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 the

Population, Health and Nutrition Information (PHNI) Project.

The MEDS Project is funded by USAID under Contract No. HRN-I-02-99-0002-

00, Task Order No. 02, and is implemented by LTG Associates, Inc. and TvT

Global Health and Development StrategiesTM, a division of Social & Scientific

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 innovation

and 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 with

commercial purposes.

The opinions expressed herein are those of the Technical Writing Group and

do not necessarily reflect the views of USAID.

ISBN 0-9742991-2-X

October 2003
Immunization Essentials 1

Table of Contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Introduction 15

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

Immunization Program Management 27

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

Delivery of Immunization Services 43

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

1

2

3
2 Immunization Essentials

Monitoring, Evaluation, and Information Management 61

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

Vaccine Supply and Quality 87

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

The Cold Chain and Logistics 99

Vaccine Stock Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99

Vaccine Arrival . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100

4

5

6
Immunization Essentials 3

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

Injection Safety 121

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

Disease Surveillance 135

Types of Disease Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .136

Facility-Based Routine Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .136

Community-Based Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137

Sentinel Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138

7

8
4 Immunization Essentials

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

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

Costs and Financing 167

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

New Vaccines and Technologies 191

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

9

10

11
Immunization Essentials 5

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

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

12
6 Immunization Essentials
Immunization Essentials 7

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 that

is practical as well as technically and operationally sound. For readers who

would like to explore topics in greater depth, we have provided additional

references.

In revising EPI Essentials, we have tried to listen to readers’ feedback, which

was generally very positive. Users very much appreciated having such a

variety 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 out

of print and because, over the past 15 years, immunization programs have

undergone 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; and

operational considerations that they must weigh to devise the best solutions for

their circumstances. We have drawn on real life experiences to illustrate how

technical and operational issues can be addressed in the field. 

In addition to technical changes, immunization has been subject to boom and

bust funding cycles, which are mirrored in fluctuations in coverage rates and

disease 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.
8 Immunization Essentials

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 the

necessity 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 the

tremendous 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 this

manual will assist those responsible for immunization programs to meet this

challenge. 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.
Immunization Essentials 9

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:

Reviewers were sought for the breadth and scope of their technical expertise and a

wide 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 other

independent immunization experts. 

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 Silimperi 

Peter Strebel 

Tej Tiwari 

Mark Weeks 
10 Immunization Essentials
Immunization Essentials 11

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 team

DT 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 Haemophilus influenzae type b 

HIPC II Highly Indebted Poor Countries II

HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency 

Syndrome

ICC Inter-agency Coordinating Committee

IIP Immunization in Practice 

IMCI Integrated Management of Childhood Illness

IPV Inactivated polio vaccine

MLM Mid-level management
12 Immunization Essentials

MMR Measles-mumps-rubella vaccine

MOH Ministry of Health

MR Measles-rubella vaccine

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 Coverage Survey Analysis System

YF Yellow fever vaccine
Immunization Essentials 13

15 Immunization Essentials

Chapter 1: Introduction

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.”

– Benjamin Disraeli

On May 14, 1796, Edward Jenner, a

British physician, performed an experiment that would revolutionize public

health. He made two small cuts on the

arm of an eight-year-old boy, James

Phipps, and inserted material taken

from a sore on a woman infected with

cowpox, a mild disease common to

dairy workers. Six weeks later, Jenner

injected the boy with fluid from a

smallpox lesion, and James did not

contract smallpox. With this experiment, Jenner discovered that inoculation of

a person with relatively harmless disease material could protect the person

from a more dangerous disease. He called this process “vaccination”, derived

from the Latin name for cowpox, vaccinia. 

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 

1940s Diphtheria-tetanus-pertussis (DTP) combination introduced

1955 Inactivated polio vaccine introduced 

1963 Live 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

Courtesy of Thomas Cooper Library, University of South Carolina
16

Immunization Essentials

Chapter 1: Introduction

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 of

organs and specialized cells that protect the body by identifying harmful substances, known as antigens, and by destroying them by using antibodies and

other 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 type

of 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 blood

and 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 in

a vaccinated individual, but because they are weak, they will cause either no

disease 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 and

then inactivating them with heat or chemicals. Because they are not alive, they

cannot grow in a vaccinated individual and therefore cannot cause the disease. They are not as effective as live vaccines, and multiple doses are
17 Immunization Essentials

Chapter 1: Introduction

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 of

an entire bacterial or viral cell. Fractional

vaccines, composed of only part of a cell,

are either protein- or polysaccharide-based. 

Polysaccharide-based vaccines are composed of long chains of sugar molecules

taken from the surface capsule of the

bacteria. 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 by

inserting 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 are

described in detail in Chapter 12.

Types of Vaccine

• Live attenuated

– Virus, e.g., oral polio vaccine (OPV), measles, yellow fever

– Bacteria, e.g., BCG

• Inactivated

Whole

– 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 

Credit: Aventis Pasteur
18

Immunization Essentials

Chapter 1: Introduction

Disease Transmission and the Impact of

Immunization

An infectious disease is an illness that occurs when an infectious agent is

transmitted 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

A basic concept of public health is that every individual who is protected from

a disease as a result of an immunization is one less individual capable of

transmitting 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. 

Credit: WHO
19 Immunization Essentials

Chapter 1: Introduction

The figure above illustrates the concept of herd immunity. It shows two hypothetical populations in which each individual comes in contact with four other

members 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 that

have 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 an

infected individual. This is how herd immunity can protect more people than

those who actually receive vaccinations and thus inhibit the spread of disease. Note that if the susceptible individuals are unevenly distributed, e.g., if

they cluster in urban slums, the level of protection in that population will need

to be higher to prevent transmission. 

CONCLUSION

In this hypothetical population consisting

of only susceptible individuals, the disease

can spread through the population exponentially, eventually infecting everyone

because everyone will come in contact

with an infected individual.

CONCLUSION

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 because

of the fact that they will not come in contact with an infected individual.

Therefore, the growth rate of the infection

is held in check with only a 75% immunization coverage rate. 

Good immunization coverage can also protect the unvaccinated

Adopted from: Fine, 1994
20

Immunization Essentials

Chapter 1: Introduction

The Global Effort to Immunize All Children 

In the 1970s, at the end stage of the global campaign to eradicate smallpox,

the World Health Organization (WHO) launched the Expanded Programme

on Immunization (EPI). Coverage for basic

vaccines was an estimated 5% in developing

countries at that time. The EPI goals were to

ensure 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 give

tetanus 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, the

United Nations Children’s Fund (UNICEF), the U.S. Agency for International

Development (USAID), the Italian government, and other partners. EPI and the

program to control diarrheal diseases were the “twin engines” that powered

child survival programs worldwide. As immunization coverage in developing

countries soared, EPI was helping lay the foundation for other primary health

care services. By 1990, average reported coverage for the six antigens was

over 70%. As a result of the increase in coverage, the incidence of vaccinepreventable diseases began to fall dramatically. 

EPI Logo. Credit: WHO

Reported DTP3 Coverage by WHO Region, 1980 - 1999
21 Immunization Essentials

Chapter 1: Introduction

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 other

immunization activities such as vertical disease eradication programs. Some

donors 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 was

a 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. 
22

Immunization Essentials

Chapter 1: Introduction

The deteriorating situation in the 1990s sounded alarms in the public health

community, 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 the

formation 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 of

helping countries strengthen immunization services and introduce new and

underutilized vaccines. 

The lessons of the 1980s and 1990s and the new opportunities put forth

at the turn of the century have set the stage for great strides in national

immunization programs. Realizing the potential of immunization requires a

commitment 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 coordinated

strategies 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 to

do this requires attention to many program details, which are described in the

chapters 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
23 Immunization Essentials

Chapter 1: Introduction

Chapter 4: Monitoring, Evaluation, and Information

Management

Using information to record, monitor, and evaluate services, to raise

coverage, and to reduce drop-out rates; tools to support these objectives

Chapter 5: Vaccine Supply and Quality

Forecasting vaccine needs, vaccine wastage, procurement, and

quality 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 and

adverse 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 and

facilitate 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
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. and

Peter 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
25 Immunization Essentials

Chapter 1: Introduction

27 Immunization Essentials

Chapter 2: Immunization Program Management

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 through

the 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, and

social 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 critical

link between the health system and the political environment. 

Good health is good politics 
28

Immunization Essentials

Chapter 2: Immunization Program Management

The Public and Private Health Sectors 

Public Sector

The public health sector includes ministries of health, public hospitals, and

government health facilities at the local, district, other sub-national, and

national 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 that

provide 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 access

to public-sector services. Many NGOs have good relationships with people in

the communities they serve and involve community members in planning and

supporting 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 and

immunization equipment. On the other hand, their extensive involvement in

programs 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. 
29 Immunization Essentials

Chapter 2: Immunization Program Management

National immunization programs can take advantage of NGOs’ experience

and appeal by encouraging their participation in: 

• Organizing and providing immunization services directly, although the

government 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 to

receive 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.

Credit: Hari Krishna Shah, BASICS II

An outpatient center.
30

Immunization Essentials

Chapter 2: Immunization Program Management

The Organization of Immunization Services 

In recent years, ministries of health have been increasingly faced with the

challenge of balancing the potential benefits of local decision-making with the

efficiencies of centralized policymaking and procurement. Setting policies and

standards at the central level helps to ensure technical reliability and consistent practices throughout their countries. Central-level procurement of some

commodities, particularly vaccines, makes it easier to negotiate lower prices

and to control quality. Staff in local health facilities and district health offices

need to continue to plan and monitor the services that they are responsible 

for 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, although

traditionally a national responsibility, could effectively be located at more

peripheral levels. 
31 Immunization Essentials

Chapter 2: Immunization Program Management

Distribution of Immunization Service Functions Among Levels

Function National level only National and/or other levels

Formulating national policies,

standards, and guidelines

Yes

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

Planning service delivery

strategies

National coordinates with other

levels and disseminates news of

creative and successful local

solutions.

Advocacy for allocation of

funds from central government;

coordinating donor support

Preferable to ensure

equitable distribution

Procurement: preparation of

tender documents, monitoring

quality of products bought

under the tender (vaccines,

equipment, and supplies)

Yes

Purchase, customs clearances,

storage, stock management,

distribution

These functions may be

delegated (as in South Africa).

Forecasting, quantification 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, and

reporting; design of formats for

use nationwide

Aggregate data from

lower levels; key role

for AFP (acute flaccid

paralysis) surveillance. Forward data

to WHO Regional

Office

Local staff, close to point of

service, can act promptly, before

data reach the national level.

Focal point for research pertaining to immunizationYes: choice of topics,

priority setting and

coordination are

needed for best use

of resources

Organizing reviews Yes Lower levels participate.

In-service training; updating

skills

Skill requirements

defined as per

policies, standards

and guidelines

National participates in

curriculum development; training

itself can be delegated and

decentralized.

Supervision Yes
32

Immunization Essentials

Chapter 2: Immunization Program Management

Immunization Service Personnel

Typical assignments of immunization functions of government personnel at

various levels of the system are shown in the table below. It is important for

government 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

Disease surveillance officers 

Information management

specialist

National vaccine store

manager and storekeepers

National cold chain and

logistics manager

Workshop managers and

technicians

For repairs of cold chain equipment

that cannot be made at more peripheral levels

Transport officer

Training officer and training

staff

May be a private-sector organization

Communication and social

mobilization staff 

Often part of a health education or

social mobilization unit that assists

multiple health services

Laboratory technicians

Accounting and clerical

workers

District Health

Management

Team

Day-to-day immunization operations may

be the responsibility of

a public health nurse

or district cold chain

officer on the team.

Disease surveillance officer or

focal point 

Cold chain and

logistics officer

Transport officer

In some districts

Accounting and

clerical workers

Officer-in-charge

Usually a nurse who plans,

manages, and monitors

immunization services,

among other responsibilities. In small facilities, this

may be the only person

who is authorized to give

injections.

Nurse assistant

Usually prohibited by law

from giving injections but

can give OPV, register,

and advise parents.

Custodial staff

Responsible for maintenance and repair of cold

chain equipment and vehicles. In some facilities, they

may take on some of the

nurse assistant roles.

Clerical workers

May be volunteers

* In many small dispensaries and health posts, the staff consists of one person who is a

manager, medical professional, technician, administrator, and custodian, all in one.

Source: Adapted from Feilden and Nielsen, 2001
33 Immunization Essentials

Chapter 2: Immunization Program Management

In addition to the three levels shown in the table, many countries also have

sub-national levels (provincial, regional, or state), but few staff members at

these 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 and

investigating 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: 

• Ministry of Health staff (e.g., the

national immunization program

manager and the director of preventive services)

• Staff from related ministries (e.g.,

the Ministry of Finance and

Ministry of Planning) 

• Multilateral donors (WHO and

UNICEF)

• 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 and

other 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. 

Credit: Kelley Sams, BASICS II

“Many hands make light the work.”
34

Immunization Essentials

Chapter 2: Immunization Program Management

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.

The Role of ICCs

Technical

• Development of a national policy framework for vaccines and immunization that

gives 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
35 Immunization Essentials

Chapter 2: Immunization Program Management

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, and

budgeting cycles of different institutions

• Building an open, inclusive, and collegial partnership among members

that 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)

Enhancing the Effectiveness of an ICC 

The ICC for immunization in the DRC was formed in the late 1990s as a unit of a

health sector-wide ICC, which has seven sub-committees to address interventions that

have 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.

Credit: Nelson and Shimp,2002
36

Immunization Essentials

Chapter 2: Immunization Program Management

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 and

introduce new and underutilized vaccines. GAVI

provides a forum for partners to agree upon goals,

share strategies, and coordinate activities. As of

2003, the financial arm of GAVI, the Vaccine

Fund, provides financing to over 70 countries to

help them reach national and GAVI objectives (see

Chapter 10). The box below summarizes GAVI’s organizational structure. 

GAVI Board – includes the highest-level

representatives of

Alliance members to set policy.

Renewable members:

WHO

UNICEF

The World Bank

Bill & Melinda Gates Foundation 

The Vaccine Fund

Rotating members:

One foundation

Two developing country governments

Three industrialized country governments

One NGO 

Pharmaceutical industry – industrialized

country 

Pharmaceutical industry – developing

country

Research institute

Technical health institute 

GAVI Working Group – comprises

managers from GAVI partner institutions, some on a rotating basis.

Supports the Board in policy development and implementation. Members

make sure that GAVI priorities are

reflected in their institutions’ work

plans.

GAVI Secretariat – facilitates coordination among partners and manages the

review 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

Financing

Regional Working Groups (RWGs)

– includes partners with a technical

presence in regions. These groups

coordinate technical assistance activities between national and international

levels.

Source: Global Alliance for Vaccines and

Immunization, 2002

Organizational Structure of GAVI
37 Immunization Essentials

Chapter 2: Immunization Program Management

Community Participation

Community participation in immunization programs has been shown to result

in 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 in

scheduling 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.

Village Development Councils

Improve Immunization Services!

The Primary Health Care Center (PHC) in Abba,

Nepal, had a refrigerator but no kerosene to

run it. The lack of refrigeration for vaccines

meant that every day a member of the PHC

staff would have to go to the district health

office 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 health

center or when VHWs were not able to collect

vaccine from the center, fixed sessions were cancelled. Outreach sessions were difficult to schedule. The availability of frozen icepacks was also

a problem.

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 eventually

agreed 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 outreach

sessions are offered. The VDCs participate more actively in planning and monitoring

immunization activities in their areas, and there are indications that coverage is

increasing and the drop-out rate is decreasing.

Community participation made the difference.

Source: Siddiqi and Weeks, 2002 Credit: Mizan Siddiqi
38

Immunization Essentials

Chapter 2: Immunization Program Management

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 health

sector. It is imperative that immunization program managers participate in any

national level discussions on the organization and financing of the overall

health sector.

One of the many lessons of

health sector reform has been

that health priorities are not

the same at the national and

local levels. Indeed, one result

of decentralization in many

countries has been a reduction in support for immunization and other preventive

services. District health management teams tend to give

higher priority to curative care

and services, such as ambulances, that are visible to the

public and to politicians.

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 health

sector reform that are most likely to affect the management and delivery of vaccination

services include:

Decentralization: moving decision-making authority and resources (financial and

human) 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

Source: WHO, 2002

Credit: Kelley Sams, BASICS II

Members of the community share their concerns

with local health officials.
39 Immunization Essentials

Chapter 2: Immunization Program Management

Another lesson of health reform is that when responsibility for the delivery of

health 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 is

available 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 team

members make budget decisions, they also need to be skilled in assessing the

merits 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 not

vary from place to place within a country.
40

Immunization Essentials

Chapter 2: Immunization Program Management

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 of

Congo. 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
41 Immunization Essentials

Chapter 2: Immunization Program Management

43 Immunization Essentials

Chapter 3: Delivery of Immunization Services

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 overcoming

some of these problems. 

Immunization Schedules

The schedule recommended by WHO for delivering the primary series of

vaccines 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 of

Childhood 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

Measles

Hep 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.
44

Immunization Essentials

Chapter 3: Delivery of Immunization Services

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 to

adapt the recommended schedule to a given country’s needs. In so doing,

local experts should keep in mind the importance of limiting the number of

contacts and reaching children as soon as their immune systems are able to

respond to the vaccine. 

Provision of Routine Immunization Services

There are several strategies for the routine delivery of immunization services in

or from health facilities. 

Fixed facility: This refers to the regular delivery of vaccinations in a health

facility on specified days of the week and hours of the day. Larger facilities

may give vaccinations whenever eligible clients come. 

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 usually

completed within a day and are

made by health facility staff on

foot or using motorized vehicles,

bicycles, or pack animals.

Monthly visits provide the most

timely 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 to

schedule 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 to

people living in remote areas. Mobile teams may spend several days traveling

to reach the people. In Nepal, it can take up to ten days of walking from the

district center to reach some villages. 

Credit: Veronique Leger
45 Immunization Essentials

Chapter 3: Delivery of Immunization Services

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 are

transportation and per diem costs involved. However, some people cannot be

reached 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 and

communities. This contrasts with other practices, such as exclusive breastfeeding, which require repeated and frequent actions on the part of mothers and

which 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 know

what services are offered and where and when they are available. They will

return if: 

• They know when to come back.

• They have been treated

respectfully.

• They have confidence that they

will receive the vaccinations that

they come for. 

We also know why families do not

use immunization services. Focus

group discussions, interviews, and

knowledge-attitude-practice surveys in

a wide range of countries have consistently found that a majority of parents

wish to immunize their children but

that many encounter obstacles, such

as those described below. These are

often due to perceived and actual

deficiencies within the health services.

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

Credit: Kelley Sams, BASICS II

Health workers should be sure mothers

know when and where to return for the

next vaccination.
46

Immunization Essentials

Chapter 3: Delivery of Immunization Services

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 miss

a scheduled immunization date,

they can still be immunized; so they

should come as soon as they can.

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 that

takes 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 public

authority. People will not return to health facilities where they feel unwelcome. 

Misinformation. False beliefs or malicious rumors also keep people from

using 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 some

immunizations.

• Sick children cannot be vaccinated.

• Immunizations commonly cause sterilization, disease, or dangerous

side effects.

Credit: Kelley Sams, BASICS II
47 Immunization Essentials

Chapter 3: Delivery of Immunization Services

• 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 the

move (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 them

after 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 Unreached 

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, raising

awareness, or expanding outreach. 

Improvements in scheduling.

Immunization sessions should be

scheduled to be convenient for

parents. 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 the

community. Both epidemiological

and practical considerations are

important. For example, holding

sessions less often than once per

month may delay protection, but

overly ambitious schedules may

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 month

permits health workers to reach twice as many villages.

A clear schedule of vaccination sessions can

help parents avoid wasted trips.

Credit: Kelley Sams, BASICS II

One indicator of good management is the number of vaccination sessions that are actually

held compared to the number planned. 
48

Immunization Essentials

Chapter 3: Delivery of Immunization Services

Raising awareness. Families need to know about immunization services

before they can use them. Local health workers play a particularly important

role in increasing awareness and providing information to the target population. Individual volunteers and community-based groups can assist in this

effort, as described in Chapter 9. 

Improving and expanding outreach. Effective outreach must be well

planned, organized, and supported. Vehicles must have fuel and must be in

good condition. Vaccines, sterile syringes and needles, vaccine carriers,

icepacks, and other supplies must be available in the right amount, in the right

place, and at the right time. In

addition, outreach workers often

need per diems. 

Several strategies can be employed

to maximize limited resources and

assure continuity of outreach services. Village health days can be used

to reach remote populations three

times per year with vaccinations,

vitamin A supplementation, and

other health services. Communities

can also support visiting teams by

providing work sites, furniture,

food, and lodging. These strategies can broaden the appeal of outreach,

share costs with other programs, and help avoid overdependence on external

funding 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 slum

areas weakens residents’ resistance to disease and increases their risk of

severe illness and death.

Credit: WHO
49 Immunization Essentials

Chapter 3: Delivery of Immunization Services

Improving immunization coverage in

urban areas can be complex. In some

situations, the ministry of health,

municipal governments, ministry of

local governments, and NGOs all

share responsibility for managing and

providing vaccination services.

Ongoing coordination is needed to

ensure that policies and standards are

applied uniformly, trained health

workers are available, and marginalized populations that may fall outside

of established jurisdictions, such as

transient slum-dwellers, have access to

services. Data on vaccination coverage and disease surveillance should

be collected from all service

providers, private as well as public. 

Urban health facilities, like their rural

counterparts, can marshal the help of

community members and local health

teams 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, or

previous 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 the

many 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 not

complete 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 child

does not receive all of the doses required for full protection, the resources that

have 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

Credit: Richard Pollard

Pockets in urban areas are likely to

have low coverage and high disease

transmission.
50

Immunization Essentials

Chapter 3: Delivery of Immunization Services

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 is

likely 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 give

priority to reducing drop-outs.
51 Immunization Essentials

Chapter 3: Delivery of Immunization Services

decide where their efforts will result in the greatest benefit, as shown in the

example 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 or

lack 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

A missed opportunity occurs when

a client, present in a situation in which

vaccinations should be available,

does not receive all of the vaccines

for which he or she is eligible. Missed

opportunities delay protection and

prolong the risk of getting the disease.

The missed opportunity and 30-cluster

surveys are good tools for identifying

whether potential vaccination clients

are being missed and for what

reasons. (See pages 82-83.) Those

reasons 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.

Improve screening. Health workers

should check children’s and women’s

vaccination 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 for

Integrated Management of Childhood

Illness (IMCI). Girls and women receiving antenatal and postnatal care

should be screened and, if eligible,

vaccinated with tetanus toxoid.

Failure to Screen

Can Be Fatal

While on a visit to a health center in

her district, the supervisor talked with

a woman whose baby had recently

died of neonatal tetanus. She was

receiving weekly treatment for tuberculosis from a health facility a few hundred meters from her home, but not

once during her pregnancy had she

been screened for tetanus toxoid. This

was the second baby she had lost to

neonatal tetanus.

Credit: Kelley Sams, BASICS II
52

Immunization Essentials

Chapter 3: Delivery of Immunization Services

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 health

facility for any reason. Health facility registers also can be used to identify

children who are due for a vaccination. Vaccination cards, registers, and

other methods of record-keeping are described further in Chapter 4.

Give all vaccines due. Some studies have found that health workers fail

to 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 of

health workers or parents that

giving too many vaccines at

once will harm a child, when,

in fact, vaccines are as safe

and effective in combination as

they are individually. Some

health workers mistakenly delay

the measles vaccination

because they believe that it must

be the last vaccination given to

the child.

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 and

returns 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

Job aids can help remind health workers how to

administer vaccines correctly.

Credit: Kelley Sams, BASICS II

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 to

screen recipients carefully.
53 Immunization Essentials

Chapter 3: Delivery of Immunization Services

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, or

other mild illness can safely and effectively be vaccinated. Prematurity, low

birth weight, and breastfeeding are not reasons to withhold a vaccination. It is

particularly 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 vaccination

of 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 particular

risk 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 is

intended 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 not

show 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 the

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 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 at

nine 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 risk

of 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. 
54

Immunization Essentials

Chapter 3: Delivery of Immunization Services

Because both health workers and parents may hesitate before vaccinating a

sick 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 full

immunization 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 he

or 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 this

protection.

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 especially

true 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.
55 Immunization Essentials

Chapter 3: Delivery of Immunization Services

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 subsequent

sessions (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 the

common features are: the target age group is expanded, all children are vaccinated regardless of their immunization status, immunizations do not need to

be marked on vaccination cards, volunteers are used, and civil society is

mobilized. Examples include polio national immunization days (NIDs) and

measles campaigns. Supplemental immunization strategies should not replace

routine services.

Accelerated Disease Control

Accelerated disease control strategies

differ by disease. For polio, population immunity levels must be increased

quickly in order to interrupt chains of

poliovirus transmission. In the few

remaining polio-endemic countries,

NIDs are held two or more times

annually to vaccinate everyone in the

target population (usually children under five years of age) in a one- to- threeday period. In non-endemic countries with low population immunity, NIDs are

needed approximately every three years. 

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.)

Credit: Ellyn W. Ogden/USAID

Using local transport to move vaccine.
56

Immunization Essentials

Chapter 3: Delivery of Immunization Services

Catch-up campaigns for

accelerated measles control

are conducted during a

period of several days or a

week over wide geographic

areas. Follow-up campaigns

are held after catch-up campaigns to reach children in

a narrower age range. 

Measles catch-up and follow-up strategies provide a

“second opportunity”

because all children in the

target population are included, regardless of immunization status. For those who were missed before, such strategies provide a

second 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

The door-to-door, or child-to-child,

strategy is sometimes used as a

supplemental immunization strategy to reach families that are not

served at health facilities and

other collection points. 

At least two visits to the same

area may be necessary: the first

to map residences, enumerate the

target population, and publicize

the approaching visit, and the second to provide vaccinations and

perhaps other services. Even

when going door to door, health

workers 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 human

resources, transport, and other costs.

Credit: Daniel Cima, American Red Cross

Credit: WHO

Children receiving vitamin A during measles campaign.
57 Immunization Essentials

Chapter 3: Delivery of Immunization Services

Mop-up strategies are used occasionally when control activities have succeeded in reducing the incidence of disease and in containing the disease

geographically, 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 such

campaigns are people who are at risk in terms of both age and location.

Decisions about target groups, age range, geographic scope, and type and

duration 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 and

other 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 in

measles 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 even

national 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, the

minimum 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 and

may also supplement routine immunization services, as shown in the example

on the following page.
58

Immunization Essentials

Chapter 3: Delivery of Immunization Services

Protecting Refugees against Disease

All children in refugee camps in Macedonia who were younger than 48 months of

age were targeted for immunization against eight vaccine-preventable diseases. Three

mass 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.

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

Credit: Tim Healing, Merlin
59 Immunization Essentials

Chapter 3: Delivery of Immunization Services

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 Health

Organization. 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 

61 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

Chapter 4:

Monitoring, Evaluation, and

Information 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 are

being 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, and

dissemination 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 by

limiting the information they need to

collect and record to that which is

most essential for program management and assessment. The following

questions can help information system

developers distinguish “need to

know” 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 rush

back and tally.” 

Source: GAVI, 2001

“
62

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

• 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 their

collection, 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 of

reports? 

• 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 and

monitor 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

• Sensitive to changes and

trends

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, they

must ensure that the items that

they 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 other

program characteristics. As the name implies, an indicator describes one or

more 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. 

Credit: Kelley Sams, BASICS II
63 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

Immunization Coverage and Drop-Out Indicators 

Indicator What It May Indicate Limitations

DTP1 coverage Availability of, access to, and

initial use of immunization

services by children.

Measures only the first in a three-dose

series.

BCG, although the first vaccination in

the schedule, is not an effective indicator where births take place at home and

no BCG is given. When BCG is given

to babies born in hospitals, it may be

recorded in a different information

system, if at all.

DTP3 coverage Continuity of use by parents,

client satisfaction with

services, and capability of the

system to deliver a series of

vaccinations.

Shows only completion of DTP series

and not other antigens. 

Measles coverage Protection against a disease of

major public health importance.

Does not indicate the capability of the

system to deliver a series of vaccines.

Supplementary doses may be confused

with routine doses.

DTP1 to DTP3

(Difference in the

number of children

who receive DTP1

and the number who

receive DTP3,

expressed as a rate)

Quality of service as perceived by parents and the

quality of communication

between parents and health

workers — this is the classic

drop-out indicator. 

Does not stand on its own; must be

interpreted in light of actual coverage

levels.

Does not give a complete picture of

drop-outs that may be occurring

between other antigens.

TT1 coverage Availability of, access to, and

use 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 of

the system to deliver a series

of vaccinations to women.

The series of five TT doses is given at

different intervals over the course of

many years. 

Once a woman has received five doses,

she should no longer be counted in the

denominator as a member of the target

population.

Fully immunized child

(FIC)

Capability of the system to

provide all vaccines in the

childhood schedule at the

appropriate age and the

appropriate interval between

doses in the first year of life;

also measures public demand

and perceived quality of

services. 

Generally not available from routine

service statistics.

Information can usually be derived from

population-based surveys analyzed by

WinCOSAS or other software.

Absence of vaccination cards limits the

reliability of this indicator.

The definition of FIC may vary among

countries.
64

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

Governments, organizations that provide technical assistance, donors, and

community 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 public

health 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

Indicator What It May Indicate For More

Information,

Refer to:

Number of immunization sessions that are actually held compared to the number plannedQuality of program management Chapter 3

Supply of unexpired vaccines Effectiveness of vaccine procurement, delivery, and managementChapter 5

Vaccine usage Effectiveness of fixed and outreach

session 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 district

level on status of equipment 

Quality of cold chain management Chapter 6

Use of a sterile syringe and needle for each injectionQuality of injection practices Chapter 7

Disease incidence Impact of immunization services Chapter 8

Parents’ knowledge of common

side effects and when to return

for additional vaccinations

Quality of communication between

parents and health workers

Chapter 9
65 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

Basic Monitoring Tools

Many of the basic monitoring tools that could benefit health workers, their

supervisors, and managers throughout the system are neglected because people don’t know how to use them. This is true despite the fact that many have

been 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. 

Maps

In addition to geographical distribution

of cases (see Chapter 8), maps can

show access to services, particularly in

rural areas. For example, local maps

can show population distribution in

relation to the location of health

facilities. 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. 

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, to

check the accuracy of reporting, and to target case investigations.

At a minimum, a patient register should include: the day, month, and year of

visit; the patient’s name; the patient’s address; the patient’s date of birth; and a

summary of services provided, including vaccinations given and dose number.

Another way to organize the immunization register is to set aside one or more

pages for each month of the year. When a child comes to the facility, a health

worker records the child’s name on the page for the month of his or her date of

birth. As vaccinations are given to that child, they are recorded on the same

line 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 not

received the vaccination or vaccinations for which they are eligible and then

follow up with these children. For example, children should have a measles

Credit: Kelley Sams, BASICS II

Hand-drawn maps posted where they are

to be used can be helpful in planning.
66

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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

Vaccination cards and other home-based records enable parents and health

workers to monitor an individual child’s progress toward full immunization.

Families keep these records of childhood and tetanus toxoid vaccinations to

remind them which vaccinations and doses have been given, which have not,

and when vaccinations are due. These cards may be the only records health

workers have of vaccination history and status if patient registers are not well

maintained or for clients who have moved from another health facility. 

A vaccination record may be a separate document or part of a general

child 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 of

taking advantage of all

health contacts and missing

no opportunities to provide

preventive services; this

applies whether a child

has come for an immunization and needs growth

monitoring or a woman

has come for antenatal

care and needs a tetanus

toxoid vaccination.

Credit: Jereo Salama Isika, JSI/Madagascar

Home record and reminder materials from Madagascar. Credit: WHO, 2003
67 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

There is reliable evidence that clients

generally value and retain their cards

and that, if reminded, they will bring

the cards to the health facility at each

visit. However, the cards’ meaning

and possible utility is not always recognized. Before any new card is

introduced, health workers and representative families should be asked to

assess how well they can read and

understand everything on it.

Managers should make sure that

health workers have adequate supplies of cards; many health facilities

fail to issue them because there are

none available. 

It can be difficult to interpret the information on vaccination cards without

assistance. Oral reminders may be

needed to communicate information,

particularly to people with poor

reading skills. 

When new vaccines are added to

national immunization programs,

changes to the old cards may be

required. To avoid the expense and

effort of revising the card, programs

may leave a space in which to

write additional vaccines as they

are introduced. 

Tickler Files

Tickler files are boxes in which copies

of children’s vaccination cards or similar records are filed according to the

month when each child’s next vaccination is due. For example, when a

child comes to a health facility and

receives a vaccination card, a health

Do They Understand

the Card?

A recent study of 600 mothers in one

country revealed that many could not

understand basic information on their

vaccination card. 

A reading test was first given to all

mothers. 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 last

visit.

• Only 45% could tell when the next

immunization was due.

• Only 44% could identify which vaccines the child had already

received.

Source: CHANGE Project, 2002

Credit: Craig Manning

Credit: Kelley Sams, BASICS II
68

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

worker writes on the card the vaccine, dose, and date of each vaccination the

child 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 are

pulled, 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 of

these children receives the vaccinations that are now overdue.

Tally Sheets

Tally sheets are forms on which health workers make a mark every time they

administer a vaccination. These are used as a basis for reporting to the district

level. Supervisors use them to monitor the accuracy of reporting from health

facilities to districts. 

Source: WHO, Immunization in Practice (2002 draft)

Daily Tally Sheet

For recording immunization and children protected at birth against neonatal tetanus

Health center:____________________________________ Date:____________________

Children

under 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
69 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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 health

workers 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.

Immunization Monitoring Charts 

Every health facility that offers immunization services needs to monitor progress

toward coverage objectives. Providing tools such as monitoring charts and

ensuring that health workers have the skills to use them can motivate health

workers, enhance performance, and improve the quality of data. 

The information on the following

page explains how to complete and

interpret a monitoring chart. 

Immunization monitoring charts

should be posted in every health

facility for inspection by health facility

staff, clients, and supervisors. The

charts can be shared with political

and community leaders. 

Determining Tetanus Protection at Birth

If the number of

valid doses already

received is:

And the last dose received was: Last born child

must be considered as:

0 Not protected

1 At any time Not protected

2 Less than three years before last birth Protected

3 Less than five years before last birth Protected

4 Less than ten years before last birth Protected

5 or more At any time Protected

Credit: Kelley Sams, BASICS II
70

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

STEP 3: Record vaccine doses

per month

Two 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 that

month under the graph. 

STEP 2: Enter yearly and monthly coverage objectives 

In the monitoring chart, a printed diagonal line goes straight

from 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 is

shown as a percent on the left side of the table and as a number on the right.

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, the

number 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 year

of age and pregnant women in their catchment area. 

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.

Example of Completing and Interpreting a Monitoring Chart
71 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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, the

chart 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 the

target population. These, in turn, are the result of inaccurate or outdated

Sample Self-Monitoring Chart for a Health Post

It has been shown that if

service providers understand such information,

they can use it to guide

action to improve immunization coverage. In

order to accomplish this,

data should be presented in a way that is useful to health workers and

understandable by community members. This is

an example of a combined tally sheet and

monitoring chart that

might be used by

peripheral health workers with limited arithmetic skills. In this

example, the health

worker did an annual

head count in the community and identified

340 children less than

12 months of age. Dots

are filled in to represent

doses of vaccine given.

They are counted and

compared against quarterly targets as shown in

the glasses of water

(cylinders).

The level of water is hand-drawn

each quarter. Based upon the

tally sheet below the glass, the

health 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 vaccinated

with DTP1. In this

example, 90 children have been

vaccinated during

the first six months

of the year.
72

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

census counts, population migrations,

and unforeseen changes in birth rates

or infant mortality. 

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. 

Calculating Annual Coverage for DTP1, DTP3, and

Measles Vaccines for 2003

DTP1 coverage:

number immunized by 12 months with DTP1 in 2003 

number of surviving infants <12 mos. of age in 2003 

DTP3 coverage:

number immunized by 12 months with DTP3 in 2003 

number of surviving infants <12 mos. of age in 2003 

Measles coverage: 

number immunized by 12 months with measles vaccine in 2003

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

Credit: Lauren Goodsmith

Immunization chart in Morocco.

x 100

x 100

x 100
73 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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.

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. 

Examples of Using Coverage Data to

Improve Vaccination Services

Coverage

Data

Issue Possible

Reasons

Suggested Remedy 

Example 1:

BCG 80%

DTP1 60%

DTP3 55%

Measles 55%

Why the

decrease

between BCG

and DTP1

vaccinations?

Missed opportunities to give

vaccination card

and 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 to

bring 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:

BCG 80%

DTP1 75%

DTP3 70%

Measles 45% 

Why the

decrease

between DTP3

and measles?

The long interval

between vaccination with DTP3 at

14 weeks and

measles at nine

months

Inform parents about preventing

measles by means of vaccination. 

Remind parents when and where to

bring the child in for measles vaccine.

Example 3:

BCG 70%

DTP1 70%

DTP3 40%

Measles 60%

Why is

measles coverage higher

than DTP3?

Difficult and/or

infrequent access

to vaccinations

Health workers

may be (incorrectly) re-starting

DTP series after

long intervals

between doses.

Remind health workers that if a child

has reached nine months of age

without completing DTP vaccinations,

a DTP vaccination can be given at the

same time as measles vaccine. 

After DTP1 vaccination, remind

parents that three doses are needed

and when to bring child for DTP2

and DTP3. 
74

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

Health workers should investigate the reasons, determine the solutions, and

take 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.

INSTRUCTIONS:

A. Enter the monthly total of DTP1 immunizations given to children below the age

of 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 age

of 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

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 !

x 100

Drop-Out Rate Monitoring Chart, 2004

Health Facility: Sub Health District: District:

Month

J F M A M J J A S O N D

DTP1 A. Month

B. Cumulative

DTP3 C. Month

D. Cumulative

E. Cumulative Drop-Out

DTP1–DTP3 (B–D)

F. Cumulative Drop-Out Rate %

60%

G. Bar Chart 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%
75

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

Example of Monitoring Drop–Out Rates

A drop-out chart used in a health facility in Uganda helps health workers track their

progress in reducing drop-outs. In this example, drop-out rates between DTP1 and

measles 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. 

Credit: Mark Weeks, BASICS II
76

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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 of

policies 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 same

data 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. 

Justifying budget requests.

Health reform and decentralization

have increased the need to advocate for immunization services at

the district level, where budgetary

decisions are increasingly being

made. Active monitoring and

sharing of a few indicators on

coverage, drop-outs, and other

data can be used to mobilize

communities, determine strengths

and weaknesses in health services, attract political support, and

justify funding requests. 

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 unnecessary

contraindications that left many children unprotected. 

The Ministry of Health issued a policy to clarify the use of contraindications, but health

workers 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

Constellation of Activities
77 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 that

facilities collected during the month. 

District health

management teams

usually need coverage

data for all vaccines

by dose. They may

also ask for data on

other aspects of

immunization services,

such as amount of

vaccine used and

disease 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 the

health facility? Is it up to date? Can health workers in the facility explain

what it means?
78

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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 the

reports are actually received.

Accuracy of reporting, as well as completeness and timeliness, should be

monitored. 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 their

knowledge of the area, their experience, and even their intuitions about

“funny numbers,” i.e., numbers that are unexpected, that stand out in some

way, or that otherwise don’t make sense. Some true examples of funny numbers from the field are described in the box.

Giving health workers the tools and skills to use data to assess their own performance can improve staff motivation, strengthen performance, and improve

data quality. Self-assessment through a process of active, continuous monitoring at each level should always be encouraged.

“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 that

clients 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, the

health 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.)
79 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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, and

reports of actions taken at district and

higher levels, as well as guidance for

local action. 

Evaluation

An evaluation can be a comprehensive study of the whole health system, a

service 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, evaluation

is 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? 

• What was the impact of the service on organizational or national goals?

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 sorting

out variables and determining

cause and effect relationships.

Measuring impact is time-consuming

and requires significant resources

and epidemiological expertise.

Nevertheless, impact evaluations

Credit: Anne B. Keiser Credit: Kelley Sams, BASICS II
80

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

are needed periodically to show whether activities have made a difference in

the 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, which

enables key stakeholders to participate in designing, planning, and executing

the evaluation.

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 that

at 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 of

these coverage estimates. The population-based MICS included estimated coverage by

12 months of age, and excluded doses given to children over 12 months. 

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 means

that 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 
81 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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 source

of 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 what

dates 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 time

of 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 the

sources 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 is

needed 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-year

planning exercise. 
82

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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 health

managers, academicians, donors, and international development organizations use these for assessments, evaluations, reviews, coverage surveys, and

other purposes.

Immunization Services Assessment Guide 

This guide (sometimes called “the common assessment tool”) is used to

analyze 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 of

a 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 is

based 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 and

tetanus 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

clusters or specific health facilities. 

A Coverage Survey Analysis System

(WinCOSAS) is available for the compilation and analysis of data from

cluster sampling surveys. The software

can be used to identify:

• Coverage by 12 months of

age and coverage from 12 to

23 months of age for each

vaccine dose

Coverage Surveys Can

Make a Difference!

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%.

Source: GAO, 1999
83 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

• 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 of

nine months

For more information, refer to Training for Mid-level Managers: The EPI

Coverage Survey (WHO).

WinCOSAS software is

available on the WHO/EPI

website.

Seventy-FiveHousehold Survey

This method focuses on

households 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 not

receiving services, then use

of services in the wider

catchment area must be

poor indeed. This type of survey is valuable because it encourages interaction

between community members and the health workers who collect the data

from 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).

Missed Opportunity Survey

A missed opportunity survey assesses whether all clients who were present in

a facility offering vaccinations for which they were eligible that day received

them. Available from WHO/EPI, the survey includes reviews of coverage data

and patient registers and interviews with clients as they leave health facilities.

Credit: Richard Pollard
84

Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

Lot Quality Assurance Sampling

This technique is used to assess the quality of service, coverage, or both for

the purpose of directing attention and support to the facilities or areas that

need 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 data

from 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 are

needed in the first instance to collect data and report them accurately, completely, and on time. 

When considering using computers for immunization data, managers and

donors 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
85 Immunization Essentials

Chapter 4: Monitoring, Evaluation, and Information Management

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

87 Immunization Essentials

Chapter 5: Vaccine Supply and Quality

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 each

year cannot be fulfilled unless potent vaccine is available when and where it

is 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 to

forecast vaccine needs accurately. This involves assessing the impact of

policies 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 

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 supply

of vaccines must then

be available to meet

that demand. 

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 to

ensure that the best vial

size is procured, given

availability, demand, storage space, transportation capabilities, and cost. 

Credit: Harvey Nelson
88

Immunization Essentials

Chapter 5: Vaccine Supply and Quality

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. 

Inaccurate or outdated census counts,

population migrations, and unforeseen

changes in birth rates contribute to

difficulties in determining the size of

a target population. Local health

managers may try to overcome such

problems by working with community

leaders to count people in their catchment areas (“head counts”), but this

is not easy, as any demographer

can attest. 

In addition to problems in counting

people, some managers inflate the

size of the target population to make

sure 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 data

in which they have confidence, usage,

rather than population size, is likely to

become the preferred basis for calculating vaccine needs. 

Overestimating the Target

Population for Campaigns

May Result in Oversupply

In preparing for high-visibility campaigns, planners forecast vaccine

requirements based on the desire to

have an adequate supply of vaccines.

At every level, they tend to calculate

target population size, coverage objectives, and vaccine wastage on the high

side 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 at

the district and health facility levels. 

After campaigns, managers should collect excess vaccine, move it to higher

and safer levels of the cold chain for

storage, and make adjustments in

future vaccine orders to account for the

presence of these stocks. In addition,

campaign planners should use the

number of children immunized in previous campaign rounds to estimate the

target for the next. 
89 Immunization Essentials

Chapter 5: Vaccine Supply and Quality

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 to

ensure that:

• Adequate amounts are available

• Space is available to store the

stock

• Vaccine is used before the expiry

date

• The duration of storage is consistent with recommendations (see

Chapter 6)

Supply Intervals 

Another variable in calculating vaccine needs is frequency of supply. Typical

supply intervals, which should be adapted by each level to account for transport availability, cold chain storage capacity and quality, and continuity of

energy supply, are listed below.

Storage Capacity

An additional consideration in

forecasting vaccine needs is the

amount of cold chain storage space

available at each level for vaccines.

A vaccine volume calculator has been

developed by WHO to help national

immunization programs determine

their space requirements when introducing new vaccines. With this tool,

managers can use the national

Typical Supply Intervals for Vaccines at Different Levels

Level Interval

National store Six months

Regional stores Three months

District stores One month

Health centers One month

Health posts One week

Credit: Craig Manning

A vaccine volume calculator spreadsheet

is available from WHO.

Credit: WHO

It is good stock management practice

to organize vaccines by type and

expiry date.
90

Immunization Essentials

Chapter 5: Vaccine Supply and Quality

immunization schedule and the vaccine vial sizes to estimate net storage

requirements per fully immunized child and woman of childbearing age. 

Reserve Stock

Reserve, 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 the

amount 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 are

needed 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 is

the proportion of vaccine that is supplied but never administered, calculated

as shown below.

Some so-called “wastage” is not wastage at all but rather a predictable and

acceptable cost of providing immunization services. Common causes of

unavoidable 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. 

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 of

usable 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 the

period: Starting balance + doses received - balance remaining = doses supplied
91 Immunization Essentials

Chapter 5: Vaccine Supply and Quality

• Any immunization session may attract fewer eligible people than anticipated. For example, based on experience, a health worker expects seven or

eight 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. 

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 instead

of 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

Unlike the messy refrigerator on the left, the tidy refrigerator on the right permits better

management of vaccine stocks.

Credit: WHO
92

Immunization Essentials

Chapter 5: Vaccine Supply and Quality

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.

Source: WHO, 2000Credit: Anne B. Keiser
93 Immunization Essentials

Chapter 5: Vaccine Supply and Quality

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.

Calculating How Much Vaccine to Order 

As 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 doses

of the particular vaccine required x wastage factor

The calculation is then adjusted based on the amount of stock on hand and

the reserve stock needed, as shown below.

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).

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 = 3

1000 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
94

Immunization Essentials

Chapter 5: Vaccine Supply and Quality

Forecasting the requirements for tetanus toxoid (TT) is more difficult than for

childhood 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, a

TT campaign in high-risk areas may increase the demand for TT, while the

demand 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 international

organizations, 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 perform

these tasks, as described in detail in

the WHO manual Procurement of

Vaccines for Public-Sector Programs. 

WHO’s Ensuring Quality of Vaccines

at Country Level–Guidelines for

Health Staff describes international

requirements that national immunization programs need to follow for

shipping, 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 listed

on the following page. 

A vaccine arrival procedure has been

developed to monitor and record the

condition of vaccines upon arrival.

This is described in Chapter 6.

All countries need National Regulatory Authorities, or control authorities, to

monitor the quality of vaccines. NRAs in countries that purchase their vaccines

directly from manufacturers are also responsible for:

Steps for Procuring

Vaccines at the

National Level

• 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
95 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 the

vaccine themselves. 

International organizations, particularly WHO and UNICEF, also provide

vaccine quality assurance and financing services. Once WHO is satisfied that

a 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 other

arrangements. The PAHO Revolving Fund and the Vaccine Independence

Initiative (VII) both function as payment guarantees in lieu of prepayment for

vaccines (see Chapter 10).

A Short List of Threats to Vaccine Quality

• During shipment: Inadequate notice of arrival, scheduling arrival during long

holidays, 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
96

Immunization Essentials

Chapter 5: Vaccine Supply and Quality

Global Vaccine Shortages

The supply of the six traditional vaccines was more than adequate to meet

demand until the late 1990s. Some manufacturers then stopped producing

these vaccines, and as their availability decreased, prices began to rise

significantly. 

By 2002, most vaccines given to children and women in developing countries, including the newer vaccines, were in short supply. Reduction in the

availability of some of the traditional vaccines is shown in the graph below. 

Supplies can be jeopardized if there are significant variations in vaccine

production, sizable batch failures during manufacturing, or changes in

vaccine formulations that require

approvals and increased manufacturing

capacity. Poor forecasting, inefficient

use, and sudden increases in demand

can add to shortages. Global responses

to shortages include: 

• Providing manufacturers with sufficient guarantees that the vaccines

that they produce will be purchased

• Making long-term funding available

to cover vaccine costs

• Improving the accuracy of forecasting, especially long-term

Availability Versus Demand for Traditional Vaccines Procured

Through UNICEF

Source: UNICEF, 2002

Credit: BASICS
97 Immunization Essentials

Chapter 5: Vaccine Supply and Quality

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 Health

Organization. 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

99 Immunization Essentials

Chapter 6: Cold Chain and Logistics

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, temperature

monitoring, equipment selection and maintenance, vaccine handling, and

transporting 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 in

and out of storage areas. 
100

Immunization Essentials

Chapter 6: Cold Chain and Logistics

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 the

quantities 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.

Credit: REACH Project/JSI

Staff should be ready to collect the vaccines upon arrival.
101 Immunization Essentials

Chapter 6: Cold Chain and Logistics

Source: WHO, 2001

Vaccine Arrival Report
102

Immunization Essentials

Chapter 6: Cold Chain and Logistics

Use of this WHO-recommended VAR form helps logisticians to identify and

document problems at the highest link of the cold chain through which all

imported 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

Accurate vaccine forecasting and ordering depends on knowing the quantity

of vaccines in stock at all times. Whenever vaccines and diluents enter or

leave a storage area, they should be counted. Ordering should be based on

a physical count of vaccine stocks rather than on stock records alone.

Vaccine stock records, like the one

shown above, are used to record the

name of the manufacturer of each lot

of vaccine, the vial size, the lot number, expiry date, vaccine vial monitor

status (see pages 106-109), doses of

vaccine received, doses issued, and

the 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. 

To ensure that no vaccine remains too

long in storage, stocks should be

arranged in order of “earliest expiration date — first out” (EEFO) at every

Credit: WHO Source: WHO, 2003
103 Immunization Essentials

Chapter 6: Cold Chain and Logistics

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, it

cannot be regained. Damaged vaccines must be destroyed, which can leave a

country 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.

Vaccines have different cold storage requirements, which change at different

levels of the cold chain, as shown below. 

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
104

Immunization Essentials

Chapter 6: Cold Chain and Logistics

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 to

track 16 shipments of vaccine from the national manufacturer to the point of

use. 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 to

district with vaccine in 10 shipments affected. Freezing episodes at such a

high level of the cold chain affect several month’s worth of vaccine supplied to

many districts and health centers. In the Indonesian study, vaccine was also

frozen at district levels within ice-lined refrigerators and in some health center

refrigerators. The temperature is shown below for one vaccine shipment from

a province to a district to a health center. Freezing occurred during storage at

both 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 fromSource: Nelson, 2001

Freezing Study Results, Indonesia

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

supervision, and monitoring.
105 Immunization Essentials

Chapter 6: Cold Chain and Logistics

touching icepacks has proven to be ineffective against freezing. During immunization sessions, vaccines can be kept cool but should be protected from

freezing by standing opened vials in a foam pad above the ice packs in the

vaccine 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 another

To perform the shake test, take a vaccine vial of the same type, manufacturer and

batch 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 that

any other damaged vials are also identified and withdrawn from use.
106

Immunization Essentials

Chapter 6: Cold Chain and Logistics

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 health

facilities, 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 are

used 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 label

or, for freeze-dried vaccines, placed on the vial cap. A square inside the disk

darkens irreversibly when exposed to heat over time. By comparing the color

of the inner square to that of the outer ring, users can determine the extent to

which the vaccine inside has been exposed to heat.
107 Immunization Essentials

Chapter 6: Cold Chain and Logistics

This is used to monitor temperature

during 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 these

cartons 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.

This is an irreversible

temperature indicator that

bursts 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 than

an hour.

Manufacturers pack these

devices with DTP, TT, DT,

Td, liquid Hib, and hepatitis B vaccines. They can

also serve as “silent supervisors” in refrigerators.

However, they do not

indicate whether vaccine

in individual vials has

been frozen.

Different

types of

thermometers are

used for

transport

and for

storage at

different

levels of

the cold

chain.

A combination of a Cold

Chain Monitor and Freeze

WatchTM indicator is used to

continuously monitor temperature range in vaccine refrigerators. The heat indicator

irreversibly records cumulative

heat exposures of +10°C or

any exposure over +34°C. The

freeze component bursts at

temperatures below freezing. 

REFRIGERATOR

 MONITOR CARD

CARTE DE CONTRÔLE

RÉFRIGÉRATION

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 of

a computer with MS

Windows-supported

software.

Vaccine Cold Chain Monitor Card (CCM)

Credit: WHO

Credit: WHO

Freeze indicator

(FreezeWatchTM)

Credit: WHO Credit: WHO

Thermometer

Credit: WHO

Temperature

data logger

(Tiny TTMTM)

Cold Chain Monitor and Freeze

Watch (STOP!WatchTM)

Some Tools Used for Monitoring Temperature
108

Immunization Essentials

Chapter 6: Cold Chain and Logistics

Different VVM models correspond to the heat stability of

different vaccines and, therefore, react at different rates.

For example, a VVM on a vial of OPV, which is the

most heat-sensitive of all vaccines used in national

immunization programs, will reach its end

point within two days of

exposure to

+37°C. At the

other extreme, a

VVM on a vial

containing TT,

which is very stable, will reach its

end point only

after 30 days of

+37°C exposure.

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 directly

from 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

Always check the VVM before using the vial. The vaccines in these

vials can be used because the inner square is still lighter than the

outer ring. Credit: WHO
109 Immunization Essentials

Chapter 6: Cold Chain and Logistics

• 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 found

that they must issue policies authorizing staff to use VVMs; disseminate clear

instructions to public and private health facilities; provide hands-on training in

reading 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 of

spare parts, tools, repairs, and fuel to

run the equipment must not be

overlooked during budget

preparation. As the pie chart

shows, these costs are much

more significant over a 10-year

period than the initial cost to

purchase cold chain equipment.

Cold Rooms

Cold rooms are large, specially

constructed rooms or self-contained

buildings located at the national,

and in some cases regional, level

for storage of large quantities of

vaccines. They have a 24-hour temperature monitoring system with an

alarm, a recorder, and a back-up

Cost of Cold Chain Equipment over a

10-year Period
110

Immunization Essentials

Chapter 6: Cold Chain and Logistics

generator that will turn

on automatically when

the regular power is

interrupted.

Freezers and

Refrigerators

Freezers and refrigerators are used in

district, regional, and

central stores. Freezers

are used for freezing

icepacks and storing

certain vaccines, particularly OPV, that

need to be kept at

temperatures below 0°C. Other vaccines are stored in refrigerators, which are

also used for chilling diluent before it is mixed with freeze-dried vaccine. Icelined refrigerators, which are used at the central and sub-national levels, are

capable 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 in

health facilities should be large enough to freeze and store icepacks needed

for outreach and fixed sessions.

Source of power. Electric appliances are the least expensive to buy and

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. 

Credit: WHO

Storage of Vaccines and

Ice packs in the Refrigerator
111 Immunization Essentials

Chapter 6: Cold Chain and Logistics

the easiest to maintain, but reliable electric power is not available in many

rural areas.Voltage stabilizers are usually needed to avoid damage to compressors caused by fluctuations in power. Where electricity is unreliable, gas

or 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 supply

of 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 a

three-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

Cold boxes and vaccine carriers are

insulated containers that are lined

with icepacks to keep vaccines and

diluent cold. 

Managers should consider a number

of technical questions in selecting a

cold box or vaccine carrier, including:

• How much vaccine, ice, and diluent must be carried

• How much the equipment weighs – especially if it is to be carried on a

bicycle 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

Credit: Kelley Sams, BASICS II

At this health facility, a cold box is used to

store vaccines on a temporary basis.
112

Immunization Essentials

Chapter 6: Cold Chain and Logistics

+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 a

closed vehicle in the tropics), cold life can range from eight hours for NID carriers to 120 hours for large long-range cold boxes.

Cold boxes are normally used to transport vaccine from the central level to

the provinces, from provinces to districts, and sometimes from districts to the

service delivery level. (Refrigerated vehicles are rarely used for vaccines in

developing countries because they are costly and subject to frequent breakdowns: a good cold box works as well

or better.) Cold boxes also are used

for temporary storage when a refrigerator is out of order or being defrosted. 

Vaccine carriers, which are more

portable, are commonly used to transport vaccine from district stores to

smaller health facilities and to outreach

sessions. Special “NID carriers” are

bags or boxes that have the benefit of

being lightweight; however, they have

a short cold life and are not durable. 

Icepacks

An icepack is a flat rectangular plastic container designed to be filled with

water, frozen, and then used to keep

vaccines cold. Icepacks must be

placed 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 are

advised 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 at

least 24 hours.

Management of Storage

Equipment

Obtaining the best available and most

appropriate equipment at the lowest

cost is only one aspect of keeping the

Credit: WHO

Placing icepacks inside a cold box.

Credit: WHO

Icepacks inside vaccine carrier.
113 Immunization Essentials

Chapter 6: Cold Chain and Logistics

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 the

equipment, tools, and spare parts that are being used or in stock. A good

equipment inventory will provide the information that is needed to track the

location 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, and

repair is performed to fix equipment when it fails. Planning for maintenance

includes identifying what needs to be done on a regular basis to clean the

equipment and keep it running, ensuring that appropriate tools and spare

parts 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., cold

boxes and vaccine carriers. 

Equipment manufacturers usually

describe maintenance requirements in

the manuals and other documents that

accompany their products. Health

workers and others who use or are

responsible for maintaining cold chain

equipment need training. 

Credit: WHO
114

Immunization Essentials

Chapter 6: Cold Chain and Logistics

Since any equipment can break down, repair workshops are needed with

appropriate tools, spare parts, and skilled technicians.

The availability of tools, spare parts, fuel, training, and labor for maintenance

and repair can be major problems. Planners and donors tend to fund the purchase of new equipment

and vehicles without also

planning and budgeting for

fuel, spare parts, maintenance, and repair. 

Replacement

Planning

Even with the best of care,

equipment will eventually

wear out or become obsolete. To avoid interruptions

of immunization services,

long-term and annual plans

are needed for replacing

equipment. Most manufacturers provide estimates of the life expectancy of

their equipment, and the Product Information Sheets, a reference published

every few years by WHO and UNICEF, include life-expectancy norms. 

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 be

determined 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. 

Regular maintenance and repair can extend the life

of vehicles.

Credit: TRANSAID

“It is sometimes easier to get a donor to provide a new vehicle than a set

of new tires for a vehicle that we already have.”

– An African health worker
115 Immunization Essentials

Chapter 6: Cold Chain and Logistics

Planning for

Emergencies

Many things can interrupt

immunization services,

including equipment breakdown, loss of electric power,

and shortage of spare parts

or fuel. Planning for these

emergencies can minimize

damage to vaccines and disruptions in immunization

services. In every place that

has vaccine storage equipment, staff should set up

warning systems for identifying an equipment failure and

make arrangements in

advance 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. 

Equipment outages caused by shortages of spare parts and fuel should not

occur. They should be avoided if there is regular monitoring of stocks and

ordering of new supplies.

Vaccine Handling

Proper handling of vaccines requires correct packing and storing of vaccines

and diluents, and correct reconstitution of freeze-dried vaccines. 

Packing Vaccines in Cold

Boxes and Vaccine Carriers

Freeze-sensitive vaccines may be

damaged if they are placed in close

contact with icepacks. This can be

an expensive loss, especially when

new vaccines are involved. Health

workers are therefore advised to

remove icepacks from the freezer

and keep them at room temperature

before putting them in cold boxes or

carriers. This “conditioning” process

Credit: Anne B. Keiser

Continuous monitoring of vaccine stocks is needed, as

shown in this national cold room. 

Credit: Anne B. Keiser
116

Immunization Essentials

Chapter 6: Cold Chain and Logistics

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, and

freeze-dried formulations of monovalent Hib vaccines. Combination vaccines

that include freeze-dried Hib are reconstituted with DTP or with a DTP-Hep B

combination. The manufacturers of freeze-dried vaccines also manufacture the

diluents needed for reconstituting their vaccines. The vaccine should always

be reconstituted with the diluent provided by the manufacturer for that

same 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 be

taken 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, and

health 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.”
117 Immunization Essentials

Chapter 6: Cold Chain and Logistics

Fleet management

This consists of the selection, purchase,

record keeping, maintenance, and repair

of 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, average

days used per month, and condition

• Identifying vehicle replacement

needs for a given period of

time, for example five years

• Defining technical specifications for the purchase of vehicles;

selecting and procuring vehicles

• Providing preventive

maintenance that

includes driver training, daily vehicle defect reporting,

vehicle inspection, vehicle servicing at

regular intervals, and correction of

defects; maintenance may be performed

by an organization’s own staff or an

outside contractor

• Arranging for disposal of vehicles at the

end of their useful lives

Operational management

This involves planning, scheduling, and

controlling the use of vehicles and defining

roles and responsibilities of managers,

transport officers, drivers, and users. When

done correctly, it can increase the number

of kilometers traveled per vehicle by 20%

per month and increase the total length of

time 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 to

unreached populations or meet other

service objectives.

Management Information 

Transportation management relies on information. Transportation experts recommend

that 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 ready

for use as compared to the time it

was broken down or undergoing

maintenance

• Utilization: Amount of

time that a vehicle was actually used

• Needs satisfaction:

Percentage of authorized requests for vehicle use that were met

• Safety record

Human Resources 

All staff members contribute to the effectiveness of the transport system, but specialists

are needed to manage and operate it. The

specialists for whom training and supervision are required include transport officers,

service managers, vehicle operators,

mechanics, vehicle inspectors, and vehicle

operator trainers.

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, and

passengers

• Selection, procurement, replacement,

and disposal of vehicles

• Vehicle planning at national, subnational, district, and local levels.

The Five Components of Transportation Management

Source: TRANSAID, 2001
118

Immunization Essentials

Chapter 6: Cold Chain and Logistics

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 and

Answers 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. 
119 Immunization Essentials

Chapter 6: Cold Chain and Logistics

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

121 Immunization Essentials

Chapter 7: Injection Safety

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 injection

that:

• 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, and

other diseases. Poor injection techniques can cause abscesses and infected

lymph nodes as well. 

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

Global Estimates of Infections Attributable to

Unsafe 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)
122

Immunization Essentials

Chapter 7: Injection Safety

providers to address safety issues more seriously than ever. Improved equipment, such as auto-disable (A-D) syringes and safety boxes, has helped, but

changes are required in human behavior and in the health system, too. The first

step is to identify the primary causes of unsafe injections. Programs can then

plan and implement training, supervision, provision of injection equipment,

waste disposal, information campaigns and other activities as appropriate.

Assessing Injection Safety 

Unsafe injection practices may not always be obvious nor the causes and

magnitude of problems clear. To help national immunization programs and

others 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; health

worker practices and reasons for them; and issues related to equipment. They

include the Rapid Assessment and Response Guide, the EPI tool to assess the

safety of injection practices, and a WHO tool to assess health care waste

management.

As with any generic assessment instrument, these tools should be adapted to

reflect local needs and conditions. Most importantly, an effort should be made

to 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, data

collection, analysis, and formulation of recommendations.

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 international

organizations 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 the

development and use of innovative, cost-effective

approaches to promote safe and appropriate use of

injections for all health care applications.
123 Immunization Essentials

Chapter 7: Injection Safety

Safe Injection Policies

Governments have the primary responsibility for ensuring that injections are

safe. 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 and

infection 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, family

planning, 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:

• Needles and syringes

• Safety boxes

• Training

• Incinerator equipment and spare parts

• Fuel for incinerators

• Sterilizing equipment, spare parts, and fuel

in 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.”

Credit: Daniel Cima, American Red Cross
124

Immunization Essentials

Chapter 7: Injection Safety

To assist countries with planning for injection safety, SIGN has published an

aide-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. 

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 to

reduce 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. Credit: WHO
125 Immunization Essentials

Chapter 7: Injection Safety

Another response to injection safety problems is public information, but this

can be a double-edged sword. While information campaigns can increase the

demand 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 to

reduce the risks. 

Injection Practice Problems and Recommendations

Problems Recommendations

1. Use of unsterile injection equipment. 

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 and 

needles, which are still commonly used for

therapeutic purposes.

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. 

Health workers should alert supervisors of

shortages. 

Managers should ensure that equipment,

fuel and spare parts are included in the

budget and provided as planned.

2. Unsafe collection of sharps. 

Health workers are unaware of the danger

to themselves and others caused by their not

placing disposable syringes and needles in

safety boxes.

Health workers are unaware of the dangers

of recapping needles.

Health workers do not have or do not use

safety boxes.

The health system should promote safe handling of injection equipment through policies, training, supervision, and

informational campaigns.

Trainers should require that health workers

demonstrate mastery of safe injection

techniques.

Supervisors should monitor handling of

injection equipment, use of safety boxes,

and management of supplies.

3. Unsafe management of waste.

Health workers do not know how to handle

waste or lack the appropriate equipment to

destroy it. 

Used equipment is dumped into public areas

where children and others scavenge it.

Trainers and supervisors should require that

health workers demonstrate the ability to

handle and destroy waste.

Supervisors should monitor waste

management.

The health system should provide information 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.

Patients may prefer injections to oral

medication.

Health workers should prescribe oral medication whenever possible.

The health system should educate the public

on the effectiveness of oral medication. 
126

Immunization Essentials

Chapter 7: Injection Safety

Local circumstances and awareness

of the problem should be used to

gauge 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 other

settings, publicity about A-D

syringes may create needless anxiety and do more harm than good. 

Of course, the most important factor in maintaining public confidence in immunization services is

to ensure the safety of injections.

Injection Equipment

Injection equipment that can be used to administer injectable

vaccines includes: 

• Auto-disable syringes 

• Standard disposable syringes

• Pre-filled, single dose, non-reusable devices (e.g., UnijectTM)

• Sterilizable syringes and needles

Auto-Disable Syringes 

A-D syringes are disposable injection devices that are specially

made to prevent reuse and are

therefore less likely than standard

disposable syringes or sterilizables

to cause person-to-person transmission of blood-borne pathogens.

Many health workers prefer A-D

syringes because they save the time

that they would otherwise spend on sterilization. Although these syringes are

more costly than other types, the cost is decreasing as demand increases. 

Auto-disable (A-D) syringe.

Credit: Becton-Dickinson

Improper disposal of syringes and other

medical waste behind a clinic.

Credit: SIGN
127 Immunization Essentials

Chapter 7: Injection Safety

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 are

needed 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 to

provide 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. 

Conventional Disposable Syringes

Conventional disposable syringes are plastic syringes with steel needles that are

provided 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 just

before use. These syringes are intended to be used only once, but they are, in

fact, 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. 

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 of

choice 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 sterilizable

syringes 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
128

Immunization Essentials

Chapter 7: Injection Safety

Pre-Filled, Single-Dose,

Non-Reusable Devices 

Some injection devices (e.g. UnijectTM)

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 that

the injection is safe. In some settings,

they have been used to take more

heat-stable vaccines like tetanus toxoid

and hepatitis B vaccine to hard-toreach areas beyond the cold chain.

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 by

health workers for cleaning and sterilizing the equipment, which may increase

the risk of needle-stick injury. Health personnel must also order supplies such

as fuel and spare parts for the sterilizers. Supervisors need to monitor the use

of 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 are

still 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 to

order 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, the

quantity 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 along

with other non-immunization equipment. 

Credit: San Francisco Chronicle

Pre-filled, single-dose, non-reusable devices.
129 Immunization Essentials

Chapter 7: Injection Safety

Sterilization of Injection

Equipment

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 vaccination

equipment have one, two, or

three racks, each of which holds approximately 40 syringes and 50 needles.

In addition to the sterilizer itself, the

following items are needed for the

cleaning and sterilizing procedure: a

basin for washing used syringes and

needles, forceps, a timer, stove, and

fuel. Time, steam, and temperature

indicators (TST) are required for every

sterilization cycle. These strips or

spots change color irreversibly when

the contents of a sterilizer have been

sterilized. Health workers must keep

records of their use to document that

sterilization has been done.

In compliance with a joint statement issued by WHO, UNICEF, UNFPA, and

the 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 make

the full transition to A-D syringes. 

Management of Sharps

Waste

As the use of A-D syringes has

increased, so has the urgency of

ensuring that all injection supplies are

disposed 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

These Practices Are Unsafe!

• Recapping needles (can result in

needle sticks for health workers)

• Changing the needle after an injection but using the same syringe 

• Reusing the needle and syringe for

multiple patients

• Boiling needles and syringes

• Flaming the needle

• Reusing mixing syringes

Credit: San Francisco Chronicle Credit: Veronique Leger
130

Immunization Essentials

Chapter 7: Injection Safety

where people might pick them up, step on them, or come in contact with them

in 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 of

awareness 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

Safety boxes, or sharps containers,

are puncture-resistant containers into

which A-D syringes and needles are

placed 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.

The volume of used syringes and needles that safety boxes must accommodate can be significant, as described

in the box. 

Wastage Volume of Used Needles and Syringes

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. 

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 for

children’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.

Credit: SIGN

A safety box should be available within

reach of every health worker who gives an

injection.

Credit: WHO
131 Immunization Essentials

Chapter 7: Injection Safety

Waste Disposal and Destruction

Once nearly full, safety boxes should be incinerated. If an incinerator is not available, a

much less desirable and effective alternative is

to douse them with kerosene and burn them.

In planning waste disposal, managers should

consult medical waste disposal policies and

environmental regulations for the national and

local levels. They should make plans for the:

• Location of disposal facilities:

Ideally, every health facility would have

an incinerator. Because cost and demand

limit the practicality of this solution, districts may install incinerators at strategic

locations, such as hospitals. 

• Disposal of filled safety boxes:

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 other

means at lower temperatures. Burning in a metal drum is considered the

next best option after incineration but may not destroy the waste completely and may result in heavy smoke. Open burning and burying are much

less effective and not recommended.

• Schedule and budget for destruction of safety boxes: A regular

schedule should be developed and maintained, and funds should be provided for sufficient quantities of fuel.

• Logistics: What arrangements are needed to ensure transport of waste

from 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 in

many countries to equip district hospitals and large health centers with this

kind of incinerator. However, means of disposing of waste from small facilities, like dispensaries and health posts, and at the end of outreach visits are

still under study.

While improvements in waste management continue, work is under way to

develop new disposal technologies. Some of the technologies that soon may

be available are described in Chapter 11.

Credit: D. Marchand/IDRC

Improper disposal poses risks to

the community.
132

Immunization Essentials

Chapter 7: Injection Safety

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 and

Appropriate 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 Clinical

Technology. 

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 of

Protection of the Human Environment. 

WHO. 2001b. Injection Safety: First Do No Harm. Geneva: World Health

Organization. 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.
133 Immunization Essentials

Chapter 7: Injection Safety

WHO. 1999. WHO-UNICEF-UNFPA Joint statement on the Use of AutoDisable Syringes in Immunization Services. Geneva: World Health

Organization. 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

135 Immunization Essentials

Chapter 8: Disease Surveillance

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 on

reaching the Universal Childhood

Immunization goal of 80% coverage

by 1990. In the 1990s, national program managers and donors started to

look more closely at the effect of immunization services on the incidence of

disease, and disease surveillance

became a more prominent activity. 

Disease surveillance is the collection,

analysis, and interpretation of data to

determine disease trends and patterns.

Disease surveillance provides information such as: 

• Disease incidence, morbidity, and

mortality, and progress in achieving disease control goals

• 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 to

identify the presence of infectious diseases and guide actions to prevent them

from becoming threats to public health. This chapter describes the activities

required to carry out that function.

Health worker at a rural clinic displays the

surveillance and coverage charts he created.Credit: Ann Jimerson
136

Immunization Essentials

Chapter 8: Disease Surveillance

Types of

Disease

Surveillance 

Different methods

are used to obtain

different types of surveillance information,

as described below.

Facility-Based

Routine

Surveillance

In many countries, health workers are required to report on the number of

individuals that come to their facility and are diagnosed with reportable

diseases. These reportable diseases are usually diseases that have outbreak

potential, such as cholera, polio, and measles, or diseases that are targets of

national 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 bring

patients to the health facility is known as passive surveillance.

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 and

account for these limitations, they may

incorrectly interpret

trends and patterns of

infectious diseases. 

One way to overcome

the limitations of passive surveillance and

get a better picture of

disease burden in the

Credit: Veronique Leger

Active surveillance.

Credit: Kristina Engstrom
137 Immunization Essentials

Chapter 8: Disease Surveillance

community is for health workers to visit health facilities and communities to

seek out cases. This is known as active surveillance. 

Since passive surveillance has limitations due to its lack of access to some

groups within the population, active surveillance is often used to enhance the

completeness of a passive surveillance system. Active surveillance is also more

expensive than a passive system and requires considerable additional effort to

organize. This means that active surveillance is usually conducted on a limited segment of the population and for only a brief period. Active surveillance

is, therefore, used to gain targeted insight into a situation and not collect routine data over a long period of time.

Routine surveillance by health facilities, whether passive or active, is often

hampered by the difficulty of making accurate diagnoses. Health workers may

lack the proper equipment or training for diagnosis in the health facility, and

laboratory services are often not available to confirm clinical diagnoses. 

In certain instances, health workers conduct case-based investigations to learn

more about a specific illness pattern, for example, when there is a suspected

case 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). 

Community-Based Surveillance

With training, members of the community can expand facility-based surveillance by detecting and reporting cases that may go undetected by the health

facility. 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 such

as bandaging the ulcer, instructing infected persons not to bathe in water from

ponds and streams, and promoting the use of filtered drinking water. 

Community-based surveillance needs the support of trained health care work- Credit: Kelley Sams, BASICS II
138

Immunization Essentials

Chapter 8: Disease Surveillance

ers who in turn provide training to the community on how to recognize the

disease 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 and

health workers can work together to organize transport, childcare, and other

assistance 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 and

surrounding areas. 

Community-based surveillance can be very useful in detecting and treating

some 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 by

someone with more advanced training. While it is always wise to involve the

community 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 and

should be prepared to regularly monitor activities to ensure that definitions are

being 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 designated

institutions selected for their geographic location, medical specialty, and

ability 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
139 Immunization Essentials

Chapter 8: Disease Surveillance

Detection

Surveillance begins with case detection. To accurately detect disease, health

workers need case definitions that are appropriate for the local context, and

they 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 of

yellow eyes or dark urine, but case detection became easier after they

learned 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 be

differentiated only by laboratory tests that may not be accessible. 

Reporting

Most ministries of health require that facilities routinely report the total count of

cases 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. 

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

Zero Reporting: Does No News

Necessarily Mean Good News?

A hypothetical health post’s disease report showed the following:

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 number

of cases that were detected.

Disease Number of cases

Measles 25

Cholera

Diphtheria 0
140

Immunization Essentials

Chapter 8: Disease Surveillance

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 computers

available to health facilities in the capital city are available to health workers

throughout the country. They should recognize that some facilities might depend

on 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. 

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 outbreaks, local health workers should have the authority and resources to take

quick action to stem the spread of the disease while help is being summoned

from 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 their

implications. Health workers need to be able to interpret trends and patterns

of disease in order to inact prompt control measures and avoid actions that

are not appropriate. 

In order to analyze and interpret surveillance data, health workers need to be

aware 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

Telecommunications Capacity to Report

Disease in One African Country

Means of communication Percent of Facilities with Access

Regional Health

Bureaus

(n = 11 )

Zonal Health

Departments

(n = 12 )

Health Facilities

(n = 33 )

Telephone services

Radio communications

Computers

Computers with modem

100%

100%

64%

27%

67%

33%

25%

8%

48%

3%*

12%

3%*

Source: WHO, January 2001

*one facility only
141 Immunization Essentials

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 and

evaluation 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 because

of better reporting rather than because of an increase in disease incidence, as

shown in the example.

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 and

determine 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 deaths

and 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. 

Measles Outbreak or Improved Surveillance?

Source: WHO, 2000
142

Immunization Essentials

Chapter 8: Disease Surveillance

Presentation

When data are analyzed

and the results interpreted,

the information must be

presented in a way that

meets the needs of the target audience. For example, highly technical

presentations of data may

be appropriate for senior

ministry officials but not

for local government staff.

A presentation to the

Minister of Health about

the impact of a health

event should be designed

differently than one made

to the Minister of Finance. 

A variety of presentation methods are available. For example,

maps that show the

location of cases are

useful for presenting

surveillance information, as well as for

analyzing incidence.

They can illustrate relationships among cases

and geographical and

demographic features

as well as show how

cases are clustered.

Maps of district and facility catchment areas can be sketched by hand, or

government 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 these

methods help make raw data more easily understood and should be tailored

to the appropriate audience.
143 Immunization Essentials

Chapter 8: Disease Surveillance

Response

Disease surveillance enables managers to respond to existing problems and

take steps to prevent anticipated problems. Responses may include verification

of 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 can

have 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

outbreaks, local health workers should have the authority and resources to take

quick action to stem the spread of the disease while help is being summoned

from district or national authorities.

Responding to routine reports is as important as responding to emergencies.

Routine surveillance data, together with coverage and other information, can

lead to improvements in immunization services such as the implementation of

strategies to provide unreached children with services. Managers who receive

surveillance reports should also provide feedback on their timeliness and

Outbreak Preparedness Committees

Outbreak preparedness committees are used at subnational, national, regional, and

global 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 technical

advice is available where needed, that supplies and manpower are distributed and

used appropriately, and that communication links are maintained with the public, the

media, neighboring countries, and regional and global networks.
144

Immunization Essentials

Chapter 8: Disease Surveillance

accuracy, send summaries of the analysis back to health facilities, and

describe how they used the data.

Laboratories

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 when

available, they often lack the equipment, reagents, and trained staff to

properly carry out their functions. 

The process of collecting and transporting specimens from the patient to the

laboratory 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 health

laboratory. These diagnostics are simple tests that can be performed by a

trained health worker in the field to confirm a suspected diagnosis.

Decentralized laboratory facilities are also being considered as a way to

move diagnostic confirmation closer to the health facility. 

As with other aspects of surveillance, communication is important. Health

workers 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 a

connection 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:

Credit: WHO
145 Immunization Essentials

Chapter 8: Disease Surveillance

• 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 a

health 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 form

of the disease but pose no serious health risk. These reactions occur more

commonly after injections with live attenuated vaccines than with inactivated vaccines.

Allergic: These are the most serious and most rare reactions. They are

caused by the body’s reaction to a particular component in a vaccine.

Severe allergic reactions can be life threatening, which is why good

screening prior to vaccination is important. Health workers who give vaccinations should know the signs of allergic reactions and be prepared to

take 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-preventable

diseases in developing countries, the danger from the disease is much greater
146

Immunization Essentials

Chapter 8: Disease Surveillance

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.

Dealing with Rumors

Health officials often have to deal with rumors,

especially when adverse events occur. Out of

genuine fear, concern, or less respectable

motives, people start and spread rumors about

vaccination. These exaggerations of risk can

seriously disrupt immunization programs.

There are four things that health officials should

do to combat rumors:

• Predict: The same rumors circulate regularly, for example, the unfounded accusation

that tetanus toxoid causes sterilization or the

false association of measles-mumps-rubella vaccine (MMR) with autism.

• Prepare: Knowing what rumors are likely to arise, health officials can

prepare materials to counteract them in advance. Information should

always be available for parents and the media on common side effects of

vaccines.

• 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

Complications Caused by Measles Compared to

Adverse Events following Measles Vaccination

Complication Measles Complications

per 100,000 Cases

Measles Vaccine Adverse Events

per 100,000 Vaccinations

Encephalopathy/

encephalitis 50 - 400 0.1

Convulsions 500 - 1,000 0.02 - 190

Death 10 - 10,000 0.02 - 0.3

Credit: Washington Post
147 Immunization Essentials

Chapter 8: Disease Surveillance

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.

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 have

their 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 as

that information flows upward, it branches out to numerous users in other

departments and ministries. If integration can make this process more efficient

and 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. 

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 the

child’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 the

rest 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.

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 surveillance

data for EPI.
148

Immunization Essentials

Chapter 8: Disease Surveillance

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 Health

Organization. WHO/EPI/TRAM/93.02 Rev.1.
149 Immunization Essentials

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

151 Immunization Essentials

Chapter 9: The Role of Behavior Change

Chapter 9:

The Role of Behavior Change

“Knowing is not enough, we must apply,

Willing is not enough, we must do.”

– Goethe

As described in Chapter 3, immunization services are less likely to be used by

people 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, and

friendly. 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 in

a mutually supportive way to promote complete and timely immunization of

women and children.

Achievement of immunization goals is affected by the behavior of many

groups, 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 and

caretakers.

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. 
152

Immunization Essentials

Chapter 9: The Role of Behavior Change 

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 and

other 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 around

the home and have them immunized when the team arrives. 

Fathers

• Bring children to immunization service delivery points yourself, or encourage their

mother to do so.

• Provide mothers with money for transport or other expenses related to immunizing

children.

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 first

year of life. 

• Inform families about outreach services, supplemental immunization activities, and

new 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
153 Immunization Essentials

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, and

increased 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.

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 and

the type of respondents. For example, parents and community leaders may

reveal information and beliefs in focus group discussions that they would not

share 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 front

of their peers. 

Focus group discussions are

in-depth discussions, usually

lasting one to two hours, in

which six to ten representatives

of 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 mothers

of fully immunized children or

fathers of drop-outs.

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 useful

for convincing decision-makers of the need to take action. They also provide a

baseline for evaluating results. 

Focus group participants exchange views on healthrelated topics.

Credit: Ann Jimerson
154

Immunization Essentials

Chapter 9: The Role of Behavior Change 

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 name

one 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 are

desired as proof that the vaccination is working.

3. The major reason children are not vaccinated is the distance to the place of

vaccination. Another barrier is competing demands on mothers’ time from other

children 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, and

report 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. 
155 Immunization Essentials

Chapter 9: The Role of Behavior Change

Using a combination of methods

and exploring the same topic with

different groups may provide the

most complete insights. For example,

in one setting, health workers conducted exit interviews to measure

client satisfaction after an immunization session, and the mothers interviewed reported no problems. Later,

focus group discussions conducted

by independent consultants showed

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 even

harshly 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, though

well-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 research

in the geographical area where they normally work.

Behavioral Analysis 

To identify the barriers that seem to discourage a desired behavior and the

factors 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 a

high 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 of

people 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. 

Exit interviews help health workers to

understand parents’ concerns.

Credit: Kelley Sams, BASICS II
156

Immunization Essentials

Chapter 9: The Role of Behavior Change 

Examples of Behavioral Analyses

Current

Behavior

Desired

Behavior

Barriers Motivating

Factors

Few health workers

(HWs) give information to parents

about the need to

return with their

children for the next

dose(s) and when.

Few listen to parents’ concerns or

check for understanding.

All HWs

always provide parents

with this

information

and check

for understanding

HWs don’t perceive the importance of informing parents when to

return for the next immunization. 

HWs believe that someone else in

the health facility is giving the

information or that the information

on vaccination cards is adequate.

They feel they don’t have time.

HWs get positive

feedback from clients

when they communicate well.

When communication

improves, HWs see

an impact in reduced

drop-out rates.

One-third of parents

do not bring their

children back on

time for subsequent

doses.

All parents

get their children immunized at

appropriate

ages and

intervals, so

that they are

fully immunized before

their oneyear birthday. 

Parents do not understand the

importance of their children completing the primary series of vaccinations on time.

They do not know when to return

for the next immunization.

They feel intimidated by HWs. 

They don’t expect to receive information, to understand it, or to get

a response to their questions, and

so they don’t ask.

Many families have other priorities,

so delay returning. 

Many families live far away from

the health facility, or outreach services have been discontinued.

Facility operations are poorly managed, e.g., sometimes children

who come to a scheduled session

cannot get vaccinated because

there is no vaccine.

Parents realize that

vaccines prevent

some dangerous diseases.

They want to protect

their young children

from disease.

They want to do the

right thing, i.e., make

their children safe

from vaccine-preventable diseases.

Community leaders

are not engaged in

ensuring that children receive vaccinations on time and

that they are fully

immunized before

the age of one

year. 

Leaders participate

actively in

getting

resources for

outreach.

Leaders work

with HWs to

schedule sessions at convenient

times.

Leaders believe that the health system alone is responsible for making

sure that children are immunized.

They do not realize that they can

actually do something to help.

They are contending with other

social, economic, and health problems.

Child health is a priority for communities.

Community leaders

like to solve problems

that affect members

of their community.

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.

Health Workers Parents Community Leaders
157 Immunization Essentials

Chapter 9: The Role of Behavior Change

Behavior Change

Strategies

The research and analysis described

above 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 and

facilitate those behaviors. Such

actions often include communication,

training, service improvement, policy,

and other activities. 

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 not

always 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 among

target 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 

Community members plan how to mobilize

mothers and children for immunization.

Credit: Kelley Sams, BASICS II
158

Immunization Essentials

Chapter 9: The Role of Behavior Change 

Communication Channels

Immunization programs use numerous communication channels to reach parents and other target audiences, from radio and television, to folk media, to

community events, to counseling at health facilities. Too often, decisions about

what channels to use are based on the beliefs and personal preferences of

people who think they know the target audience well but in fact do not. If the

decision 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. 

Communication experts have found

that the best channels for reaching

rural people are health workers, local

leaders and groups, and, in some

cases, radio. It is generally not very

effective to use print materials with

low-literacy populations or mass media

for those with little access to television

and other mass media. Generally, parents perceive health workers as a

credible 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 and

then 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 a

health facility to: 

• Address people’s doubts about immunizations

• Identify and fill information gaps and correct misinformation

• Respond to questions

• Reinforce positive attitudes and

behaviors

One-on-one counseling is the best

way to give parents information on

when and where to bring their child

for the next vaccination. However,

simply giving people information is

not enough; the message must be

understood and remembered, as

shown in the box.

It Was Said, but Was it

Understood?

In a study conducted in the Northwest

Frontier Province, Pakistan, health

workers were observed telling 85% of

the mothers when to bring their children for the next vaccination. Exit

interviews held later the same morning

with these mothers indicated that only

8% remembered when they were supposed to return!

Source: PRICOR, 1990

Credit: Kelley Sams, BASICS II
159 Immunization Essentials

Chapter 9: The Role of Behavior Change

Mass communication media can complement the basic channel of interpersonal

communication, 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. 

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 the

vaccination session will be held in three days, two days,

and one day. The flags demonstrate a public

commitment by health

workers that the session will take place,

that they will provide

community members

with advance notice,

and that they will

announce the

session’s start. 

Materials for Introducing Hep B Vaccine

Materials Intended Use Main Messages

Booklet for

health

workers

A reference for health workers to describe their responsibilities and help them

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

community

leaders

A reference for community,

religious, and social leaders

to help them plan support

activities and respond to the

public’s questions

What leaders can do to provide support

Basic facts about hepatitis B disease and vaccine

Posters To raise public awareness

and provide information

about the immunization

schedule

Childhood vaccines offered by the national

immunization program, including the new vaccine

Ages at which children should get vaccines

The importance of immunization for child health

Radio and

television

spots

To raise awareness among

the public, local and national leaders, and health staff

Increased protection to the public through new

vaccine and auto-disable syringes

No additional visits and injections needed to

benefit from the new vaccine

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

Flags indicating countdown to vaccination session.

Credit: JSI/Madagascar
160

Immunization Essentials

Chapter 9: The Role of Behavior Change 

Content. The content of the communication is as important as the channel.

There is ample evidence that shows that because most parents already know

that immunizations prevent some dangerous diseases, they do not need further

convincing nor hear clinical details. The most essential information they need is

when 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 these

do 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, and

partners about upcoming events and activities and increase their participation

in 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.

Training to Improve Knowledge and Skills 

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 health

workers’ knowledge and

improve technical and communication skills. Where there are

educational, cultural, and

economic differences that

prevent 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 needed

in the organization and patient flow during vaccination sessions, as indicated

in the sample behavioral analyses on page 156. 

Knowledge. Like members of the public, health workers themselves sometimes have misconceptions about immunization. For example, some believe

that 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

Credit: Kelley Sams, BASICS II
161 Immunization Essentials

Chapter 9: The Role of Behavior Change

a child comes late for a dose. Some fail to provide vaccinations because of

false 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 international

sources. Reading is not enough, however; people need to use knowledge in

order 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.

Technical Skills. With growing awareness of the fact that HIV/AIDS, hepatitis B, and hepatitis C can be acquired through unsafe injections, clients and

parents are beginning to watch how health workers handle needles and

syringes, 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 outreach

sessions, and handling waste. These skills are best learned from people who

do them well and should be reinforced through practice.

Communication Skills. Effective communication begins when a health

worker starts thinking about what keeps people from coming to a health

facility and/or what prevents them from returning. As noted above, people

may not get the information they need or may have unpleasant experiences

with health workers. To overcome

such communication problems,

health workers need skills in

listening, questioning, giving

instructions, and confirming that

they are understood. These skills

are best learned by observing

good models of communication

and practicing using role plays

and simulations.

Supervision and Other

Strategies to Support

Positive Behavior 

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

As part of training, health workers use role play

to practice their counseling skills.

Credit: Kelley Sams, BASICS II
162

Immunization Essentials

Chapter 9: The Role of Behavior Change 

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 that

national immunization policies and their own supervisors will support them.

Supervision. Supervision plays a major role in supporting positive health

worker 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 sure

that system supports are in place.

They should provide feedback to

Dissemination – A Critical Step

Dissemination is important! Unfortunately, after devoting substantial time and money to

develop guidelines, tools, and other print or electronic documents, too many people

and organizations then disseminate them in ways and formats that either do not reach

or 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 and

electronic) 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 that

they feel it is appropriate and useful for them.

Credit: Kelley Sams, BASICS II
163 Immunization Essentials

Chapter 9: The Role of Behavior Change

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 a

fully immunized child by using a rubber stamp to mark a seal of completion

on the child’s vaccination card or giving a diploma, as shown in the examples

from Kenya and Madagascar. 
164

Immunization Essentials

Chapter 9: The Role of Behavior Change 

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 table

shows how communication activities and other interventions might interact to

solve the drop-out problem discussed in earlier examples.

Comprehensive Approach to Reduce Drop-Outs

Communication Advocacy Social

Mobilization

Training System Support

HWs learn how to

give clear information to parents on

when to bring their

children back for the

next dose(s). 

Supervisors provide

job aids to remind

HWs of the key

messages.

Parents learn how to

use vaccination

cards as reminders

about next dose(s).

District Health

Management Team

(DHMT) and HWs

explain at every

opportunity the

importance of completing the immunization schedule.

HWs and communities publicly recognize families whose

children are fully

immunized by their

first birthday.

DHMT persuades local

politicians to

publicly state

the importance

of completing

the immunization schedule

by the first

birthday.

DHMT persuades local

politicians to

provide financial support

for outreach

visits.

HWs organize women’s

groups to visit

families that

have dropped

out of the

immunization

program.

HWs routinely

review

progress

toward targets

with community leaders.

DHMT

arranges for

training to

improve HW

communication skills,

knowledge,

and behavior

toward

families.

If language is

a barrier,

HWs find and

train community volunteers

to help HWs

communicate

with families.

HWs organize

facility operations

to enable them to

spend more time

with each client.

DHMT and

management at

higher levels plan

and implement

timely deliveries

of vaccines and

supplies.

Budget planners

include transport

and per diems for

outreach in

budget.

Supervisors monitor and reward

good HW

communication.

HWs and their

own supervisors

use data to guide

appropriate

actions.
165 Immunization Essentials

Chapter 9: The Role of Behavior Change

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 for

International Development.

Srinivasan, Lyra. 1993. Tools for Community Participation: A Manual for

Training 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 Health

Organization.

WHO, UNICEF, and USAID. 2002. Communication for Polio Eradication and

Routine Immunization. Checklists and Easy Reference Guides. Geneva: World

Health Organization. WHO/POLIO/02.06.

Wittet, Scott. January 2001. Hepatitis B Vaccine Introduction: Lessons Learned

in 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: Bill

and Melinda Gates Children’s Vaccine Program. PATH.

Full page photo credit: David Cantor, ORC Macro

167 Immunization Essentials

Chapter 10: Costs and Financing

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, but

also 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 first

year 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 clearly

requires 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 protection

of 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 is

embodied 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 and

efficiently 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.”
168

Immunization Essentials

Chapter 10: Costs and Financing

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 need

to 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 assess

needs, calculate costs, monitor expenditures, arrange financing, and make

efficient 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 to

state 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: 

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 that

these costs are for the six traditional antigens only. 

• Injection safety and social mobilization costs may be under-represented.

CAPITAL COSTS RECURRENT COSTS

• Building space

• Vehicles

• Equipment: refrigerators, cold boxes,

vaccine carriers, steam

sterilizers, incinerators

• Long-term training

(pre-service)

• Vaccines 

• Building operation and maintenance

• Transportation: vehicle operation and maintenance, fuel,

freight charges, fares for public transport, per diems

• Supplies: needles and syringes, ice packs, safety boxes,

fuel for refrigerators, reporting forms 

• Personnel 

• In-service training

• Materials for training, health promotion, social mobilization

• Contracts with commercial or nonprofit organizations for

training, social mobilization, fleet management
169 Immunization Essentials

Chapter 10: Costs and Financing

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. 

Estimated Costs of Immunization Services in Three Countries

Morocco

(1997 - 1998)

Bangladesh

(1997 - 1998)

Côte d’Ivoire

(1998)

Number of surviving infants (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

Capital costs

Building 12% 6% 7%

Vehicles <1 <1 <1

Equipment 4 4 2

Long-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%

Cost per FIC US$20.89 US$21.47 US$24.29

NA = not available Adapted from Kaddar, Levin, Dougherty, and Maceira
170

Immunization Essentials

Chapter 10: Costs and Financing

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

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 to

include 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). 

The following table illustrates

the types of expenses that need to

be considered in just one

program function.

Posters for national polio immunization

days on a boat for reaching distant

populations.

Credit: WHO
171 Immunization Essentials

Chapter 10: Costs and Financing

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 computers

and other equipment)

Strategy formulation Staff time

Consultants

Per diem, lodging, and travel expenses

Meeting room rent

Supplies (e.g., paper, renting or purchasing computers

and 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 of

broadcast materials

Staff time and consultant time (managerial, creative, and

technical input)

Cost of subcontract to advertising firm

Air time

Development of local communication channels

(e.g., drama groups, mosque

announcements, miking, etc.)

Staff time and consultant time (managerial, creative, and

technical input)

Cost of subcontract and/or of ongoing expenses (per

diem, 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 or

social mobilization efforts

Staff and consultant time (e.g., for planning, implementing, data processing)

Per diem, lodging, and travel expenses

Fuel
172

Immunization Essentials

Chapter 10: Costs and Financing

Commonly Overlooked Costs

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. 

For example, one country’s immunization program, which planned

to utilize volunteers for social mobilization activities, budgeted for the

bulk purchase of bicycles so as to

provide one bicycle per volunteer.

However, the manufacturer delivered the bicycles unassembled.

Local bicycle “repairmen” had to

be hired to properly assemble the

bicycles, which added significant,

unforeseen expenses. This required

diverting funds away from other program areas. 

The box below notes costs that are commonly overlooked in the development

of 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 and

supplies. 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. 

Credit: WHO

Budgets should include the cost of vehicle

repair and replacement.
173 Immunization Essentials

Chapter 10: Costs and Financing

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 of 

vaccines.

• 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 the

need 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 ensure

that the resources are available to meet all vaccine requirements. 

Waste Management. As the field of immunization evolves, some programmatic areas increase in importance, resulting in funding needs that had not

previously been fully recognized. One such area is that of waste management

for contaminated needles and syringes. Increased efforts to reduce the spread

of 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. 

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 be

devastating to the overall program. New vaccine costs must be met with new

resources.
174

Immunization Essentials

Chapter 10: Costs and Financing

How Can Different Service Delivery Strategies

Affect Cost? 

A variety of service delivery strategies are needed to reach different segments

of 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-reach

groups. At first glance, the less costly strategies may seem to represent more

efficient use of resources; however, efficiency includes the dimensions of both

cost and effectiveness. If providing services at a low cost does not achieve the

desired 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.

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? 

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

Scattered population

Cost of transport high

Key characteristics of the area

Densely settled population

Cost of transport low

Team organization and tactics

The team was large.

It provided services at many posts 

that were far apart.

It returned to headquarters several times 

every month for re-supply.

It identified eligible clients, traced clients

who did not use the services, and 

followed up on drop-outs.

Team organization and tactics

The team was small.

It provided services at a few posts that 

were short distances apart.

It returned to headquarters once a month 

for re-supply.

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
175 Immunization Essentials

Chapter 10: Costs and Financing

How Can Resources Be Used Efficiently and

Effectively?

A critical consideration in any planning and budgeting exercise is the effective and efficient use of funds. Efficiency implies a minimum of expense and

waste 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 child

for 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

Costs of Supplemental Immunization Activities

Budgets for special disease

control initiatives and

outbreak campaigns contain

the same line items as budgets for routine vaccination,

but the proportions and the

overall size of the budgets

are different. Costs for

expanded outreach and

door-to-door vaccination

strategies are generally

higher than for routine

vaccination because of the

need for more vaccines,

personnel, transport, and

per diem. Additionally, costs

for social mobilization,

communications, and media

are usually higher so as to

create broad awareness

about the campaign.

Credit: WHO
176

Immunization Essentials

Chapter 10: Costs and Financing

regional personnel. Many health care systems are organized inefficiently in

that they depend heavily on centralized authority to initiate local action. Better

organization of services can lead to significant savings in costs; for example,

well-publicized and appropriately scheduled outreach sessions can reach

large 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-dose

vials (see Chapter 6)

• Designing activities such as disease surveillance and social mobilization

so that they serve objectives in addition to the immediate intention, for

example, 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. 
177 Immunization Essentials

Chapter 10: Costs and Financing

Cost Implications of Increasing Vaccination Coverage by

Expanding Outreach Services 

Reaching new targets requires careful and detailed budgeting. Regardless of the new

target or the strategy used to achieve that target, there are common steps to follow in

order 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)
178

Immunization Essentials

Chapter 10: Costs and Financing

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

Number of HC visits, each HC visited 2

times per year

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

Calculation of total cost of per diem

Year 1 Year 2 Year 3 Year 4 Year 5

Number of outreach sessions 60,000 60,000 60,000 60,000 60,000

Per diem 1.00 1.10 1.21 1.33 1.46

Total outreach per diem 60,000 66,000 72,600 79,860 87,846

Number of supervisory visits with per

diem (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 60,200 66,220 72,842 80,126 88,138
179 Immunization Essentials

Chapter 10: Costs and Financing

Step 8 Prepare a multi-year budget based on the assumptions in steps 5 and 6, and

the calculations in step 7.

Kress, 2002

Sample Five-Year Budget for

Strengthening Outreach Services

Unit

cost

Year 1 Year 2 Year 3 Year 4 Year 5

Capital costs

Bicycles 100 50,000 0 0 0 0

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

Recurrent costs

Maintenance of bicycles 10 5,000 5,500 6,050 6,655 7,321

Training 10,000 0 0 0 0

Fuel for supervision 1,467 1,613 1,775 1,952 2,147

Total cost of per diem 60,200 66,220 72,842 80,126 88,138

Total 139,167 78,833 86,717 95,388 104,927

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. 

Important, but less obvious, costs associated with

new 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.

Immunization managers who plan for the

expansion of the program need to work closely

with financial planners who budget for the

overall health sector costs. Poorly conceived

and planned expansion will most likely fall short

of goals and undermine confidence in the

immunization program. The actual and full cost

of any change to the immunization program must

be carefully calculated and presented to

decision-makers.

Credit: WHO
180

Immunization Essentials

Chapter 10: Costs and Financing

How Can Vaccination Services Be Financed?

It is important to identify adequate and sustainable sources of financing in

order for immunization programs to be effective. Financing needs to be sufficient, provide for all appropriate vaccines, ensure that immunizations are

delivered safely, and reach all the children in the country. Today’s funding

environment allows health sector officials to choose from a wide variety of

options 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 to

overcome 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 the

detriment of the immunization program. One example is user fees. 

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 of

each financing mechanism’s characteristics is needed before selecting an

appropriate strategy. It is recommended that a financing strategy be evaluated

based on the following criteria:

Does the mechanism:

• Promote equity

• Achieve efficiency (cost effectiveness) 

• Provide resources in an adequate, timely, and reliable manner

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 that

funds raised through user fees are not necessarily used for intended purposes, and in

some 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.”
181 Immunization Essentials

Chapter 10: Costs and Financing

• 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 with

external 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

equity

Achieves

efficiency

Provides adequate, timely and

reliable resources

Engenders

accountability

Encourages

selfsufficiency

Domestic public

General

revenues

(central level)

+/–

depends on

tax structure

+

requires no

additional

resources to

manage

– /+ 

allocation is often

lower than program requirements; delays in

accessing funds;

potential exists for

high levels of funding

+/–

depends on

quality of 

public administration

+

General

revenues

(sub-national)

–

depends on

tax structure;

poorer subnational units

are disadvantaged

+

requires no

additional

resources to

manage

–

allocation is often

lower than program requirements; delays in

accessing funds

+/–

depends on

quality of 

public administration

+

Social health

insurance

(compulsory)

+/–

depends on

solidarity of

system

–

may have

high administrative

costs

+ + +

+ generally positive effect

– generally negative effect

o no clear positive or negative effect; depends on country conditions

+/– both positive and negative effects
182

Immunization Essentials

Chapter 10: Costs and Financing

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

Financing

option or mechanism

Promotes

equity

Achieves efficiency Provides adequate, timely

and reliable

resources

Engenders

accountability

Encourages

self-sufficiency

External public

Project grants o –

requires additional

resources to manage

+/–

year-to-year

allocations

can vary

greatly

+ –

Debt relief proceeds+ +

requires no additional resources to

manage

+ +/–

depends on

how procedures are

established

for tracking

+

Sector-wide

approach

(SWAps)

+ + + + –

Budget support o +

requires few additional resources to

manage

+ + – /+

can contribute to

better sectoral planning

GAVI/Vaccine

Fund

o +

requires few additional resources to

manage

+ +

accountability based on

program

results

– /+

Mixed external and domestic public

Development

loans

(no interest)

+/–

depends

on future

tax structure

–

requires additional

resources to manage

+ + +
183 Immunization Essentials

Chapter 10: Costs and Financing

A recent addition to external public financing is the Vaccine Fund. Established

in 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 by

advocating for financial commitment to immunization and providing support in

the form of grants.

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

Financing

option or

mechanism

Promotes

equity

Achieves

efficiency

Provides adequate, timely and

reliable resources

Engenders

accountability

Encourages

self-sufficiency

Domestic private

User fees – –

requires

additional

resources to

manage

+

positive, though

small contribution

to volume of

resources

– –

Crosssubsidies+/–

depends on

who pays the

subsidies

–

requires

additional

resources to

manage

+

positive, though

small contribution

to volume of

resources

– +

Health

insurance

– –

may have

high administrative

costs

+ o +

Financial Instruments

National trust

funds

e.g., endowments

o –

may have

high administrative

costs

+

steady availability

of funding

+ +

Revolving

funds

o +

typically

reduces

management

burden

+

access to foreign

exchange on a

reliable basis

+ +

Source: GAVI Financing Task Force, 2002
184

Immunization Essentials

Chapter 10: Costs and Financing

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 for

the 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 the

country’s immunization goals. Governments can consider several actions to

promote sustainable financing. 

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 to

receive initial support: 

1. The country must have a functioning Inter-agency Coordinating Committee (or an

equivalent 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 
185 Immunization Essentials

Chapter 10: Costs and Financing

These include:

• Develop a targeted program to reduce barriers to access through new

delivery 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.

• Earmark funds and establish performance targets for sub-national entities.

A critical step that every country can take to mobilize resources for immunization is to develop a multi-year

plan. This plan should be

based on input from all partners. It should address operational deficiencies, define

programmatic priorities (such

as increasing coverage, introduction of new vaccines and

reduction 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. 

In conjunction with the multi-year plan, countries should develop a financial

sustainability plan. This is a plan that assesses the financial issues that the

country 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. 

Credit: Kelley Sams, BASICS II
186

Immunization Essentials

Chapter 10: Costs and Financing

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 toward

achieving financial sustainability

Financial planning should always take into account the financial needs at all

levels 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 this

process and, when needed, draw on technical expertise to review plans and

suggest 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 to

give 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 year

of life, year after year. A sustained financial commitment is needed for immunization programs to succeed in preventing disease. Time-specific, short-term

targets 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 concept

of sustainability that embodies the following principles:

• It is a shared commitment and a shared responsibility of both governments

and their development partners.
187 Immunization Essentials

Chapter 10: Costs and Financing

• 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 the

places 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 allocation

of resources is adequate to provide a complete range of services to all

children. In addition, programs need to use the appropriate technologies and

practices for the setting, they need proper training and supervision programs,

and they need to be organizationally stable enough to provide services on a

continual basis.

Achievable objectives and sound planning and management are essential if

sustainability is to be achieved. Public demand can also contribute. Public

demand for safe and effective services will help generate the political support

needed to sustain immunization programs and provide the necessary level of

funding. 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 that

will 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 health

that is within our grasp. We have a responsibility that we

cannot ignore.” 

Source: WHO, 2002
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 of

Zambia, 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 a

Country 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 

188

Immunization Essentials

Chapter 10: Costs and Financing
189 Immunization Essentials

Chapter 10: Costs and Financing

191 Immunization Essentials

Chapter 11: New Vaccines and Technologies

Chapter 11:

New Vaccines and Technologies

“If you always do what you have done, you

will 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 the

effects 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 and

identify 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 should

carefully consider the need for the technology, its likely benefits, its costs, the

system 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 the

community, improve services, and ultimately serve broader health objectives. 

Introducing New Vaccines

The process of introducing vaccines into a national immunization program is

complex, as discussed in the following summary of key decisions to be made

and 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 well

as guidelines to support the implementation of those policies. For example, the

immunization schedule usually has to be amended and guidelines introduced

on vaccine storage, injection techniques, reconstitution, and the use of open

vials, among other matters. The revised policies should take into account both

the epidemiology of the target disease and the feasibility of putting these poli-
192

Immunization Essentials

Chapter 11: New Vaccines and Technologies

cies 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 the

birth dose will be delivered to newborns. A new or changed delivery

strategy may itself require revisions in

policies or guidelines if health personnel are to take on different responsibilities; for example, if traditional birth

attendants are to administer the birth

dose of Hep B vaccine. 

Service Delivery Strategies

In introducing new vaccines, every effort should be made to maintain the

existing vaccination schedule in order to avoid creating additional visits that

are not absolutely necessary. This approach helps minimize confusion and

inconvenience 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 and

the 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 the

vaccine (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 the

birth 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. 

A nurse in Malawi practices drawing up

pentavalent vaccine into a syringe.

Credit: WHO
193 Immunization Essentials

Chapter 11: New Vaccines and Technologies

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 phasing

in the new vaccine: 

• One alternative is to give the new combination vaccine and then stop as

soon as a child has received a total of three doses of DTP. This means that

some children will be only partially protected with Hep B vaccine. 

• A second option is to continue giving the new combination vaccine until a

child has received the full series of Hep B. This means that some children

receive extra doses of DTP. 

• A third option is to use monovalent Hep B for children who have already

begun DTP and use the new combination vaccine for those who

have not begun the DTP series.

However, ordering, storing, and

handling more than one formulation of vaccine introduces substantial logistical and other

programmatic complexities.

Vaccine Supply

The availability of a vaccine may be

limited during the first years after its

introduction, as has been the case

with new combination vaccines (see

Chapter 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 of

Are Stocks of Traditional Vaccines at Risk?

Historically, the availability of traditional EPI vaccines has been more than adequate to

meet demand. In the last few years, however, ensuring the continuous supply of these

vaccines has become a serious problem in developing and industrialized countries

alike. Fewer manufacturers are producing vaccines, the supply has been reduced, and

prices 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.

Launch of pentavalent vaccine in Malawi,

2002.

Credit: WHO
194

Immunization Essentials

Chapter 11: New Vaccines and Technologies

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 (see

Chapters 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 be

based on the number of children at a typical immunization session, the cost of

various 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. More

space 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 be

reported about the “new” disease, who should report such information, and

how often (see Chapter 8). Special training should be provided to enable

health workers to recognize and discuss the symptoms of diseases that are not

often 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 so

that they can administer it correctly and can provide essential information to

caretakers. 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 and

address their concerns. 
195 Immunization Essentials

Chapter 11: New Vaccines and Technologies

Training

All of these changes mean that health workers, supervisors, and others need

new information and, sometimes, new skills (see Chapter 9). Managers will

need 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 the

initial 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 shown

on 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.

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 early

in 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, this

usually happens only decades later. Moreover, if publicity surrounding the introduction

of 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 to

answer people’s detailed questions. 
196

Immunization Essentials

Chapter 11: New Vaccines and Technologies

Planning for the Introduction of Pentavalent Vaccine

Activity Area 2001 2002

Q3 Q4 Q1 Q2

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 clinicians

Social 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
197 Immunization Essentials

Chapter 11: New Vaccines and Technologies

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

Adapted from UNEPI, Uganda, 2000 

Activity Area 2001 2002

Q3 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 maintenance On-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
198

Immunization Essentials

Chapter 11: New Vaccines and Technologies

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 be

revised (see Chapter 4). This may be an opportunity to improve the overall

information system. For example, managers may decide to monitor specific

information that has not been routinely collected, such as the use and disposal

of auto-disable syringes. 

In the first year after introducing a new vaccine, it is particularly difficult to

accurately 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 the

course 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. 

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

Approximate vaccine development time 
199 Immunization Essentials

Chapter 11: New Vaccines and Technologies

Available Vaccines Not Widely Used in Developing 

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

Occurrence and IncidenceWorldwide, especially in the“meningitis belt” in subSaharan Africa, causingabout 50,000 deaths peryear

S. pneumoniae is a leading

cause of severe pneumonia ichildren under age five yearsworldwide. This bacteriumcauses more than one milliondeaths in children every yea

Worldwide, accounts for ove500,000 deaths and approximately one third of hospitalized cases of severe diarrheain infants and children.

TransmissionClose respiratorycontact with infected individualDroplets, direct oralcontact, or througharticles soiled withrespiratory discharges

Fecal-oral routepossibly spread byrespiratory or othercontact; may bepresent in contaminated water

IdentificationHigh fever, headache, andstiff neck This form of meningitis canlead to brain damage,hearing loss, or learningdisability.Sudden onset with severeshaking, chills, high fever,chest pain, shortness ofbreath, rapid breathing,and coughingS. pneumoniae causes

acute respiratory disease,meningitis, and septicemia.

Vomiting, fever, and waterydiarrhea

Disease andAgent

MeningococcalmeningitisBacteriumNeisseria meningitidis

PneumococcalpneumoniaBacteriumStreptococcus

pneumoniae

Rotavirus diarrheaVirus
200 Chapter 11: New Vaccines and Technologies

Immunization Essentials Available Vaccines Not Widely Used in Developing Co

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

Occurrence and Inciden2.4 billion people at risk Asia/Pacific region; 500cases reported annually;severe neurological damaone third of survivors.Worldwide, with an estim300 million acute cases eyear and one million deaHeaviest toll is in Africa, 90% of the total deaths oMalaria is the leading cadeath in young children. 

Transmission

Bite of the Culexmosquito.Person to personthrough the bite ofan infected femaleAnopheles mosquito

IdentificationInflammation involving parts of thebrain, spinal cord, and meninges.Bouts of fever accompanied by othersymptoms, alternating with periodsof feelings of freedom from any illnessThe most severe forms of malariaresult in organ failure, delirium,impaired consciousness, and generalized convulsions followed by persistent coma and death.

Disease andAgent

JapaneseencephalitisVirusMalariaPlasmodium

falciparum;

P. vivax; P.

ovale; and P.

malariae

Parasite
201 Immunization Essentials

Chapter 11: New Vaccines and Technologies

For any of these vaccines, disease burden, price, competing health priorities,

and health system infrastructure should be considered. The major features of

these 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 can

create major changes in how services are delivered. Some of the technologies

under development are described below. 

Needle-Free (or Jet) Injectors

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 by

successive use. 

Needle Removal and

Storage

The type of auto-disable (A-D)

syringes that are used in immunization programs have a needle that is

permanently 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 the

syringe, removing the needle and

storing it safely eliminates the most

hazardous component. Needle

removal and storage technologies,

such as point-of-use needle removal,

are under development. There is some

Credit: PATH Credit: PATH
202

Immunization Essentials

Chapter 11: New Vaccines and Technologies

controversy as to whether the benefits of such devices in greatly reducing the

volume 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 that

the mixing and injection steps are combined. This technology could reduce the

risks 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 such

as measles and identifying high-risk areas and populations for tetanus. Such

tools will help planners decide what prevention strategies to use and where to

concentrate 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 risk

of 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 cold

box, 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 when

vials 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.
203 Immunization Essentials

Chapter 11: New Vaccines and Technologies

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: Bill

and Melinda Gates Children’s Vaccine Program at PATH.

Full page photo credit: Aventis Pasteur

205 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 type

b 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 in

developing countries.
206 Chapter 12: Vaccines and Vaccine-Preventable Diseases

Immunization Essentials Vaccine-Preventable Diseases 

Duration induced Usually lifeUsually lifeIf infection long immulifelong caLifelongUsually life

Lifelong tyimmunity

Spread

Close respiratory contact or contact withinfectious material

Close respiratory contactMother to newborn,child to child, blood,sexual. In developingcountries, transmissionat birth or early childhood is dominant.Close respiratory contact and aerosolizeddropletsClose respiratory contactFecal-oralClose respiratorycontact

ReservoirHumansHumansHumansHumansHumansHumans

Agent

Toxin-producingbacterium(Corynebacterium

diphtheriae)

Haemophilus influenzaetype b, bacterium VirusVirusBacterium (Bordetella

pertussis)

Poliomyelitis virus –serotypes 1, 2, 3

DiseaseDiphtheriaMeningitis and pneumonia caused byHaemophilus influenzaetype b Hepatitis B (infectionincreases risk of deathfrom liver cancer andcirrhosis)MeaslesPertussisPolio
207 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Vaccine-Preventable Diseases, Cont’d

* Risk factors in addition to the failure to be fully immunized

Duration induced NoneNot knowof old infecauses disLifelong

SpreadSpores enter bodythrough wounds orthrough the umbilicalcord of newbornsAirborne droplets

Bite of infected mosquito

ReservoirSoilAnimalintestinesHumansUrban: humansand mosquitoes(Aedes aegypti)Forest: othervertebrates andmosquitoes

AgentToxin-producingbacterium(Clostridium tetani)Bacterium(Mycobacterium tuberculosis)

Virus 

Disease

TetanusTuberculosis Yellow fever
208 Chapter 12: Vaccines and Vaccine-Preventable Diseases

Immunization Essentials Vaccines Used in National Immunization Programs in Dev

Stability at High (for appr6 weeks)

High in freezeWhen reconstdiscard after s

HighMedium in driWhen reconstdiscard after s50% loss in poafter 1 weekLoss of 20% pafter 1 day, 5days

Common vialsizes*10 dose20 dose1 dose2 dose10 dose1 dose2 dose6 dose10 dose20 dose1 dose10 dose10 dose20 dose10 dose20 dose

Usual number ofdoses in primaryseries and routeof administration3 doses of DTP —intramuscular3 doses —intramuscular

3 doses —intramuscular

1 dose —subcutaneous3 doses of DTP —intramuscular

4 doses — oral

FormulationLiquidDTP, DT, TdBoth freeze-dried and liquidMonovalent,DTP–Hep B+Hib,** andDTP+Hib**LiquidMonovalent,DTP–Hep B,** andDTP–Hep B+Hib**Freeze-driedMonovalent, measles-rubella (MR), and measles- mumps-rubella (MMR)LiquidAvailable as DTP

Liquid

Nature ofvaccineInactivated:toxoidInactivated:conjugate polysaccharidevaccineRecombinantLive attenuatedInactivatedwhole-cell orprotein-based,acellularLive attenuatedOPV contains 3types of poliovirus

Disease

Diphtheria

Haemophilus

influenzae

type b (Hib)diseases

Hepatitis B(Hep B)Measles

Pertussis

Polio (OralPolioVaccine)
209 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Vaccines Used in National Immunization Programs in Develop

*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 saseparate vials and reconstituted before use.

Stabilit

Less thapotency 

High = approxiHighHigh

Medium When rcard aftMedium When rcard aft

Commonvial sizes*1 dose10 dose

DTP:10 dose20 doseDT: 10 dose20 doseTT and Td:10 dose20 dose

20 dose10 dose

Usual number of doses inprimary series and routeof administration3 doses — subcutaneous

DTP — 3 doses — intramuscularfor childrenDT — intramuscular for childrenwith contraindications for pertussis; booster for children throughsix years of age.TT or Td — 5 doses — intramuscular for schoolgirls and womenof childbearing age 1 dose — intradermal

1 dose — subcutaneous

FormulationLiquidLiquidMonovalentform–TT Multivalentforms–DTP,DT, TdFreeze-driedFreeze-dried

Nature of vaccineInactivated,whole-cellIPV contains 3 typesof polio virus.Inactivated: toxoid 

Bacillus Calmette–Guérin (BCG),which is live attenuated Mycobacterium

bovis

Live attenuated

DiseasePolio(InactivatedPolioVaccine)Tetanus

Tuberculosis

Yellow fever
210

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Diphtheria

Diphtheria is a bacterial infection caused

by Corynebacterium diphtheriae. The

infection can involve almost any mucous

membrane, but the most common sites of

infection are the tonsils and pharynx. This

type of diphtheria can lead to obstructed

breathing and death. In tropical countries, the disease usually affects the skin

(cutaneous diphtheria) and may result in

high 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.

Transmission – The type of diphtheria that affects the throat and respiratory

tract is spread in droplets and secretions from the nose, throat, and eyes of

an infected person. Skin diphtheria is spread through direct contact with

diphtheria 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 and

immunization coverage. In developing countries, the disease is occurring less

frequently 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.

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

Credit: WHO

A grayish membrane on the pharanx is

a well-known sign of diphtheria.
211 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 then

may reemerge in serious outbreaks in both temperate and tropical climates.

The largest epidemic since diphtheria vaccine was introduced in national

immunization programs occurred from 1990 to 1998 in countries of the

former 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 of

susceptible 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 Source: WHO, 2000

Reported global incidence of Diphtheria, 1980 - 1999
212

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

not need reconstitution. It is available in a variety of forms, including the three

listed below. 

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 it

should 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, and

14 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

Presentations of Diphtheria Toxoid

Presentation Ingredients Primary age group

DTP Diphtheria toxoid, tetanus toxoid,

pertussis vaccine

Children through six years of

age

DT Diphtheria toxoid and tetanus 

toxoid

Children through six years of

age

Td Tetanus toxoid with reduced 

diphtheria content

Children seven years of age

and older; adults
213 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 the

second is given at four or five years of age. 

Due to the increased risk of adverse reactions to the pertussis component in

older children, DTP should not be given to children after they reach the age of

seven 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 been

previously immunized should receive booster doses; unimmunized infants and

children should receive the primary series of three doses. Patients and close

contacts should be given antibiotics.

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
214

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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.
215 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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.

Transmission – Hib bacteria are passed to other children in droplets of

saliva 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 in

crowded 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. 

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 disease

cannot be diagnosed on clinical grounds. 

Laboratory criteria for diagnosis: 

Culture method: Isolation of Hib from a normally sterile clinical specimen, such as

cerebrospinal fluid (CSF) or blood. Culture of Hib from a non-sterile site, such as the

throat, does not define Hib disease since the bacteria can grow in these other areas

and 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
216

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

The WHO has recently devised a methodology for rapidly estimating the

incidence of Hib disease. This rapid assessment tool, which requires about ten

days 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 occurrence

of disease caused by Hib. While data from Africa and Latin America have

clearly indicated its importance as a cause of pneumonia, meningitis, and

other 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 effective

means 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 of

invasive Hib disease, including Hib meningitis.

Form and Presentation – Hib vaccines are available in monovalent and

multivalent forms. Its formulations include liquid and freeze-dried (or

lyophilized) vaccines, as described in the box on the following page.

Changing from one formulation of Hib vaccine to another before a child has

completed the primary Hib series causes no harm.

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 be

measured by combining Hib coverage data from all facilities that provide Hib vaccinations with disease data from sentinel surveillance sites that have the necessary clinical

and laboratory capacity. 

Source: WHO, 1998b 
217 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 the

form 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. 

Choices among Hib Vaccines

Choices among Hib vaccines are likely to change; it is always advisable to check

availability 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 and

administration).

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.

Hib Vaccination Schedule for Children under One Year of Age

Age Minimum Interval between Doses Dose

6 weeks Hib1

10 weeks 4 weeks Hib2

14 weeks 4 weeks Hib3
218

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 by

Vaccination. 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 of

Haemophilus influenzae type B. Geneva: World Health Organization.

WHO/VRD/95.05.
219 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 or

liver 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 infected

child 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). Note

that 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 asymptomatic

for decades after infection, but during this time they can transmit the virus to

others 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, and

right upper quadrant tenderness. (None of these symptoms is common in infants and

young 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
220

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Transmission – In developing countries, the hepatitis B virus is most commonly transmitted to children by: 

• Child-to-child transmission through open wounds or shared implements

that 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 the

mother 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 contaminated

blood 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.

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. 

Age-dependent risk of becoming a carrier

Source: International Conference on the Control of

Hepatitis B in the Developing World, 1991
221 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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. 

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 in

preventing transmission if the first dose is administered within 24 hours and

the series completed at the recommended intervals.

Side Effects – Mild, temporary local reactions are common after an injection

of 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, then

Hep B should not be given again.

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 of

age. 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.)

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 is

common, freezing of hepatitis B vaccine is likely to be a problem as well. 
222

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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-dose

schedule when a birth dose is given. 

In countries where perinatal transmission is a significant problem, the first

dose 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 other

vaccines. Scheduling options recommended by WHO are shown below. 

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.

Options for Scheduling Hep B for Children under

One Year of Age

Age

I

Countries with

low perinatal

transmission

II

Countries with high

perinatal transmission

Monovalent Hep B

for birth dose; thereafter, combination of

Hep B and DTP

III

Countries with high perinatal

transmission

Monovalent Hep B for all

three doses

Provides longer interval

between Hep B2 and Hep B3

Birth Hep B1 Hep B1

6 weeks Hep B1 Hep B2 Hep B2

10 weeks Hep B2 Hep B3

14 weeks Hep B3 Hep B4 Hep B3

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.
223 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 for

Doctors, 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 Health

Organization. WHO/EPI/GEN/88.05.
224

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Measles

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.

Transmission – Measles is extremely infectious. The virus is transmitted

through the air by respiratory droplets expelled by infected individuals. 

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. 

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 

Ease of Measles Transmission

One study found that two-thirds of the children coming to a clinic in West Africa with

measles probably caught the measles at the clinic on earlier visits one to three weeks

before.

Source: Klein-Zabban et al., 1987

Credit: Daniel Cima, American Red Cross

Credit: Daniel Cima, American Red Cross
225 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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’s

maternal 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 of

measles cases occur in children less than five years of age, as illustrated by

data from Nigeria. 

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 and

older. Widespread malnutrition in the outbreak area was believed to have

contributed to the mortality rate, which eventually exceeded 15,000. 

Population density affects the age of infection. Among rural populations, the

age 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.

Source: Foster, 2001
226

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Estimated Morbidity and Mortality – Measles deaths occur as a result

of complications, including pneumonia, acute diarrhea and dehydration,

chronic diarrhea with malnutrition, and rarely, encephalitis. The disease can

also cause serious disability, including permanent blindness, deafness, and

brain damage.

Infection with measles depresses the immune system, depletes the body’s

stores of vitamin A, leads to weight loss, and leaves children susceptible to

diseases like pneumonia and diarrhea. Because the health system receives

reports of complications rather than measles disease itself, measles cases and

deaths 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 and

treatment of complications. Vitamin A supplementation reduces the number of

deaths from measles. 

Measles Vaccine

Measles vaccination is one of the most effective preventive measures

available. Maintaining coverage above 90% can have a major impact

on public health. 

Form and Presentation – Most national programs, except in the

Americas, use monovalent measles vaccine, which is in freeze-dried form

and must be reconstituted with measles diluent from the same manufacturer.

Vitamin A in Measles Case Management

Measles seriously depletes vitamin A in children, making them more susceptible to

complications. 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. 
227 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Reconstituted measles vaccine is highly sensitive to heat and should be

discarded at the end of a session or six hours after reconstitution, whichever

comes 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 of

measles 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 the

first time. In areas with low measles vaccination coverage, however, failure to

vaccinate 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 a

measles 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 malnourished

children are at great risk of dying from measles, their vaccination should be

given 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 their

child has already been infected.

Because children with HIV are at higher risk of severe measles disease and

measles 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 is

relatively 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.
228

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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). 

In District A, 87% of the unprotected children are unprotected because of failure to

vaccinate, 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 achieved

in 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 from

5750 to 834 and in District B from 2350 to 341. 

District A

(low-performing)

District B

(high-performing)

Total number of children 10,000 10,000

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 (=10,000-

5000)

1000 (=10,000-

9000)

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. 
229 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Second Opportunity for Measles Vaccination

District A District B

10,000 Total number of children 10,000

4250 Protected after first opportunity 7650

5750 Unprotected after first opportunity 2350

5000

(no previous dose)

750

(one dose,

unprotected)

Reasons for lack of protection after

first opportunity

1000

(no previous

dose)

1350

(one dose,

unprotected)

4500

(1st dose)

675

(2nd dose)

Vaccinated after second opportunity

(90%)

900

(1st dose)

1215

(2nd dose)

-4275 -641 Protected by vaccination

(95% efficacy) -855 -1154

225 34 Unprotected due to failure to

seroconvert (5%) 45 61

500 75 Unprotected due to failure to

vaccinate 100 135

725 + 109 = 834 Total unprotected* 145 + 196 = 341

* 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 of

these children are now protected from measles infection, as shown below. 

Protection against Measles Due to First and Second Doses

District A (low-performing)

1st opportunity 2nd opportunity Total

1st dose 4250 4275 8525 (93%)

2nd dose 641 641 (7%)

9166 (100%)

District B (high-performing)

1st dose 7650 855 8505 (88%)

2nd dose 1154 1154 (12%)

9659 (100%)

This example shows that, as in the real world, most children are protected by the first dose

of 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 is

relatively small (7% in District A and 12% in District B). Therefore, failure to deliver that

first dose to all infants remains the primary reason for high measles morbidity.
230

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 and

other 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. 

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 targeting

a 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 when

both 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.

The Measles Challenge

In developing countries, vaccinations against measles are usually given at nine months

of 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. 
231 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 the

target age group for these campaigns, usually from nine months of age to less

than 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 reach

previously 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 to

eliminate the disease.

Projected impact of different measles vaccination strategies on

measles dealths in Africa 2001-2025

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

Routine coverage

(%)

Duration of Impact in Years at Different Levels of Routine

and Campaign Coverage

Campaign Coverage

20% 40% 60% 80%

20 0.25 0.5 0.75 1

50 0.4 0.8 1 1.6

80 1 2 3 4

90 2 4 6 9

Source: WHO, 2003
232

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 that

children who have been vaccinated but are still unprotected will seroconvert. 

To maintain elimination, high coverage must continue with a combination of

routine services and with periodic campaigns to prevent the build-up of

susceptibles.

Outbreak response – Measles importation should be expected even in

areas that have eliminated the disease, and when outbreaks occur, control can

be 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, should

be the focus of management efforts to prevent outbreaks from occurring at all.
233 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 Health

Care. Based on Observations in Kano State. Emory University and

BASICS/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.
234

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Pertussis

Pertussis, also called whooping cough,

is a highly contagious, acute bacterial

disease affecting the respiratory tract.

Worldwide, it causes an estimated

300,000 deaths per year.

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.

Transmission – Pertussis is spread in droplets from the nose and throat that

are 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 from

their 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 can

lead to frailty and wasting.

WHO-Recommended Case Definition: Pertussis

Clinical description: A person with a cough lasting at least two weeks with at least one

of 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 

Credit: WHO
235 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 unimmunized

infants, 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 even

reduce symptoms unless they are given during the incubation period or soon

after symptoms appear. 

Pertussis Vaccine

The most effective strategy for preventing pertussis requires the timely delivery

of 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, other

acute 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 programs

in 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 vaccines

compare 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 or

more hours or high fever over 105°F may occur with pertussis vaccine. 
236

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Contraindications – There are no contraindications to DTP except that it

should not be given to children who have suffered a severe reaction to a

previous dose.

Schedule and Target Age Group – WHO recommends that three doses

of pertussis vaccine in the DTP formulation be given to infants at six, 10, and

14 weeks of age. 

If a child does not get the second dose of DTP at the scheduled time, he

or 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. 

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.

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
237 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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.
238

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Polio

In 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 the

goal of polio eradication. 

Identification – Polio is a disease

of the central nervous system caused

by three closely related polioviruses:

types 1, 2, and 3. Approximately

5% of people exposed to any of

these 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.

In paralytic polio, severe muscle pains follow the milder symptoms, and then

paralysis develops, usually in the first week of illness. The use of one or both

legs 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 of

lameness worldwide.

Transmission – Poliovirus is highly communicable. It is spread from person

to person by contact with infected feces or secretions from the nose and

mouth. 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:

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

Credit: WHO
239 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

• 95% will show no effect.

• 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.

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 and

benefit 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

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. This

phenomenon, known as circulating vaccine-derived polio virus, has been documented

in Egypt, Haiti, the Dominican Republic, the Philippines, and Madagascar. In each

case, 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. 
240

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

the wild virus being shed in their stool could result in transmission to other

persons. Children vaccinated with IPV, as opposed to OPV, cannot spread

their 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 to

both 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 that

children 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 for

polio eradication. These strategies must ensure that immunity remains high

and susceptibility low everywhere until there is global agreement to stop

vaccinating against polio.

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. 

OPV Immunization Schedule for Children under

One Year of Age

Age Minimum Interval Between Doses Dose

Within 14 days of birth OPV0

6 weeks 4 weeks OPV1

10 weeks 4 weeks OPV2

14 weeks 4 weeks OPV3
241 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 their

immunization 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 have

been required. Sometimes, door-to-door vaccination has been used to try to

reach all children.

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 case

of acute flaccid (floppy) paralysis, including Guillian-Barre Syndrome, in a child

less 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 and

investigated 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 to

administer 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.

What Is Polio Eradication?

Polio eradication has been defined as the absence of cases and the absence of wild

poliovirus everywhere in the world. 
242

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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.
243 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Tetanus

Tetanus is a common cause of neonatal and maternal mortality wherever

maternal protection with tetanus

toxoid is low and clean umbilical

cord care practices are not followed. 

Tetanus, also known as lockjaw, is

caused by a bacillus (Clostridium

tetani) that is present in the soil and

in animal and human feces. After

entering the body through a wound,

the bacterium produces a toxin that

makes 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. 

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 with

tetanus spores that occurs when babies are delivered in unclean conditions. 

Maternal tetanus strikes women during pregnancy or within six weeks of the

termination of pregnancy. Women are exposed to tetanus when non-sterile

instruments or objects are used during and after delivery, including during

non-sterile abortions. 

Credit: WHO

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 from

neonatal 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 first

two 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 upon

laboratory 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
244

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 estimated

200,000 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 home

soon 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

Tetanus as a Cause of Neonatal Mortality

If the total neonatal mortality rate exceeds 30 per 1000 live births, the burden due to

neonatal tetanus is substantial.

Source: Steinglass et al., 1993
245 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 in

socioeconomic 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 a

particular 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 of

drugs 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. 
246

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Form and Presentation – Tetanus toxoid is available in different formulations for different age groups, as shown below.

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. 

Contraindications – There are no contraindications to DTP. However, DTP,

DT, and Td should not be given to individuals who have suffered a severe

reaction to a previous dose. DTP should not be given to children seven years

of 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.

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 find

out 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. 

Tetanus Toxoid Presentations

Presentation Antigens Primary Age Group

DTP Diphtheria toxoid, tetanus toxoid,

pertussis vaccine

Children under one year

of age

DT Diphtheria toxoid and tetanus toxoid Children through six years

of age

Td Tetanus toxoid with reduced diphtheria

content

Children seven years of age

and older, and adults

TT Tetanus toxoid Adults
247 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Schedules and Target Ages – For the prevention of tetanus in infants and

children, 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 a

four-week interval. Children do not have to begin a series of vaccinations

again if a dose is delayed. 

For the prevention of tetanus in women through their childbearing years and

in 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 additional

doses of tetanus toxoid-containing vaccine during their school years do not

need all five doses of TT in adulthood for protection. They must retain their

vaccination cards for health workers to determine the number of additional

doses they do need. 

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

Tetanus Toxoid Immunization Schedule

Dose When To Give Expected Duration of

Protection for Woman

TT1 As early as possible in pregnancy, or at first

contact 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 years

TT5 At least one year after TT4 or in next

pregnancy All childbearing years
248

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Administration of Tetanus Toxoid-Containing Vaccines

DTP: The 0.5 ml dose of DTP is injected intramuscularly, usually into the outer

part 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 of

age. The booster dose can be in the form of DTP or DT. When one booster is

given, it is administered in the second year of life. When two are given, the

first injection is given in the second year, and the second between four and

six 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. 

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. Three

doses 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 the

umbilical cord.

Maternal and Neonatal Tetanus Elimination – Definitions

Neonatal tetanus elimination is defined as the reduction of neonatal tetanus cases to

fewer 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.
249 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Because tetanus cannot be eradicated, health officials must take steps to maintain the status of elimination year after year. To do this, UNICEF, WHO and

UNFPA 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.

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, or

trained 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.

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 childhood

and 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.
250

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

References

Steinglass, R. 2001. "Eliminating neonatal tetanus.” A Better Future for

Children: 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 Maintain

the 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 MNT

Elimination. 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.
251 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Tuberculosis

Tuberculosis (TB) is a chronic disease that

affects people of all ages and is one of the

most important public health problems

worldwide. National routine immunization

programs use the Bacillus Calmette-Guérin

(BCG) vaccine to prevent miliary and

meningeal TB in the first years of life. BCG

offers limited protection against tuberculosis

in older children and adults.

Identification – TB is caused by

Myobacterium tuberculosis. It usually attacks

the lungs, but other parts of the body can

also 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 will

show radiological evidence of the disease.

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.

WHO-Recommended Case Definition: Tuberculosis

Tuberculosis suspect: any person who presents with symptoms or signs suggestive

of 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 patient

with two sputum smears positive for acid-fast bacilli [AFB] is also considered a “definite” case). 

Credit: WHO
252

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 for

younger people. Infants are more likely than adults to contract miliary and

meningeal TB, which attack vital organs and are usually fatal.

Estimated Morbidity and Mortality – Nearly two million people die

from 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-term

care, 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 short

course 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.

Form and Presentation – BCG vaccine is freeze-dried, so it must be

reconstituted 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. 

The First Step toward a Fully Immunized Child

BCG 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 the

health care system than later in life. When this encounter with the health system is a

satisfactory one for the parents, they are likely to return for other vaccinations and

other health services.
253 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 and

leaves a small round scar, which health workers look for to determine whether

a 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 the

vaccine 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 high

risk 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 at

birth. If not given at birth, BCG may be given at the infant’s first contact with

the health system.

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. 

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 to

master 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.
254

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

References

WHO. 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.
255 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Yellow Fever

Yellow fever is a viral hemorrhagic fever transmitted by infected Aedes aegypti mosquitoes in tropical and subtropical areas. Outbreaks with major public

health 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 to

jaundice and hemorrhaging. 

Transmission – The agent that causes yellow fever is a mosquito-born virus

that 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 then

transmitted from monkeys to other mosquitoes. The infected mosquitoes can

then 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-humid

savannahs of Africa and can produce small-scale epidemics in rural villages.

Semi-domestic mosquitoes can infect both monkey and human hosts, and

increased contact between humans and infected mosquitoes leads to an

increase in disease. This is the most common type of outbreak seen in Africa

in recent decades. 

WHO-Recommended Case Definition: Yellow Fever 

Clinical description: An illness characterized by acute onset of fever followed by

jaundice 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 IgG

levels, 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
256

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Urban yellow fever results in large explosive epidemics when travelers from

rural 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 a

wide area. 

Population at Risk – In the Americas, yellow fever occurs predominantly in

adult 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 to

yellow fever every year.

Occurrence – In 2001, more than 30 countries were considered at risk for

yellow 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 hydration

and prevent hypoglycemia can improve the outcome. 
257 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 be

appropriate among populations and within areas at high risk of epidemics. A

single dose provides protection against the disease for at least 10 years and

often 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% of

recipients.

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 with

symptomatic 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 the

use of insecticide-treated bednets reduces the mosquito population thereby

reducing transmission of mosquito-born diseases such as yellow fever, dengue

fever, and malaria.
258

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

References

WHO. 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.
259 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Vitamin A Deficiency

Vitamin A deficiency (VAD) occurs

when an individual’s diet does not

contain enough vitamin A for

growth, development, and physiological functions. It may be exacerbated by infections such as malaria

and measles and by parasites such

as hookworm. Related vitamin A

deficiency disorders (VADD) include

subclinical and clinical problems.

Mortality and morbidity caused by

these disorders increase with the

severity 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. 

Credit: Mizan Siddiqi

Prevalence Criteria Indicating Significant Vitamin A Deficiency

Clinical Criteria

Population Group Indicator Prevalence (%)

Children 2 to 5 years of age Night blindness >1.0

Bitot’s spots >0.5

Corneal xerosis and corneal scars >0.01

Corneal scars >0.05

Women of childbearing age 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
260

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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 deficient

in 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 born

with 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.

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 more

than 25,000 IU for at least three months duration. If a woman shows acute

corneal lesions, she should receive a dose of not more than 200,000 IU on

days one, two, and 14 after diagnosis.

Vitamin A Treatment for Xerophthalmia in Infants and Children

Target Group Vitamin A dosage (IU) Schedule

Young infants (0-5 months) 50,000 Three doses administered on

days 1, 2 and 14 following

Older infants (6-11 months) diagnosis 100,000

Children (males – 12 months

or more; females – 12 months

to 12 years)

200,000
261 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Vitamin A Supplementation

Vitamin A supplementation for infants, children, and postpartum women is

used as a preventive strategy until all members of the population are certain

to get an adequate intake of vitamin A through breastfeeding, improved diet

with 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 Dose Time 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

Postpartum women Two doses of 200,000 IU at

least one day apart

and/or 10,000 IU daily or

25,000 IU weekly

As soon after delivery as possible and not more than six

weeks later

and/or during the first six

months following delivery

Source: International Vitamin A Consultative Group (IVACG), 2001
262

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

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, health

officials are trying to integrate vitamin A supplementation into the routine

immunization schedule and distribute supplements through periodic outreach

(e.g., health weeks or days). 

To date, coverage has been far higher using periodic outreach than through

integration, as illustrated by the example below. 

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, technical

support by a national NGO (Nepali Technical Assistance Group), and participation of

volunteers 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 with

refresher 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 data

from focus groups and key informants and developed an overall strategy based on the

findings. The program encouraged districts to review the findings and decide what

methods might work best in their districts. Parades, involvement of schools, magic

shows, and involvement of local political leaders were used. Today, the program is so

well known that once distribution dates are known, parents and other caregivers need

little 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 
263 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

References

Goodman, Tracey, N. Dalmiya, B. de Benoist and W. Schultink. 2000. Polio

as 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 and

Other 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 Health

Workers. Geneva: World Health Organization. WHO/EPI/TRAM/93.6.

WHO. [n.d.] Integrating Vitamin A with Immunization: An Information and

Training Package. Geneva: World Health Organization (CD-ROM). 

Full page credit: Institut Pasteur
264

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Available Vaccines Not Widely Used in

Developing Countries

Some vaccines now available are not widely used in developing countries for

a 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 the

diseases they prevent. 
265 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Available Vaccines Not Widely Used in Developing Countries

Disease

and Agent

Identification TransmissionOccurrence

and

Incidence

Effectiveness and

Limitations of

Available Vaccines 

Chickenpox

Virus 

An acute, generalized

viral disease with

sudden onset of slight

fever, rash, and

malaise

Can result in secondary bacterial and

other complications,

including skin lesions,

dehydration, pneumonia, and central nervous system involvement

Virus can stay in body

after primary infection

and lead to herpes

zoster (shingles)

Most commonly, person to

person via

infected

respiratory

tract

secretions

Worldwide

Among children

1-14 years of

age, case fatality rate is one

per 100,000

cases. In adults

30-49 years of

age, the case

fatality rate is

over 25 per

100,000 cases.

Live attenuated viral

vaccine

Effectiveness estimates

range from 80% to 90%

against infection; 95%

against severe disease.

Routine vaccination of

children from age 12 to

18 months is now carried

out in some industrialized

countries.

Cholera

Bacterium

Vibrio

cholerae

An acute bacterial

enteric disease characterized by sudden

onset, profuse painless

watery stools, nausea,

and vomiting in the

early course of illness.

If untreated, cholera

leads to rapid dehydration, acidosis,

circulatory collapse,

hypoglycemia, and

renal failure.

Ingestion of

contaminated food

or water

Worldwide 

In severe

untreated cases,

death may

occur within a

few hours and

the case fatality

rate may

exceed 50%. 

In the 1990s,

outbreaks

occurred in

South America,

Zaire, and

India.

The killed cholera vaccine

that was formerly used is

no longer recommended

because it provides only

partial protection of short

duration.

Oral vaccines that provide

significant protection

against certain cholera

strains have recently

become available in

several countries.

However, these vaccines

do not protect against all

new cholera serogroups. 

Hepatitis A

Virus

Abrupt onset with

fever, malaise, anorexia, nausea, and

abdominal discomfort

followed by jaundice.

Often asymptomatic or

mild in children in

developing countries,

but can be severely

disabling, and relapses can occur for one

year. No chronic

infection.

Person to

person by

the fecaloral route.

Worldwide

In developing

countries, adults

are usually

immune and

epidemics are

uncommon, but

adults become

more susceptible as hepatitis

A incidence

decreases.

Several inactivated

vaccines are available that

are safe and almost 100%

effective, but these are not

licensed for children under

two years of age.
266

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Disease

and Agent

Identification Transmission Occurrence Vaccines Available

Effectiveness and

Limitations of Vaccines 

Mumps –

Infectious

parotitis

Virus

Fever, swelling,

and tenderness

of one or more

salivary glands.

Common complications

include central

nervous system

involvement and

testicular inflammation in postpubescent

males.

Airborne transmission, droplet

spread, and by

direct contact

with saliva of

an infected

person

Worldwide

Deaths due to

mumps are

rare.

Live attenuated vaccine is

available as a monovalent

vaccine or in combination

with measles and rubella

(MMR).

Mumps vaccine is highly

effective, but including it in

national childhood immunization programs often has

low priority.

Rabies

Virus

Begins with

sense of apprehension,

headache, fever,

malaise, and

indefinite sensory changes; progresses to

paresis or paralysis, spasm of

swallowing muscles, fear of

water; delirium,

and convulsions

Virus-laden

saliva of a

rabid animal

introduced by

a scratch or bite

Worldwide

If left untreated, rabies is

almost always

fatal.

Causes an

estimated

35,000 to

40,000

deaths a

year, mostly

in developing

countries

Vaccines are available for

pre-exposure vaccination

and post-exposure treatment.

WHO recommends vaccination of :

• Individuals at high risk

because of their occupations

(e.g., veterinarians, wildlife

conservation personnel, and

park rangers).

• Children five to 15 years

of age in developing countries where canine rabies is

endemic and not well

controlled and where rabies

immune globulin for postexposure treatment is not

available.

• Dogs, cats, and other animal hosts.
267 Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

Disease

and

Agent

Identification Transmission Occurrence Vaccines Available

Effectiveness and

Limitations of Vaccines 

Rubella

(German

measles)

Virus

Mild rash disease

in children. If

rubella is contracted in the first

three months of

pregnancy, the

consequence is

fetal death or

congenital rubella

syndrome (CRS).

CRS is characterized by blindness, deafness,

brain damage,

and heart

defects.

By droplets or

direct contact

with patients

Where childhood transmission is

widespread,

few women of

childbearing

age are susceptible. Where

transmission is

moderate, more

women will be

susceptible.

In developing

countries,

250,000

babies are

born per year

with CRS.

In epidemic

years, incidence may

increase ten

times.

Live attenuated vaccine 

• Monovalent vaccine

• Combination with mumps

(MR)

• Combination with mumps

and measles (MMR)

Rubella vaccine should be

introduced only where routine immunization coverage

can be sustained at 80% or

higher. Lower coverage with

rubella vaccine increases

rather than decreases the

susceptibility of women of

childbearing age, by shifting infection to older ages.

Typhoid

fever,

paratyphoid fever

Bacterial

organisms

Insidious onset of

sustained fever,

severe headache,

malaise, anorexia,

a slow heart rate,

enlargement of the

spleen, and other

symptoms

Contaminated

food and water

Worldwide

Annual incidence

approximately 17 million

cases, with

600,000

deaths

Available vaccines are safe

and effective in individuals

above five years of age, but

further studies are needed to

test 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.
268

Immunization Essentials

Chapter 12: Vaccines and Vaccine-Preventable Diseases

To order copies of Immunization Essentials, please follow the

link to the order form found on the USAID Global Health website, http://www.usaid.gov/our_work/global_health. 
Immunization Essentials 269

Accelerated 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, 115

Freezers 110

Freeze WatchTM 107

Ice-lined refrigerators 110

Icepacks 110-112, 115-116

Inventory 113

Maintenance and repair 109, 113-

114

Management of storage equipment 112-

115

Planning for emergencies 115

Power source 110-111

Refrigerators 110

Replacement 113-114

Spare parts 109, 113-115

Stop!WatchTM 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 55-

57, 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 55-

57, 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

Index
270 Immunization Essentials

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

Japanese encephalitis 200

Laboratory 144

Logistics (see cold chain and logistics)

Lot Quality Assurance Sampling 84

Malaria 200 

Maternal tetanus 243, 248-249

Measles

Second opportunity 56, 228-229, 227-

229

Supplemental immunization strategies 55-

57, 231-232

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

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
Immunization Essentials 271

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 TM 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
U.S. Agency for International Development

Washington, D.C.

www.usaid.gov