 1999. WHO-UNICEF-UNFPA Joint statement on the Use of AutoDisable Syringes in Immunization Services. Geneva: World HealthOrganization. WHO/V&B/99.25.
WHO. 1996. Injection Safety in Immunization Programmes: WHO
Recommended Policy. Geneva: World Health Organization.
WHO/EPI/LHIS/96.05.
Full page photo credit: Don Douglas/PATH

Immunization Essentials
Chapter 7: Injection Safety

133Chapter 8:
Disease Surveillance“All interest in disease and death is only
another expression of interest in life.”– Thomas Mann
During the 1970s and 1980s,
the national and global focus of
the Expanded Programme on
Immunization was primarily onreaching the Universal Childhood
Immunization goal of 80% coverageby 1990. In the 1990s, national program managers and donors started tolook more closely at the effect of immunization services on the incidence ofdisease, and disease surveillance
became a more prominent activity.

• Disease incidence, morbidity, andmortality, and progress in achieving disease control goals

Credit: Ann Jimerson

Disease surveillance is the collection,
analysis, and interpretation of data to
determine disease trends and patterns.
Disease surveillance provides information such as:

Health worker at a rural clinic displays thesurveillance and coverage charts he created.

• Changes in patterns of morbidity
and mortality among different age groups in different geographical areas
and among different economic, social, or cultural groups• Impact of immunization strategies on disease incidence• Disease trends
The overriding value of disease surveillance, however, is its use as a tool toidentify the presence of infectious diseases and guide actions to prevent themfrom becoming threats to public health. This chapter describes the activities
required to carry out that function.

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Types of
DiseaseSurveillance

Credit: Veronique Leger

Different methods
are used to obtain
different types of surveillance information,
as described below.

Facility-Based
RoutineSurveillance
In many countries, health workers are required to report on the number ofindividuals that come to their facility and are diagnosed with reportablediseases. These reportable diseases are usually diseases that have outbreakpotential, such as cholera, polio, and measles, or diseases that are targets ofnational control programs, such as malaria and tetanus. Data on individual
patients, which are recorded in patient registers (Chapter 4), are used to calculate the number of cases of reportable diseases diagnosed by health facility
staff over a certain period of time. These data are periodically reported to
district authorities who compile and send them to higher administrative levels.
This process of detecting and reporting information on diseases that bringpatients to the health facility is known as passive surveillance.

One way to overcome
the limitations of passive surveillance andget a better picture ofdisease burden in the136

Credit: Kristina Engstrom

Passive surveillance yields only limited data because many sick people do
not visit a health facility and because those cases that do show up may not
be correctly classified,recorded, or reported.
If managers fail to fully
understand andaccount for these limitations, they may
incorrectly interpret
trends and patterns ofinfectious diseases.

Active surveillance.

Immunization Essentials
Chapter 8: Disease Surveillancecommunity is for health workers to visit health facilities and communities toseek out cases. This is known as active surveillance.
Since passive surveillance has limitations due to its lack of access to somegroups within the population, active surveillance is often used to enhance thecompleteness of a passive surveillance system. Active surveillance is also more
expensive than a passive system and requires considerable additional effort toorganize. This means that active surveillance is usually conducted on a limited segment of the population and for only a brief period. Active surveillanceis, therefore, used to gain targeted insight into a situation and not collect routine data over a long period of time.

In certain instances, health workers conduct case-based investigations to learn
more about a specific illness pattern, for example, when there is a suspectedcase of a disease targeted for
eradication, such as polio, or during suspected outbreaks of epidemic-prone diseases such as
yellow fever. In case-based investigations, health workers record
information such as the patient’s
name, age, vaccination status,
location, date of disease onset,
suspected diagnosis, and laboratory results (when available).

Credit: Kelley Sams, BASICS II

Routine surveillance by health facilities, whether passive or active, is often
hampered by the difficulty of making accurate diagnoses. Health workers maylack the proper equipment or training for diagnosis in the health facility, andlaboratory services are often not available to confirm clinical diagnoses.

Community-Based SurveillanceWith training, members of the community can expand facility-based surveillance by detecting and reporting cases that may go undetected by the healthfacility. A good example of this is the use of community members to detect
cases of guinea worm (dracunculiasis). In villages where the disease is endemic, volunteers are trained to detect and report cases using a standard diagnostic criterion, e.g., painful legs that have skin ulcers with worms protruding.
They then may undertake treatment, referral, and containment measures suchas bandaging the ulcer, instructing infected persons not to bathe in water fromponds and streams, and promoting the use of filtered drinking water.
Community-based surveillance needs the support of trained health care work-

Immunization Essentials
Chapter 8: Disease Surveillance137ers who in turn provide training to the community on how to recognize thedisease and how to respond when people are ill. While the focus of community surveillance may be on a specific disease, community members may also
be trained to detect an array of health problems. Community members andhealth workers can work together to organize transport, childcare, and otherassistance and, sometimes, provide medical supplies, treatment, and vaccinations. Reports by community members should be incorporated into the overall
surveillance data managed by health personnel. Health systems should also
provide feedback to the community about disease patterns in their own andsurrounding areas.
Community-based surveillance can be very useful in detecting and treatingsome illnesses. However, it generally has a high error rate and should be
used carefully. Case definitions need to be very simple and specific for community identification and this means that diagnoses need to be confirmed bysomeone with more advanced training. While it is always wise to involve thecommunity as much as possible in health initiatives, community-based surveillance is not appropriate for all conditions and situations. Health workers
should carefully test the community-based approach before initiating it andshould be prepared to regularly monitor activities to ensure that definitions arebeing applied correctly and that the health of the community members is
being served well by this approach to surveillance.

Sentinel Surveillance
Sentinel surveillance is the collection and analysis of data by designatedinstitutions selected for their geographic location, medical specialty, andability to accurately diagnose and report high quality data. For example,
district hospitals may be required to report specific conditions such as bacterial meningitis in order to quantify the burden of disease due to Haemophilus
influenzae type b. Generally, sentinel surveillance is useful for answering
specific epidemiologic questions, but, because sentinel sites may not represent
the general population or the general incidence of disease, they may have
limited usefulness in analyzing national disease patterns and trends.

Surveillance Activities
Surveillance for communicable diseases involves:• Detection• Reporting• Analysis and interpretation• Presentation• Response

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Chapter 8: Disease SurveillanceDetection
Surveillance begins with case detection. To accurately detect disease, healthworkers need case definitions that are appropriate for the local context, andthey need practice in applying them, especially when they do not see a specific illness very often. For example, health workers in one country had difficulty identifying yellow fever cases according to the clinical symptoms ofyellow eyes or dark urine, but case detection became easier after theylearned the local term for the disease: “horse-urine eye disease.”
Even with appropriate case definitions, clinical diagnoses can be a problem.
Many illnesses have similar symptoms, such as fever and rash, and can bedifferentiated only by laboratory tests that may not be accessible.

Reporting
Most ministries of health require that facilities routinely report the total count ofcases of each reportable disease that has occurred within a specified time
period (weekly or monthly). When no cases have occurred during the period,
the report should indicate this fact. WHO has developed forms for reporting
each disease that can be adapted to meet national needs.
Zero Reporting: Does No News
Necessarily Mean Good News?
A hypothetical health post’s disease report showed the following:
DiseaseNumber of cases

Measles

25

CholeraDiphtheria0

In this example, it is clear that there were no cases of diphtheria during the reporting
period, but it is not clear whether there were any cases of cholera. The practice of putting a “0” when there are no cases is called “zero reporting.” Knowing that there
were no cases of a specific disease may be just as important as knowing the numberof cases that were detected.

In most countries, policies require that routine reports include the aggregate
number of cases of each disease over a specified time period, for example one
month. But for some diseases or conditions, such as acute flaccid paralysis(AFP), cases must be notified immediately upon detection. Individual case

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Chapter 8: Disease Surveillance139reports usually include case information, exposures prior to illness, contacts after
illness, and laboratory results, but the details differ depending on the disease.
Reporting procedures should be designed to operate effectively under the wide
variety of local conditions in a given country. Health officials at the national
level should not assume that the electric power, telephone lines, and computersavailable to health facilities in the capital city are available to health workers
throughout the country. They should recognize that some facilities might dependon truck drivers or other travelers to carry news of an outbreak to the appropriate authorities. For example, only half the health facilities in the study reported
below would be able to report an outbreak by telephone.
Telecommunications Capacity to Report
Disease in One African Country
Means of communication

Percent of Facilities with AccessRegional HealthBureaus(n = 11 )Telephone services
Radio communications
Computers
Computers with modem

100%
100%
64%
27%

Zonal Health
Departments(n = 12 )
67%
33%
25%
8%

Health Facilities(n = 33 )
48%
3%*
12%
3%*
Source: WHO, January 2001
*one facility only

The ability to report and act immediately becomes critical when dealing withdiseases that have outbreak potential, such as measles and cholera. Whencommunication capabilities do not allow for immediate notification of outbreaks, local health workers should have the authority and resources to takequick action to stem the spread of the disease while help is being summonedfrom district or national authorities.

Analysis and Interpretation
Surveillance data are of little use for local decision-making and planning
unless health workers know how to analyze the data and understand theirimplications. Health workers need to be able to interpret trends and patternsof disease in order to inact prompt control measures and avoid actions thatare not appropriate.
In order to analyze and interpret surveillance data, health workers need to beaware of the limitations and peculiarities of the data set. They need to conduct basic analyses first and then proceed to more complex forms of analysis.
They need to recognize when the data will no longer support the type of

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Chapter 8: Disease Surveillanceanalysis they are proposing, and finally, their analyses should be directed at
answering critical questions that are needed for planning, implementation andevaluation of public health actions.
Health workers also need to be aware of phenomena such as “the surveillance effect” that occurs when improvements are made in disease surveillance— that is, the number of reported cases almost invariably increases becauseof better reporting rather than because of an increase in disease incidence, as
shown in the example.
Measles Outbreak or Improved Surveillance?

Source: WHO, 2000

In this example, even though an increase like the one that occurred in 1999
may simply reflect the surveillance effect rather than a genuine rise in disease
incidence, because such data can also indicate real problems, they should not
be ignored. Trend data only indicate possible problems, so health workers
need to investigate further to be able to correctly interpret their meaning anddetermine what actions to take.
Other cautions should be taken in interpreting surveillance data. For example,
some diseases are still underreported, notably neonatal tetanus and measles.
Planners must realize that these diseases are major contributors to child mortality even if the data are incomplete. Similarly, immunization services also
can be the victims of their own success when planners use disease surveillance data as the basis for budget allocations. Because there are fewer deathsand disabilities caused by vaccine-preventable diseases when people are vaccinated, fewer resources may be allocated for the prevention, identification,and treatment of vaccine-preventable diseases. In some cases, a decrease in
the number of reported cases causes districts to shift priorities from immunization services to other interventions, thus weakening immunization programs
and risking a return of vaccine-preventable diseases.

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Chapter 8: Disease Surveillance141

Presentation
When data are analyzed
and the results interpreted,the information must bepresented in a way thatmeets the needs of the target audience. For example, highly technicalpresentations of data may
be appropriate for senior
ministry officials but notfor local government staff.
A presentation to the
Minister of Health about
the impact of a health
event should be designed
differently than one madeto the Minister of Finance.

A variety of presentation methods are available. For example,
maps that show thelocation of cases areuseful for presenting
surveillance information, as well as foranalyzing incidence.
They can illustrate relationships among casesand geographical anddemographic features
as well as show how
cases are clustered.
Maps of district and facility catchment areas can be sketched by hand, orgovernment maps may be available in hard copy or electronically.
Besides maps, information can be made more understandable by use of rates,
tables, graphs, trend lines, data transformations, and projections. All of thesemethods help make raw data more easily understood and should be tailoredto the appropriate audience.

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Chapter 8: Disease SurveillanceResponse
Disease surveillance enables managers to respond to existing problems andtake steps to prevent anticipated problems. Responses may include verificationof reported cases, treatment, search for new cases, or supplemental vaccination activities, but all must be tailored to the disease and the situation. For
example, it may be difficult to quickly contain an outbreak of a highly contagious disease, such as measles, with only a mass vaccination response. For
other less contagious diseases, such as yellow fever, mass vaccination canhave a more dramatic short-term impact.
The ability to report and act immediately becomes critical when dealing
with diseases that have outbreak potential, such as measles and cholera.
When communication capabilities do not allow for immediate notification of

Outbreak Preparedness Committees
Outbreak preparedness committees are used at subnational, national, regional, andglobal levels to prepare for and coordinate responses to outbreaks. Committee membership varies but usually includes epidemiologists, logistics experts, government planners, NGOs, donors, and multilateral agencies.
Before outbreaks occur, committees may:
• Establish guidelines for when and how to respond to outbreaks of different diseases• Assess the capacity of the health system to respond• Advocate for training in field epidemiology• Ensure that vaccine stocks and other supplies will be available in case of an outbreak• Establish communication channels among partners• Set up response coordination mechanisms
During an outbreak, the committee coordinates the response, making sure that technicaladvice is available where needed, that supplies and manpower are distributed andused appropriately, and that communication links are maintained with the public, themedia, neighboring countries, and regional and global networks.

outbreaks, local health workers should have the authority and resources to takequick action to stem the spread of the disease while help is being summonedfrom district or national authorities.
Responding to routine reports is as important as responding to emergencies.
Routine surveillance data, together with coverage and other information, canlead to improvements in immunization services such as the implementation ofstrategies to provide unreached children with services. Managers who receive
surveillance reports should also provide feedback on their timeliness and

Immunization Essentials
Chapter 8: Disease Surveillance143accuracy, send summaries of the analysis back to health facilities, anddescribe how they used the data.

Not all diseases can be diagnosed
accurately using clinical definitions
alone. Laboratories are needed to
identify the exact cause of the illness,but well-functioning public health laboratories are still unavailable in many
developing countries. Even whenavailable, they often lack the equipment, reagents, and trained staff toproperly carry out their functions.
The process of collecting and transporting specimens from the patient to thelaboratory can also be problematic. There are also problems getting laboratory results back to health workers. Results often come too late to inform treatment or control activities, or they never come, leaving health workers to
respond as best as they can with inadequate information.
To overcome some of these problems, research is being done on the development of rapid diagnostics that can be used to supplement the public healthlaboratory. These diagnostics are simple tests that can be performed by atrained health worker in the field to confirm a suspected diagnosis.
Decentralized laboratory facilities are also being considered as a way tomove diagnostic confirmation closer to the health facility.
As with other aspects of surveillance, communication is important. Healthworkers need to advise laboratories about the samples they are sending, laboratories need to inform health workers and managers of their test findings,
and health workers need to notify patients about laboratory results.

Adverse Events Following Immunization (AEFI)Adverse events following immunization occur even in the safest programs.
Only rarely is there a causal relationship between a vaccination and an
adverse event, but health officials need to be vigilant to the possibility of aconnection and take appropriate action.
Causes of adverse events are classified under four categories:
1. Program error. An error in vaccine preparation, handling, or administration, such as:

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Chapter 8: Disease Surveillance

Credit: WHO

Laboratories• Giving too much vaccine in one dose
• Injecting vaccine in the wrong place, such as the buttocks• Not using sterilized syringes and needles for each injection• Using the wrong diluent or the wrong amount of diluent• Giving the wrong vaccine or other biological substance
2. Vaccine reaction. The reaction of a particular individual to the inherent
properties of a particular vaccine even when the vaccine has been prepared,
handled, and administered correctly. A reaction is usually one of three types:
Local: The most common type of reaction usually shows as pain,
swelling, or redness at the site of injection. These reactions occur within a
few hours of injection, go away in a short period of time, and pose little
danger. Parents should still report any local reaction that persists to ahealth worker. This type of reaction is most commonly caused by inactivated vaccines.
Systemic: Generalized reactions may include fever, malaise, muscle
pain, headache, or loss of appetite. They are similar to a very mild formof the disease but pose no serious health risk. These reactions occur morecommonly after injections with live attenuated vaccines than with inactivated vaccines.
Allergic: These are the most serious and most rare reactions. They arecaused by the body’s reaction to a particular component in a vaccine.
Severe allergic reactions can be life threatening, which is why goodscreening prior to vaccination is important. Health workers who give vaccinations should know the signs of allergic reactions and be prepared totake immediate action.
Local and systemic reactions, or side effects, are described for each vaccine
in Chapter 12.
3. Coincidental. The adverse event occurs after a vaccination has been
given but is not caused by the vaccine or its administration. A coincidental
event is one that would have occurred even if the person had not been
vaccinated.
4. Unknown. The adverse event cannot be directly related to the vaccine,its administration, or any other identifiable cause.
While every effort needs to be taken to eliminate avoidable adverse events,
concern over the possibility of an adverse reaction needs to be balanced
against the threat that the disease poses. With respect to vaccine-preventablediseases in developing countries, the danger from the disease is much greater

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than from the vaccine. For example, measles poses a far more serious threat
than the possibility of an adverse reaction to a measles-containing vaccine, as
shown below.
One of the responsibilities of National Regulatory Authorities (NRAs)
described in Chapter 5 is to monitor and investigate adverse events. Most
adverse events are caused by errors in the handling and administration of
vaccines long after they have left the manufacturer. However, NRAs must also
investigate the possibility that a particular vaccine was mislabeled or not manufactured correctly even though such problems are extremely rare.
Complications Caused by Measles Compared toAdverse Events following Measles Vaccination
Complication

Measles Complications
per 100,000 Cases

Measles Vaccine Adverse Events
per 100,000 Vaccinations

50 - 400

0.1

Convulsions

500 - 1,000

0.02 - 190

Death

10 - 10,000

0.02 - 0.3

Encephalopathy/
encephalitis

Dealing with Rumors

There are four things that health officials should
do to combat rumors:• Predict: The same rumors circulate regularly, for example, the unfounded accusationthat tetanus toxoid causes sterilization or thefalse association of measles-mumps-rubella vaccine (MMR) with autism.
• Prepare: Knowing what rumors are likely to arise, health officials canprepare materials to counteract them in advance. Information should
always be available for parents and the media on common side effects ofvaccines.
• Fast, positive response: When an adverse event occurs, action
should be taken immediately to discover the cause and then to correct the
problem and minimize its impact by giving out information. Messages

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Chapter 8: Disease Surveillance

Credit: Washington Post

Health officials often have to deal with rumors,
especially when adverse events occur. Out of
genuine fear, concern, or less respectablemotives, people start and spread rumors about
vaccination. These exaggerations of risk canseriously disrupt immunization programs.

should be honest and in language that the public understands.
• Professional and political support: Endorsement of immunizations
and assurance of their safety should be sought from academic institutions,professional associations, politicians, and respected community leaders.
The Expanded Programme on Immunization unit in WHO has created informational and training materials on how to deal with the public and the press
when an adverse event occurs.
Rumors Have Legs!
A two-year old boy in an Asian country died five days after he was given vitamin A
during a national immunization day for polio. The child’s doctor said that the boy had
died of childhood pneumonia, a common cause of death for malnourished children in
the area.
In spite of the fact that there was no indication that vitamin A was associated with thechild’s death, other doctors began to say that vitamin A had caused the death. The
rumor spread throughout the country, and health officials were forced to cancel therest of the campaign. As a result, millions of children received neither polio vaccination nor vitamin A supplementation.
Rumors have legs and travel quickly. In essence, it is the rumor itself that puts children’s lives at risk.

Integrated Disease Surveillance
Many national health care systems have separate disease surveillance systems
that serve different purposes or users. For example, vertical disease programs,
such as polio eradication and tuberculosis and malaria control, often havetheir own surveillance systems in order to facilitate rapid response.
A fragmented approach to disease surveillance results in costly and inefficient
duplications of effort, and many countries are trying to respond by developing
Integrated Disease Surveillance (IDS) systems. The collection of disease surveillance data has always been integrated at the service delivery level, but asthat information flows upward, it branches out to numerous users in otherdepartments and ministries. If integration can make this process more efficientand still meet the information needs of various users, it will make a valuable
contribution to the increase of knowledge about diseases and to the improvement of public health services.
WHO Surveillance Software• EpiInfo. Organizes data for disease surveillance systems, as well as other epidemiological information.
• EpiMap. Produces and displays maps from geographic boundary files and data
values entered from the keyboard or EpiInfo.
• Information for Action (IFA). Developed for the computerization of surveillancedata for EPI.

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References
An Integrated Approach to Communicable Disease Surveillance. Weekly
Epidemiological Record, No. 1, 2000, 75, 1-8. 7 January 2000.
Community Surveillance Kit. 2001. Washington, DC: The CHANGE Project.
Galazka, A.M. et al. 1984. Indications and Contraindications for Vaccines
Used in the Expanded Programme on Immunization.
Kharabsheh, Saad, Haidar Al-Otoum, John Clements, Adnan Abbas, Najwa
Khuri-Bulos, Adel Belbesi, Taky Gaafar, and Nora Dellepiane. Mass
Psychogenic Illness Following Tetanus-Diphtheria Toxoid Vaccination in Jordan.
Bulletin of the World Health Organization, 2001, 79(8). Pages 764-770.
Mansoor, Osman, Susan Chin, and Chris Maher. 1999. Immunization Safety
Surveillance: Guidelines for Managers of Immunization Programmes on
Reporting and Investigating Adverse Events Following Immunization. Manila,
Philippines: World Health Organization, Western Pacific Regional Office.
WPRO/EPI/99.01.
Vaughan, J.P. and R.H. Morrow. 1989. Manual of Epidemiology for District
Health Management. Geneva: World Health Organization.
WHO. January 2001. Assessment of the National Communicable Disease
Surveillance and Response, Ethiopia. Weekly Epidemiological Record, No. 2,
12.
WHO. 2001. Making Surveillance Work: Module 3: Logistics Management.
Geneva: World Health Organization. WHO/V&B/01.10.
WHO, 2001. Making Surveillance Work: Module 4 Data Management.
Geneva: World Health Organization. WHO/01.011.
WHO. 2000. A Framework for Global Outbreak Alert and Response.
Geneva: World Health Organization. WHO/CDS/CDR/2000.2.
WHO. September 2000. Measles Bulletin, Issue 4.
WHO. 1998. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. Geneva: World Health Organization.
WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1993. Surveillance of Adverse Events Following Immunization: Field
Guide for Managers of Immunization Programmes. Geneva: World HealthOrganization. WHO/EPI/TRAM/93.02 Rev.1.

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Chapter 8: Disease SurveillanceWHO. 1991. Training for Mid-Level Managers: Disease Surveillance.
Geneva: World Health Organization. WHO/EPI/MLM/91.5.
Full page photo credit: Pav Govindasamy, ORC Macro

Immunization Essentials
Chapter 8: Disease Surveillance149Chapter 9:
The Role of Behavior Change“Knowing is not enough, we must apply,
Willing is not enough, we must do.”– GoetheAs described in Chapter 3, immunization services are less likely to be used bypeople who are:
• Uninformed• Dissatisfied• Too busy
• Poor and powerless• Misinformed• Distant
Other chapters discuss health system actions that can address these problems,such as shifting session schedules and ensuring that vaccines are available
when clients seek them. This chapter describes how to take a comprehensive
approach to behavior change in order to improve the delivery of immunization services and encourage their appropriate use.
In country after country, studies have shown that most people will use
immunization services as long as they to know when and where to bring
their children, and those services are available, accessible, reliable, andfriendly. Thus, the role of communication activities in achieving these conditions is important but not sufficient. Dissemination of information, training,supervision, and other ways of improving services need to be employed ina mutually supportive way to promote complete and timely immunization of
women and children.
Achievement of immunization goals is affected by the behavior of manygroups, including: politicians, community leaders, health care providers,managers and supervisors, women of reproductive age, parents, children,and their families. The focus of this chapter is on health care providers andcaretakers.
Some of the desired behaviors for different groups that affect immunization
services are listed on the following page. These behaviors are generally applicable but should be modified as needed to fit specific situations.

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Desired Immunization-Related Behaviors
Mothers and Other Primary Caretakers• Bring children to immunization service delivery points at the ages recommended in
the national schedule.
• Bring each child’s health or vaccination card to each health visit.
• Treat side effects as recommended.
• Seek tetanus toxoid immunizations for yourself. (This is applicable to mothers andother women of childbearing age.)• For campaigns, bring children of the recommended ages to immunization sites on
the day(s) recommended. For a house-to-house strategy, keep those children aroundthe home and have them immunized when the team arrives.

Fathers• Bring children to immunization service delivery points yourself, or encourage theirmother to do so.
• Provide mothers with money for transport or other expenses related to immunizingchildren.

Health Workers• Perform immunization tasks correctly, including those that ensure safe injections.
• Give mothers and other caretakers essential information.
• Schedule and organize services to make them convenient for parents.
• Praise families whose children are fully immunized by one year of age.
Political and Public Health Leaders• Allocate sufficient financial and human resources for immunization services.
• Show personal support for immunization services.

Community Leaders• Describe the benefits and safety of vaccinations to others in the community.
• Remind families when children need to receive the next dose(s) of vaccine.
• Encourage families to complete each child’s basic immunizations in his or her firstyear of life.
• Inform families about outreach services, supplemental immunization activities, andnew vaccines and improvements in the immunization program.
• Assist health facility staff in planning and monitoring services.
• Provide logistical support, e.g., by transporting vaccines, supplies, and staff.

Source: WHO, UNICEF, and USAID, 2002

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Chapter 9: The Role of Behavior ChangeIdentifying Barriers to Desired Behaviors
Indications that various groups are not carrying out the desired behaviors
can be found in low immunization coverage data, high drop-out rates, andincreased disease incidence. In light of such indications, program staff should
undertake additional information gathering to understand the causes of these
problems and, in behavioral terms, the gaps between desired and actual
performance.

Focus group discussions are
in-depth discussions, usually
lasting one to two hours, inwhich six to ten representativesof a target audience talk about
their experiences, attitudes,
perceptions and feelings
regarding a focused topic
under the guidance of a
facilitator. Participants are purposefully selected, for example, because they are mothersof fully immunized children or
fathers of drop-outs.

Credit: Ann Jimerson

Qualitative methods, such as focus group discussions and in-depth
interviews, can be used to discover reasons why people act as they do. The
methods selected depend on the nature of the questions to be answered andthe type of respondents. For example, parents and community leaders may
reveal information and beliefs in focus group discussions that they would notshare in one-on-one interviews. In-depth individual interviews, on the other
hand, work better with health workers, whose worry about giving “wrong
answers” regarding knowledge and practices may keep them silent in frontof their peers.

Focus group participants exchange views on healthrelated topics.

In-depth interviews are one-on-one conversations between an interviewer
and a respondent, held in a private, confidential setting. In effective interviews, respondents will offer insights into their practices, thoughts, feelings,
and beliefs.
Quantitative methods, such as knowledge, attitude, and practice (KAP)
surveys, are helpful in prioritizing causes and calculating the scope of problems identified through qualitative methods. Quantitative data may be usefulfor convincing decision-makers of the need to take action. They also provide abaseline for evaluating results.

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What Mothers Say about Vaccination
In focus group discussions, mothers in an African country expressed their perceptions and experiences:
1. Mothers’ knowledge of immunization is poor. More than half could not nameone vaccine-preventable disease. However, regardless of their level of knowledge or the vaccination status of their children, mothers universally embrace
the importance of vaccination for children’s health.
2. Side effects concern some mothers, but many accept the fevers and swelling as
normal results of vaccinating. Some even suggest that these side effects aredesired as proof that the vaccination is working.
3. The major reason children are not vaccinated is the distance to the place ofvaccination. Another barrier is competing demands on mothers’ time from otherchildren and fieldwork.
4. Mothers are frustrated by inconsistencies in service provision. “We lose our
motivation to go to the hospital because when we arrive there are often no
medicines.”
5. In some districts, scheduled vaccination by outreach is unreliable and of poor
quality.
6. Mothers value and protect their child’s health card like an identity card, andreport that a health worker won’t treat a child without it.
7. Mothers have varying views on how they are treated by health workers, ranging from “They’re marvelous” to “There are some that vaccinate as though they
are vaccinating a dog.”
8. Health education talks are the only form of education on immunization.
9. Focus group mothers considered mothers who don’t have their children vaccinated as “stupid,” “criminals,” or “witches.”
10. Mothers generally have confidence in the technical ability of health workers–
although the mothers do not feel informed enough to judge.
11. Illicit charging for services is not reported to be a big problem.
Such findings, once combined with results from other interviews and observations,will provide the basis for program actions.
While some of these findings are typical for many countries, others are not. For
example, distance to health facilities is a major barrier to coverage in this particular country because the government is still rebuilding health infrastructure after
years of war. Because of the variety of program circumstances in different countries, in-depth, but not necessarily large-scale, research is recommended in countries or districts that are trying to improve their coverage or reduce drop-outs.

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Chapter 9: The Role of Behavior ChangeCredit: Kelley Sams, BASICS II

Using a combination of methods
and exploring the same topic withdifferent groups may provide themost complete insights. For example,
in one setting, health workers conducted exit interviews to measureclient satisfaction after an immunization session, and the mothers interviewed reported no problems. Later,
focus group discussions conductedby independent consultants showed Exit interviews help health workers tounderstand parents’ concerns.
that these same mothers had serious problems with the way they
were treated by health workers. In separate interviews, the health workers
themselves explained that they treated parents firmly and sometimes evenharshly because they wanted parents to understand how important immunizations were. It took the presentation of findings from focus group discussions
with mothers to make health workers realize that such harsh behavior, thoughwell-intentioned, was driving the mothers away.
To avoid compromising the candor of responses, it is recommended that
health workers not serve as interviewers or group facilitators. If a program
does decide to use health workers in these roles, they should not do researchin the geographical area where they normally work.

Behavioral Analysis
To identify the barriers that seem to discourage a desired behavior and thefactors that support and motivate it, a strength-weakness-opportunity-threat(SWOT) type of analysis can be carried out. In the hypothetical example in
the three boxes on the next page, planners are investigating the reasons for ahigh immunization drop-out rate in a particular district. To help in the analysis,
they record current and desired behaviors and the barriers and motivating factors they have found in their research. They look at three different groups ofpeople who may be involved in the problem and who definitely should be
involved in the solution: health workers, parents, and community leaders.
Other groups might be included in another situation.

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Health Workers

Examples of Behavioral Analyses
Current
Behavior

DesiredBehavior

Barriers

Motivating
Factors

Few health workers(HWs) give information to parents
about the need toreturn with theirchildren for the nextdose(s) and when.

All HWs
always provide parents
with thisinformationand checkfor understanding

HWs don’t perceive the importance of informing parents when to
return for the next immunization.

HWs get positive
feedback from clients
when they communicate well.

They feel they don’t have time.

When communication
improves, HWs see
an impact in reduced
drop-out rates.

All parents
get their children immunized at
appropriate
ages andintervals, sothat they are
fully immunized before
their oneyear birthday.

Parents do not understand theimportance of their children completing the primary series of vaccinations on time.

Parents realize thatvaccines prevent
some dangerous diseases.

They do not know when to returnfor the next immunization.

They want to protect
their young children
from disease.

Few listen to parents’ concerns orcheck for understanding.

Parents

One-third of parents
do not bring theirchildren back ontime for subsequent
doses.

HWs believe that someone else in
the health facility is giving theinformation or that the information
on vaccination cards is adequate.

They feel intimidated by HWs.
They don’t expect to receive information, to understand it, or to geta response to their questions, andso they don’t ask.
Many families have other priorities,
so delay returning.

They want to do theright thing, i.e., maketheir children safe
from vaccine-preventable diseases.

Many families live far away fromthe health facility, or outreach services have been discontinued.

Community Leaders

Facility operations are poorly managed, e.g., sometimes children
who come to a scheduled session
cannot get vaccinated because
there is no vaccine.

156

Community leaders
are not engaged inensuring that children receive vaccinations on time andthat they are fully
immunized before
the age of one
year.

Leaders participate
actively ingettingresources foroutreach.

Leaders believe that the health sys- Child health is a pritem alone is responsible for making ority for communities.
sure that children are immunized.
Community leaders
They do not realize that they canlike to solve problems
actually do something to help.
that affect membersof their community.
They are contending with other

Leaders work social, economic, and health probwith HWs to lems.
schedule sessions at convenient
times.

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Chapter 9: The Role of Behavior Change

Community leaders
have some control
over local fund allocations.
Once they are actively involved, community leaders may well
see an impact on
reduced drop-out
rates.

The research and analysis describedabove should give planners a good
picture of feasible behaviors, barriers
that must be overcome, and positive
knowlege, perceptions, and circumstances. They can then devise appropriate program actions to promote andfacilitate those behaviors. Suchactions often include communication,
training, service improvement, policy,
and other activities.

Credit: Kelley Sams, BASICS II

Behavior Change
Strategies

Community members plan how to mobilize
mothers and children for immunization.

Communication Strategies
Communication specialists differentiate among various types of communication
depending on the purpose of the communication and the target audience they
are trying to reach. Although different researchers and organizations do notalways share the same terms to describe the same concepts, some widely
accepted definitions are found in the box.
Types of Communication
Communication can raise awareness, increase knowledge and motivation, and facilitate people’s actions. Communication activities include behavior change communication, social mobilization, and advocacy.

Behavior change (or program) communication encourages actions amongtarget populations that directly support more effective immunization coverage and disease control; for example, providing information, motivation, and job aids so that
health workers will treat parents with respect, give information clearly, and encourage
parents to bring children for vaccinations as soon as they are due.
Social mobilization aims at gaining and maintaining the involvement of a broad
range of groups and sectors; for example, by holding a series of meetings with representatives of private companies, other government agencies, and NGOs to discuss
how they can support polio eradication as well as routine immunization. Social mobilization also includes mobilizing the public to participate in immunization activities.
Advocacy focuses on gaining and maintaining the support of political leaders, opinion leaders, and other decision-makers; for example, by making presentations and producing an information packet that describes the burden of hepatitis B disease and how
this audience can support efforts to reduce it.
Adapted from UNICEF and WHO, 2000

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Communication Channels

Communication experts have foundthat the best channels for reachingrural people are health workers, local
leaders and groups, and, in somecases, radio. It is generally not very
effective to use print materials with
low-literacy populations or mass media
for those with little access to televisionand other mass media. Generally, parents perceive health workers as acredible source of information about
health. Growth promotion and IMCI
(Integrated Management of Childhood
Illness) contacts provide excellent
opportunities for health workers to assess a child’s immunization status andthen to give needed vaccinations or advise caretakers how to get the vaccinations as soon as possible.
Disscussions between health workers and small groups of parents can be held
as part of immunization sessions and on other occasions in and outside of ahealth facility to:• Address people’s doubts about immunizations• Identify and fill information gaps and correct misinformation• Respond to questions• Reinforce positive attitudes andbehaviors
One-on-one counseling is the best
way to give parents information onwhen and where to bring their childfor the next vaccination. However,
simply giving people information is
not enough; the message must be
understood and remembered, as
shown in the box.

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It Was Said, but Was it
Understood?
In a study conducted in the Northwest
Frontier Province, Pakistan, healthworkers were observed telling 85% of
the mothers when to bring their children for the next vaccination. Exit
interviews held later the same morningwith these mothers indicated that only
8% remembered when they were supposed to return!
Source: PRICOR, 1990

Credit: Kelley Sams, BASICS II

Immunization programs use numerous communication channels to reach parents and other target audiences, from radio and television, to folk media, tocommunity events, to counseling at health facilities. Too often, decisions about
what channels to use are based on the beliefs and personal preferences ofpeople who think they know the target audience well but in fact do not. If thedecision is not based on good evidence on how to reach the audience(obtained from evaluations and/or formative research), the choice of communication channels may well be inappropriate.

Mass communication media can complement the basic channel of interpersonalcommunication, but it is not a substitute for it and is inadequate by itself. In
Mozambique, the national immunization program staff developed the following
materials to support both interpersonal communication and mass media when
they introduced Hep B vaccine into their routine program.
Materials for Introducing Hep B Vaccine
Materials Intended Use

Main Messages

Booklet for A reference for health workers to describe their responhealthsibilities and help themworkers
respond to parents’ questions

What health workers have to do to introduce
Hep B vaccine
Basic facts about hepatitis B disease and vaccine

Booklet for A reference for community,
What leaders can do to provide support
community religious, and social leaders
Basic facts about hepatitis B disease and vaccine
leaders
to help them plan support
activities and respond to the
public’s questions
Posters

To raise public awarenessand provide information
about the immunization
scheduleChildhood vaccines offered by the national
immunization program, including the new vaccine
Ages at which children should get vaccines
The importance of immunization for child healthRadio and To raise awareness among
television
the public, local and nationspots
al leaders, and health staff

Increased protection to the public through new
vaccine and auto-disable syringes
No additional visits and injections needed tobenefit from the new vaccine

On the right is an illustration of the use of flags to notify
communities when and where vaccination will take place.
Note the use of “countdown” flags to inform people that thevaccination session will be held in three days, two days,
and one day. The flags demonstrate a public
commitment by healthworkers that the session will take place,that they will provide
community memberswith advance notice,and that they will
announce thesession’s start.

Credit: JSI/Madagascar

Reinforce that caretakers should bring their children to receive all basic childhood immunizations

Flags indicating countdown to vaccination session.
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Content. The content of the communication is as important as the channel.
There is ample evidence that shows that because most parents already knowthat immunizations prevent some dangerous diseases, they do not need further
convincing nor hear clinical details. The most essential information they need iswhen and where they should bring their child for his or her next immunization,
what common side effects they might expect, and what they should do if thesedo occur. In addition, if any rumors or common misconceptions regarding
immunization are detected, they should be corrected (see Chapter 8).
Advocacy and social mobilization. Advocacy and social mobilization
techniques can be used to inform political leaders, community members, andpartners about upcoming events and activities and increase their participationin them. Health workers at all levels should talk with leaders and other influential people individually, hold joint planning meetings and provide informational materials. The communication techniques discussed above can also be used
to mobilize the community. Historically, social mobilization has been used
more frequently to build support for campaigns than for routine immunization,
but it is needed for both.

How can health workers and managers learn and improve communication
skills, including promoting behavior change on the part of parents? Training,
reinforced by supervision and reporting requirements, can increase healthworkers’ knowledge andimprove technical and communication skills. Where there are
educational, cultural, andeconomic differences thatprevent effective communication between health workers
and community members,
health workers may require
special training to recognize
and overcome these barriers.
Although training can help,changes may also be neededin the organization and patient flow during vaccination sessions, as indicatedin the sample behavioral analyses on page 156.
Knowledge. Like members of the public, health workers themselves sometimes have misconceptions about immunization. For example, some believethat giving a child antibiotics on the same day as a vaccination will destroy
the vaccine’s effectiveness. Some start the vaccination series all over again if

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Credit: Kelley Sams, BASICS II

Training to Improve Knowledge and Skills

a child comes late for a dose. Some fail to provide vaccinations because offalse contraindications. These health workers need technical information,
which is best acquired in a setting similar to their work environment.
Health workers also need information on key immunization messages, which
they can find in manuals from their country program or from internationalsources. Reading is not enough, however; people need to use knowledge inorder to retain it. Health workers also need to be confident that the health system in which they work (e.g., supervisors, vaccine supply) will support their
putting correct knowledge into practice.

Communication Skills. Effective communication begins when a healthworker starts thinking about what keeps people from coming to a healthfacility and/or what prevents them from returning. As noted above, people
may not get the information they need or may have unpleasant experienceswith health workers. To overcome
such communication problems,
health workers need skills in
listening, questioning, giving
instructions, and confirming thatthey are understood. These skills
are best learned by observing
good models of communicationand practicing using role plays
and simulations.

Supervision and Other
Strategies to Support
Positive Behavior

Credit: Kelley Sams, BASICS II

Technical Skills. With growing awareness of the fact that HIV/AIDS, hepatitis B, and hepatitis C can be acquired through unsafe injections, clients andparents are beginning to watch how health workers handle needles andsyringes, and what they see can inspire confidence or fear. Health workers
can build confidence among clients and parents by mastering skills in reconstituting and administering vaccines. They also need skills in such areas as forecasting vaccine and other supply needs, organizing fixed and outreachsessions, and handling waste. These skills are best learned from people who
do them well and should be reinforced through practice.

As part of training, health workers use role play
to practice their counseling skills.

For people to continue acting in positive ways, they need to feel that what
they are doing is having a desired outcome and few, if any, negative consequences. For example, if health workers discard vaccine vials because the

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Dissemination – A Critical Step
Dissemination is important! Unfortunately, after devoting substantial time and money todevelop guidelines, tools, and other print or electronic documents, too many people
and organizations then disseminate them in ways and formats that either do not reachor are not convenient for the intended audience to use. The materials often end up
warehoused at some intermediate point. A few general guidelines for more effective
dissemination are the following:
Design a dissemination plan that specifies:• who is supposed to use and therefore receive the materials• in what quantity end users need them• by what means they will be sent to the intended users• who is responsible for sending them
• the budget needed to do so.
Additionally,• Use those channels that are most convenient for the audience, not those most easily
used by the sender.
• Ask audience members what channels and formats are easiest for them to use.
• When feasible, make resources available in more than one format (e.g., print andelectronic) and via multiple distribution channels.
• Do not rely on electronic formats alone for dissemination.
• Do not depend on colleagues to take on the dissemination burden; no matter how
well intentioned, they are likely to be too busy to make this a priority.
• Monitor dissemination – that the material is reaching the intended people and thatthey feel it is appropriate and useful for them.

Supervision. Supervision plays a major role in supporting positive healthworker performance. Supervisors
can monitor performance and identify both successes and problems
and then help plan corrections.
They can help health workers monitor the impact of their activities.
Supervisors also can make surethat system supports are in place.
They should provide feedback to

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Credit: Kelley Sams, BASICS II

VVMs have changed color, they should be confident that they will not be punished for it, but rather recognized for taking the correct action. If they immunize a slightly ill child according to national policy, they should know thatnational immunization policies and their own supervisors will support them.

health workers, coach them, model positive behavior, and include interpersonal communication skills in performance evaluations.
Recognition. Parents and health workers alike feel motivated when others
notice and praise good performance. Some countries formally recognize afully immunized child by using a rubber stamp to mark a seal of completionon the child’s vaccination card or giving a diploma, as shown in the examples
from Kenya and Madagascar.

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System Support. Changes in individual behavior do not result in improved
services and higher coverage without complementary actions in other parts of
the health system. For example, managers must make sure that vaccines, injection equipment, and other supplies are available to meet increased demand
created by social mobilization and health promotion activities. The tableshows how communication activities and other interventions might interact tosolve the drop-out problem discussed in earlier examples.
Comprehensive Approach to Reduce Drop-Outs
Communication

Advocacy

SocialMobilization

Training

System Support

HWs learn how togive clear information to parents on
when to bring theirchildren back for the
next dose(s).

DHMT persuades local
politicians topublicly state
the importanceof completing
the immunization scheduleby the firstbirthday.

HWs organize women’sgroups to visit
families thathave dropped
out of theimmunization
program.

DHMT
arranges fortraining to
improve HWcommunication skills,
knowledge,
and behavior
towardfamilies.

HWs organize
facility operations
to enable them tospend more timewith each client.

Supervisors provide
job aids to remind
HWs of the key
messages.

DHMT perParents learn how tosuades local
use vaccination
politicians to
cards as reminders
provide finanabout next dose(s).
cial support
for outreachDistrict Healthvisits.
Management Team(DHMT) and HWs
explain at every
opportunity theimportance of completing the immunization schedule.
HWs and communities publicly recognize families whosechildren are fully
immunized by theirfirst birthday.

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HWs routinely
review
progresstoward targets
with community leaders.

If language isa barrier,
HWs find andtrain community volunteers
to help HWs
communicate
with families.

DHMT andmanagement at
higher levels planand implement
timely deliveriesof vaccines andsupplies.
Budget planners
include transportand per diems foroutreach inbudget.
Supervisors monitor and reward
good HW
communication.
HWs and theirown supervisors
use data to guide
appropriate
actions.

References
GAVI. 2000. Advocacy for Immunization. How to Generate and Maintain
Support for Vaccination Programs. Geneva: Secretariat for the Global Alliance
for Vaccines and Immunization.
Graeff, Judith A., John P. Elder, and Elizabeth Mills Booth. 1993.
Communication for Health and Behavior Change. A Developing Country
Perspective. San Francisco: Jossey Bass Inc. (HealthCom Project, Academy for
Educational Development, funded by U.S. Agency for International
Development).
PRICOR. 1990. Child Survival Report. Pakistan. Bethesda, MD: PRICOR.
Rasmusson, Mark R., Renata E. Seidel, William A. Smith, and Elizabeth Mills
Booth. 1988. Communication for Child Survival. Washington, DC: HealthCom
Project, Academy for Educational Development, funded by U.S. Agency forInternational Development.
Srinivasan, Lyra. 1993. Tools for Community Participation: A Manual forTraining Trainers in Participatory Techniques. New York: PACT, Inc.
UNICEF and WHO. 2000. Communication Handbook for Polio Eradication
and Routine EPI. New York: UNICEF and WHO in collaboration with Polio
Partners and Ministries of Health Representatives. Geneva: World HealthOrganization.
WHO, UNICEF, and USAID. 2002. Communication for Polio Eradication andRoutine Immunization. Checklists and Easy Reference Guides. Geneva: World
Health Organization. WHO/POLIO/02.06.
Wittet, Scott. January 2001. Hepatitis B Vaccine Introduction: Lessons Learnedin Advocacy, Communication and Training. Children’s Vaccine Program
Occasional Paper No. 4. Seattle: Bill and Melinda Gates Children’s Vaccine
Program.
Younger, Elizabeth, Scott Wittet, Carol Hook, and Heidi Lasher. 2001.
Immunization and Child Health Materials Development Guide. Seattle: Billand Melinda Gates Children’s Vaccine Program. PATH.
Full page photo credit: David Cantor, ORC Macro

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Chapter 10:
Costs and Financing“We know in our hearts that we are in the world for keeps,
yet we are still tackling 20-year problems with five-year plans
staffed by two-year personnel working with one-year
appropriations. It’s simply not good enough.”– Harlan Cleveland
As an investment in health, immunization is widely regarded as a “best buy.”
Immunization not only protects individuals and populations at low cost, butalso provides a platform for delivering other health interventions, such as vitamin A. As described in the World Bank’s World Development Report 1993,“In most developing countries…an ‘EPI Plus’ cluster of interventions in the firstyear of life would have the highest cost-effectiveness of any health measure
available in the world today.”As one of the most effective and affordable ways to control infectious diseases, immunization should be a financial priority for national governments
and donor agencies. If the financial commitment to immunization services was
reduced, the subsequent increase in morbidity and mortality would have serious social and economic consequences. Therefore, immunization clearlyrequires a sustained commitment even though the incidence of vaccinepreventable diseases has been significantly reduced.
Ultimately, the primary responsibility for ensuring sufficient financing for immunization services rests with governments of developing countries. Since national governments alone may not be able to provide all of the required funding,
it is a shared responsibility of the central government, district governments,
and communities to identify and mobilize the necessary resources to sustain
safe and effective immunization services.
Since infectious diseases do not honor national borders, and the full protectionof any child depends on the protection of all children, donor organizations
should share the burden of making services available and introducing new
vaccines. This shared obligation to immunize all the world’s children isembodied in the GAVI definition for sustainable financing (GAVI, 2001):“Although self-sufficiency is the ultimate goal, in the nearer term
sustainable financing is the ability of a country to mobilize andefficiently use domestic and supplementary external resources
on a reliable basis to achieve current and future target levels of
immunization performance in terms of access, utilization, quality, safety and equity.”

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The challenge of sustaining the resources for immunization is a task that falls
on many groups. National policy makers need to prioritize immunization services so that they compete successfully with other health services, donors needto provide support in ways that eliminate funding uncertainties and avoid
dependencies, and program managers need to take advantage of service
delivery efficiencies to minimize costs. All of these partners should assessneeds, calculate costs, monitor expenditures, arrange financing, and makeefficient use of resources without losing sight of the immunization program
goal to minimize the impact of vaccine-preventable diseases.

What Does It Cost to Provide Vaccination
Services?
Given frequent changes in the cost of new vaccines, new technologies, service
delivery strategies, labor, and the variation among countries, it is difficult tostate the actual cost of vaccination in absolute terms. However, it is useful to
examine some of the elements that go into the cost of immunizing a child.
Cost estimates, or budgets, usually include two categories: capital costs,
which last one year or more, and recurrent costs, which cover items that are
consumed in a year or less or services that are provided and paid for regularly. Some examples of the types of costs included in these two categories are:
CAPITAL COSTS

RECURRENT COSTS• Building space• Vaccines• Vehicles• Building operation and maintenance• Equipment: refrigerators, cold boxes,
vaccine carriers, steam
sterilizers, incinerators• Transportation: vehicle operation and maintenance, fuel,freight charges, fares for public transport, per diems• Long-term training(pre-service)• Personnel• Supplies: needles and syringes, ice packs, safety boxes,
fuel for refrigerators, reporting forms• In-service training• Materials for training, health promotion, social mobilization• Contracts with commercial or nonprofit organizations fortraining, social mobilization, fleet management

The table on the next page shows routine immunization expenditures in
Morocco, Bangladesh, and Côte d’Ivoire. This cost analysis indicates several
common trends across the three countries:• Personnel costs are over one-half of the budget.
• Vaccine costs account for the next highest share of the budget. Note thatthese costs are for the six traditional antigens only.
• Injection safety and social mobilization costs may be under-represented.

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Estimated Costs of Immunization Services in Three Countries

Number of surviving infants (1998)

Morocco(1997 - 1998)

Bangladesh(1997 - 1998)

Côte d’Ivoire(1998)

735,000

3,852,000

513,000

Annual Costs of Immunization Services (percent of total budget)
Recurrent costs
Personnel

62

56

65

Vaccines

17

27

16

Supplies

1

3

4

Transportation

<1

1

2

Short-term training

<1

<1

<1

Social mobilization

<1

<1

<1

Maintenance/overhead

2

1

2

Subtotal

83

89

90

Building

12%

6%

7%

Vehicles

<1

<1

<1

Equipment

442Long-term training

<1

<1

NA

Subtotal

17

11

10

Total Annual Costs

US$7,648,166

US$28,948,889

US$7,876,941

Percent of children fully
immunized (FIC)

83%

54%

65%

US$20.89

US$21.47

US$24.29

Capital costs

Cost per FIC
NA = not available

Adapted from Kaddar, Levin, Dougherty, and Maceira

These data provide historical information on the actual, but not necessarily
optimal, levels of expenditures. The ideal level of funding needed for each line
item should be determined by monitoring program performance and allocating sufficient funding to ensure that immunization targets are being met.

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What Costs Need to Be Included in an
Immunization Budget?
To develop a comprehensive immunization budget, managers need to calculate the full cost of all program elements that make up a specific immunization
service activity, even those that may not be obvious. Some common program
elements that should be budgeted include the following:• Vaccine• Cold chain• Needles, syringes, safety boxes, waste management• Disease surveillance• Supervision• Training• Management information systems• Social mobilization, communications, and advocacy

The following table illustrates
the types of expenses that need tobe considered in just one
program function.

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Credit: WHO

Each of these elements has several
cost components that should be
included when preparing a budget.
For example, a budget for vaccine
procurement should include not only
the cost of vaccines, but also freight,
insurance, and customs clearance.
Program areas such as cold chain,disease surveillance, and training
require expenditures for transportation, supplies, materials, and per
diems. In addition to such recurrent
costs, managers should remember toinclude costs for conducting special
studies (such as EPI reviews or injection safety studies) and developing,producing, and disseminating materials (such as training materials or cold
chain manuals).

Posters for national polio immunization
days on a boat for reaching distantpopulations.

Itemized List of Cost Components for Social
Mobilization/Communication/Advocacy
Program Function

Possible Costs to Budget

Audience research

Staff time
Consultants and/or subcontracts
Per diem, lodging, and travel expenses
Fuel
Supplies (e.g., paper, renting or purchasing computersand other equipment)

Strategy formulation

Staff time
Consultants
Per diem, lodging, and travel expenses
Meeting room rent
Supplies (e.g., paper, renting or purchasing computersand other equipment)

Development of print materials(for all audiences)

Staff time and consultant time (e.g., for writing, drawing,
photography, design, word processing)
Dissemination costs (postage, fuel, staff time)

Development and airing ofbroadcast materials

Staff time and consultant time (managerial, creative, andtechnical input)
Cost of subcontract to advertising firm
Air time

Development of local communication channels(e.g., drama groups, mosqueannouncements, miking, etc.)

Staff time and consultant time (managerial, creative, andtechnical input)
Cost of subcontract and/or of ongoing expenses (perdiem, travel, etc.)
Equipment purchase or rental

Pre-testing of materials

Staff and consultant time and expenses (per diem, lodging, travel) and/or subcontract
Supplies (e.g., paper, video equipment, tape recorders)

Production of materials

Printing
Audio and video recording and production

Training in communication,social mobilization, or
advocacy

Staff and consultant time and/or subcontract for planning, implementing, and evaluation
Training of health staff, local leaders, journalists, etc.
Per diem and expenses of participants
Training room rent

Monitoring and evaluation(routine monitoring and special
studies) of communication orsocial mobilization efforts

Staff and consultant time (e.g., for planning, implementing, data processing)Per diem, lodging, and travel expenses
Fuel

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Commonly Overlooked Costs

For example, one country’s immunization program, which planned
to utilize volunteers for social mobilization activities, budgeted for thebulk purchase of bicycles so as toprovide one bicycle per volunteer.
However, the manufacturer delivered the bicycles unassembled.
Local bicycle “repairmen” had tobe hired to properly assemble thebicycles, which added significant,unforeseen expenses. This required Budgets should include the cost of vehicle
repair and replacement.
diverting funds away from other program areas.
The box below notes costs that are commonly overlooked in the developmentof immunization budgets. To avoid overlooking necessary costs, partners supporting immunization in a given country should jointly develop common immunization plans that cover all aspects of the program, including equipment andsupplies. This approach helps to ensure the compatibility of spare parts, identify long-term repair and maintenance needs, and simplify training plans for
personnel who use the equipment and supplies.
Commonly Overlooked and Under-Budgeted Items
The following items tend to be overlooked in budgeting for immunization services.
• Spare parts, tools, fuel for equipment, and labor costs for repair and maintenance• Waste disposal• Per diem and travel expenses for outreach, surveillance, and supervision• Public announcements and other communications for routine immunization• Replacing capital equipment, such as vehicles and refrigerators
It has been estimated that recurrent costs account for approximately 70% of the
lifetime cost of a piece of equipment! A simple donation of a piece of equipment
can generate an expensive legacy for the recipient.

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Credit: WHO

It is important to make sure that all necessary costs have been included,
because when a cost is overlooked, additional resources must be found to
avoid compromising safety, quality, or the services themselves.

Costs in Transition: Vaccine and Waste Management
Vaccines. One budget line item that needs special attention is vaccine.
Dramatic changes are taking place in the vaccine industry:• Fewer manufacturers are producing new vaccines.
• Manufacturers are developing new vaccines and new combinations ofvaccines.
• Periodic shortages, even of traditional vaccines, may emerge.
Each of these changes will be felt in the price and availability of vaccine.
While the dynamic vaccine market presents a significant opportunity to
improve the public health impact of immunization, it also underscores theneed for careful financial planning to ensure a steady supply of the necessary
vaccines. Country program managers need to be aware of these changes in
the global market and work closely with national financial planners to ensurethat the resources are available to meet all vaccine requirements.
Example of the Impact of New Vaccines on Vaccine Costs
One African country decided to introduce pentavalent DTP-Hep B+Hib vaccine into its
routine schedule. This decision raised the total annual cost of vaccines for the country
from just under $1 million to about $8 million. The line item for vaccines jumped from
26% to 60% of the total immunization budget.
An important challenge is to ensure that this sudden increase in the vaccine line item
does not displace other budget line items. If vaccines are paid for at the cost of cold
chain replacement or fuel for outreach services, the impact of the new vaccines can bedevastating to the overall program. New vaccine costs must be met with new
resources.

Waste Management. As the field of immunization evolves, some programmatic areas increase in importance, resulting in funding needs that had notpreviously been fully recognized. One such area is that of waste management
for contaminated needles and syringes. Increased efforts to reduce the spreadof HIV/AIDS, hepatitis B, and other blood-borne pathogens have led to more
attention to the area of injection safety, including waste management. Because
there is no standard approach for waste management and practical solutions
to the problem are still being sought, there is no standard unit cost to include
in budgets. Nevertheless, managers should prepare plans and budgets that
address waste management to the extent possible, basing budget estimates on
local circumstances and the best information available.

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173How Can Different Service Delivery Strategies
Affect Cost?
A variety of service delivery strategies are needed to reach different segmentsof the population. Some strategies that are less costly may be more appropriate and effective for reaching some groups, while other, more costly strategies
are required to provide services to dispersed, or otherwise hard-to-reachgroups. At first glance, the less costly strategies may seem to represent more
efficient use of resources; however, efficiency includes the dimensions of bothcost and effectiveness. If providing services at a low cost does not achieve thedesired programmatic goal, then it is neither efficient nor cost-effective. Thus,
it may be necessary to spend more money in order to achieve the desired target for the hard-to-reach segments of the population. The following example
from one African country demonstrates this concept.
Location and Tactics Affect the Cost and Effectiveness of
Immunization
Catchment Area 1: High Cost

Catchment Area 2: Low Cost

Key characteristics of the area

Key characteristics of the area

Scattered population
Cost of transport highTeam organization and tactics

Densely settled population
Cost of transport low
Team organization and tactics

The team was large.

The team was small.

It provided services at many posts
that were far apart.

It provided services at a few posts thatwere short distances apart.

It returned to headquarters several times
every month for re-supply.

It returned to headquarters once a monthfor re-supply.

It identified eligible clients, traced clients
who did not use the services, andfollowed up on drop-outs.

Community members enumerated eligible
clients for the team, traced clients who did
not use the services, and followed up on
drop-outs.

Adapted from Foster et al.,1998

Maximizing the use of immunization resources requires more than accurately
assessing the comparative costs of line items, service delivery strategies, or
activities. Planners also need to weigh the effectiveness of each strategy.
What proportion of the target population will be reached? What is the likely
impact of delivery strategies on other aspects of the health system and on various public health objectives?

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Costs of Supplemental Immunization Activities

Credit: WHO

Budgets for special disease
control initiatives andoutbreak campaigns containthe same line items as budgets for routine vaccination,
but the proportions and theoverall size of the budgets
are different. Costs for
expanded outreach anddoor-to-door vaccination
strategies are generally
higher than for routine
vaccination because of theneed for more vaccines,
personnel, transport, andper diem. Additionally, costs
for social mobilization,communications, and media
are usually higher so as tocreate broad awarenessabout the campaign.

How Can Resources Be Used Efficiently andEffectively?
A critical consideration in any planning and budgeting exercise is the effective and efficient use of funds. Efficiency implies a minimum of expense andwaste for reaching the desired results. However, as described earlier, to reach
their public health objectives of controlling disease, some immunization programs must spend more money per mother or child than other programs. Thus
there should be a careful balance between efficiency and effectiveness,because systems that minimize expense to the detriment of effectiveness are
not efficient. For example, if there is only one opportunity to immunize a childfor a disease such as measles, but this means opening a multi-dose vial for
only one child, the public health importance of immunizing the child should
outweigh the cost inefficiency of opening a vial for only that child.
Efficiency in immunization programming can be achieved in many ways.
Reducing waste is one important way, as is organizing services so that they
achieve the desired impact with the minimum of cost. Efficiency can also be
addressed through decentralizing decision making so as to allow for more
timely and appropriate local response to problems. However, this may require
investments to build the technical and managerial capacity of local and

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regional personnel. Many health care systems are organized inefficiently inthat they depend heavily on centralized authority to initiate local action. Betterorganization of services can lead to significant savings in costs; for example,
well-publicized and appropriately scheduled outreach sessions can reachlarge numbers of clients.
The flow of funds to where they are needed is an important aspect of efficiency. In order to ensure their effective use, resources need to move in a timely
manner to the level in the health system where they are required. Bottlenecks
in this flow seriously impair the efficiency of the program and can significantly
reduce impact. ICCs may be able to play a useful role in identifying and taking steps to remove such bottlenecks.
Some other ways to increase the efficiency of available resources that are
addressed in this book include:• Reducing drop-outs (see Chapters 3, 4, and 9)• Reducing missed opportunities (see Chapter 3)• Including other interventions during outreach, for example, vitamin A supplementation (see Chapters 3 and 12)• Scheduling sessions according to the needs of the target population(Chapter 3)• Limiting vaccine wastage by protecting vaccines from freezing, using vaccine vial monitors, and implementing the policy on opened multi-dosevials (see Chapter 6)• Designing activities such as disease surveillance and social mobilization
so that they serve objectives in addition to the immediate intention, forexample, social mobilization for polio campaigns should also inform mothers about other routine immunization services (see Chapters 8 and 9).

What Does It Cost to Reach New Targets?
Most ministries of health and immunization managers seek to improve vaccination services by increasing coverage, adding new vaccines, improving
injection safety, reducing drop-outs, or strengthening disease surveillance.
Each of these improvements carries with it costs that need to be reflected in
immunization budgets, as detailed in the example on the next page.

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Cost Implications of Increasing Vaccination Coverage byExpanding Outreach Services
Reaching new targets requires careful and detailed budgeting. Regardless of the newtarget or the strategy used to achieve that target, there are common steps to follow inorder to budget for all components of the strategy. These steps are described below
and illustrated by an example using hypothetical data for strengthening outreach services to increase coverage.

Step 1 What objective are you trying to achieve?
• Increase coverage

Step 2 How will the objective be achieved?
• Strengthen outreach

Step 3 What will be the strategy for strengthening outreach?
• Vaccinators will be provided with bicycles, equipment, and per diem to conduct outreach in under-served areas.

Step 4 What are the costs associated with this strategy?
• Transportation – bicycles, repair kits
• Transportation – maintenance, spare parts• Per diem
• Vaccine carriers and ice packs• Training• Supervision

Step 5 What assumptions need to be considered in developing a budget for the
strategy?
• Number of health facilities and outreach teams (500)• New material needed for each health facility• 1 bicycle ($100)• 1 vaccine carrier and ice packs ($15)• 1 bicycle repair kit ($10)• One day of training for health workers at the district office (50 districts x $200)• Number of villages to be covered with outreach services (5,000)• One outreach session per village per month• Per diem ($1)
• On average 10 villages per health center• Fuel for district supervision of health facilities (2 visits per year)• Replacement of 10% of bicycles per year
• Maintenance of bicycles per year ($10 per bicycle)

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177

Step 6 What factors need to be taken into account in order to develop a multi-year
budget?
• Target population• Population growth• Coverage rate
• Inflation rate
• Vaccine costs• Vaccine wastage rate
• Life expectancy of equipment (replacement)

Step 7 Calculate specific costs associated with outreach.

Calculation of fuel for supervision
Year 1

Year 2

Year 3

Year 4

Year 5

1,000

1,000

1,000

1,000

1,000

Avg. distance from district HC

20

20

20

20

20

Avg. km/liter petrol

15

15

15

15

15

Cost of petrol/liter

1.10

1.21

1.33

1.46

1.61

Total cost of fuel for supervision

1,467

1,613

1,775

1,952

2,147

Number of HC visits, each HC visited 2
times per year

Calculation of total cost of per diemYear 1

Year 2

Year 3

Year 4

Year 5

Number of outreach sessions

60,00060,00060,00060,00060,000Per diem

1.00

1.10

1.21

1.33

1.46

Total outreach per diem
Number of supervisory visits with perdiem (20% of total)

200

200

200

200

200

Per diem

1.00

1.10

1.21

1.33

1.46

Total supervisors per diem

200

220

242

266

292

Total cost of per diem

178

60,000 66,000 72,600 79,860 87,846

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Chapter 10: Costs and Financing

60,200 66,220 72,842 80,126 88,138

Step 8 Prepare a multi-year budget based on the assumptions in steps 5 and 6, andthe calculations in step 7.

Sample Five-Year Budget forStrengthening Outreach Services
Unit
cost

Year 1

Year 2

Year 3

Year 4

Year 5

Bicycles

100

50,0000

0

00

Vaccine carriers and ice packs

15

7,500

0

0

0

0

Bicycle repair kits

10

5,000

0

0

0

0

Bicycle replacement

100

0

5,500

6,050

6,655

7,321

10

5,000

5,500

6,050

6,655

7,321

Capital costs

Recurrent costs
Maintenance of bicycles
Training

10,00000

00Fuel for supervision

1,467

1,613

1,775

1,952

2,147

Total cost of per diem

60,20066,22072,84280,126

88,138

Total

139,167 78,833 86,717 95,388 104,927
Kress, 2002

Cost Implications of Introducing a New Vaccine
With the introduction of new vaccines and new
formulations, the most obvious line item to consider is that for vaccines: vaccine costs will increase
dramatically in national immunization budgets.

Immunization managers who plan for the
expansion of the program need to work closelywith financial planners who budget for theoverall health sector costs. Poorly conceived
and planned expansion will most likely fall shortof goals and undermine confidence in the
immunization program. The actual and full costof any change to the immunization program must
be carefully calculated and presented todecision-makers.

Credit: WHO

Important, but less obvious, costs associated withnew vaccine introduction include additional cold
chain capacity, training of health workers in correct vaccine administration, and public education
to inform parents about the added benefits of the
new vaccine.

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179How Can Vaccination Services Be Financed?
It is important to identify adequate and sustainable sources of financing inorder for immunization programs to be effective. Financing needs to be sufficient, provide for all appropriate vaccines, ensure that immunizations aredelivered safely, and reach all the children in the country. Today’s funding
environment allows health sector officials to choose from a wide variety ofoptions in selecting appropriate financing mechanisms for immunization.
In addition to these financing sources, there are mechanisms such as revolving
funds, which do not necessarily provide funding but which allow countries toovercome obstacles such as the need for hard currency or advance payment
for vaccines.
Some financing mechanisms, while appearing to be effective solutions to funding problems, may have unintended consequences that actually work to thedetriment of the immunization program. One example is user fees.
User Fees
Many countries have experimented with charging user fees for immunization in a variety of circumstances with mixed results. Reviews of such experience have found thatfunds raised through user fees are not necessarily used for intended purposes, and insome settings, user fees were found to act as a disincentive to seeking immunization
services. These findings have led the Board of GAVI to issue the following statement:“The GAVI Board recommends that in the absence of compelling country or regional
data unequivocally documenting their value, user fees should not be levied in publicly
financed national immunization services.”

Each type of financing has advantages and constraints that need to be carefully assessed with respect to the structure of the immunization program and its
intended goals. Along with planning and management, financing is a critical
determinant of whether programs reach their goals. Careful examination ofeach financing mechanism’s characteristics is needed before selecting anappropriate strategy. It is recommended that a financing strategy be evaluatedbased on the following criteria:
Does the mechanism:• Promote equity• Achieve efficiency (cost effectiveness)• Provide resources in an adequate, timely, and reliable manner

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• Engender accountability• Encourage maximum self-sufficiency
While each country is different in areas such as public health policy, regulatory structure, governance, macroeconomic context, and its relationship withexternal donors, this table provides some insight into how each mechanism
would perform in light of these criteria.

Characteristics of Financing Options: A Summary
Financing
option or
mechanism

Promotes
equityAchieves
efficiency

Provides adequate, timely andreliable resources

Engendersaccountability

Encourages
selfsufficiency

Domestic public
General+/–revenues
depends on(central level) tax structure+– /+requires no allocation is often
additional lower than proresources to gram requiremanage
ments; delays inaccessing funds;
potential exists forhigh levels of funding+/–
depends on
quality of
public administration+

General–revenues
depends on(sub-national) tax structure;
poorer subnational units
are disadvantaged+–
requires no allocation is often
additional lower than proresources to gram requiremanage
ments; delays inaccessing funds+/–
depends on
quality of
public administration+

Social health+/–insurance
depends on(compulsory) solidarity ofsystem–may havehigh administrative
costs

+

+

+

+ generally positive effect– generally negative effecto no clear positive or negative effect; depends on country conditions+/– both positive and negative effects

Immunization Essentials
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181Characteristics of Financing Options: A Summary (cont’d.)Financing
option or mechanism

Promotes
equityAchieves efficiency Provides ade- Engenders
quate, timely accountand reliable ability
resources

Encourages
self-sufficiency

External public
Project grants

o

–
+/–
requires additional year-to-year
resources to man- allocations
age
can vary
greatly+–

Debt relief proceeds++
requires no additional resources tomanage++/–depends on
how procedures are
established
for tracking+

Sector-wide
approach(SWAps)

+

+

+

+

–

Budget support

o

+

+

+

– /+
can contribute tobetter sectoral planning

+

– /+

requires few additional resources tomanageGAVI/Vaccine
Fund

o

+

+

requires few additional resources tomanageaccountability based onprogramresults

Mixed external and domestic public
Developmentloans(no interest)

182

+/–

–

depends
on future
tax structure

requires additional
resources to manage

Immunization Essentials
Chapter 10: Costs and Financing

+

+

+

Characteristics of Financing Options: A Summary (cont’d.)Financing
option or
mechanism

Promotes
equityAchieves
efficiency

Provides adequate, timely andreliable resources

Engendersaccountability

Encourages
self-sufficiency

–

–

–

+

o

+

+

+

+

+

Domestic private
User fees––+

requirespositive, thoughadditional small contribution
resources to to volume ofmanageresources
Crosssubsidies

Healthinsurance

+/–

–

+

depends on requires
positive, though
who pays the additional small contribution
subsidiesresources to to volume ofmanageresources––
may havehigh administrative
costs

+

Financial Instruments
National trust
funds

o

+

may havesteady availability
high admin- of funding
istrative
costs

e.g., endowments
Revolving
funds

–

o

+
typically
reducesmanagement
burden+access to foreignexchange on areliable basis

Source: GAVI Financing Task Force, 2002

A recent addition to external public financing is the Vaccine Fund. Establishedin 1999 with a grant from the Bill and Melinda Gates Foundation and bolstered by subsequent contributions from many donor governments, the Vaccine
Fund is the funding arm of the Global Alliance for Vaccines and Immunization(GAVI). GAVI encourages the strengthening of national immunization programs and increased coverage through many approaches, for example byadvocating for financial commitment to immunization and providing support in
the form of grants.

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183

The Vaccine Fund
The Vaccine Fund, the financial arm of GAVI, was set up to strengthen basic immunization services and support the introduction of new and underused vaccines. The
Vaccine Fund purchases vaccines ( i.e., Hep B, Hib, and yellow fever) along with
auto-disable syringes and safety boxes and provides financial support for immunization service strengthening. It does not pay for traditional vaccines for the routine immunization system, although it does pay for combination vaccines that contain DTP.
All countries with populations under 150 million and per capita GNP less than $1000– over 70 countries – are eligible for support from the Vaccine Fund. Separate procedures have been negotiated to provide assistance to China, India, and Indonesia,
whose populations exceed this guideline. Countries must meet four conditions toreceive initial support:
1. The country must have a functioning Inter-agency Coordinating Committee (or anequivalent collaborative mechanism) that focuses on immunization to ensure local
coordination and accountability.
2. The country must submit a recent assessment of immunization services.
3. The country must submit a coherent, multi-year plan for immunization.
4. The country must have an injection safety plan.
Other requirements for renewed funding include the provision of financial sustainability
plans and evidence of responsible and effective use of funds.
Source: GAVI

Several other external financing mechanisms are getting increased attention.
HIPC II (Highly Indebted Poor Countries II) is a debt relief program administered by the World Bank that was introduced in 1999 by the Group of Seven
industrialized countries to support poverty reduction activities. In some HIPC II
countries, resources no longer targeted for debt relief have been set aside for
immunization services.
SWAps (Sector-Wide Approaches) are arrangements in which external donors
pool their funds and direct them to the overall health budget rather than to
specific programs. The recipient government works with the donors to set priorities and decide how the funds will be distributed. Many developing countries prefer this approach because it gives them decision-making authority forthe use of the funds.

What Needs to Be Done to Obtain Funding?
The primary responsibility for identifying and mobilizing funding for vaccination services rests with the governments of developing countries. These governments need to take the leading role to secure a sustainable level of funding,from both domestic and external sources, to ensure the achievement of thecountry’s immunization goals. Governments can consider several actions topromote sustainable financing.

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These include:• Develop a targeted program to reduce barriers to access through newdelivery strategies, including involvement of the private sector, as appropriate.
• Promote allocation of resources on the basis of cost-effectiveness and public finance principles.
• Develop and implement a targeted program to reduce waste, with quantitative endpoints.
• Establish legal mandates for baseline funding of national immunization
programs.
• Engage development partners in informed discussion of resource requirements, and seek structured commitments to fill in key funding gaps.
A critical step that every country can take to mobilize resources for immunization is to develop a multi-year
plan. This plan should bebased on input from all partners. It should address operational deficiencies, define
programmatic priorities (suchas increasing coverage, introduction of new vaccines andreduction in drop-out rates),
establish realistic targets,
identify necessary inputs(such as technical assistance,
training, and managerial
tools), and present a clear
budget that takes into
account all capital and recurrent costs, including those overlooked costs mentioned earlier in this chapter. The plan needs to include a budget that takes into
account all the costs associated with achieving new targets.

Credit: Kelley Sams, BASICS II• Earmark funds and establish performance targets for sub-national entities.

In conjunction with the multi-year plan, countries should develop a financial
sustainability plan. This is a plan that assesses the financial issues that thecountry faces and defines a process for mobilizing the necessary resources
needed to achieve the country’s immunization objectives. As with the multiyear plan, the financial sustainability plan should be prepared in close coordination with partner organizations through the ICC.

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GAVI notes that a good financial sustainability plan should:• Serve as an advocacy tool
• Generate a clear picture of the financing situation and challenges• Develop relevant, realistic, and specific strategies and actions supporting
financial sustainability• Identify process and outcome indicators to measure progress towardachieving financial sustainability
Financial planning should always take into account the financial needs at alllevels of the health system. A plan that is fully funded for national-level activities is not necessarily fully funded at the operational level of the district. A
financial plan should be built from the ground up, accounting for all costs
required to meet program goals. All levels should provide technical review
and feedback prior to finalization.
The role of the ICC is very important to this process (see pages 33-35).
Ministry of health officials and donors need to be able to communicate openly
and effectively with each other to ensure sustained support for the health sector and immunization specifically. Donors need to be active participants in thisprocess and, when needed, draw on technical expertise to review plans andsuggest possible approaches. MOH officials need to understand the funding
cycles of donors and what constraints they are under in providing assistance.
Many donors are on one-year funding cycles that make it difficult for them togive long-term commitments of support. An open dialogue between donors
and MOH officials needs to be a priority for both sides in order to mobilize
the resources needed to achieve the immunization goals.

Sustainability of Immunization Financing
A successful immunization program should reach every child in the first yearof life, year after year. A sustained financial commitment is needed for immunization programs to succeed in preventing disease. Time-specific, short-termtargets may help programs focus attention and funding. However, achievements also need to be sustained beyond the target dates. To do so, funding
levels must be maintained. The level of required financial commitment increases as higher goals are set and new, more expensive vaccines are introduced
into the schedule.
In the past, sustainability was equated with self-sufficiency. However, GAVI
has moved the immunization community past that point toward a new conceptof sustainability that embodies the following principles:• It is a shared commitment and a shared responsibility of both governments
and their development partners.

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• It requires matching financing for expanding program objectives.
• It includes the concept of adequate and reliable financial resources, focusing not only on the quantity of funds but also on how well they reach theplaces where they are needed.
• It is related to both mobilization and efficient use of financial resources.
It is desirable, but difficult, to measure sustainability in a way that captures all
the important determinants and outcomes. GAVI has worked with countries
and international partners to develop and test a limited number of sustainability indicators that should allow both the detection of progress within a country
and comparisons among countries.
Sustainability also has political, technical, and organizational dimensions.
Immunization programs need to maintain a high level of political commitment
to ensure that appropriate policies are adopted and that the allocationof resources is adequate to provide a complete range of services to all
children. In addition, programs need to use the appropriate technologies andpractices for the setting, they need proper training and supervision programs,
and they need to be organizationally stable enough to provide services on acontinual basis.
Achievable objectives and sound planning and management are essential ifsustainability is to be achieved. Public demand can also contribute. Publicdemand for safe and effective services will help generate the political support
needed to sustain immunization programs and provide the necessary level offunding. Every aspect of good program management is critical to the sustainability of immunization and the development of secure and stable funding.
Sustainability is a shared commitment among all those who support immunization as an effective and important tool in the control of childhood morbidity
and mortality. Immunization has moved from being a local responsibility to a
global responsibility: it therefore requires a sustained global commitment thatwill ensure that all children receive its benefits.
The Director of WHO, the Executive Director of UNICEF and the President of
the World Bank noted that commitment when they stated:“Together we truly can deliver a ‘global public good’, a benefit for all, regardless of national borders, by making a concerted effort to use the tools that medically promise so much.
Immunization remains one of the best investments in healththat is within our grasp. We have a responsibility that wecannot ignore.”
Source: WHO, 2002

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References
Creese, Andrew, and David Parker, editors. 1990. Cost Analysis in Primary
Health Care: A Training Manual for Programme Managers. Geneva: World
Health Organization. WHO/SHS/NHP/90.5.
Foster, S.O. et al. September - October 1997. Sustaining the Benefits of
Immunization within Zambian Health Reform: A Review. Government ofZambia, WHO, UNICEF, DANIDA, JICA, and USAID (BASICS).
GAVI. (undated) Questions and Answers about GAVI and the Fund.
Immunization Advocacy Resource Kit.
GAVI Financing Task Force. March 2002. Immunization Financing Options: A
Resource for Policymakers. Geneva: GAVI Secretariat.
Kaddar, Miloud, Ann Levin, Leanne Dougherty, and Daniel Maceira. 2000.
Costs and Financing of Immunization Programs: Findings of Four Case
Studies. Special Initiatives Report 26. Partnerships for Health Reform.
Bethesda, MD: Abt Associates Inc.
Kaddar, Miloud, Marty Makinen, and Mona Khan. April 2000. Financing
Assessment Tool for Immunization Services: Guidelines for Performing aCountry Assessment. Health Reform Tools Series. Partnerships for Health
Reform. Bethesda, MD: Abt Associates Inc.
Kaddar, Miloud, Marty Makinen and Mona Khan. 2000. Financing
Assessment Tool for Immunization Services. PHRplus/USAID.
Kress, D. “Future Resource Requirements and financing.” Presentation at GAVI
Financial Sustainability Planning workshop, Nairobi, Kenya, July 17-19,
2002.
UNICEF. 1996. Sustainability of Achievements: Lessons Learned from
Universal Child Immunization. Report for a Steering Committee. New York.
WHO. 2002. State of The World’s Vaccines and Immunization. Geneva:
World Health Organization. WHO/V&B/02.21.
World Bank. 2000. World Development Report 2000/2001: Attacking
Poverty. New York. Oxford University Press.
World Bank. 1993. World Development Report 1993: Investing in Health.
New York. Oxford University Press.
Photo credit: WHO

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Immunization Essentials
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189Chapter 11:
New Vaccines and Technologies“If you always do what you have done, youwill always get what you have gotten.”– Anonymous proverb
New vaccines and technologies present both opportunities and challenges.
Changing one aspect of a system has broad consequences, so anticipating theeffects and preparing the system to accommodate them can mean the difference
between a positive outcome and chaos. Before deciding to incorporate new
vaccines into their immunization program, managers should assess the disease
burden and competing public health priorities. They should estimate the cost of
introducing and sustaining the new vaccine, identify funding sources, and analyze the impact on the health system as a whole. Once a change has been
implemented, monitoring and evaluation are required to assess progress andidentify any problems or unintended effects.
The introduction of new technologies should be treated with the same care.
Before making a decision and subsequent plans, program managers shouldcarefully consider the need for the technology, its likely benefits, its costs, thesystem changes needed to introduce and accommodate it, and how its use
will be monitored.
If carefully managed, the introduction process provides an opportunity to affirm
the importance of immunization, motivate health workers and members of thecommunity, improve services, and ultimately serve broader health objectives.

Introducing New Vaccines
The process of introducing vaccines into a national immunization program iscomplex, as discussed in the following summary of key decisions to be madeand factors that should be considered. Each of these factors is discussed in
more detail in other parts of this guide.

Policies
A new vaccine or technology may require changes in national policies as wellas guidelines to support the implementation of those policies. For example, theimmunization schedule usually has to be amended and guidelines introducedon vaccine storage, injection techniques, reconstitution, and the use of open
vials, among other matters. The revised policies should take into account boththe epidemiology of the target disease and the feasibility of putting these poli-

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Credit: WHOcies into practice. For hepatitis B vaccination, for example, the local epidemiology should determine whether
a birth dose is needed, but consideration is also needed as to how thebirth dose will be delivered to newborns. A new or changed delivery
strategy may itself require revisions inpolicies or guidelines if health personnel are to take on different responsibilities; for example, if traditional birthattendants are to administer the birthdose of Hep B vaccine.

A nurse in Malawi practices drawing up
pentavalent vaccine into a syringe.

Service Delivery Strategies
In introducing new vaccines, every effort should be made to maintain theexisting vaccination schedule in order to avoid creating additional visits thatare not absolutely necessary. This approach helps minimize confusion andinconvenience for both caretakers and health workers. The creation of an optimal service delivery schedule for vaccination sessions is best determined at
the district or sub-district level, taking into account the typical vaccination session size and the times and places that caretakers find most convenient. These
factors can help reduce drop-out rates, contributing to full immunization andthe efficient and effective use of all vaccines. For “traditional” as well as
newer, more expensive vaccines, a balance must be struck between achieving
low wastage rates and offering vaccination sessions frequently enough to
avoid prolonged exposure to the disease-causing organisms.

Target Population
When a new vaccine or vaccine combination is added to the routine schedule, managers and epidemiologists must identify the age group to receive thevaccine (see Chapters 4 and 5). In the start-up year of a new children’s vaccine, there are two cohorts to be considered:• Children between 0 and 11 months of age at the beginning of the year.
• Children born during the start-up year (the birth cohort).
In principle, the decision about whether to include the two cohorts or only thebirth cohort should be based on the age distribution of the disease, public
expectations, availability of the new vaccine, practicality, and cost. In reality,
however, funding restrictions are critical. For example, the Vaccine Fund supports the purchase of vaccines for the birth cohort only.

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If the vaccine being introduced is a combination vaccine (e.g., DTP-Hep B),
which includes a new vaccine (Hep B) and an old one (DTP), managers must
decide what to do with children who have already been vaccinated with one
or two doses of the old vaccine.
Using DTP-Hep B as an example, there are at least three options for phasingin the new vaccine:• One alternative is to give the new combination vaccine and then stop assoon as a child has received a total of three doses of DTP. This means thatsome children will be only partially protected with Hep B vaccine.
• A second option is to continue giving the new combination vaccine until achild has received the full series of Hep B. This means that some children
receive extra doses of DTP.

Vaccine Supply
The availability of a vaccine may belimited during the first years after its
Launch of pentavalent vaccine in Malawi,
introduction, as has been the case2002.
with new combination vaccines (seeChapter 5). The phasing out of an old vaccine and introduction of a new combination vaccine has to be timed carefully to avoid over- or under-stocking ofCredit: WHO• A third option is to use monovalent Hep B for children who have alreadybegun DTP and use the new combination vaccine for those whohave not begun the DTP series.
However, ordering, storing, andhandling more than one formulation of vaccine introduces substantial logistical and otherprogrammatic complexities.

Are Stocks of Traditional Vaccines at Risk?
Historically, the availability of traditional EPI vaccines has been more than adequate tomeet demand. In the last few years, however, ensuring the continuous supply of thesevaccines has become a serious problem in developing and industrialized countries
alike. Fewer manufacturers are producing vaccines, the supply has been reduced, andprices are increasing.
With the introduction of new formulations and combinations of vaccines, the dynamics
of vaccine supply are changing. Program managers and donors need to take this into
account as they plan for and provide long-term support to immunization services.
Although the benefit of these new vaccines is widely recognized, there are also concerns about maintaining consistent and dependable services to the public.

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either vaccine. Immunization program managers and ICC members should
develop contingency plans in the event that the anticipated vaccine formulations do not arrive in the required quantities at the specified time.

Cold Chain and Logistics
Immunization program managers must decide what vial sizes to order (seeChapters 5 and 6). For example, monovalent Hep B vaccine comes in one-,two-, six-, and 10-dose vial sizes. The most appropriate vial size should bebased on the number of children at a typical immunization session, the cost ofvarious presentations, storage requirements, and other operational factors.
Staff at all levels of the system (including the drivers who deliver the vaccines)
may need new instructions about vaccine storage. These instructions should
include the protection of both freeze-sensitive and heat-sensitive vaccines.
The addition of a vaccine to the immunization schedule may require increased
quantities of syringes and needles. The need for such equipment must be estimated and delivery schedules planned to ensure continuous supplies. Morespace may be needed to store auto-disable syringes and needles and safety
boxes. Vaccine arrival reports, stock control records, and requisition forms
may have to be revised.

Disease Surveillance
Program managers and epidemiologists need to decide what should bereported about the “new” disease, who should report such information, andhow often (see Chapter 8). Special training should be provided to enable
health workers to recognize and discuss the symptoms of diseases that are notoften seen or diseases that cannot be diagnosed on the basis of symptoms
alone. For example, health workers need to know that jaundice is a symptom
not only of hepatitis B but also of other forms of hepatitis and of yellow fever.
Therefore, they should be aware that the only reliable way to detect hepatitis
B infection is through serologic testing.

Communication
When a new vaccine is introduced, immunization programs should provide
needed information to two main target audiences via appropriate channels.
First, health workers need technical information on the disease and vaccine sothat they can administer it correctly and can provide essential information tocaretakers. On the other hand, parents or other caretakers need more concise
information, including the name of the vaccine, its benefits (in brief), the vaccination schedule, and possible side effects. For the most part, health workers
themselves are a primary source of information for parents, so it is especially
important that health workers are adequately prepared to advise parents andaddress their concerns.

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Hepatitis B: Inform but Don’t Confuse
In introducing a new vaccine, immunization programs should provide essential information that the public needs to be able to make informed decisions. However, providing excessive technical information is not necessary and may even confuse people.
In the case of hepatitis B, the technical story is quite complicated. Often acquired earlyin life, the infection is usually asymptomatic in children, who may however, become
carriers. In the 25% or so of carriers that do contract hepatitis B-related disease, thisusually happens only decades later. Moreover, if publicity surrounding the introductionof Hep B vaccine discusses jaundice, cancers, and other symptoms associated with
hepatitis, the public might expect the vaccine to prevent all such conditions.
Because of the difficulty of clearly explaining such complicated and subtle information,
it is recommended that immunization programs provide only general information on
the disease in public communication, while thoroughly preparing health workers toanswer people’s detailed questions.

Training
All of these changes mean that health workers, supervisors, and others need
new information and, sometimes, new skills (see Chapter 9). Managers willneed to identify who needs training, in what, for how long, and by whom.
Job aids and supervisory skills should be developed or upgraded to reinforce
the training.

Financing
Introduction of new vaccines requires additional funding. To help bridge theinitial resource gap, in early 2002 the GAVI Board approved the allocation of
a fixed amount of $100,000 to each country approved to receive support for
introducing new and underused vaccines. These funds help pay for changes
associated with their introduction. The national government, with the assistance of ICC partners, is expected to make additional resources available for
ensuring the continuous use of the new vaccines.

Planning
A plan is needed to manage the introduction process. Planning should begin
six to 12 months before the vaccine is to be introduced. The schedule shownon the following page, which was developed for the introduction of pentavalent vaccine (DTP-Hep B + Hib), illustrates the many steps and time needed. In
this example, note that planning began more than six months before the vaccine was introduced.

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Planning for the Introduction of Pentavalent Vaccine
Activity Area

2001
Q3

Training
Development of training materials
Conduct TOT for central and district level
Training of District Health Management Teams
Training of health workers, vaccinators and community
resource persons
Training of cliniciansSocial mobilization
Development, translation and production of IEC materials
Distribution of IEC materials
Advocacy and social mobilization meetings– central level– district level– sub-district and lower levels
Sensitization of health professionals, MOH officials, journalists and media operators
Intensified district-based mass media campaigns
Launching of vaccine
Vaccines & injection equipment
Place orders for vaccines & A-D syringes
Procure vehicle (trailer) for vaccine distribution
Arrival of vaccine into the country
Distribution to regions/districts
Distribution to health units
Introduction of vaccine
Planning
Development of micro-plans– central level– district level
Meetings of the National Task Force
Production of guidelines for district micro-planning

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2002
Q4

Q1

Q2

Planning for the Introduction of Pentavalent Vaccine (Cont’d)
Activity Area

2001
Q3

2002
Q4

Q1

Q2

Cold Chain
Assessment of cold chain capacity

Done

Procurement of cold chain equipment

On-going

Distribution of equipment

On-going

Cold chain maintenanceOn-going

Refill and distribute gas for fridges

On-going

Monitoring
Incorporate Hep B and Hib into existing HMIS forms
Introduce Hep B and Hib in the existing
immunization schedule
Print reviewed cards
Monitoring district preparation activities
Monitoring implementation of new vaccine
introduction
Develop monitoring tool for adverse events
Monitor adverse events
Surveillance
Hib rapid assessment

Done

Setting up Hib sentinel site
Carry out Hep B baseline survey

Done

Establish Hep B laboratory at national laboratory
Develop and disseminate case definitions and guidelines for Hib and Hep B
Orient/train surveillance focal points, records assistants, & HMIS persons in Hib/Hep B surveillance
Procure computers, e-mail for Hib and Hep B sentinel laboratories
Adapted from UNEPI, Uganda, 2000

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Monitoring and the Information System
When a new vaccine is added to the schedule, new or revised forms (including tally sheets and monthly coverage reports) are required for reporting disease incidence and coverage, and vaccination cards usually have to berevised (see Chapter 4). This may be an opportunity to improve the overall
information system. For example, managers may decide to monitor specificinformation that has not been routinely collected, such as the use and disposalof auto-disable syringes.
In the first year after introducing a new vaccine, it is particularly difficult toaccurately monitor coverage for that vaccine because of changes resulting
from the introduction process. For example, the vaccine may be introduced at
different times in different parts of the country. Revised vaccination cards,
record-keeping forms, and recording procedures may be put in place over thecourse of several months; this can lead to a lack of uniformity in reporting during the transitional period.

Vaccines in Development
The expanding universe of vaccine development offers the potential to prevent
additional diseases and improve the ease and safety of vaccine administration. However, it may require decades before some of the most exciting developments are proven safe and effective, and are available at affordable prices.
Approximate vaccine development time

The following vaccines for children in developing countries are at various
stages of development:• Meningococcal meningitis• Pneumococcal pneumonia• Rotavirus (a major cause of diarrhea)• Japanese encephalitis• Malaria

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Available Vaccines Not Widely Used in Developing Countries
Disease andAgent

Identification

Transmission

Occurrence and Incidence

Effectiveness and Limitations of
Available Vaccines

Meningococcal
meningitis

High fever, headache, andstiff neck

BacteriumThis form of meningitis canlead to brain damage,hearing loss, or learning
disability.

Close respiratory
contact with infected individual

Worldwide, especially in the“meningitis belt” in subSaharan Africa, causing
about 50,000 deaths per
year

Polysaccharide vaccine is not very effective
in children under two years of age. A conjugate vaccine, which protects children
under two for strain A, which causes mostepidemics in Africa, is under development.

Droplets, direct oral
contact, or througharticles soiled withrespiratory discharges

S. pneumoniae is a leading
cause of severe pneumonia inchildren under age five years
worldwide. This bacteriumcauses more than one million
deaths in children every year.

A 9-valent pneumococcal conjugate vaccinethat protects infants is on trial in Africa. If
trials go well, a license could be granted
by 2006.

Fecal-oral routepossibly spread byrespiratory or othercontact; may bepresent in contaminated waterWorldwide, accounts for over
500,000 deaths and approximately one third of hospitalized cases of severe diarrhea
in infants and children.

Work is in progress to improve the effectiveness of recently developed vaccines, limit
unwanted side effects, and lower costs.
Newer kinds of vaccines also are underdevelopment.

Neisseria meningitidis
Pneumococcal
pneumonia
Bacterium
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Chapter 11: New Vaccines and Technologies

Streptococcus
pneumoniae

Rotavirus diarrhea
Virus

Sudden onset with severe
shaking, chills, high fever,chest pain, shortness ofbreath, rapid breathing,and coughing

S. pneumoniae causes
acute respiratory disease,meningitis, and septicemia.

Vomiting, fever, and waterydiarrhea

Adapted from Chin, 2000. Control of Communicable Diseases Manual. See also fact sheets issued by CDC and NIAID.

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Available Vaccines Not Widely Used in Developing Countries, Cont’dDisease andAgent

Identification

Transmission

Occurrence and Incidence

Effectiveness and Limitations of
Available Vaccines

Japanese
encephalitis

Inflammation involving parts of thebrain, spinal cord, and meninges.

Bite of the Culex
mosquito.

2.4 billion people at risk in
Asia/Pacific region; 500,000
cases reported annually;
severe neurological damage in
one third of survivors.

An inactivated vaccine has been usedin several countries. Efforts are ongoing to develop alternatives withimproved safety, efficacy and affordability.

Bouts of fever accompanied by othersymptoms, alternating with periodsof feelings of freedom from any illness

Person to person
through the bite of
an infected female
Anopheles mosquito

Worldwide, with an estimated
300 million acute cases every
year and one million deaths

There is no vaccine available at this
time.

Virus

Malaria

Plasmodium
falciparum;
P. vivax; P.
ovale; and P.
malariae
Parasite

The most severe forms of malaria
result in organ failure, delirium,
impaired consciousness, and generalized convulsions followed by persistent coma and death.

Heaviest toll is in Africa, where
90% of the total deaths occur.
Malaria is the leading cause ofdeath in young children.

Research is focusing on two recombinant vaccines. One addresses the preblood stage of the parasite and would
prevent all infections. The otheraddresses the parasite’s blood-stage
and would support the acquisition ofnatural immunity by allowing a mild
form of the disease to develop without
the risk of severe disease or death.
Another vaccine in development would
prevent transmission of the disease
from humans to mosquitoes.
A combination of these types of vaccine is probable.

Adapted from Chin, 2000. Control of Communicable Diseases Manual. See also fact sheets issued by CDC and NIAID.

For any of these vaccines, disease burden, price, competing health priorities,
and health system infrastructure should be considered. The major features ofthese diseases and the status of vaccine development are summarized in
the preceding table.
Research is under way to develop vaccines against malaria, HIV, and tuberculosis, all of which are major causes of mortality. It is impossible to predict
when these vaccines will be available for use on a large scale.

New Technologies
Immunization services rely on technologies for storing, monitoring, and administering vaccines, and for disposing of waste. As the introduction of the vaccine vial monitor (VVM) has demonstrated, even relatively simple devices cancreate major changes in how services are delivered. Some of the technologies
under development are described below.

Needle-Free (or Jet) Injectors

Credit: PATH

These operate by ejecting a high-pressure stream of vaccine that penetrates
the skin when the injector is held
against it. Use of these injectors eliminates sharps waste. Work is under
way to reduce any risk of cross-contamination that may be caused bysuccessive use.

Needle Removal andStorage

Credit: PATH

The type of auto-disable (A-D)
syringes that are used in immunization programs have a needle that ispermanently fixed to the syringe. This
creates more sharps waste than sterilizable needles and syringes. Because
the needle poses a much greater
danger in the waste stream than thesyringe, removing the needle andstoring it safely eliminates the mosthazardous component. Needle
removal and storage technologies,
such as point-of-use needle removal,
are under development. There is some

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controversy as to whether the benefits of such devices in greatly reducing thevolume of sharps waste and securely storing contaminated needles is offset by
the disadvantage of adding extra handling steps for health workers in removing the needles. As described in Chapter 7, there is still the need for destruction of both the syringes and needles.

Vaccine Preservation
New technologies are being applied to improve the thermostability of vaccines. These promise to reduce the reliance on the cold chain, and thereby
increase the accessibility of vaccines to people living in remote areas.

Auto-Reconstitution
A process is being developed to link freeze-dried vaccine and diluent so thatthe mixing and injection steps are combined. This technology could reduce therisks of contamination and loss of efficacy in reconstituted vaccines, but is likely to increase the need for storage space.

Improved Rapid Field Diagnostic Tests
Researchers are working on simple tests for rapidly diagnosing diseases suchas measles and identifying high-risk areas and populations for tetanus. Suchtools will help planners decide what prevention strategies to use and where toconcentrate scarce resources.
A New Use for a Household Technology
Multi-dose vials from which at least one dose of vaccine has been removed are at riskof contamination from immersion in water. This contamination occurs when the perforated rubber stopper (septum) comes in contact with melted ice.
Health workers have found that when they put opened vials in resealable plastic bags(e.g., Ziploc® bags) and close them securely before putting the vials back in a coldbox, the vial septum stays dry and uncontaminated. An added benefit is that the vaccine label does not come loose and become separated from the vial as it does whenvials are soaked in water.
Clearly, technology does not have to be “high-tech,” high-cost, or new. But even simple
technologies should be thoroughly field-tested before they are recommended for widespread use.

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References
Chin, James. 2000. Control of Communicable Diseases Manual. Washington
DC: American Public Health Association.
Lloyd, John. 10 May 2001. Vaccine Delivery Technologies and Systems:
Priorities for Development. A discussion paper published in Technet Forum,
Post 00341.
NIAID. 2000. The Jordan Report: Accelerated Report on Vaccines. National
Institutes for Health. Bethesda, Maryland.
PATH. 2002. 2001 PATH Annual Report. Seattle: Program for Appropriate
Technology in Health.
WHO. October 2002. State of the World’s Vaccines and Immunizations
Report. Geneva: World Health Organization. WHO/V&B/02.21.
Wittet, Scott. 2001. Hepatitis B Vaccine Introduction: Lessons Learned in
Advocacy, Communication, and Training. Occasional Paper #4. Seattle: Billand Melinda Gates Children’s Vaccine Program at PATH.
Full page photo credit: Aventis Pasteur

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Chapter 12:
Vaccines and VaccinePreventable Diseases“An ounce of prevention is worth a pound of cure.”– Anonymous proverb
The Expanded Programme on Immunization (EPI) began with six vaccine-preventable diseases: diphtheria, measles, pertussis, polio, tetanus, and tuberculosis. In 1989, WHO recommended that yellow fever vaccine be used in
endemic countries. In the 1990s, hepatitis B and Haemophilus influenzae typeb vaccines were recommended where the disease burden was known or suspected to be high and control of the diseases was a public health priority.
This chapter describes the following vaccine-preventable diseases and the vaccines in use to prevent them:• Diphtheria• Hib Disease• Hepatitis B• Measles• Pertussis (whooping cough)• Polio• Tetanus• Tuberculosis• Yellow fever
Vitamin A deficiency (VAD), which is being addressed as part of national
immunization programs in many developing countries, is then discussed. The
chapter concludes with descriptions of vaccines that are not widely used indeveloping countries.

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Chapter 12: Vaccines and Vaccine-Preventable Diseases

Vaccine-Preventable Diseases
DiseaseAgentReservoir

SpreadDuration of immunity
induced by infection

Risk factors for infection
in developing countries*

Diphtheria

Toxin-producing
bacterium(Corynebacterium
diphtheriae)

HumansClose respiratory
contact or contact with
infectious material

Usually lifelong

Crowding

Meningitis and pneumonia caused by
Haemophilus influenzae
type b

Haemophilus influenzae
type b, bacterium

HumansClose respiratory contact

Usually lifelong

Not being breastfed

Hepatitis B (infection
increases risk of deathfrom liver cancer andcirrhosis)

Virus

HumansMother to newborn,child to child, blood,
sexual. In developing
countries, transmission
at birth or early childhood is dominant.

If infection resolves, lifelong immunity; otherwise,
lifelong carrier status

Crowding

Infected mother
Unsafe injections
Unsafe blood transfusions
In low endemicity situations:multiple sexual partners

Measles

Virus

HumansClose respiratory
contact and aerosolized
droplets

Lifelong

Crowding

Pertussis

Bacterium (Bordetella
pertussis)

HumansClose respiratory
contact

Usually lifelong

Crowding

Polio

Poliomyelitis virus –serotypes 1, 2, 3

HumansFecal-oral

Lifelong type-specificimmunity

Poor environmental hygiene

Close respiratory
contactVaccine-Preventable Diseases, Cont’dDiseaseAgentReservoir

SpreadDuration of immunity
induced by infection

Risk factors for infection
in developing countries*

Tetanus

Toxin-producing
bacterium

Soil

Spores enter bodythrough wounds or
through the umbilicalcord of newborns

None

Inadequately trained birthattendants(Clostridium tetani)

Animalintestines

Lack of supplies for clean andsafe deliveries
Exposure to animal feces
Untreated wounds

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Chapter 12: Vaccines and Vaccine-Preventable Diseases

Tuberculosis

Bacterium

HumansAirborne droplets(Mycobacterium tuberculosis)

Not known. Reactivationof old infection commonly
causes disease

Crowding
Immunodeficiency
Malnutrition
In adults, alcoholism, diabetes,and HIV

Yellow fever

Virus

Urban: humans Bite of infected
and mosquitoes mosquito(Aedes aegypti)
Forest: othervertebrates andmosquitoes* Risk factors in addition to the failure to be fully immunized

LifelongWorking in forest areas or living in urban areas infested bymosquitoes (Aedes aegypti)

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Vaccines Used in National Immunization Programs in Developing Countries
DiseaseNature ofvaccineFormulation

Usual number of Commdoses in primary on vial
series and route sizes*of administration

Diphtheria

Inactivated:toxoidLiquid3 doses of DTP —intramuscular

Haemophilus
influenzae

Inactivated:
Both freeze-dried and liqconjugate poly- uid
saccharide
Monovalent,vaccineDTP–Hep B+Hib,** andDTP+Hib**

Hepatitis B(Hep B)

Recombinant

Measles

Live attenuatedtype b (Hib)diseases

DTP, DT, Td

LiquidMonovalent,
DTP–Hep B,** and
DTP–Hep B+Hib**
Freeze-dried
Monovalent, measles-rubella (MR), and measlesmumps-rubella (MMR)

Pertussis

Polio (Oral
Polio
Vaccine)Inactivatedwhole-cell orprotein-based,
acellular

LiquidAvailable as DTP

Live attenuated Liquid
OPV contains 3
types of polio
virus

Stability at 37°C

Damaged by Duration offreezing?
immunity after
primary series

10 dose20 doseHigh (for approximately
6 weeks)Yes

3 doses —intramuscular

1 dose2 dose10 doseHigh in freeze-dried form Yes, in liquid
form
When reconstituted,
Diluent for
discard after six hours.
reconstitution
should not befrozen.

Through 5 years ofage, the age groupmost at risk for Hib

3 doses —intramuscular

1 dose2 dose6 dose10 dose20 doseHigh

Yes

More than 15 years

1 dose —subcutaneous

1 dose10 doseMedium in dried form.
When reconstituted,
discard after six hours.

Diluent should
not be frozen

Lifelong if boosted
by exposure to wild
virus; shorter when
no wild virus circulating

3 doses of DTP —intramuscular

10 dose20 dose50% loss in potency
after 1 weekYes

At least throughearly childhood

4 doses — oral

10 dose20 doseLoss of 20% potency
Noafter 1 day, 50% after 2
days

Variable; 5 to 10
years

Lifelong if boosted
by exposure to wild
virus; shorter when
no wild virus circulatingVaccines Used in National Immunization Programs in Developing Countries, Cont’d

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Chapter 12: Vaccines and Vaccine-Preventable Diseases

DiseaseNature ofvaccineFormulation

Usual number of doses inprimary series and routeof administration

Commonvial sizes*

Stability at 37°C

Damagedby freezing?

Duration of
immunity
after primaryseriesPolio(Inactivated
Polio
Vaccine)Inactivated,
whole-cell

Liquid3 doses — subcutaneous

1 dose10 doseLess than 5% loss ofpotency per day

Yes

Unknown but
suspected to be
many years

Tetanus

Inactivated: toxoid

LiquidDTP — 3 doses — intramuscular DTP:10 dosefor children
20 doseHigh = Stable forapproximately 6 weeks

Yes

5 years

DT — intramuscular for children DT: 10 dosewith contraindications for pertus- 20 dose
sis; booster for children throughTT and Td:
six years of age.
10 doseTT or Td — 5 doses — intramus- 20 dose
cular for schoolgirls and womenof childbearing age

High

Yes

More than 5
years

High

Yes

More than 30
years after fivedoses

IPV contains 3 typesof polio virus.

Monovalentform–TTMultivalent
forms–DTP,
DT, TdTuberculosis

Bacillus Calmette–
Freeze-dried
Guérin (BCG),
which is live attenuated Mycobacterium
bovis

1 dose — intradermal

20 doseMedium in dried formNo, but dilu- Unknown
When reconstituted, dis- ent should notcard after six hours.
be frozen

Yellow fever

Live attenuated

1 dose — subcutaneous

10 doseMedium in dried form

Freeze-driedNo, but dilu- 10 — 30 years
ent should not
When reconstituted, dis- be frozen
card after six hours.

*Availability of vial sizes varies by vaccine formulation and is subject to change.
** When designating combinations of antigens, — is used when combined antigens are presented in the same vial; + is used when they are presented inseparate vials and reconstituted before use.

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Diphtheria

Credit: WHO

Diphtheria is a bacterial infection caused
by Corynebacterium diphtheriae. The
infection can involve almost any mucous
membrane, but the most common sites ofinfection are the tonsils and pharynx. This
type of diphtheria can lead to obstructedbreathing and death. In tropical counA grayish membrane on the pharanx istries, the disease usually affects the skina well-known sign of diphtheria.
(cutaneous diphtheria) and may result inhigh levels of natural immunity against respiratory diphtheria.

Identification – In its tonsillar and pharyngeal form, diphtheria infection
results in the formation of a bluish-white membrane that can cover the back of
the throat, as seen in the photograph above. The membrane causes gagging
and difficulty in swallowing and breathing.

WHO-Recommended Case Definition: Diphtheria
Clinical description: An illness characterized by laryngitis or pharyngitis or tonsillitis
and the presence of an adherent membrane of the tonsils, pharynx, and/or nose.
Laboratory criteria for diagnosis: Isolation of Corynebacterium diphtheriae from a clinical specimen, or fourfold or greater rise in serum antibody (but only if both serum samples were obtained before the administration of diphtheria toxoid or antitoxin).
Source: WHO, 1998

Transmission – The type of diphtheria that affects the throat and respiratory
tract is spread in droplets and secretions from the nose, throat, and eyes ofan infected person. Skin diphtheria is spread through direct contact withdiphtheria ulcers or through clothing and other articles that have been
contaminated with fluid from the ulcers. Diphtheria can also be transmitted
through unpasteurized milk products.
Population at Risk – The epidemiology of diphtheria has changed considerably over recent decades due to improvements in sanitary conditions andimmunization coverage. In developing countries, the disease is occurring lessfrequently in very young children, and more outbreaks are being seen among
schoolchildren, adolescents, and adults.
Estimated Morbidity and Mortality – In 1999, according to WHO,
approximately 5,000 cases of diphtheria were reported worldwide. Between
5% and 10% of patients die, even with treatment.

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Occurrence – Diphtheria occurs worldwide among unimmunized populations
and, in industrialized countries, among populations whose immunity has
waned, largely because of the lack of routine booster immunizations for adults.
As shown in the chart, diphtheria can be reduced to a very low level but thenmay reemerge in serious outbreaks in both temperate and tropical climates.

Source: WHO, 2000

Reported global incidence of Diphtheria, 1980 - 1999

The largest epidemic since diphtheria vaccine was introduced in national
immunization programs occurred from 1990 to 1998 in countries of theformer Soviet Union, with over 50,000 cases and 1,500 deaths reported in
the peak year of 1995. Among the epidemic’s causes were the build-up ofsusceptible children and adults due to low coverage with diphtheria toxoid
and large migrations of unprotected people. The response — which included
vaccination of all children, diphtheria boosters for older children and adults,
and treatment of cases and contacts — was initially slow because of vaccine
and drug shortages, inadequate cold chains, and other operational problems.
Coverage eventually improved significantly and incidence has dropped.
Treatment – Diphtheria antitoxin and antibiotics (erythromycin or penicillin)are prescribed for suspected diphtheria. Cases are isolated and contacts are
vaccinated with diphtheria toxoid to prevent additional cases. People in close
contact with diphtheria patients should also be given antibiotics.

Diphtheria Toxoid
The most effective way to control diphtheria is to prevent it through immunization of children in their first year of life with three doses of diphtheria toxoid,
in the trivalent presentation of diphtheria, tetanus, and pertussis (DTP).
Diphtheria toxoid can also be used to immunize adults during outbreaks.
Form and Presentation – Diphtheria toxoid is a liquid vaccine that does

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211not need reconstitution. It is available in a variety of forms, including the threelisted below.

Presentations of Diphtheria Toxoid
Presentation

Ingredients

Primary age group

DTP

Diphtheria toxoid, tetanus toxoid,
pertussis vaccine

Children through six years ofageDT

Diphtheria toxoid and tetanus
toxoidChildren through six years ofage

Td

Tetanus toxoid with reduced
diphtheria content

Children seven years of age
and older; adults

Diphtheria toxoid is also available with tetanus toxoid and pertussis vaccine in
combinations with hepatitis B and Hib vaccines.
Efficacy – Three doses of diphtheria-containing vaccine provide over 95%
protection against diphtheria for at least 10 years.
Side Effects – Mild fever and crying are common reactions to DTP. Many
infants also have a mild local reaction with redness and swelling.
Severe systemic reactions (e.g., seizures, neurologic complications, and anaphylaxis) may follow DTP vaccinations, but these occur only rarely.
Contraindications – There are no contraindications to DTP except that itshould not be given to children who have suffered a severe reaction to a previous dose.
Schedule and Target Age Group – For the primary series, WHO recommends that infants be given three doses of DTP, one dose each at six, 10, and14 weeks of age.
If children do not get a second or third dose of DTP on time, they should not
be given another first dose: they should continue with the remaining doses only.
Administration of DTP Vaccine – A 0.5 ml DTP dose is injected intramuscularly, usually into the outer part of the thigh. If more than one injection is
given at the same time, different injection sites should be used for each.
Booster Doses after a Child’s First Year – For longer-lasting protection,
countries that have reached high coverage with the primary series of three
DTP doses may give one or two booster doses after children reach one year

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DTP Immunization Schedule for Children under One Year of Age
Age

Minimum Interval between Doses

6 weeks

Dose

DTP1

10 weeks

4 weeks

DTP2

14 weeks

4 weeks

DTP3

of age. When one booster is given, it is administered in the second year of
life. When two are given, one injection is given in the second year, and thesecond is given at four or five years of age.
Due to the increased risk of adverse reactions to the pertussis component inolder children, DTP should not be given to children after they reach the age ofseven years. These children should be given DT or Td.
Outbreak Control Strategies – During diphtheria epidemics, the largest
possible proportion of the population group involved should be vaccinated,with priority given to infants and preschool children. Those who have beenpreviously immunized should receive booster doses; unimmunized infants andchildren should receive the primary series of three doses. Patients and close
contacts should be given antibiotics.

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References
Public Health Foundation. 2001. Epidemiology and Prevention of VaccinePreventable Diseases, 6th edition. Waldorf, MD: Public Health Foundation.
WHO. 1998. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1993. Diphtheria: The Immunological Basis for Immunization. Geneva:
WHO. WHO/EPI/GEN/93.12.

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Hib Disease
Haemophilus influenzae type b, or Hib, is the most common cause of bacterial
meningitis in children under five years of age in most countries where it has
been studied, and the second most common cause (after Streptococcus pneumoniae) of serious bacterial pneumonia in children. In addition to bacterial
meningitis and pneumonia, manifestations of Hib disease include septic
arthritis, osteomyelitis, septicaemia, and epiglottitis.
Identification – Diagnosis of Hib pneumonia is difficult, so efforts to identify
Hib cases focus on bacterial meningitis, as defined in the box below.
WHO-Recommended Case Definition: Bacterial Meningitis
Clinical description: Bacterial meningitis is characterized by acute onset of fever,headache, and stiff neck. Meningitis is not specific for Hib disease, and Hib diseasecannot be diagnosed on clinical grounds.
Laboratory criteria for diagnosis:

Culture method: Isolation of Hib from a normally sterile clinical specimen, such ascerebrospinal fluid (CSF) or blood. Culture of Hib from a non-sterile site, such as thethroat, does not define Hib disease since the bacteria can grow in these other areasand not cause disease.
Antigen detection methods: Identification of Hib antigen in normally sterile fluids (i.e.,
CSF or blood) by antigen detection methods such as latex agglutination of counter
immunoelectrophoresis.
Source: WHO, 1998b

Transmission – Hib bacteria are passed to other children in droplets ofsaliva expelled when an infected child coughs or sneezes. Hib also spreads
when children share toys and other things that they put in their mouths. The
risk of transmission increases when children spend long periods of time incrowded households, day care settings, or crèches.
Population at Risk – Children under one year of age are at the highest
risk for Hib disease. The disease is rare in children older than five years.
Estimated Morbidity and Mortality – Population-based data on Hib
incidence are limited, but WHO estimates that Hib causes approximately
three million cases of serious disease and approximately 450,000 deaths
each year. Approximately 20% of meningitis survivors have long-term
neurological problems.

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Special Aspects of Hib Surveillance
Since Hib diagnosis requires a lumbar puncture to obtain cerebrospinal fluid for laboratory confirmation, nationwide surveillance may not be practical in many countries. In
such countries, disease burden and the impact of Hib immunization programs can bemeasured by combining Hib coverage data from all facilities that provide Hib vaccinations with disease data from sentinel surveillance sites that have the necessary clinicaland laboratory capacity.
Source: WHO, 1998b

The WHO has recently devised a methodology for rapidly estimating theincidence of Hib disease. This rapid assessment tool, which requires about tendays of field work, uses detailed local data on bacterial meningitis to generate estimates of overall Hib burden. See Estimating the Local Burden of Hib
Diseases Preventable by Vaccination (WHO, 2001).
Occurrence – There appears to be geographic variation in the occurrenceof disease caused by Hib. While data from Africa and Latin America haveclearly indicated its importance as a cause of pneumonia, meningitis, andother childhood diseases, studies in Asia have yielded lower-than-expected
estimates of the burden of Hib disease. Ongoing research will help establish
the magnitude and patterns of disease from Hib in Asian countries.
Treatment – Antibiotics are used for treatment. Bacterial resistance is now
being seen with some antibiotics.

Hib Vaccine
Hib vaccination of children in the first six months of life is the most effectivemeans of controlling invasive Hib disease, but this will only protect them from
diseases caused by type b Haemophilus influenzae. Hib vaccine will not prevent meningitis and pneumonia caused by other types of Haemophilus influenzae or other agents.
As of early 2001, 71 countries had included Hib vaccine in their routine
immunization schedule. Countries with Hib vaccine coverage rates above
80% for young children have documented a 99% decline in the incidence ofinvasive Hib disease, including Hib meningitis.
Form and Presentation – Hib vaccines are available in monovalent andmultivalent forms. Its formulations include liquid and freeze-dried (orlyophilized) vaccines, as described in the box on the following page.
Changing from one formulation of Hib vaccine to another before a child hascompleted the primary Hib series causes no harm.

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Choices among Hib Vaccines
Choices among Hib vaccines are likely to change; it is always advisable to checkavailability with UNICEF or other vaccine suppliers.

Liquid monovalent Hib: No reconstitution is required. Monovalent Hib vaccine
adds another injection to the number a child receives.

Lyophilized monovalent: This vaccine needs to be reconstituted, which increases
operational complexity and the risk of contamination. As a monovalent vaccine, it
requires an additional injection. Storage space is needed for the vaccine and its diluent (although diluent does not need refrigeration until shortly before reconstitution andadministration).

Lyophilized combinations:• DTP-Hep B+Hib – Freeze-dried Hib is reconstituted with DTP-Hep B. The combination reduces the number of injections needed from nine to three.
• DTP+Hib – Freeze-dried Hib vaccine is reconstituted with DTP.

Efficacy – Three doses of Hib vaccine are more than 95% effective in preventing invasive Hib disease.
Side Effects – Hib vaccine has not been associated with any serious side
effects, although there may be redness, swelling, and soreness at the injection
site.
Contraindications – There are no contraindications to Hib vaccine.
Schedule and Target Age Group – Hib immunization schedules for children under one year of age differ from country to country, depending on theform of Hib vaccine and the schedule for other vaccines. In general, it is given
at the same time as DTP, as shown in the commonly used schedule below.
Administration – A 0.5 ml of a dose of Hib vaccine is injected intramuscularly, usually into the outer part of the thigh. If more than one injection is given
at the same time, different injection sites should be used for each.
Booster Doses after a Child’s First Year – Booster doses of Hib vaccine
are not recommended in developing countries.
Hib Vaccination Schedule for Children under One Year of Age
Age

Minimum Interval between Doses

6 weeks

Dose

Hib1

10 weeks

4 weeks

Hib2

14 weeks

4 weeks

Hib3

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References
PATH, 2003. Immunizing Children Against Haemophilus influenzae type b: A
Training Module for Vaccinators. Seattle: Children’s Vaccine Program at PATH.
WHO. 2001. Estimating the Local Burden of Hib Diseases Preventable byVaccination. Geneva: World Health Organization. WHO/V&B/01.27.
WHO. 2000. Introduction of Haemophilus influenzae type B into
Immunization Programmes: Management Guidelines, Including Information for
Health Workers and Parents. Geneva: World Health Organization.
WHO/V&B/00.05.
WHO. 1998a. WHO Position Paper on Haemophilus influenzae type b
Conjugate Vaccines. Weekly Epidemiological Record 1998, 73, 64-8.
WHO. 1998b. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases.WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1995. Generic Protocol for Population-Based Surveillance ofHaemophilus influenzae type B. Geneva: World Health Organization.
WHO/VRD/95.05.

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Hepatitis B
Hepatitis B is a viral infection of the liver. If not fatal, acute infection either
resolves or progresses to chronic infection, which may lead to cirrhosis orliver cancer several decades later. When it resolves, patients develop
lifelong immunity.
In developing countries, hepatitis B infection usually occurs in childhood — at
the time of birth, during infancy, or in early childhood. Symptoms are not usually apparent in infected young people, but the likelihood that an infectedchild will develop lifelong chronic infection is higher than if the infection
occurs in older children or adults.
Identification
Acute infection – The clinical description of acute hepatitis B is indistinguishable from that of other types of acute viral hepatitis (A through E). Notethat the clinical description below is the same for all acute viral hepatitis infections, and that laboratory testing is necessary for diagnosis.
Chronic infection – People with chronic infection are often asymptomaticfor decades after infection, but during this time they can transmit the virus toothers and are at high risk of eventually developing liver disease themselves.
The risk of death from cirrhosis and primary liver cancer is approximately
25% for persons who become chronically infected during early childhood and
15% for persons who become chronically infected at an older age.
WHO-Recommended Case Definition:
Acute Viral Hepatitis Diseases
Clinical description of acute viral hepatitis disease: An acute illness typically including acute jaundice, dark urine, anorexia, malaise, extreme fatigue, andright upper quadrant tenderness. (None of these symptoms is common in infants andyoung children.) Biologic signs include increased urine urobilonogen and >2.5 times
the upper limit of serum alanine aminotransferase.
Laboratory criteria for diagnosis:• Hepatitis A: positive for IgM anti-HAV• Hepatitis B: positive for IgM anti-HBc-positive or, less preferably, hepatitis B surface
antigen (HBsAg)• Non-A, non-B: negative for IgM anti-HAV and IgM anti-HBc or HBsAg• Hepatitis C: positive for anti-HCV• Hepatitis D (occurs only as co-infection or super-infection of hepatitis B): positive for
IgM anti-HBc or, less preferably, HBsAg plus anti-HDV positive• Hepatitis E: positive for IgM anti-HEV
Source: WHO, 1998

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Transmission – In developing countries, the hepatitis B virus is most commonly transmitted to children by:• Child-to-child transmission through open wounds or shared implementsthat contain blood or body fluids. This accounts for the majority of hepatitis B infections worldwide.
• Exposure of babies to maternal blood or other fluids during delivery, if themother is a chronic carrier.
• Use of contaminated needles and syringes for vaccinations, injections,and transfusions.
In countries where infection occurs later in life, the disease is transmitted
through sexual activity, contaminated needles and syringes, and contaminatedblood products.
Population at Risk – Hepatitis B virus infection can occur at any age. In
Asia and Africa, infection often occurs in infancy and childhood, when infected individuals are more likely to become chronically infected.
Age-dependent risk of becoming a carrier

Source: International Conference on the Control of
Hepatitis B in the Developing World, 1991

Estimated Morbidity and Mortality – More than two billion individuals
alive today have been infected at some time in their lives with the hepatitis B
virus. Approximately 350 million of these are chronic carriers. Over 500,000
people die every year from cirrhosis and primary liver cancer.
Occurrence – Hepatitis B is endemic worldwide.

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Treatment – The drugs interferon or lamivudine are used to treat chronic hepatitis B, but they are only moderately effective, cost thousands of dollars per
patient, and are not realistic options for most people in developing countries.

Hepatitis B Vaccine
WHO recommends that hepatitis B vaccine be offered to all children under
one year of age in all countries. More than 130 developing countries now
routinely provide the vaccine, and more are preparing to do so with the support of GAVI and the Vaccine Fund.
Form and Presentation – Hepatitis B vaccine is available in liquid form,in monovalent and combination formulations, as shown below.
Hepatitis B vaccines are available in single-dose and multi-dose glass vials.
Multi-dose vials contain two, six, 10, or 20 doses.
Formulations of Hep B Vaccines
Monovalent: This is the only Hep B vaccine that can be used at birth. May be used
for later doses.

Combination vaccines: Must not be used until a child is at least six weeks ofage. Combination vaccines now available include:• DTP-Hep B (liquid)• DTP-Hep B+Hib (Comes in two vials: liquid DTP and Hep B in one vial and freezedried Hib in the other. Mixing is required.)

Efficacy – Hep B is one of the safest and most effective of vaccines. Studies
have shown that it is 95% effective in preventing chronic infection. For infants
exposed by the mother at birth, monovalent Hep B vaccine is 90% effective inpreventing transmission if the first dose is administered within 24 hours andthe series completed at the recommended intervals.
Side Effects – Mild, temporary local reactions are common after an injectionof Hep B vaccine. It is highly unusual to see an anaphylactic reaction.
Contraindications – There are no contraindications to this vaccine, except
if a very rare anaphylactic reaction to a previous dose has occurred, thenHep B should not be given again.
Do Not Freeze Hep B Vaccine!
Freezing Hep B vaccine reduces its efficacy, and the vaccine freezes at –0.5°C, several degrees warmer than the freezing point of DTP. Since accidental freezing of DTP iscommon, freezing of hepatitis B vaccine is likely to be a problem as well.

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Schedule and Target Age Group – Hep B is usually given as a threedose series, with each dose at least four weeks apart. Scheduling options
include a longer interval between the second and third dose and a four-doseschedule when a birth dose is given.
In countries where perinatal transmission is a significant problem, the firstdose should be given at birth. Only monovalent Hep B vaccine can be given
safely at this time, but later doses may be given in combination with othervaccines. Scheduling options recommended by WHO are shown below.
Options for Scheduling Hep B for Children under
One Year of Age

I

II

III

Countries withlow perinataltransmission

Countries with highperinatal transmission

Countries with high perinataltransmission

Monovalent Hep B
for birth dose; thereafter, combination ofHep B and DTP

Age
Birth

Monovalent Hep B for all
three doses
Provides longer interval
between Hep B2 and Hep B3

Hep B1

Hep B1

Hep B1

Hep B2

Hep B2

10 weeks Hep B2

Hep B314 weeks Hep B3

Hep B46 weeksHep B3

When countries introduce Hep B into their routine immunization schedules,
managers must decide whether to use a gradual strategy, in which only children born after the date of introduction are immunized, or a catch-up strategy,
in which children born before the date of introduction are also immunized(see Chapter 11).
Administration – A 0.5 ml dose of Hep B vaccine injected intramuscularly,
usually into the outer part of the thigh. If more than one vaccine is injected at
the same time, different injection sites should be used for each injection.
Booster Doses – Booster doses are not recommended.
Hepatitis B Vaccination of Health Workers
Hepatitis B vaccination is usually not recommended for health workers in developing
countries because it is likely that they have been exposed to the virus during childhood. Also, they are less likely to become carriers if they become infected as adults.

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References
International Conference on the Control of Hepatitis B in the Developing
World: Towards the Elimination of Hepatitis B. Yaoundé, Cameroon. 1991.
PATH. 2002. Immunizing Children Against Hepatitis B: A Training Module forDoctors, Nurses, and Other Immunization Providers. Draft 5. Seattle:
Children’s Vaccine Program at PATH.
PATH. 2001. Hepatitis B Vaccine Introduction: Lessons Learned in Advocacy,Communication, and Training. Seattle: Gate’s Children’s Vaccine Program at
PATH.
WHO. 2001. Introduction of Hepatitis B Vaccine into Childhood Immunization
Services: Management Guidelines, Including Information for Health Workers
and Parents. Geneva: World Health Organization. WHO/V&B/01.31.
WHO. 2000. Aide-Memoire: Hepatitis B Immunization (2000). Geneva:
World Health Organization.
WHO. 1998. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1993. Hepatitis B: Immunological Basis for Immunization. Geneva:
World Health Organization.
WHO. 1988. Hepatitis B Immunization Strategies. Geneva: World HealthOrganization. WHO/EPI/GEN/88.05.

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MeaslesCredit: Daniel Cima,
American Red Cross

Credit: Daniel Cima,
American Red Cross

Measles is responsible for more deaths
than any other vaccine-preventable disease, killing an estimated 750,000
children each year. Over one-half of these
deaths occur in sub-Saharan Africa.

Identification – Measles is an acute viral infection characterized by a variety of symptoms, including fever, rash, cough, conjunctivitis, diarrhea, ear
infections, pneumonia, and brain inflammation.
WHO-Recommended Case Definition: Measles
Clinical case definition: Any person in whom a clinician suspects measles infection or any person with fever and maculopapular rash (i.e., non-vesicular or without
fluid) and cough, coryza (i.e., runny nose), or conjunctivitis (i.e., red eyes).

Laboratory criteria for diagnosis: At least a fourfold increase in antibody titer,or isolation of measles virus, or presence of measles-specific IgM antibodies.
Source: WHO, 1998

Transmission – Measles is extremely infectious. The virus is transmitted
through the air by respiratory droplets expelled by infected individuals.

Ease of Measles Transmission
One study found that two-thirds of the children coming to a clinic in West Africa withmeasles probably caught the measles at the clinic on earlier visits one to three weeks
before.
Source: Klein-Zabban et al., 1987

Susceptible individuals in close contact with infected people are most likely to
become infected, so transmission is more easily maintained in crowded homes,
urban slum areas, and congested places than in isolated or rural situations.

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Population at Risk – A person is susceptible to measles when he or she
has lost maternal antibodies, has never been infected, or has not been effectively vaccinated.
Maternal antibodies provide immunity to infants against measles infection until
they are at least six months of age. After that, immunity begins to wane.
Infection provides lifelong immunity.
Vaccination provides immunity if vaccine is given at an age when the child’smaternal antibodies have been lost and the child can seroconvert for protection. In developing countries, the best age for most children is nine months.
In both urban and rural areas in developing countries, the majority ofmeasles cases occur in children less than five years of age, as illustrated bydata from Nigeria.

Source: Foster, 2001

In this study, case fatality rates were estimated at 8% for children under one
year of age, 4% for children ages two to four, and 2% for children five andolder. Widespread malnutrition in the outbreak area was believed to havecontributed to the mortality rate, which eventually exceeded 15,000.
Population density affects the age of infection. Among rural populations, theage of infection is usually older than in densely settled urban populations. In
countries with low measles vaccination coverage, most measles deaths occur
among unvaccinated children who are younger than five years old. However,as high measles coverage is achieved and sustained over a period of five
years or longer, measles outbreaks affect older children and young adults, as
has occurred in the Western Hemisphere.

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Estimated Morbidity and Mortality – Measles deaths occur as a resultof complications, including pneumonia, acute diarrhea and dehydration,
chronic diarrhea with malnutrition, and rarely, encephalitis. The disease canalso cause serious disability, including permanent blindness, deafness, andbrain damage.
Infection with measles depresses the immune system, depletes the body’s
stores of vitamin A, leads to weight loss, and leaves children susceptible todiseases like pneumonia and diarrhea. Because the health system receives
reports of complications rather than measles disease itself, measles cases anddeaths are often underestimated.
Occurrence – Measles is generally a seasonal disease. In temperate
climates, transmission peaks in late winter and early spring. In the tropics, it
increases in the dry season. In large, crowded cities with low measles vaccine
coverage, transmission can be continuous throughout the year. In these areas,
measles is a particularly important problem because infection can occur
before children are old enough to be effectively vaccinated.
The frequency of measles outbreaks depends on the density of people
susceptible to the disease and the probability of exposure to infectious cases.
In countries with low coverage, epidemics occur every two to three years. In
countries with high coverage, epidemics occur at five- to seven-year intervals.
Treatment – Supportive care includes frequent food and fluid intake andtreatment of complications. Vitamin A supplementation reduces the number ofdeaths from measles.
Vitamin A in Measles Case Management
Measles seriously depletes vitamin A in children, making them more susceptible tocomplications. For example, until recently, half of the blindness in children in one East
African country resulted from corneal scarring following measles infection. Vitamin A
supplementation for these children would have prevented this outcome.

Measles Vaccine
Measles vaccination is one of the most effective preventive measuresavailable. Maintaining coverage above 90% can have a major impact
on public health.
Form and Presentation – Most national programs, except in theAmericas, use monovalent measles vaccine, which is in freeze-dried form
and must be reconstituted with measles diluent from the same manufacturer.

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Reconstituted measles vaccine is highly sensitive to heat and should bediscarded at the end of a session or six hours after reconstitution, whichevercomes first.
Measles vaccine is also available in combination with rubella vaccine as MR
and in combination with mumps and rubella vaccines as MMR.
Efficacy – Up to 15% of children who are vaccinated before their first birthday do not seroconvert (develop sufficient antibodies) and so are not protected against measles. In areas where vaccination coverage with one dose ofmeasles is high, this failure to seroconvert accounts for a large proportion of
the remaining susceptible children. In these high coverage areas, a second
opportunity may be advisable to protect children who did not seroconvert thefirst time. In areas with low measles vaccination coverage, however, failure tovaccinate with the first dose rather than failure to seroconvert is by far the
more significant problem (see pages 228-229).
Side Effects – Approximately 10% of children develop a low fever after ameasles vaccination, and 5% develop a generalized, non-infectious rash.
Contraindications – There are no contraindications to measles vaccination.
Measles vaccine should be given to eligible children at the first opportunity,
even if the child is sick or malnourished. In fact, because malnourishedchildren are at great risk of dying from measles, their vaccination should begiven priority.
In the absence of documented proof of measles vaccination, such as a vaccination card, measles vaccine should be given even if parents believe that theirchild has already been infected.
Because children with HIV are at higher risk of severe measles disease andmeasles vaccine can safely be given to HIV-infected children, measles
vaccination is recommended for all children regardless of their HIV status.
Measles Vaccination in the Presence of HIV
Measles can be very severe in HIV-infected children.
WHO currently recommends that an early dose be given at six months, followed by
the scheduled dose at nine months to children who are known to be infected with HIV.
For children who are symptomatic for AIDS, the potential risks and benefits must be
evaluated on an individual basis. The overall risk of adverse events from the vaccine isrelatively low compared with the risk of measles infection in HIV-infected children.
Children should not be screened for HIV antibody status before receiving
measles vaccine.

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First Opportunity for Measles Vaccination
The relative importance of the first and second opportunities to vaccinate is illustrated
below using two hypothetical districts with the same population size. District A is low
performing with only 50% measles coverage. District B is high performing with 90%.
After the first opportunity, District A has many more unprotected children (5750) than
District B (2350).
District A(low-performing)

District B(high-performing)

Total number of children

10,00010,000

Vaccinated with 1 dose

5000 (cov=50%)

9000 (cov=90%)– of whom protected (85% efficacy)

4250

7650

– of whom unprotected

750 (=5000-4250)

1350 (=9000-7650)

Unvaccinated with 1 dose

5000 (=10,0005000)

1000 (=10,0009000)

Total unprotected *5750 (=5000+750)

2350 (=1000 +1350)– of which due to FAILURE TO
VACCINATE

87% (=5000/5750) 43% (=1000/2350)– of which due to FAILURE TO SEROCONVERT

13% (=750/5750)

57% (=1350/2350)* Assuming all unprotected children eventually contract measles.

In District A, 87% of the unprotected children are unprotected because of failure tovaccinate, and 13% remain unprotected because of a failure to seroconvert. In District
B, the majority of the unprotected children (57% ) are due to a failure to seroconvert.
In the same two hypothetical districts, health officials decide to offer a second opportunity for measles vaccination through mass campaigns. Coverage of 90% is achievedin both districts. The vaccine efficacy is 95% because older children are targeted. As
seen in the next table, the number of unprotected children in District A drops from5750 to 834 and in District B from 2350 to 341.

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Second Opportunity for Measles Vaccination
District A

District B

10,000Total number of children

10,0004250

Protected after first opportunity

7650

5750

Unprotected after first opportunity

2350

5000
(no previous dose)

750
Reasons for lack of protection after(one dose,first opportunity
unprotected)

1000
1350
(no previous (one dose,
dose)
unprotected)

4500(1st dose)675(2nd dose)

900(1st dose)1215(2nd dose)

-4275

-641

Protected by vaccination(95% efficacy)

-855

-1154

225

34

Unprotected due to failure toseroconvert (5%)

45

61

500

75

Unprotected due to failure tovaccinate

100

135

Total unprotected*

145 + 196 = 341

725 + 109 = 834

Vaccinated after second opportunity(90%)* Assuming all unprotected children eventually contract measles.

The success of the hypothetical campaign shown above depended on reaching a high percentage (90%) of children who were missed by routine services. The great majority ofthese children are now protected from measles infection, as shown below.

Protection against Measles Due to First and Second Doses
District A (low-performing)

1st dose

1st opportunity

2nd opportunity

Total

4250

4275

8525 (93%)

641

641 (7%)

2nd dose

9166 (100%)
District B (high-performing)
1st dose
2nd dose

7650

855

8505 (88%)

1154

1154 (12%)
9659 (100%)

This example shows that, as in the real world, most children are protected by the first doseof measles vaccine that they receive, whether they receive it as a part of routine immunization services or during a campaign. It also shows that protection due to a second dose isrelatively small (7% in District A and 12% in District B). Therefore, failure to deliver thatfirst dose to all infants remains the primary reason for high measles morbidity.

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Schedule and Target Age Group – Vaccination with measles vaccine is
not usually effective before a child reaches nine months of age. In developing
countries, measles vaccine should be given at nine months of age or as soon
as possible thereafter.
The age of vaccination may be altered in response to epidemiological andother data. For example, in refugee situations, measles vaccine is often recommended at six months and again at 12 months.
Administration – The 0.5 ml dose of measles vaccine is injected subcutaneously into the upper left arm.
The Measles Challenge
In developing countries, vaccinations against measles are usually given at nine monthsof age, which is nearly six months after the other vaccines in the schedule have been
given. The time gap means that even when coverage for OPV and DTP is high, coverage with measles may be low.

Booster Doses – Booster doses are not given.
Control Strategies – In 2001, WHO and UNICEF proposed a global strategy for measles mortality reduction that combines routine and supplemental
immunization. As shown in the graph on page 231, a combination of
approaches is needed to achieve and sustain reduction in measles deaths.
The rapid reduction in mortality through supplemental immunization targetinga wide age range will last for only a few years unless routine immunization is
also strengthened. Strengthened routine immunization, resulting in a modest
increase in coverage of 5% each year, will lead to long-term sustained mortality reduction; because this will take many years to achieve in some countries,
it is essential that a start be made now. Comprehensive plans for measles mortality reduction should include clear objectives and activities for strengthening
routine immunization with provision of budgetary and technical support.
Sustained and optimal reduction in measles mortality will only occur whenboth supplemental immunization and strengthened routine immunization are
implemented in combination, followed by less frequent follow-up campaigns
targeting a narrower age range.
The essential elements of a comprehensive control strategy include:• Provide a first dose of measles vaccine to all infants.
• Guarantee a “second opportunity” for measles vaccination.
• Establish an effective system to monitor coverage and conduct measles
surveillance.
• Improve the management of complicated measles cases, including vitamin
A supplementation.

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Source: WHO, 2003

Projected impact of different measles vaccination strategies on
measles dealths in Africa 2001-2025

Measles mortality reduction – Countries with less than 80% measles
coverage should focus on improving and expanding routine immunization
services. These countries may sometimes use campaigns to reach children
who do not have access to routine immunization services. All children in thetarget age group for these campaigns, usually from nine months of age to lessthan five years, should be eligible for vaccination, irrespective of past measles
illness or vaccination history. For some children, such campaigns provide a“second opportunity” to become immunized. Note that the upper age range
may be expanded depending on the local epidemiology.
The primary objective of mortality reduction campaigns should be to reachpreviously unimmunized children.
Measles elimination – Some countries that have achieved and maintained
measles vaccination coverage above 80% across all districts for at least three
years conduct periodic campaigns to supplement routine services in order toeliminate the disease.

Routine coverage
(%)
20
50
80
90

Duration of Impact in Years at Different Levels of Routine
and Campaign CoverageCampaign Coverage
20%

40%

60%

80%

0.25
0.4
1
2

0.5
0.8
2
4

0.75
1
3
6

1
1.6
4
9

Source: Foster, S., 2001, adapted from N. Gay

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First, a “catch-up” campaign is carried out to interrupt chains of transmission in
all children from the age of nine months through an upper age that is consistent
with local epidemiology. Thereafter, “follow-up” campaigns are used periodically to reach those who have not been reached at all and to ensure thatchildren who have been vaccinated but are still unprotected will seroconvert.
To maintain elimination, high coverage must continue with a combination ofroutine services and with periodic campaigns to prevent the build-up ofsusceptibles.
Outbreak response – Measles importation should be expected even inareas that have eliminated the disease, and when outbreaks occur, control canbe difficult because many susceptible people can be infected before a vaccination campaign can be organized. Health services can still respond effectively,
however, by treating complications, administering vitamin A supplementation,and investigating cases to determine how to prevent recurrences.
Routine measles vaccination coverage, supplemented by campaigns, shouldbe the focus of management efforts to prevent outbreaks from occurring at all.

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References
Brown, Phyllida. November 2000. Coming to Grips with the Big One. GAVI
Immunization Focus. www.VaccineAlliance.org.
Foster, Stanley O. 2001. Mortality Reduction: BASICS II and Primary HealthCare. Based on Observations in Kano State. Emory University andBASICS/USAID.
Hersh, Bradley S. February 11, 2003. “Global Measles Update.” Presented
at Red Cross Partners Meeting, Washington DC. EPI/V&B WHO, Geneva.
Klein-Zabban ML; G. Foulon; C.Gaudebout; J. Badoual; J. Assi Adou. 1987.
Frequence des rougeoles nosocomiales dans un centre de protection maternelle et infantile d’Abidjan. Bulletin of the World Health Organization. 65 (2):
197-201.
PAHO. 1999. Measles Eradication Field Guide, Technical Paper No. 41.
Washington, DC: Pan American Health Organization.
WHO-UNICEF. 2000. WHO-UNICEF Joint Statement on Strategies to Reduce
Measles Mortality Worldwide. Geneva: World Health Organization.
WHO/V&B/01.40.
WHO. 2001. Module on Best Practices for Measles Surveillance. Geneva:
World Health Organization. WHO/V&B/01.43.
WHO. 1998. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1993. Measles: The Immunological Basis for Immunization. Geneva:
World Health Organization. WHO/EPI/GEN/93.17.

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233Pertussis
Pertussis, also called whooping cough,is a highly contagious, acute bacterial
disease affecting the respiratory tract.
Worldwide, it causes an estimated300,000 deaths per year.

Credit: WHO

Identification – Patients with pertussis have long-lasting coughs. Infants
are more likely to choke than whoop,
and those less than three months old
may stop breathing altogether.
Together, pertussis and measles
account for up to one-quarter of deaths
due to acute respiratory infections.
WHO-Recommended Case Definition: Pertussis
Clinical description: A person with a cough lasting at least two weeks with at least oneof the following:• Fits of coughing• Intake of breath accompanied by a whooping sound• Vomiting immediately after coughing and without any other apparent cause
Laboratory criteria for diagnosis: Isolation of Bordetella pertussis or detection of
genomic sequences by polymerase chain reaction.
Source: WHO, 1998

Transmission – Pertussis is spread in droplets from the nose and throat thatare expelled when an infected person coughs or sneezes. The disease
spreads easily among susceptible people who live in crowded conditions.
Population at Risk – Newborns receive minimal antibody protection fromtheir mothers, and it quickly wanes. Approximately one-third of all cases occur
in infants under six months old, and half of all deaths are in children under
one year.
Estimated Morbidity and Mortality – 80% or more of unprotected children get pertussis, and 1% of those who get the disease die. Pertussis canlead to frailty and wasting.

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Occurrence – Pertussis occurs in both urban and rural areas. In urban areas,
infants are more commonly affected; in rural areas, most cases occur in older
children and are milder. The majority of pertussis cases occur in developing
countries; in industrialized countries incidence is high among unimmunizedinfants, and outbreaks occur among adolescents and young adults.
Treatment – Antibiotics may be given to shorten the period of communicability (approximately three weeks), but they do not cure the disease or evenreduce symptoms unless they are given during the incubation period or soonafter symptoms appear.

Pertussis Vaccine
The most effective strategy for preventing pertussis requires the timely deliveryof three doses of vaccine at the proper intervals during a child’s first year of
life. Pertussis vaccine also helps to reduce mortality from pneumonia, otheracute respiratory infections, and malnutrition.
Form and Presentation – Two types of pertussis vaccine are available:
whole-cell and acellular.
Whole-cell vaccine, which has been in use in national immunization programsin developing countries for several decades, has had a significant impact on
pertussis incidence.
Concern about very rare adverse events following whole-cell pertussis vaccination led to the development of acellular pertussis vaccine. Acellular vaccinescompare favorably with whole-cell vaccines in terms of efficacy and side
effects, but they are more expensive. DTP with whole-cell pertussis costs
approximately US$0.07 per dose compared to approximately US$10.00 per
dose of DTP with acellular pertussis.
Acellular pertussis vaccine is now licensed in many industrialized countries,
but in developing countries only whole-cell pertussis vaccine is used in national immunization programs.
Efficacy – Efficacy is estimated to be approximately 80% after three doses.
Side Effects – Mild fever and crying are common reactions to DTP. Many
infants also have a mild local reaction with redness and swelling.
Rarely, severe systemic reactions, such as seizures, neurological complications, and anaphylaxis, follow DTP vaccination. Severe crying for three ormore hours or high fever over 105°F may occur with pertussis vaccine.

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Contraindications – There are no contraindications to DTP except that itshould not be given to children who have suffered a severe reaction to aprevious dose.
Schedule and Target Age Group – WHO recommends that three dosesof pertussis vaccine in the DTP formulation be given to infants at six, 10, and14 weeks of age.
If a child does not get the second dose of DTP at the scheduled time, heor she does not need to restart the series. The second dose should be given
at the earliest opportunity, and the third dose should be given after a fourweek interval.
DTP Immunization Schedule for Children under One Year of Age
Age

Minimum Interval Between Doses

6 weeks

Dose

DTP1

10 weeks

4 weeks

DTP2

14 weeks

4 weeks

DTP3

Administration of DTP Vaccine – The 0.5 ml dose of DTP is injected
intramuscularly, usually into the outer part of the thigh.
Booster Doses after a Child’s First Year – For longer-lasting protection,
countries that have reached high coverage with the primary series of three DTP
doses may give one or two booster doses after children reach one year of age
up to the age of seven. Thereafter, children should not be given pertussis vaccine, even in combination, due to the increased risk of adverse reactions.

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References
Preziosi, Marie-Pierre, A. Yam, S. Wassilak, L. Chabirand, A. Simaga, M.
Ndiaye, M. Dia, F. Dabis, and F. Simondon. 2002. Epidemiology of Pertussis
in a West African Community Before and After Introduction of a Widespread
Vaccination Program. American Journal of Epidemiology 155 (10): 891-896.
WHO. 1999. Pertussis Vaccines: WHO Position Paper. Weekly
Epidemiological Record No. 18. Geneva: World Health Organization.
WHO. 1998. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1993. Pertussis: The Immunological Basis for Immunization. Geneva:
World Health Organization. WHO/EPI/GEN/93.14.

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237

PolioIn 1988, the World Health Assembly
set a goal to eradicate poliomyelitis(polio), worldwide. Since then,national governments, WHO,
UNICEF, Rotary International, CDC,
USAID, and other bilateral agencies
have been working to achieve thegoal of polio eradication.

Credit: WHO

Identification – Polio is a diseaseof the central nervous system causedby three closely related polioviruses:
types 1, 2, and 3. Approximately
5% of people exposed to any ofthese viruses have influenza-like
symptoms such as fever, loose stools,
sore throat, headache, or upset
stomach. Some may have pain or
stiffness in the neck, back, and legs,and 1% become paralyzed.

WHO-Recommended Case Definition: Poliomyelitis
Clinical case definition: Any child under fifteen years of age with acute flaccid paralysis (AFP) or any person with paralytic illness at any age when polio is suspected.
Source: WHO, 1998

In paralytic polio, severe muscle pains follow the milder symptoms, and thenparalysis develops, usually in the first week of illness. The use of one or bothlegs or arms may be lost, and breathing without a respirator may become
impossible. People with these severe symptoms can, but do not always,
recover. Prior to the eradication initiative, polio was the leading cause oflameness worldwide.
Transmission – Poliovirus is highly communicable. It is spread from person
to person by contact with infected feces or secretions from the nose andmouth. People who do not have symptoms may spread the disease.
Population at Risk – Every person who is not vaccinated against polio
will acquire the infection if the virus is in the environment, with the following
outcomes:

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• 4% will have a mild flu-like illness.
• 1% will become paralyzed or lame.
• 0.5% will be lame for life.
• 0.1% will die during the acute phase.
Circulating Vaccine-Derived Polio Virus (cVDPV):A Newly Emerging Threat
Under very rare circumstances that are not fully understood, the virus strains in oral
polio vaccine (OPV) can regain two important properties of wild polio virus: the abilities to cause paralytic disease in humans and to spread from person to person. Thisphenomenon, known as circulating vaccine-derived polio virus, has been documented
in Egypt, Haiti, the Dominican Republic, the Philippines, and Madagascar. In eachcase, vaccination coverage was very low in the affected areas. As with wild polio
virus, the critical factor in controlling cVDPV is achieving and maintaining high vaccination coverage rates through a combination of strengthening the routine immunization
system and supplemental vaccination.

Estimated Morbidity and Mortality – As a result of the Polio Eradication
Initiative (PEI), there has been a 99% decrease in the number of confirmed
polio cases compared with the 350,000 cases reported in 1988.
Occurrence – Polio can occur anywhere in the world. In regions where it
has been eliminated, such as the Americas, Europe, and the Western Pacific,
control measures and certification-quality surveillance must be sustained until
the disease is eradicated worldwide.
Treatment – There is no specific treatment for polio. However, physical therapy can limit deformity and increase the likelihood that a patient can use andbenefit from braces.

Polio Vaccine
Immunization is the only protection against polio infection.
Form and Presentation – Most immunization programs in developing
countries use oral polio vaccine (OPV). OPV, unlike other vaccines, is given
orally and therefore, can be given by people with limited training.
Inactivated polio vaccine (IPV) is an injectable vaccine and is relatively
expensive. IPV appears to produce less immunity in the intestines than OPV, so
persons who receive IPV are more readily infected with wild polio virus than
OPV recipients. Such infected persons are protected from paralytic polio, but

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239

the wild virus being shed in their stool could result in transmission to otherpersons. Children vaccinated with IPV, as opposed to OPV, cannot spreadtheir vaccine-derived immunity to contacts through fecal-oral contamination.
Efficacy – In more than 95% of recipients, three doses of OPV produce
immunity for all three of the poliovirus types in the vaccine.
Side Effects – Reactions to OPV are rare. Vaccine-associated paralytic polio(VAPP) is a rare adverse event that occurs following the administration of OPV.
It is estimated that there is one case of VAPP per 2.4 million doses given toboth healthy and immunodeficient individuals.
Contraindications – There are no contraindications to polio vaccination.
However, if a child has diarrhea when OPV is given, an extra dose should be
administered four weeks later.
Routine Schedule and Target Age Group – WHO recommends thatchildren receive four doses of OPV before one year of age as part of the routine immunization program. These doses should be given at least four weeks
apart, usually at the same time as DTP, as shown in the table below. If the
OPV0 dose is not given within 14 days of birth, it should not be given at all,and the primary series should begin with OPV1 at six weeks of age.
Administration of OPV – OPV is dropped into the mouth. Usually two
drops are given, but this may differ by vaccine manufacturer.
Eradication Strategies – A combination of strategies is being used forpolio eradication. These strategies must ensure that immunity remains highand susceptibility low everywhere until there is global agreement to stop
vaccinating against polio.
OPV Immunization Schedule for Children under
One Year of Age
Age

Minimum Interval Between Doses

Within 14 days of birth

Dose

OPV0

6 weeks

4 weeks

OPV1

10 weeks

4 weeks

OPV2

14 weeks

4 weeks

OPV3

Routine immunization. National immunization programs in all countries should
immunize at least 90% of infants by one year of age with four doses of OPV
through routine immunization services.

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Supplemental immunization through national immunization days. To interrupt
wild poliovirus circulation in endemic countries, routine polio vaccinations
should be supplemented by national immunization days (NIDs). During NIDs,
all children less than five years of age should receive OPV, regardless of theirimmunization status.
In most countries that have been able to interrupt transmission, two rounds of
NIDs each year, spaced four weeks apart, were repeated for three consecutive years. In countries with continuing transmission, low routine OPV immunization, and high population density, as many as five rounds of NIDs havebeen required. Sometimes, door-to-door vaccination has been used to try toreach all children.
What Is Polio Eradication?
Polio eradication has been defined as the absence of cases and the absence of wild
poliovirus everywhere in the world.

Sub-national immunization days (SNIDs) and local immunization days (LIDs)
should be used to reach children in high-risk areas. The frequency and geographic scope of SNIDs and LIDs should reflect the epidemiology of polio in
the country or neighboring countries.

Acute flaccid paralysis surveillance and laboratory investigation. AFP surveillance should be established in all polio-endemic or recently polio-endemic
countries to ensure that all cases of polio are detected. According to WHO
guidelines, the goal of AFP surveillance is to report and investigate “any caseof acute flaccid (floppy) paralysis, including Guillian-Barre Syndrome, in a childless than 15 years and any case of suspected polio in persons of any age.”
All AFP cases within the above definition should be reported immediately andinvestigated within 48 hours. Two stool samples should be collected 24 to 48
hours apart and within 14 days of paralysis onset for laboratory analysis. A
follow-up visit to the patient should be made after 60 days.

Mop-up campaigns. Mop-up campaigns are intended for the most difficult-toreach children in areas where wild poliovirus transmission is occurring.
Immunization teams go from door to door over a large geographic area toadminister two doses of OPV (at a four-week interval) to all children less than
five years of age, regardless of their immunization status. Mop-up activities
may also include an active search for new AFP cases.

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241References
Loevinsohn, Benjamin, Bruce Aylward, Robert Steinglass, Ellyn Ogden, Tracey
Goodman, and Bjorn Melgaard. Impact of Targeted Programs on Health
Systems: A Case Study of the Polio Eradication Initiative. American Journal of
Public Health. January 2002, Vol 92, No. 1. Pages 19-23.
Mogedal, Sigrun, and Bo Stenson. 2000. Disease Eradication: Friend or Foe
to the Health System. Synthesis Report from Field Studies on the Polio
Eradication Initiative in Tanzania, Nepal and the Lao People’s Democratic
Republic. Geneva: World Health Organization. WHO/V&B/00.28.
Steinglass, Robert, and Rebecca Fields. 2000. Practical Checklist to Use the
Polio Eradication Initiative to Strengthen the Routine Immunization Program.
Arlington, VA: BASICS II.
WHO. 2000. Global Polio Eradication Initiative Strategic Plan 2001-2005.
Geneva: World Health Organization. WHO/POLIO/00.05.
WHO. 1998. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. Geneva: World Health Organization.
WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1997. Manual for the Virological Investigation of Poliomyelitis.
Geneva: World Health Organization. WHO/EPI/GEN/97.01.
WHO. 1995. Field Guide for Supplementary Activities Aimed at Achieving
Polio Eradication. Geneva: World Health Organization.
WHO/EPI/GEN/95.1 Rev. 1.
WHO. 1993. Polio: The Immunological Basis for Immunization. Geneva:
World Health Organization. WHO/EPI/GEN/93.16.

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Tetanus

Tetanus, also known as lockjaw, iscaused by a bacillus (Clostridium
tetani) that is present in the soil andin animal and human feces. After
entering the body through a wound,the bacterium produces a toxin thatmakes muscles rigid, causes spasms,
and makes breathing difficult or impossible, resulting in death. It is the only
vaccine-preventable disease that is not spread from person to person.

Credit: WHO

Tetanus is a common cause of neonatal and maternal mortality wherevermaternal protection with tetanus
toxoid is low and clean umbilicalcord care practices are not followed.

A typical feature of the spasms associated with tetanus is the facial expression
known as “risus sardonicus,” or sardonic smile, as shown in the photograph.
Identification
Neonatal tetanus affects newborn babies and results from contamination withtetanus spores that occurs when babies are delivered in unclean conditions.
WHO-Recommended Case Definition: Neonatal Tetanus
Suspected case: Any neonatal death between three and 28 days of age in which
the cause of death is unknown; or any neonate reported as having suffered fromneonatal tetanus between three and 28 days of age and not investigated.

Confirmed case: Any neonate with a normal ability to suck and cry during the firsttwo days of life, AND who, between three and 28 days of age, cannot suck normally
AND becomes stiff or has spasms (i.e., jerking of the muscles), or both.
Note: The basis for case classification is entirely clinical and does not depend uponlaboratory confirmation. Neonatal tetanus cases reported by physicians are considered confirmed. However, investigators should review neonatal tetanus case records
during annual hospital record reviews.
Source: WHO

Maternal tetanus strikes women during pregnancy or within six weeks of thetermination of pregnancy. Women are exposed to tetanus when non-sterile
instruments or objects are used during and after delivery, including during
non-sterile abortions.

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243Childhood and adult tetanus can result from contaminated wounds. Tetanus
toxoid in a variety of formulations protects against tetanus.
Transmission – Tetanus is not contagious. The disease can occur in any
incompletely immunized person when tetanus spores in dirt, dung, or ashes
enter a person’s body through a break in the skin. Clusters of cases are sometimes seen among unimmunized populations sharing the same risk factors,e.g., delivery care from a practitioner who uses unsafe practices.
Population at Risk – Everyone who is unprotected through immunization is
at risk.
Estimated Morbidity and Mortality – Every year, an estimated200,000 infants die from tetanus in their first month of life. Only 5% of cases
are reported because health workers seldom see infants who die at homesoon after birth. Neither the birth nor the early death will be registered in vital
events systems. The case fatality rate of tetanus is approximately 80%. In addition, maternal tetanus causes an estimated 30,000 deaths per year.
As shown in the graph, the proportion of neonatal tetanus deaths to total
neonatal mortality does not stay constant. In high-mortality environments,
neonatal tetanus is invariably a big killler of children. This is not the case in
low-mortality environments such as Europe and the Americas. There are many

Source: Steinglass et al., 1993

Tetanus as a Cause of Neonatal Mortality

If the total neonatal mortality rate exceeds 30 per 1000 live births, the burden due toneonatal tetanus is substantial.

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reasons for this. Neonatal tetanus declines as socioeconomic conditions,
including sanitation and personal hygiene, improve; the proportion of the population engaged in agriculture diminishes; agriculture becomes mechanized
and chemical fertilizers replace use of animal manure; fertility declines; childbirth becomes more hygienic; and the use of preparations containing tetanus
toxoid increases. However, without waiting for these general improvements insocioeconomic conditions, one of the most rapid and efficient ways to reduce
neonatal mortality in high mortality environments is to tackle the problem of
neonatal tetanus through better immunization coverage.
Occurrence – Tetanus occurs worldwide. Maternal and neonatal tetanus are
considered public health problems in 57 countries.
The following characteristics may indicate that tetanus is a problem in aparticular location:• Low tetanus toxoid vaccination coverage among women• Poor access to or use of any health service• Poor access to or use of antenatal care services• Home deliveries not assisted by skilled attendants• Population engaged in agriculture• Proximity of farm animals• Low literacy levels and low income
These areas are often “silent areas” where disease surveillance is weak
and people do not notify health workers of tetanus cases or deaths.
Treatment – Excellent 24-hour-a-day nursing care and careful use ofdrugs can reduce the case fatality rate in neonatal tetanus from 80% to
50% or lower.
Recovery from tetanus does not provide immunity.

Tetanus Toxoid
Tetanus can be prevented if the client receives sufficient doses of vaccine,
appropriately spaced.

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Tetanus Toxoid Presentations
Presentation

Antigens

Primary Age Group

DTP

Diphtheria toxoid, tetanus toxoid,
pertussis vaccine

Children under one yearof ageDiphtheria toxoid and tetanus toxoid

Children through six yearsof ageTd

Tetanus toxoid with reduced diphtheria
content

Children seven years of age
and older, and adults

TT

Tetanus toxoid

AdultsDT

Tetanus toxoid is also available as DTP in combination with hepatitis B and/or
Hib vaccines.
Efficacy – After a primary series of three tetanus toxoid doses, clinical efficacy is virtually 100%. Protection falls over time and routine boosters are recommended every 10 years.
Side Effects
DTP vaccine: Mild fever and pain are common reactions; many infants also
have a mild local reaction with redness and swelling. Rarely, severe systemic
reactions, such as seizures, neurological complications, and anaphylaxis, follow DTP vaccination.

Tetanus toxoid: The most common reported event following tetanus toxoid vaccination is a local reaction and pain, which increases in frequency and severity with the number of doses a person receives. Serious reactions to tetanus
toxoid are rare.
Tetanus Toxoid Does Not Cause Abortion or Sterilization
Because tetanus toxoid is given to women of childbearing age, some people incorrectly
perceive it to be a method of birth control or sterilization. Health workers need to findout whether this is believed in their areas and to correct any misinformation. Respected
local leaders may be especially useful in getting the right information to the community.

Contraindications – There are no contraindications to DTP. However, DTP,
DT, and Td should not be given to individuals who have suffered a severereaction to a previous dose. DTP should not be given to children seven yearsof age or older.
There are no contraindications to tetanus toxoid; it is safe to give it at any
time, even in the first trimester of pregnancy.

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Schedules and Target Ages – For the prevention of tetanus in infants andchildren, three doses of DTP should be given at six, 10, and 14 weeks of age.
If a child does not get the second dose of DTP at the scheduled time, it should
be given at the earliest opportunity, and the third dose should be given after afour-week interval. Children do not have to begin a series of vaccinations
again if a dose is delayed.
DTP Immunization Schedule for Children under One Year of Age
Age

Minimum Interval Between Doses

Dose

6 weeks

DTP1

10 weeks

4 weeks

DTP2

14 weeks

4 weeks

DTP3

For the prevention of tetanus in women through their childbearing years andin their newborns, women should receive five doses of tetanus toxoid. The
table below shows the schedule by dose and the length of protection provided.
Td can be used instead of TT to protect against both tetanus and diphtheria.
Women who have received three doses of DTP during childhood or additionaldoses of tetanus toxoid-containing vaccine during their school years do notneed all five doses of TT in adulthood for protection. They must retain theirvaccination cards for health workers to determine the number of additionaldoses they do need.
Tetanus Toxoid Immunization Schedule
Expected Duration ofProtection for Woman

Dose

When To Give

TT1

As early as possible in pregnancy, or at firstcontact when a girl reaches childbearing age

None

TT2

At least four weeks after TT1

One to three years

TT3

At least six months after TT2 or in next
pregnancy

Five years

TT4

At least one year after TT3 or in next
pregnancy

10 yearsTT5

At least one year after TT4 or in next
pregnancy

All childbearing years

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Administration of Tetanus Toxoid-Containing Vaccines
DTP: The 0.5 ml dose of DTP is injected intramuscularly, usually into the outerpart of the thigh.
TT: Each 0.5 ml dose is injected intramuscularly into the upper arm.
Booster Doses of DTP after a Child’s First Year – For longer-lasting
protection, countries that have reached high coverage with the primary DTP
series may give one or two booster doses after children reach one year ofage. The booster dose can be in the form of DTP or DT. When one booster isgiven, it is administered in the second year of life. When two are given, thefirst injection is given in the second year, and the second between four andsix years of age.
DTP should not be given to children after they reach the age of seven years
due to the increased risk of adverse reactions to the pertussis component for
older children. These children should be given DT or Td.
Maternal and Neonatal Tetanus Elimination Strategies – Because
tetanus spores are found in the environment, tetanus cannot be eradicated.
However, it can be eliminated as a public health problem.
Maternal and Neonatal Tetanus Elimination – Definitions
Neonatal tetanus elimination is defined as the reduction of neonatal tetanus cases tofewer than one case per 1000 live births in every district of every country.
Because maternal tetanus elimination has not been defined, the achievement of neonatal tetanus elimination is used as a proxy for maternal tetanus elimination.

UNICEF, WHO, and the United Nations Population Fund (UNFPA) have joined
together to support the achievement of maternal and neonatal tetanus elimination by 2005. To achieve this goal, the organizations recommend two
strategies:• The administration of three doses of tetanus toxoid to at least 80% of all
women of childbearing age in districts at highest risk. The interval
between the first and second dose is a minimum of four weeks. Between
the second and third dose, the minimum interval is six months. Threedoses at appropriate intervals will provide immunity lasting at least five
years.
• Health education and promotion of clean delivery practices focusing on
the “three cleans”: clean hands (washing hands with soap and water),clean delivery surface, and the use of clean instruments to tie and cut theumbilical cord.

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Identification of High-Risk Areas
High-risk areas are districts with a reliable reported or estimated rate of neonatal
tetanus cases greater than one case per 1000 live births.
If neonatal tetanus surveillance is not sensitive enough to rely on a count of cases,
planners find out whether 70% or more deliveries are made by a physician, nurse, ortrained midwife. This is defined as a “clean delivery.”
If clean delivery coverage is lower than 70%, planners look at TT2+ coverage, which,if below 80%, makes the district high-risk.

Because tetanus cannot be eradicated, health officials must take steps to maintain the status of elimination year after year. To do this, UNICEF, WHO andUNFPA recommend:• Routine vaccination of pregnant women with tetanus toxoid.
• Routine vaccination of infants with DTP.
• Access to and use of clean delivery services.
• Surveillance to identify high-risk areas, assess service quality, and monitor
the maintenance of elimination status.
• School-based vaccination programs with Td or TT.
School-Based Immunization
Immunization of schoolgirls and schoolboys with one dose of TT or Td annually during
the first three years of primary school protects them from tetanus during their childhoodand young adulthood. Immunization of the schoolgirl population helps to prevent
maternal and neonatal tetanus for first-time mothers and young women at risk.
The school-based strategy is effective only where a high proportion of girls attends primary school.

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References
Steinglass, R. 2001. "Eliminating neonatal tetanus.” A Better Future forChildren: Progress Toward World Summit Goals for Health and Nutrition: A
series of briefing papers prepared for the UN Special Session on Children.
Arlington, VA. BASICS.
Steinglass, Robert. 1998. Using Early Childhood Booster Doses to Maintainthe Elimination of Neonatal Tetanus. Arlington, VA: Basic Support for
Institutionalizing Child Survival (BASICS) project.
Steinglass, Robert, Logan Brenzel, Allison Percy. 1993. “Tetanus.” Chapter 8
in: Disease Control Priorities in Developing Countries. Edited by D. Jamison
and W.H. Mosley. New York: Oxford University Press for the World Bank.
UNICEF. 2002 (draft). Strategies for Achieving and Maintaining MNTElimination. New York: United Nations Children’s Fund.
WHO. 2002 WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. Geneva: World Health Organization.
WHO. 1999. Field Manual for Neonatal Tetanus Elimination. Geneva: World
Health Organization. WHO/V&B/99.14.
WHO. 1998. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. Geneva: World Health Organization.
WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1993. Tetanus: The Immunological Basis for Immunization. Geneva:
World Health Organization. WHO/EPI/GEN/93.13.
WHO. 1987. Expanded Programme on Immunization: Issues on Neonatal
Tetanus Control. WHO/EPI Global Advisory Group Meeting.
EPI/GAG/87/WP.11.

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Tuberculosis

Identification – TB is caused by
Myobacterium tuberculosis. It usually attacks
the lungs, but other parts of the body canalso be affected, including the bones, joints,
and brain. While nearly half of a developing country's population may be infected,
only one-half to 1% of these individuals willshow radiological evidence of the disease.

Credit: WHO

Tuberculosis (TB) is a chronic disease that
affects people of all ages and is one of themost important public health problems
worldwide. National routine immunization
programs use the Bacillus Calmette-Guérin(BCG) vaccine to prevent miliary andmeningeal TB in the first years of life. BCG
offers limited protection against tuberculosis
in older children and adults.

WHO-Recommended Case Definition: Tuberculosis
Tuberculosis suspect: any person who presents with symptoms or signs suggestiveof tuberculosis, in particular cough of long duration.
Case detection: the activity of identifying infectious cases, mainly among adults
attending an out-patient health facility for any reason with cough for two or three
weeks or more, through sputum smear examination.
Case Definitions

A case of tuberculosis: a patient in whom tuberculosis has been bacteriologically confirmed, or has been diagnoses by a clinician.
Note: Any person given treatment for tuberculosis should be recorded.

A definite tuberculosis case: a patient with culture positive for the Mycobacterium
tuberculosis complex (in countries where culture is not routinely available, a patientwith two sputum smears positive for acid-fast bacilli [AFB] is also considered a “definite” case).

Transmission – TB is spread through the air when a person with the disease
coughs, spits, or sneezes. Because it is highly contagious, it spreads rapidly
where people are living in crowded situations, are poorly nourished, and cannot obtain treatment.

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251Children can contract tuberculosis any time after birth. Infection is almost
always transmitted from another family member and frequently takes place
before the source case knows that he or she has the disease.
Population at Risk – The disease is most commonly seen in adults but
affects infants, children, and adolescents as well and is often more serious foryounger people. Infants are more likely than adults to contract miliary andmeningeal TB, which attack vital organs and are usually fatal.
Estimated Morbidity and Mortality – Nearly two million people diefrom tuberculosis each year. It is estimated that nearly 1% of the world’s population is newly infected with tuberculosis each year.
Occurrence – TB occurs all over the world. Industrialized countries showed
downward trends in incidence for many years until the 1980s, when morbidity remained stable or increased in areas with an elevated prevalence of HIV
infection. Developing countries also are experiencing increases in incidence of
TB associated with high rates of HIV infection.
Treatment – Patients with TB formerly required expensive and long-termcare, but many people did not stay with their treatment course long enough to
be cured. At the same time, they became resistant to anti-tuberculosis drugs. In
response, the “DOTS” strategy was developed for both treatment and control.
DOTS (Directly Observed Treatment – Short-course) is a standardized shortcourse of chemotherapy.
BCG Vaccine
BCG vaccine protects infants infected with TB from progressing to more dangerous forms of the disease and gives them some protection against recurrence at a later age. BCG does not prevent TB itself and provides little
protection against the pulmonary forms. It is not recommended for adults.
The First Step toward a Fully Immunized ChildBCG coverage rates are the highest of all vaccines because it is a single-dose vaccine
given at or soon after birth, when children are more likely to be in contact with thehealth care system than later in life. When this encounter with the health system is asatisfactory one for the parents, they are likely to return for other vaccinations andother health services.

Form and Presentation – BCG vaccine is freeze-dried, so it must bereconstituted with BCG diluent made by the same manufacturer as the vaccine. Like other reconstituted vaccines, BCG has a short life span and, once
reconstituted, must be used or disposed of within six hours.

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Efficacy – Vaccination of uninfected children with BCG vaccine can provide
protection for more than 90%, but the protective effect varies.
Side Effects – An injection of BCG vaccine normally results in a small sore
approximately the diameter of a pencil. The sore usually heals by itself andleaves a small round scar, which health workers look for to determine whethera child has been effectively immunized. However, the absence of a scar does
not mean that the BCG vaccination did not work.
When given properly, BCG vaccine has no side effects other than the ulceration described above. However, local reactions, such as abscesses and inflammation of the lymph glands, may occur if too much vaccine is given or thevaccine is injected under the skin instead of in its top layer.
Contraindications – BCG should be given to all infants, even if their mothers have HIV, unless an infant shows HIV/AIDS symptoms, which is highly
unlikely. Since testing infants for HIV before they are vaccinated is generally
not feasible, virtually all newborns should receive BCG.
This practice will protect HIV-positive and -negative children who are at highrisk of exposure to tuberculosis because their mothers are HIV-infected.
Schedule and Target Age Group – All countries with a high incidence of
TB infection should routinely immunize infants with a single dose of BCG atbirth. If not given at birth, BCG may be given at the infant’s first contact withthe health system.

BCG Injections
Health workers say that BCG is the most difficult vaccine to administer because newborns’ arms are so tiny and the vaccine must be injected intradermally, that is, in the
topmost layer of the skin. Health workers need extensive and continuing practice tomaster this skill.
A short narrow needle (15 mm, 26 gauge) is needed for this injection. All other vaccines are given with a longer, wider needle (commonly 25 mm, 23 gauge), either subcutaneously or intramuscularly.

Administration – The 0.05 ml dose of BCG is injected intradermally into
the upper arm, just below the deltoid insertion site. Some vaccine manufacturers recommend a 0.1 ml dose for children older than 12 months presenting
for their first dose. Health workers administer BCG in the same place on every
child so that their colleagues know where to look for the BCG scar. The presence of such a scar has been used as evidence for prior BCG vaccination.

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ReferencesWHO. 2002. “BCG Vaccine.” Vaccines, Immunization and Biologicals.
WHO, IUATLD, KNCV. 2001. The Language of Our Science. International
Journal of Tuberculosis and Lung Disease. 5(3):213-215.
WHO. 1999. Issues Relating to the Use of BCG in Immunization Programmes:
A Discussion Document. Geneva: World Health Organization.
WHO/V&B/99.23.
WHO. 1993. Tuberculosis: The Immunological Basis for Immunization.
Geneva: World Health Organization. WHO/EPI/GEN/93.15.

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Yellow FeverYellow fever is a viral hemorrhagic fever transmitted by infected Aedes aegypti mosquitoes in tropical and subtropical areas. Outbreaks with major publichealth impact may occur suddenly, with case fatality rates ranging from 20%
up to 60%.
Identification – Yellow fever begins with a sudden onset of fever and chills,
head, back and muscle pain, nausea, and vomiting. These may progress tojaundice and hemorrhaging.
WHO-Recommended Case Definition: Yellow FeverClinical description: An illness characterized by acute onset of fever followed byjaundice within two weeks of onset of first symptoms and one of the following: 1)
bleeding from nose, gums, skin, or gastrointestinal tract; or 2) death within three
weeks of illness onset.
Laboratory criteria for diagnosis:• Isolation of yellow fever virus, or• Presence of yellow fever-specific IgM or a fourfold or greater rise in serum IgGlevels, or• Positive post-mortem liver histopathology, or• Detection of yellow fever antigen in tissues by immunohistochemistry, or• Detection of yellow fever virus genomic sequences in blood or organs by PCR.
Source: WHO, 1998

Transmission – The agent that causes yellow fever is a mosquito-born virusthat has three transmission cycles, sylvatic, intermediate and urban. All three
types exist in Africa; only sylvatic and urban exist in South America. The transmission of yellow fever within these cycles ranges from causing sporadic
cases to severe urban epidemics.

Sylvatic or jungle yellow fever occurs when monkeys living in tropical rain
forests are infected with yellow fever by wild mosquitoes; yellow fever is thentransmitted from monkeys to other mosquitoes. The infected mosquitoes canthen bite humans who enter the forest for hunting, logging, or other activities,
resulting in sporadic cases of yellow fever.
Intermediate yellow fever transmission occurs in humid or semi-humidsavannahs of Africa and can produce small-scale epidemics in rural villages.
Semi-domestic mosquitoes can infect both monkey and human hosts, andincreased contact between humans and infected mosquitoes leads to anincrease in disease. This is the most common type of outbreak seen in Africa
in recent decades.

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Urban yellow fever results in large explosive epidemics when travelers fromrural areas introduce the virus into urban areas with high human population
densities. Domestic mosquitoes, the Aedes aegypti, carry the virus from person
to person. These outbreaks tend to spread outward from one source to cover awide area.
Population at Risk – In the Americas, yellow fever occurs predominantly inadult males, 20 to 40 years old, who are exposed to the disease in the jungle. In Africa, the disease attacks all ages and both sexes.
Estimated Morbidity and Mortality – Yellow fever surveillance is poor,and the disease is seriously under-reported. Although fewer than 5000 yellow
fever cases were actually reported in 2000, WHO estimates that, in subSaharan Africa alone, 200,000 cases and 30,000 deaths are attributable toyellow fever every year.
Occurrence – In 2001, more than 30 countries were considered at risk foryellow fever in Africa. These countries are located in a band 15°N to 10°S of
the equator. In the same year, nine South American countries and several
Caribbean islands were at risk of the disease.
Areas at Risk for Yellow Fever

Treatment – Although there is no approved and accepted antiviral medication for the treatment of yellow fever, supportive care to increase hydrationand prevent hypoglycemia can improve the outcome.

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Yellow Fever Vaccine
Immunization of children who are nine months of age or older with 17D yellow fever vaccine is the best protection. Inclusion of older age groups may beappropriate among populations and within areas at high risk of epidemics. A
single dose provides protection against the disease for at least 10 years andoften for 30 years or more.
Form and Presentation – Yellow fever vaccine is freeze-dried, so it must
be reconstituted with yellow fever diluent made by the same manufacturer.
Once the vaccine is reconstituted, it must be used or disposed of within six
hours.
Efficacy – An injection of yellow fever vaccine is effective in almost 99% ofrecipients.
Side Effects – Children may get fever, headache, or mild muscle and joint
pain after an injection of yellow fever vaccine.
Encephalitis has been reported following yellow fever vaccination of a few
infants younger than six months, leading to the recommendation that the vaccine not be given before that age, even in an outbreak.
In those rare cases when yellow fever vaccine causes severe systemic disease,
it is only in adults.
Contraindications – There are no contraindications for giving yellow fever
vaccine to children older than six months of age, except for HIV. WHO recommends that yellow fever vaccinations should not be given to patients withsymptomatic HIV infection or to pregnant women.
Schedule and Target Age Group – One dose should be given to children at nine months of age, at the same time as measles vaccine.
Administration – The 0.5 ml dose is given subcutaneously in the upper
right arm.
Control Strategies – At-risk countries should offer immunization against yellow fever on a routine basis to infants. With support available from GAVI,
more programs are setting up routine systems for yellow fever vaccinations.
In addition to immunization, the destruction of mosquito breeding sites and theuse of insecticide-treated bednets reduces the mosquito population thereby
reducing transmission of mosquito-born diseases such as yellow fever, dengue
fever, and malaria.

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ReferencesWHO. 1998. WHO-Recommended Standards for Surveillance of Selected
Vaccine-Preventable Diseases. Geneva: World Health Organization.
WHO/EPI/GEN/98.01 Rev. 1.
WHO. 1996. District Guidelines for Yellow Fever Surveillance. Geneva:
World Health Organization. WHO/EPI/GEN/96.09.
WHO. 1993. Yellow Fever: The Immunological Basis for Immunization.
Geneva: World Health Organization. WHO/EPI/GEN/93.18.

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Vitamin A Deficiency

Credit: Mizan Siddiqi

Vitamin A deficiency (VAD) occurs
when an individual’s diet does notcontain enough vitamin A for
growth, development, and physiological functions. It may be exacerbated by infections such as malaria
and measles and by parasites suchas hookworm. Related vitamin A
deficiency disorders (VADD) include
subclinical and clinical problems.
Mortality and morbidity caused bythese disorders increase with theseverity of deficiency.
Identification – In 2001, the International Vitamin A Consultative Group(IVACG) issued the criteria shown in the table below for assessing the extent
and severity of vitamin A deficiency in populations.
Prevalence Criteria Indicating Significant Vitamin A Deficiency
Clinical Criteria
Population GroupChildren 2 to 5 years of age

Women of childbearing age

Indicator

Prevalence (%)

Night blindness>1.0

Bitot’s spots>0.5

Corneal xerosis and corneal scars>0.01

Corneal scars>0.05

Night blindness during recent pregnancy>5.0

Biochemical Criteria
All age groups

Serum retinol <0.7 umol/L (20ug/dL)>15

Source: International Vitamin A Consultative Group (IVACG), 2001

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Transmission – Vitamin A deficiency is not contagious.
Population at Risk – Young children and women of childbearing age in
low-income countries where intake of vitamin A is inadequate are most at risk.
Estimated Morbidity and Mortality – In the mid-1990s, xerophthalmia(which includes eye problems ranging from night blindness through corneal
scars) was estimated to affect more than three million children annually.
Subclinical vitamin A deficiency, which has no signs or symptoms, affected
150 to 200 million. At least one million deaths of young children are attributed to VAD every year.
Occurrence – Vitamin A deficiency occurs widely where diets are deficientin nutritious foods. Recent evidence indicates that the predominantly plantbased diets in many developing countries are unlikely to provide adequate
amounts of vitamin A to meet the needs of young children.
The problem of VAD is particularly acute for infants because they are bornwith virtually no stores of vitamin A. Breastmilk as an infant’s first and only
food can provide this nutrient, but where maternal vitamin A status is poor,breastfed infants are likely to be subclinically deficient in vitamin A by six
months of age.
Vitamin A Treatment for Xerophthalmia in Infants and Children
Target Group

Vitamin A dosage (IU)

Schedule

Young infants (0-5 months)

50,000Older infants (6-11 months)

100,000

Three doses administered ondays 1, 2 and 14 following
diagnosis

Children (males – 12 months
or more; females – 12 months
to 12 years)

200,000

Treatment – Children with measles should be treated with two doses of vitamin A on consecutive days; the size of the doses depends on the age, as
shown in the table above. A third dose should be given two to four weeks
later, if there are signs of xerophthalmia. Children with severe malnutrition
should be given age-appropriate doses on two consecutive days.
Women of childbearing age with night blindness or Bitot's spots should
receive daily doses of not more than 10,000 IU or weekly doses of not morethan 25,000 IU for at least three months duration. If a woman shows acutecorneal lesions, she should receive a dose of not more than 200,000 IU on
days one, two, and 14 after diagnosis.

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Vitamin A Supplementation
Vitamin A supplementation for infants, children, and postpartum women isused as a preventive strategy until all members of the population are certain
to get an adequate intake of vitamin A through breastfeeding, improved dietwith dark green or yellow vegetables, and food fortification.
Two 200,000 IU doses of vitamin A should be given to women within six
weeks after delivery at least 24 hours apart. This will benefit the woman,replacing the losses from her vitamin A stores caused by pregnancy and lactation. It will also benefit the infant by increasing breast milk and infant serum
retinol concentrations.
Form and Presentation – Vitamin A is usually given in an oil-based solution in soft gelatin capsules that contain 50,000, 100,000, or 200,000 IU.
The capsules should be kept dry and out of direct sunlight, but it is not necessary to keep them in the cold chain. They should not be frozen.
Side Effects – High-dose vitamin A supplements cause nausea, vomiting,and headache in 3 to 9% of children aged one to four years, but these side
effects resolve spontaneously within 48 hours. In neonates and young infants
under the age of 6 months, about the same percentage may develop a transient bulging fontanelle; this also subsides within 24 to 72 hours.
Contraindications – Women who are pregnant, or who may become
pregnant, should not consume more than 10,000 IU per day or 25,000 IU
per week.
Schedule and Target Age Group
Schedule for Routine Vitamin A Supplementation in Vitamin ADeficient Populations
Target Group

Size of DoseTime of Administration

Infants 6-11 months old

100,000 IU in a single dose

At any opportunity (e.g.,measles immunization)

Children 12 months and older

200,000 IU in a single dose
every four to six months

At any opportunity

Two doses of 200,000 IU atleast one day apart

As soon after delivery as possible and not more than six
weeks later

and/or 10,000 IU daily or
25,000 IU weekly

and/or during the first six
months following delivery

Postpartum women

Source: International Vitamin A Consultative Group (IVACG), 2001

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Supplementation Strategies – In more than 60 developing countries,
vitamin A supplementation has been incorporated into NIDs for polio.
Integration of vitamin A with NIDs has been widely accepted by families and,in most cases, has resulted in high coverage for vitamin A supplementation.
As NIDs are phasing out with progress toward polio eradication goals, healthofficials are trying to integrate vitamin A supplementation into the routine
immunization schedule and distribute supplements through periodic outreach(e.g., health weeks or days).
A Model for Delivery of Vitamin A Supplementation
The National Vitamin A Supplementation Program in Nepal has achieved high coverage throughout the country, and it appears that this coverage can be sustained. The
success of the program has been attributed to: phased-in implementation, technicalsupport by a national NGO (Nepali Technical Assistance Group), and participation ofvolunteers that have been serving children and families since 1988.
Recognizing the importance of training the Female Community Health Volunteers(FCHVs) to provide quality services, the government of Nepal began vitamin A distribution in 32 high-priority districts instead of trying to launch the program countrywide
immediately. The national program supported training, logistics, and community mobilization in the selected districts prior to the first distribution and later assisted withrefresher training managed by district staff. After the first two distribution rounds, districts manage subsequent rounds with minimal additional input from the program,which goes on to support new districts.
Community involvement also plays a role. The national program first collected datafrom focus groups and key informants and developed an overall strategy based on thefindings. The program encouraged districts to review the findings and decide what
methods might work best in their districts. Parades, involvement of schools, magicshows, and involvement of local political leaders were used. Today, the program is sowell known that once distribution dates are known, parents and other caregivers needlittle prompting to participate.
Now, more than 40,000 FCHVs administer a round of vitamin A supplements to children six to 60 months of age every six months throughout Nepal, and they are reaching 94% of the target population. This distribution is independent of polio NIDs.

Source: R. Houston, 2002

To date, coverage has been far higher using periodic outreach than throughintegration, as illustrated by the example below.

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References
Goodman, Tracey, N. Dalmiya, B. de Benoist and W. Schultink. 2000. Polioas a Platform: Using National Immunization Days to Deliver Vitamin A
Supplements. Bulletin of the World Health Organization 78(3).
Houston, R. 2002. Why They Work: An Analysis of Three Successful Public
Health Interventions. Vitamin A supplementation programs in Ghana, Nepal
and Zambia. The MOST Project, The USAID Micronutrient Program,International Science and Technology Institute, Inc., Arlington, VA.
PAHO. 2001. Providing Vitamin A Supplements Through Immunization andOther Health Contacts for Children 6-59 Months and Women up to 6 Weeks
Post-Partum: A Guide for Health Workers. Washington, DC: Pan American
Health Organization.
Shrestha, Ram Kumar. September-October 2001. Women Volunteers in Nepal
Make National Vitamin A Program a Success. Global Health Link. pp. 7
and 18.
Sommer, A. and F.R. Davidson. September 2002. Assessment and Control of
Vitamin A Deficiency: The Annecy Accords. The Journal of Nutrition. Vol. 132,
No.95.
Sommer, Alfred, K.P. West Jr. with J.A. Olson, and A. Catharine Ross.
Vitamin A Deficiency: Health, Survival, and Vision. 1996. Oxford: Oxford
University Press.
WHO. 1998. Distribution of vitamin A during National Immunization Days.
A generic addendum to the Field Guide for Supplementary Activities Aimed at
Achieving Polio Eradication. Geneva: World Health Organization.
WHO/EPI/GEN/98.06.
WHO. 1994. Using Immunization Contacts as a Gateway to Eliminating
Vitamin A Deficiency. Geneva: World Health Organization.
WHO/EPI/GEN/94.9 Rev.1.
WHO. 1993. How to Give Vitamin A Supplements. A Guide for HealthWorkers. Geneva: World Health Organization. WHO/EPI/TRAM/93.6.
WHO. [n.d.] Integrating Vitamin A with Immunization: An Information andTraining Package. Geneva: World Health Organization (CD-ROM).
Full page credit: Institut Pasteur

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Available Vaccines Not Widely Used in
Developing Countries
Some vaccines now available are not widely used in developing countries fora variety of reasons:• The magnitude of the disease does not justify routine vaccination.
• Routine immunization services may not be strong enough to support the
introduction of more vaccines.
• The vaccine may not be effective enough.
• The limited resources available go to other priorities.
The following table provides information concerning these vaccines and thediseases they prevent.

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Available Vaccines Not Widely Used in Developing Countries
DiseaseIdentification
and AgentTransmission

Occurrence
andIncidence

Effectiveness andLimitations of
Available Vaccines

Chickenpox

Most commonly, person toperson via
infected
respiratory
tract
secretions

Worldwide

Live attenuated viral
vaccineAn acute bacterial
Ingestion ofenteric disease charac- contaminatterized by sudden
ed food
onset, profuse painless or water
watery stools, nausea,
and vomiting in theearly course of illness.
If untreated, cholera
leads to rapid dehydration, acidosis,
circulatory collapse,
hypoglycemia, andrenal failure.

Worldwide

Abrupt onset withfever, malaise, anorexia, nausea, andabdominal discomfort
followed by jaundice.

WorldwideVirus

An acute, generalized
viral disease withsudden onset of slightfever, rash, andmalaiseCan result in secondary bacterial andother complications,
including skin lesions,dehydration, pneumonia, and central nervous system involvement

Among children
1-14 years ofage, case fatality rate is one
per 100,000
cases. In adults
30-49 years ofage, the casefatality rate isover 25 per
100,000 cases.

Effectiveness estimates
range from 80% to 90%
against infection; 95%
against severe disease.
Routine vaccination ofchildren from age 12 to
18 months is now carriedout in some industrializedcountries.

Virus can stay in bodyafter primary infection
and lead to herpes
zoster (shingles)
CholeraBacterium
Vibriocholerae

Hepatitis A

Virus

Often asymptomatic ormild in children indeveloping countries,
but can be severely
disabling, and relapses can occur for one
year. No chronic
infection.

Person toperson by
the fecaloral route.

The killed cholera vaccinethat was formerly used is
In severeno longer recommended
untreated cases,
because it provides only
death maypartial protection of short
occur within aduration.
few hours andthe case fatality Oral vaccines that provide
rate maysignificant protection
exceed 50%.
against certain cholera
strains have recently
In the 1990s,
become available inoutbreaks
several countries.
occurred in
However, these vaccines
South America,
do not protect against all
Zaire, andnew cholera serogroups.
India.
Several inactivatedvaccines are available thatIn developing
are safe and almost 100%countries, adults
effective, but these are not
are usuallylicensed for children under
immune andtwo years of age.
epidemics areuncommon, but
adults become
more susceptible as hepatitis
A incidence
decreases.

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Chapter 12: Vaccines and Vaccine-Preventable Diseases265Disease
Identification
and AgentTransmission

Mumps –
Infectious
parotitis

Airborne transmission, droplet
spread, and bydirect contact
with saliva of
an infected
personWorldwide

Virus-ladensaliva of arabid animal
introduced bya scratch or bite

Worldwide

Virus

Fever, swelling,
and tendernessof one or more
salivary glands.
Common complications
include central
nervous system
involvement andtesticular inflammation in postpubescentmales.

RabiesVirus

Begins withsense of apprehension,
headache, fever,malaise, andindefinite sensory changes; progresses toparesis or paralysis, spasm of
swallowing muscles, fear ofwater; delirium,and convulsions

Occurrence

Vaccines Available
Effectiveness andLimitations of Vaccines

Deaths due tomumps arerare.

Live attenuated vaccine isavailable as a monovalentvaccine or in combination
with measles and rubella(MMR).
Mumps vaccine is highly
effective, but including it innational childhood immunization programs often has
low priority.

Vaccines are available forpre-exposure vaccinationand post-exposure treatment.

If left untreated, rabies isalmost always WHO recommends vaccinafatal.
tion of :Causes an
estimated
35,000 to
40,000deaths a
year, mostly
in developing
countries• Individuals at high risk
because of their occupations(e.g., veterinarians, wildlife
conservation personnel, andpark rangers).
• Children five to 15 yearsof age in developing countries where canine rabies isendemic and not wellcontrolled and where rabies
immune globulin for postexposure treatment is notavailable.
• Dogs, cats, and other animal hosts.

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Disease
and
Agent

Identification

Rubella(Germanmeasles)

Mild rash diseasein children. If
rubella is contracted in the first
three months ofpregnancy, theconsequence isfetal death orcongenital rubella
syndrome (CRS).
CRS is characterized by blindness, deafness,brain damage,and heart
defects.

By droplets ordirect contact
with patients

Insidious onset ofsustained fever,
severe headache,malaise, anorexia,
a slow heart rate,enlargement of thespleen, and othersymptoms

Contaminatedfood and water

Virus

Typhoidfever,
paratyphoid fever
Bacterialorganisms

Transmission

Occurrence

Vaccines Available
Effectiveness andLimitations of Vaccines

Where childhood transmission is
widespread,few women ofchildbearing
age are susceptible. Wheretransmission ismoderate, more
women will besusceptible.

In developing
countries,
250,000
babies areborn per yearwith CRS.
In epidemic
years, incidence may
increase tentimes.

Worldwide
Annual incidence
approximately 17 million
cases, with
600,000
deathsLive attenuated vaccine• Monovalent vaccine• Combination with mumps(MR)• Combination with mumps
and measles (MMR)
Rubella vaccine should be
introduced only where routine immunization coveragecan be sustained at 80% or
higher. Lower coverage withrubella vaccine increases
rather than decreases thesusceptibility of women ofchildbearing age, by shifting infection to older ages.

Available vaccines are safeand effective in individuals
above five years of age, but
further studies are needed totest the value of these vaccines for children under five
years in national immunization programs.

Adapted from Chin, James. 2002. Control of Communicable Diseases Manual. Washington DC: American
Public Health Association and Epidemiology and Prevention of Vaccine-Preventable Diseases. 7th edition.
Atlanta, GA: Centers for Disease Control and Prevention.

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IndexAccelerated disease control 55-57
Active surveillance 137
Acute flaccid paralysis (AFP) 241
Adverse events following immunization(AEFI) 144
Advocacy 157, 196
Antibodies 16
Antigens 16
Auto-disable (A-D) syringe 126-127
Barriers to utilization 45-47
BCG (Bacillus Calmette-Guerin) 251
Behavioral analysis 155-156
Capital costs 168
Chickenpox 265
Chlorofluorocarbons (CFCs) 110, 114
Cholera 265
Cold chain and logistics
Cold boxes, 111-113, 115
Cold chain monitor(s) 107
Equipment 109-114
Failure 91, 115Freezers 110
Freeze Watch™ 107
Ice-lined refrigerators 110
Icepacks 110-112, 115-116
Inventory 113
Maintenance and repair 109, 113114
Management of storage equipment 112115
Planning for emergencies 115
Power source 110-111
Refrigerators 110
Replacement 113-114
Spare parts 109, 113-115
Stop!Watch™ 107
Storage capacity 89-90
Voltage stabilizer 111
Cold life 111-112
Cold rooms 109
Communication
Advocacy 157-164
Behavior change (or program)communication 157-161, 163-164
New vaccines 194-195, 173, 179
Social mobilization 157, 160
Community-based surveillance 37
Community participation 37
Contraindications 52-54, 76

Coordination 34-35
Cost components 170
Cost-effectiveness 175
Cost-efficiency 175
Delivery strategies
Catch-up campaigns 56
Fixed facility 44
Mass campaigns 55-57, 88, 124
Mobile strategy 44
Mop-up 57, 241
Outreach 44, 47-48, 177
Pulse 44
School-based immunizations 249
Supplemental immunization strategies 5557, 175
Village health days 48
Diluent 115-116
Diphtheria 210
DTP (Diphtheria-tetanus-pertussis) 212, 246
Disease control strategies
Accelerated disease control 55-57
Campaigns 55-57, 88, 124
LIDs (local immunization days) 241
Measles control 231
Mop-up 57, 241
NIDs (national immunization days) 55,
241
Polio eradication 241
SNIDs (sub-national immunization days)
241
Supplemental immunization strategies 5557, 175
Dissemination of information 162
Drop-out(s) 47, 49-51, 63-64, 73-75, 156,
164
Evaluation 79-80
Expanded Program on Immunization (EPI)
20
Financing 180
Fleet management 117
Focus group discussions 45, 153-155
For-profit providers 29
GAVI (Global Alliance on Vaccines and
Immunization) 36, 167, 183, 195
Health sector reform 38-39, 76
Hepatitis A 265

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Hepatitis B 219
Hep B (Hepatitis B vaccine) 191-193, 195,
221
Hib (Haemophilus influenzae type b) 215
HIPC II (Highly Indebted Poor Countries II)
184
HIV/AIDS 53, 230
IMCI (Integrated Management of Childhood
Illness) 51
Immunity
Active 16
Herd 18
Passive 16
Immunization coverage
Calculation 71-72
Coverage survey 82-83
Interpretation 73, 78, 80-81
Lot Quality Assurance Sampling 84
Methods to assess 63-66, 68-69, 71-73,
77-78, 80-84
Monitoring 77-78
Patient registers 65-66
Routine reporting 77
Tally sheets 68-69
WinCOSAS 82-83
Immunization schedule 43-44 (see also
Chapter 12)
IPV (Inactivated Polio Vaccine) 239
Incineration equipment 131
In-depth interview(s) 153, 155
Information systems 61-62, 84
Injection equipment 126-129, 201-202
Injection safety
Aide-memoire 124
Assessment tools 122
Recapping of needles, 128
Reconstitution, needles and syringes 128
Integrated disease surveillance (IDS) 147
Inter-agency Coordinating Committee(s)(ICC) 33, 81,185

Measles vaccine 63, 72, 227
Meningitis 199, 206
Misinformation 46-47, 146
Missed opportunities 47, 51-54, 83
MMR (Measles-mumps-rubella) 227, 266
Monitoring 65-71, 77-79
Multi-dose vial(s) 55, 88, 90-93
Mumps 266
National Regulatory Authority (NRA) 94,
146
NIDs (national immunization days) 55, 112,
241
Needle removal devices 201-202
Needle-free (or jet) injectors 201
Neonatal tetanus 243-250
Non-governmental organizations (NGOs)
28-29
OPV (Oral Polio Vaccine) 239
Outbreak preparedness committees 143
Outbreak response 57, 143, 215, 232,
258
Outreach 44, 47-48, 177
Patient registers 52, 64-65
Personnel, immunization service 32-33
Pertussis (whooping cough) 234
Pertussis vaccine 235
Pneumonia 199, 206
Polio (poliomyelitis)
Circulating vaccine-derived polio virus(cVDPV) 239
Polio eradication 241
Vaccine-associated paralytic polio (VAPP)
239
Private sector 28-29
Product Information Sheets (PIS) 109
Public sector 28
Quality assurance, vaccines 94-95
Quality of services 46, 64, 84

Japanese encephalitis 200
Laboratory 144
Logistics (see cold chain and logistics)
Lot Quality Assurance Sampling 84
Malaria 200
Maternal tetanus 243, 248-249
MeaslesSecond opportunity 56, 228-229, 227229
Supplemental immunization strategies 5557, 231-232

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Rabies 266
Recurrent costs 168
Refugees 57-58
Rotavirus diarrhea 199
Rubella (German measles) 267
Rumors 146
Safe Injection Global Network (SIGN) 122
Safety boxes 130
Sector-wide approaches (SWAps) 184
Service delivery 44-47
Shake test 105

Side effects 145, 154
Social mobilization 157, 160, 196
Steam sterilizers 129
Supervision 161-163
Surveillance
Case detection 137
Case-based investigations 137
Data analysis 140
Disease reporting 77
Information presentation 142
Reportable disease 136
Sentinel surveillance 138
Surveillance effect 141
Surveys
Immunization coverage 82
Large-scale population-based 84
Lot-quality 84
Missed-opportunity 51, 83
Thirty-cluster 51, 82-83
Seventy-Five-Household 83
Sustainability 186
Syringes
Auto-disable 126-127
Conventional disposable 127
Pre-filled, single-dose 128
Sterilizable 128
Tally sheets 68-69
Target population (also see Chapter 12)
and vaccine forecasting 87-88, 93
Never-reached 50
Unreached 47-50, 57
Urban areas 48-49
Temperature monitoring 103, 106-107
Tetanus
Determining protection 69
Maternal tetanus 243-244
Neonatal tetanus 243
School-based immunizations 249
TT (Tetanus toxoid) 69, 245
Thermometers 106-107
Tickler files 67-68
Time, steam, and temperature (TST) spots
129
Training 160-161, 194-195
Transportation management 116-117
Tuberculosis 251
Typhoid fever 267
Uniject ™ 127
User fees 180
Vaccination cards 66-67
Vaccination coverage (see immunization
coverage)

Vaccination sessions 47, 87-88
Vaccine (also see Chapter 12)
Control authorities 94-95
Forecasting 87-96
Freezing 104-107
Packing and handling 115-116
Potency 103
Procurement 94-95, 108
Quality 94-95
Reconstitution 116
Shortages 96, 99
Storage capacity 89, 90, 111
Vaccine arrival 94, 100-102
Vaccine carriers 111-113, 115
Volume calculator 89
Wastage 87-88, 90-93, 103
Vaccine Fund 184
Vaccine stock management 99
Vaccine stock records 102
Vaccine supply
Buffer stock 90-93
Maximum stock 89
Minimum stock 89
Multi-dose vial(s) 55, 88, 90-93
Oversupply 88, 90, 99
Reserve stock 90, 93, 111
Supply intervals 87, 89, 111
Vaccine types
Conjugate 17
Live attenuated 16
Inactivated 16
Polysaccharide-based 17
Protein-based 17
Recombinant 17
Vaccine vial monitors (VVM) 92-93, 102,
106-109
Vaccine vial size(s) 87, 91, 93
Village development councils 37
Village health days 48
Vitamin A
Deficiency 259
Supplementation 226, 261
Measles case management 226
Waste management of sharps 129-131,
173
Whooping cough (see pertussis)
WinCOSAS 82-83
Xerophthalmia 260
Yellow fever 255
Yellow fever vaccine 257
Zero reporting 139

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Washington, D.C.
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