GAO

United States General Accounting Office

Report to Congressional Requesters

October 1999 GLOBAL HEALTH

Factors Contributing 

to Low Vaccination 

Rates in Developing 

Countries

GAO/NSIAD-00-4

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Contents

Letter 3

Appendixes Appendix I: Objectives, Scope, and Methodology 22

Appendix II: Comments From the Centers for Disease Control 

and Prevention 24

Appendix III: Comments From the U.S. Agency for International 

Development 26

Appendix IV: GAO Contact and Staff Acknowledgments 31

Figures Figure 1: Overall Immunization Coverage Rates for Countries,

Grouped by Region, 1991-97 7

Figure 2: Immunization Coverage Rates in the Poorest Countries,

With and Without Conflict, 1991-97 9

Figure 3: Immunization Coverage Rates for Measles and

Tuberculosis in Sub-Saharan Africa, 1991-97 13

Figure 4: UNICEF Expenditures on Immunization, 1990-98 19

Abbreviations

DPT Diphtheria, pertussis, and tetanus vaccine

Hib Haemophilus influenzae type b

PAHO Pan American Health Organization

TB Tuberculosis

UNICEF United Nations Children's Fund

USAID U.S. Agency for International Development

WHO World Health Organization
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United States General Accounting Office

Washington, D.C. 20548

National Security and

International Affairs Division

B-283270 Leter

October 15, 1999

The Honorable Mitch McConnell

Chairman 

The Honorable Patrick Leahy

Ranking Minority Member

Subcommittee on Foreign Operations

Committee on Appropriations

United States Senate

Over 11 million children under age 5 die each year in developing countries, 

and nearly three-quarters of these deaths result from infectious diseases. 

The World Health Organization estimates that the deaths of at least

4 million of these children are linked to their lack of access to vaccines. 

While long-term international initiatives have significantly increased global 

immunization rates, millions of children in the developing world, for 

various reasons, lack access to vaccines.

Recognizing the significance of children in the developing world not having 

access to vaccines, representatives from the international public health 

community, including the World Health Organization, the United Nations 

Children’s Fund, the United Nations Development Program, the World 

Bank, the Rockefeller Foundation, and the Bill and Melinda Gates 

Children’s Vaccine Program, along with the U.S. Agency for International 

Development and several other bilateral donors, have begun to explore 

options for improving immunization coverage in developing countries. 

They are seeking close collaboration with vaccine manufacturers and the 

governments of developing countries to devise strategies to meet current 

vaccine needs and to improve access to new vaccines as they are 

introduced. 

In anticipation of the United States being asked to fund and provide other 

support for the renewed international effort to promote childhood 

immunization, you asked us to examine some of the key issues involving 

vaccine availability. As agreed with your offices, this report provides 

information and analyses on (1) the locations where shortfalls in 

immunization coverage are most prevalent and (2) the factors that impede 

vaccine availability in these locations. Our scope and methodology for this 

report are outlined in appendix I. We will report separately on our work 
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aimed at identifying the implications of various courses of action that 

Congress may want to pursue to increase vaccine availability. 

Results in Brief While global immunization coverage for six diseases1

 originally targeted by 

the World Health Organization has improved significantly since the

mid-1970s, coverage rates are low for children living in the poorest 

countries, particularly in urban slums and remote rural areas. World Health 

Organization data indicate that the poorest countries of the world have 

vaccination rates that are about 26 percent below the global average of

82 percent.2

 In fact, immunization coverage in some countries in

sub-Saharan Africa has declined over the last decade. Some countries in 

this region reported in 1997 that they immunized less than a third of their 

children against the six diseases targeted by the World Health Organization. 

Many of the children who are not immunized live in countries that have 

experienced internal conflict in recent years. Although the level of 

coverage varies, few children in developing countries have access to the 

newer vaccines that have been added more recently to the World Health 

Organization’s list of recommended vaccines. 

Several interrelated factors that poor countries have difficulty overcoming 

have limited the availability of vaccines for children in the developing 

world, including (1) inadequate health infrastructure, (2) the relatively 

higher cost of vaccines recently recommended by the World Health 

Organization, (3) insufficient information on disease burden3

 and vaccine 

efficacy, and (4) changing priorities of international donors. In the 1990s, 

the U.N. Children’s Fund and the U.S. Agency for International 

Development have begun to reduce their level of support for immunization.

1

Diphtheria, measles, pertussis, polio, tetanus, and tuberculosis.

2

United Nations Children’s Fund officials estimate that actual coverage rates are about

10 percent lower because of reporting errors by countries.

3

Disease burden refers to the level of mortality and reduced quality of life associated with 

disease.
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Background The international public health community has played an important role in 

helping countries to improve immunization coverage. In 1974, the World 

Health Organization (WHO), which typically sets the global public health 

agenda, created the Expanded Program on Immunization to increase 

immunization of the world’s children against six diseases—diphtheria, 

measles, pertussis, polio, tetanus, and tuberculosis. In 1980, the United 

Nations Children’s Fund (UNICEF) established a goal of immunizing

80 percent of the world’s children against these diseases by 1990 and called 

upon donors to contribute to this effort. The worldwide effort that was 

mobilized by the Expanded Program on Immunization helped countries 

increase immunization rates for these diseases from less than 5 percent of 

all children when it was established in 1974 to the current rate of 82 percent 

worldwide.4

 In 1990, the international public health community created the 

Children’s Vaccine Initiative as a forum for coordinating global efforts to 

further improve immunization and to promote research and introduction of 

new vaccines. More recently, WHO recommended that countries include 

several additional vaccines in their immunization schedules, namely 

hepatitis B, yellow fever for endemic countries, and Haemophilus 

influenzae type b (Hib).5

National governments are responsible for developing and managing their 

immunization programs, including sustaining vaccine delivery systems and 

determining which vaccines will be included in their immunization 

schedules. Immunization programs must compete with other important 

priorities such as education and nutrition. In the 1990s, donors and 

international organizations have encouraged developing countries to pay 

an increasing share of the cost of procuring vaccines. However, almost all 

developing countries still rely to some extent on the technical and financial 

assistance provided by international organizations and bilateral donor 

organizations like the U.S. Agency for International Development (USAID) 

to maintain their immunization programs. 

4

This is the average coverage for the vaccines used to prevent the six diseases originally 

targeted by WHO as reported by national governments to WHO in 1997.

5

A vaccine against the Hib bacterium, which causes meningitis and pneumonia, was 

recommended by WHO for countries that have sufficient disease burden and infrastructure 

capability to warrant introduction.
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Immunization Rates 

Are Lower Than the 

Global Average in 

Many Poor Countries

Immunization rates for the six WHO-targeted diseases in many of the 

poorest countries of the world are substantially lower than the global 

average of 82 percent. In some countries, coverage has declined in recent 

years. Moreover, few developing countries have included vaccines recently 

recommended by WHO for inclusion in national immunization programs.

Shortfalls in Coverage for 

Older Vaccines

Although five countries6 in other regions have coverage rates among the 

lowest in the world, most countries with immunization coverage below

60 percent are in sub-Saharan Africa (see fig. 1). In 1997, governments in 

this region reported immunizing only about 60 percent of their children 

against the original six targeted diseases. Chad, Sierra Leone, and the 

Democratic Republic of the Congo have the lowest rates in the region, 

providing vaccines to less than 31 percent of their children.

6

Afghanistan, Djbouti, the Lao People’s Democratic Republic, Papua New Guinea, and 

Yemen.
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Figure 1: Overall Immunization Coverage Rates for Countries, Grouped by Region, 

1991-97

Legend:

CEE = Central and Eastern Europe

EA = East Asia

LA = Latin America

ME = Middle East

SA = South Asia

SSA = Sub Saharan Africa

Note: Immunization coverage for diphtheria, measles, pertussis, tetanus, tetanus, tuberculosis, and 

polio.

Source: GAO analysis based on data published by WHO in September 1998.

In addition, country studies conducted by donor organizations and national 

governments show that immunization coverage often varies markedly 

within countries, with substantially lower coverage rates in urban slums 

and remote rural areas. One USAID-funded survey, for example, found that 

in 1997, 65 percent of all children in Dhaka, Bangladesh, were immunized 

100

90

80

70

60

50

40

30

20

10

0

1991 1992 1993 1994 1995 1996 1997

Overall percent of coverage 

CEE

EA

LA

ME

SA

SSA
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against measles, but only 46 percent of children in Dhaka’s poorest 

neighborhoods had received the vaccine. Similarly, a 1998 study of measles 

coverage in Cambodia, prepared by the Cambodian Ministry of Health, 

showed that coverage rates ranged from over 75 percent in the capital 

region to below 30 percent in more remote regions. Other evidence 

includes a 1999 study by the Ugandan Ministry of Health that found that 

children in rural areas in Uganda were not immunized at all. 

While the common characteristic of countries with low coverage is low per 

capita income and a corresponding low per capita spending on health,7

countries that have experienced civil conflict tend to have the lowest 

immunization rates. Of the 25 poorest countries in the world, 11 countries 

had recently experienced or were experiencing unrest.8

 For the period 

1991-1997, these 11 countries had immunization coverage levels that were 

on average about 19 percent below the countries with comparable per 

capita income that have not experienced conflict. (See fig. 2.)

7

The World Bank estimates that the poorest countries of the world spend $22 per capita on 

health each year, rising to $209 for the wealthier developing countries.

8

Afghanistan, Angola, Burundi, Cambodia, Chad, Ethiopia, Mozambique, Myanmar, Nigeria, 

Rwanda, and Sierra Leone.
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Figure 2: Immunization Coverage Rates in the Poorest Countries, With and Without 

Conflict, 1991-97

Note: Immunization coverage for diphtheria, measles, pertussis, tetanus, tuberculosis, and polio.

Source: GAO analysis based on data published by WHO in September 1998 and on data compiled by 

Ruthann Leger Sivard, World Military and Social Expenditures (1998).

70

60

50

40

30

20

10

0

1991 1992 1993 1994 1995 1996 1997

Non-conflict

Conflict

Overall percent of coverage
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Coverage for New Vaccines 

Is Limited

Efforts by WHO to encourage countries to incorporate additional vaccines 

in national immunization programs—hepatitis B, yellow fever, and Hib—

and to introduce tetanus coverage for pregnant women to protect babies at 

birth have not resulted in high coverage rates. In 1998, WHO reported in its 

summary of global vaccine coverage that few of the poorest developing 

countries had incorporated the hepatitis B vaccine9 into their immunization 

schedules despite the estimated 1 million deaths that this disease causes 

each year.10 Of the 48 countries that fit UNICEF’s category of least 

developed (less than $785 per capita income yearly), only 6 countries 

reported any coverage as of 1997.11 In the six poor countries that have 

adopted the hepatitis B vaccine, immunization rates average only about

50 percent. Coverage rates for high-income countries that have adopted the 

vaccine average about 70 percent. 

According to WHO, in 1997 only 12 of the 34 African countries at highest 

risk for yellow fever had included a yellow fever vaccine in their national 

immunization programs.12 Only two countries in Africa—Côte d’Ivoire and 

the Gambia−reported coverage levels over 50 percent in 1997. Deaths 

associated with outbreaks in particular regions of countries can be 

significant. For example, in several remote mountain villages of Cameroon, 

WHO estimated that one epidemic in 1990 killed up to 1,000 villagers in

11 villages. 

9

In 1991, WHO recommended that all countries include the hepatitis B vaccine in their 

national immunization programs by 1997.

10Most of these deaths are among adults who were infected as children. Hepatitis B is the 

primary cause of liver cancer, which is the leading cause of cancer death in men in

sub-Saharan Africa and much of Asia. It is also an important cause of cancer deaths in 

women.

11Bhutan, Gambia, Kiribati, Maldives, Tuvalu, and Vanuatu.

12In 1988, WHO recommended that countries at risk for yellow fever outbreaks should adopt 

the vaccine into their national immunization programs. Yellow fever is endemic in 42 African 

and South American countries and several Caribbean islands. 
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WHO estimates that more than 277,000 children die each year from 

neonatal tetanus (tetanus developed within the first 4 weeks after birth). 

Because infants are infected by neonatal tetanus as a result of unclean 

delivery practices and equipment, without improvements in delivery 

conditions, the only way to protect newborns from the disease is to 

vaccinate expectant mothers. WHO reported in 1997 that 48 percent of 

pregnant women in developing countries do not pass on protective 

immunity to their babies against tetanus because they have not received 

the neonatal tetanus vaccine.13

WHO reports that 39 countries have added the Hib vaccine to their 

immunization schedules—primarily countries in the developed world. 

These 39 countries include only 12 percent of the world’s children. 

However, a WHO official noted that 500,000 children die each year from 

this disease, mostly in developing countries. Some higher income 

developing countries have successfully introduced Hib into their 

immunization programs, particularly in South America and the Caribbean. 

As of December 1999, the Pan American Health Organization (PAHO) 

reported that 75 percent of all newborns in the region14 lived in countries 

that had adopted the Hib vaccine. However, in sub-Saharan Africa, where 

the risk of Hib is considered high by experts, only one country, the Gambia, 

has introduced the Hib vaccine. 

Several Factors 

Impede Vaccine 

Availability in 

Developing Countries

Four principal factors have limited vaccine availability in developing 

countries: (1) inadequate health infrastructure, (2) the relatively higher 

cost of vaccines recommended recently by WHO, (3) insufficient 

information on disease burden and vaccine efficacy, and (4) changing 

priorities of international donors. The extent to which these factors impede 

vaccine availability varies by country, although some patterns exist across 

countries. 

13Tetanus immunization is part of the three-dose diphtheria, pertussis, and tetanus (DPT3) 

vaccine that WHO recommended as part of the original six vaccines. To decrease deaths due 

to tetanus that occurred soon after birth, in 1989 WHO recommended the tetanus toxoid 

vaccine for pregnant women.

14There are 46 countries/territories in PAHO, spanning Canada, Central America and the 

Caribbean, South America, and the United States.
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Inadequate Infrastructure 

Impedes Immunization 

Efforts

Countries must have systems that can safely and effectively deliver 

vaccines. WHO uses several indirect measures to assess countries’ 

capability to implement vaccine immunization programs. These measures, 

which include countries’ ability to administer vaccines at several intervals 

during the first year of life, to avoid vaccine waste, and to ensure vaccine 

quality, show that many developing countries have weak infrastructure. 

Inadequate infrastructure is most apparent in the poorest countries, 

resulting in low coverage rates, even when vaccines are donated. Typical 

problems include outdated or insufficient vaccine refrigeration and a lack 

of delivery trucks and trained health workers.

One indicator WHO uses to determine the ability of countries to effectively 

deliver vaccines is the percentage of children who have received the third 

dose of the combination vaccine for diphtheria, pertussis, and tetanus. 

Because three doses are required, this measure provides an indication of a 

country’s capability to immunize children at several intervals during the 

first year of life. The results of this indicator show that the poorest 

countries, particularly in sub-Saharan Africa, are not sustaining the delivery 

of all three doses. For example, in 1997 Chad had coverage for the third 

dose of the combined DPT3 vaccine of 24 percent, while overall coverage 

for the six original vaccines was 31 percent. WHO believes the data reflect 

weaknesses in health delivery capabilities.

A second indicator of a country’s capability to deliver vaccines is the 

percentage of children vaccinated against tuberculosis (TB) at birth and 

the percentage of all children receiving the measles vaccine at about

9 months of age. While some difference occurs in most countries, a greater 

difference indicates a less effective delivery system because it is often 

easier to reach a child at birth to administer a vaccine than at 9 months of 

age. On average, the percentage of children immunized against measles 

was about 10 percent lower than the immunization rate for tuberculosis. 

The poorest countries had the largest difference in coverage rates for 

tuberculosis and measles, with sub-Saharan African countries reporting a 

12 to 15 percent difference in immunization rates for tuberculosis and 

measles (see fig. 3).
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Figure 3: Immunization Coverage Rates for Measles and Tuberculosis in

Sub-Saharan Africa, 1991-97

Source: GAO analysis based on data published by WHO in September 1998.

Another indicator of the status of a country’s health infrastructure is the 

amount of vaccine that is purchased but not administered to children. The 

difference is considered waste by WHO and is used to indicate 

governments’ ability to accurately estimate demand and to effectively 

deliver the vaccines. In 1997, WHO officials estimated that, on average, 43 

percent of vaccines delivered to developing countries were not 

administered to children. Some of the loss occurs because many vaccines 

are heat sensitive and are left unrefrigerated for too long, resulting in a 

decrease in potency, so they must be discarded. In addition, vaccines have 

a limited shelf-life and must be disposed of if not used within that period. 

Finally, health care providers may decide to open a multidose vial to 

vaccinate one child even though the other doses are wasted, so as not to 

miss the opportunity to vaccinate the child. WHO estimates that much of 

the unused vaccine in developing countries resulted from poor planning 

regarding the amount of vaccine needed and the procurement of vaccine in 

large, multidose vials (10 to 20 doses). While multidose vials are the least 

expensive way to purchase vaccines, such factors as poor forecasting of 

Percent of coverage

0

10

20

30

40

50

60

70

80

90

1991 1992 1993 1994 1995 1996 1997

TB

Measles
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vaccine needs at delivery sites and inadequate training of health workers 

regarding the ability to use leftover vaccines led to unnecessarily high rates 

of vaccine waste. For example, in 1998, the difference between vaccines 

procured and vaccines used in Bangladesh ranged from 61 percent for DPT 

to 29 percent for measles. WHO has made efforts to reduce the amount of 

vaccine wasted by encouraging the use of a vaccine vial monitor that tracks 

time and temperature exposure of the polio vaccine to estimate its potency, 

and the procurement of vaccines in smaller vials. A WHO official told us 

that in order to avoid waste, countries are urged to use smaller vials for the 

more expensive hepatitis B and Hib vaccines. UNICEF reports that by the 

year 2000 it will require monitors on all heat-sensitive vaccines in an effort 

to increase confidence in vaccine potency and reduce waste.

Case studies of particular countries illustrate the problems that occur due 

to inadequate infrastructure. A 1998 special report by the United Nations 

Children’s Fund on the immunization programs of eight countries in

sub-Saharan Africa15 found that poor organization and management in 

vaccine distribution, maintenance of refrigeration, and immunization 

scheduling had resulted in an inefficient program. The study also found a 

shortage of properly trained staff. As a result, immunization coverage 

ranged between 30 and 35 percent in three of these countries—Chad, Mali, 

and Niger. Studies of Zambia and Bangladesh also pointed out excessive 

vaccine waste due to poor vaccine management practices. Health workers 

in both countries often did not know how to check DPT vaccine to ensure 

that it had not frozen (and consequently reduced its potency). A 1999 study 

prepared by the Uganda Ministry of Health found that health workers were 

inadequately trained to manage the immunization services and that these 

services were provided on an irregular basis due to the lack of transport. 

Higher Prices for Newer 

Vaccines Limit Their 

Availability

Another factor inhibiting the availability of newer vaccines in developing 

countries is their relatively high price. While the price of vaccines declines 

over time as more suppliers enter the market, it has generally taken a 

decade after vaccines were first licensed before developing countries have 

begun to purchase them. Even as the prices have declined, they remain 

high relative to the cost of the older vaccines, and the poorest countries 

15Vaccine Independence Initiative Implementation in 1997 and 1998, UNICEF (New York: 

Oct. 1998) Countries covered were Burkina Faso, Cape Verde, the Gambia, Mali, Mauritania, 

Niger, Senegal, and Chad.
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have not included them in their immunization schedules. Moreover, donors 

have not generally funded purchases of the newer vaccines. 

Vaccine companies cite the cost of research and development of vaccines 

as the primary reason for the higher prices of newer vaccines. According to 

vaccine company officials, the cost of developing a new product and 

bringing it to market is substantial, costing between $100 million and

$300 million to license a vaccine in the United States. Royalty costs—the 

amount vaccine companies must pay to use production technologies that 

are patented by others, such as biotechnology companies—can also be 

high for new vaccines. In the case of hepatitis B, for example, WHO 

estimates that royalty costs are 13 to 15 percent of the sales price. 

Experience with the introduction of hepatitis B and Hib shows that price 

was a factor inhibiting procurement by developing countries for almost a 

decade after the vaccines were first licensed and then they were only 

purchased by some higher income developing countries. For example, 

hepatitis B was introduced in the United States in the early 1980s at over 

$30 per dose, with only two manufacturers supplying the vaccine. UNICEF 

and PAHO did not begin to purchase the vaccine until 1993 and 1994, 16

respectively, after several competitive products had been introduced to the 

market and prices had dropped to less than a dollar per dose.17 The first Hib 

vaccines that were effective on infants were licensed in the United States in 

late 1987 and sold for about $14 per dose. PAHO did not purchase this 

vaccine until 1998, when it was able to negotiate a price of $2.18 per dose. 

However, very few of the poorest countries have purchased Hib or hepatitis 

B vaccines. According to WHO officials, price continues to be an 

impediment in these countries, in part because donors have generally not 

funded the purchase of these vaccines. 

Insufficient Information 

Impedes Investment in 

Vaccines and Immunization 

Programs

Governments and donors need accurate information that can serve as a 

basis for deciding how much to invest in immunization programs. 

Surveillance data are crucial in assessing the impact of individual diseases, 

determining whether existing disease reduction targets are being met, and 

deciding where resources should be targeted for maximum impact. In 

16UNICEF only purchased the vaccine for countries that reimbursed the agency. PAHO 

purchases the vaccines with money in its revolving fund but requires countries to pay for the 

vaccines.

17This is the price negotiated by PAHO for hepatitis B vaccine in 1998. 
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addition, information is necessary for citizens to help generate demand for 

vaccines. Even in developed countries that have sophisticated diagnostic 

equipment, disease burden data can be difficult to obtain. In much of the 

developing world, however, relevant data are inaccurate, inadequate, or are 

simply not collected. For example, Bolivia had refrained from making 

additional investments in its immunization system because government 

officials had accepted reports from the immunization program office 

claiming that immunization coverage was about 80 percent. Bolivian 

officials changed their position when a World Bank/PAHO team presented 

survey data indicating that the immunization coverage was closer to

40 percent. 

Moreover, in 1996 WHO reported that a 28-country study uncovered

wide-ranging problems in data gathering on disease prevalence. Many of 

the data that were collected were irrelevant, and health officials in 

developing countries did not have the necessary skills to analyze the data 

that were obtained. Disease burden data are very difficult to obtain 

because records indicating cause of death and illness are often inaccurate 

or incomplete. Without the use of sophisticated diagnostic methods, it is 

hard for health workers to determine the cause of death, particularly when 

malnutrition and other contributing factors are present.18 For example, 

WHO officials estimate that the incidence of yellow fever is up to 500 times 

greater than reported because of difficulty in diagnosing the disease and 

insufficiency of local health facilities in endemic countries.

Clinical vaccine trials are used to determine the efficacy of vaccines in 

particular countries and groups of countries. In wealthier countries where 

markets are assured for successful products, vaccine companies fund trials 

that are required for licensing. In developing countries, donor countries 

and multilateral organizations have had a more important role in funding 

clinical and disease burden studies. However, there has been limited 

clinical testing of vaccines in developing countries, and when they have 

been conducted, they were begun several years after vaccines were 

licensed in the developed world. For example, the first clinical tests for the 

Hib vaccine effective in infants were initiated by vaccine companies in the 

United States in 1984 and Finland in 1985, resulting in a U.S. license in 1987. 

It was 8 years after clinical trials began in the United States before trials 

18UNICEF reported that malnutrition alone accounts for just 3 percent of deaths for children 

under age 5, but it plays a contributing role in more than half of all child deaths in 

developing countries.
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began in a developing country. Clinical trials supported by donor countries 

and vaccine companies began in Chile in 1992 and a year later in the 

Gambia. In 1998, a Hib disease burden study, supported by USAID and 

WHO, was initiated in Indonesia. As a result of the time lag before clinical 

trials were conducted in poorer countries, governments in developing 

countries have not had information regarding the efficacy of new vaccines 

until several years after licensing in the developed world. 

According to a WHO official, the choice of a site to conduct clinical tests on 

a new vaccine is typically determined by the existence of an infrastructure 

capable of sustaining a large trial. The challenge, according to the WHO 

official, is that in some cases the highest risk populations live in areas 

where the infrastructure is insufficient to support these trials. While 

smaller scale demonstration and pilot studies could be conducted to 

determine disease burden and vaccine efficacy in countries where 

infrastructure is weak, generally these have also not been conducted until 

several years after licensing in developed countries. 

Information on disease burden and vaccine efficacy is critical for 

governments that must make vaccine investment decisions. For example, a 

vaccine that is expected to be licensed soon, pneumoccocal conjugate, 

could be more effective in lessening the overall burden of pneumonia than 

the existing Hib vaccine. While the Hib vaccine immunizes against 20 

percent of the disease strains that cause pneumonia, candidate 

pneumoccocal conjugate vaccines may prevent up to 70 percent of the 

disease strains that cause pneumonia. Information from clinical trials could 

provide a better understanding of the burden of this disease in developing 

countries and the effectiveness of various vaccines so that governments 

have the information they need to make decisions regarding the purchase 

of additional vaccines. 

These data limitations have prevented experts from conducting

cost-effectiveness studies that could assist governments in determining the 

value of investing in additional vaccines. The Children’s Vaccine Initiative, 

for example, found that of 190 published vaccination cost-effectiveness 

studies they identified, only about 10 percent pertained to developing 

countries−and most of those were of poor quality. The Children’s Vaccine 

Initiative has recently developed analytical models to estimate the

cost-effectiveness of introducing several additional vaccines into the 

immunization programs of developing countries, including hepatitis B and 

Hib.
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Shifting Priorities of 

International Donors

In the 1970s and 1980s, after WHO created the Expanded Program on 

Immunization, the international donor community provided significant 

support to efforts to improve the availability of vaccines in developing 

countries. However, during the 1990s, overall commitments by bilateral 

donors for efforts to control infectious diseases, including immunization, 

have fluctuated significantly each year. The U.S. bilateral commitment 

through USAID declined slightly as a percentage of funding in the category 

of “child survival”19 over the 1990s. UNICEF spending for immunization 

decreased in dollar value and as a percentage of total health expenditures 

over the period. Within the pool of funds committed to control of infectious 

diseases, the global effort to eradicate polio received priority attention. 20

According to USAID and UNICEF officials, this has resulted in less money 

being available to support routine immunization programs.

The priority placed by bilateral donors on infectious diseases, which 

includes support for routine immunization and polio eradication as well as 

control of other diseases such as malaria and diarrheal diseases, shifted 

yearly throughout the 1990s. Annual spending commitments fluctuated by 

at least 39 percent per year and up to 330 percent. On average, however, 

infectious disease commitments slightly increased from 10.5 to 11.4 

percent of total health commitments from the early to the later 1990s. An 

increasing percentage of infectious disease commitments was directed to 

support polio eradication, which increased from about 14 percent of 

infectious disease funding in 1995 to about 52 percent in 1997. 

While USAID funding for overall child survival programs rose by more than 

50 percent since 1990, 21 from about $223 million to about $341 million in 

1998, support for immunization programs declined as a percentage of 

funding for child survival programs. On average, immunization funding 

declined from about $53 million (19 percent of child survival funding) 

between 1990 and 1993 to about $51 million (17 percent of child survival 

funding) from 1994 to 1997. In 1998, immunization was only about

$47 million or 14 percent of the total obligated for child survival. Since 

19These are programs designed to deal directly with the special health needs of children and 

mothers, including those aimed at improving immunization, nutrition, and sanitation.

20Polio eradication is an effort targeted specifically at ensuring that the incidence of polio is 

reduced to zero, thus obviating the need for further control measures. 

21All USAID figures are fiscal year obligations.
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polio eradication began in 1996, on average, about half of USAID’s spending 

for immunization was directed toward this effort.

While UNICEF expenditures for health programs declined slightly from the 

early to the later 1990s, UNICEF funding for immunization declined more 

significantly both in terms of dollar value and also as a percentage of 

overall UNICEF expenditures (see fig. 4 for an illustration of UNICEF 

spending). Immunization funding decreased from about $182 million

(57 percent of health expenditures) in 1990 to about $51.5 million (25 

percent of health expenditures) in 1998. In addition, a growing percentage 

of immunization funds was spent on vaccine procurement, particularly to 

support the polio eradication effort, with vaccine procurement increasing 

from 25 percent of the total in 1990 to 83 percent of the total in 1998. As a 

result, support for other immunization services, such as maintaining 

national vaccine delivery systems, has declined. 

Figure 4: UNICEF Expenditures on Immunization, 1990-98

Note: Expenditures are in constant 1997 dollars (in millions). UNICEF officials note that recent data 

coding changes may slightly increase the spending totals for 1997 and 1998.

Source: GAO analysis based on 1999 UNICEF data.

Dollars in millions

0

20

40

60

80

100

120

140

160

180

200

1990 1991 1992 1993 1994 1995 1996 1997 1998

Immunization funding

Of which, vaccine procurement
B-283270

Page 20 GAO/NSIAD-00-4 Vaccine Availability

Almost no donor funding has been available to purchase more recently 

recommended vaccines. UNICEF, citing a lack of resources, has not 

purchased vaccine to prevent Hib for any country and only purchases 

hepatitis B vaccine on a very limited basis−for countries that reimburse 

UNICEF.22 A senior UNICEF official noted that the agency issued a formal 

policy in 1998 encouraging their country-level offices to take a leading role 

in introducing Hib and hepatitis B in their countries. However, these offices 

did not receive additional funds and have chosen not to use their existing 

funds to purchase the newer vaccines. PAHO has a revolving fund that 

procures hepatitis B and Hib vaccines but is reimbursed by countries that 

place the orders. These countries benefit from the lower prices that can be 

negotiated with larger procurements by UNICEF and PAHO and are 

allowed to reimburse the agencies with local currency, rather than in 

dollars, which must be used to purchase the vaccines. In addition, the 

Asian Development Bank is considering providing financial support for 

purchasing hepatitis B and Hib for its borrowing member countries. 

Agency Comments The Centers for Disease Control and Prevention and USAID provided 

written comments on a draft of this report that are reprinted in appendixes 

II and III. The Centers for Disease Control and Prevention stated that it 

generally agrees with the overall message, noting that the report provides 

an excellent introduction to the status of vaccination in developing 

countries and the barriers that exist to expanding coverage and 

implementing new vaccines. The Centers stated that one of the most 

valuable observations made in the report was that developing countries 

were facing different barriers in their attempt to increase vaccination rates. 

However, the Centers noted that we did not mention an important barrier—

the lack of advocacy for vaccination from the medical community and the 

public. We regard advocacy as a potential option to address immunization 

shortfalls rather than a barrier and therefore we did not discuss this matter 

in the report. The Centers also provided technical comments that we 

incorporated as appropriate. 

USAID stated that the report presented the issue clearly, concisely, and 

fairly. USAID noted the importance of making investments in immunization 

programs within the context of broader health and developmental 

priorities and emphasized the need for USAID and national governments to 

22The European Union Initiative, which purchases vaccines for several countries in western 

Africa, does not provide support for the purchase of more recently recommended vaccines.
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Page 21 GAO/NSIAD-00-4 Vaccine Availability

balance health investments to address all priorities. While agreeing with 

our observation that overall coverage rates in African immunization 

programs were low, USAID pointed out that some countries in Africa have 

developed strong national programs that indicate the potential for program 

improvement in other countries in the region. USAID also noted that 

vaccine costs are a small percentage of the total cost associated with 

immunization programs and that its implementation strategy assumes a 

certain amount of waste. All of USAID’s points are valid, but they do not 

affect our primary message. Thus, we did not modify the report.

As agreed with your offices, unless you publicly announce the contents 

earlier, we plan no further distribution of this report until 3 days after its 

issue date. At that time, we will send copies of this report to appropriate 

congressional committees; the Honorable Madeleine K. Albright, Secretary 

of State; the Honorable Donna Shalala, Secretary of Health and Human 

Services; the Honorable J. Brady Anderson, Administrator of USAID; and 

other interested parties. We will also make copies available to others on 

request. 

Please contact me on (202) 512-4128 if you or your staff have any questions 

concerning this report. Other GAO contacts and staff acknowledgments are 

listed in appendix IV.

Benjamin F. Nelson, Director

International Relations and Trade Issues
Page 22 GAO/NSIAD-00-4 Vaccine Availability

Appendix I

Objectives, Scope, and Methodology ApendxIi

At the joint request of the Chairman and the Ranking Minority Member of 

the Senate Committee on Appropriations, Subcommittee on Foreign 

Operations, we identified the (1) locations where shortfalls in 

immunization coverage are most prevalent and (2) factors that impede 

vaccine availability in these locations. 

To identify locations of shortfalls in immunization coverage, we reviewed 

pertinent documents and analyzed data collected from the United Nations 

Children’s Fund (UNICEF), the World Health Organization (WHO), and the 

World Bank for the years 1991 to 1997. UNICEF and WHO collect 

information on immunization coverage from each country for the six 

originally targeted diseases (that is, diphtheria, measles, pertussis, polio, 

tetanus, and tuberculosis). WHO also collects coverage information on 

hepatitis B, Haemophilus influenzae type b (Hib), neonatal tetanus, and 

yellow fever. While some experts maintain that immunization coverage 

rates provided by country officials are overstated, WHO and UNICEF 

conduct country-specific surveys to verify accuracy and make adjustments 

where necessary. We used reported immunization coverage from WHO to 

calculate the global coverage rate for the six original vaccines for 1997, the 

most recent year for which data are available. Data for 1998 will be 

available in September 1999, but WHO officials said that they did not 

expect any significant changes in the trends we identified.

We examined patterns of immunization across regions of the world and by 

selected countries. To obtain a better understanding of the immunization 

shortfalls that we identified, we reviewed reports on the immunization 

programs of specific countries. We used national economic data from the 

World Bank to identify the relationship between immunization rates and 

per capita income. We also reviewed the 1998 report, World Military and 

Social Expenditures, on the existence of conflict and civil unrest in 

developing countries to identify their correlation with immunization 

coverage. Finally, we attended two international vaccine conferences in 

Geneva, Switzerland, and New York to interview and collect information 

from national immunization program officials about the factors that 

impeded immunization coverage for older vaccines and the adoption of 

new vaccines in their programs. 

We primarily relied on reports and unpublished papers from WHO and 

UNICEF to describe the burden of disease for vaccines that have been 

recommended by WHO for inclusion in national immunization programs. 

As much of the disease burden information for developing countries is 

lacking, WHO develops models to estimate disease burden. We spoke with 
Appendix I

Objectives, Scope, and Methodology

Page 23 GAO/NSIAD-00-4 Vaccine Availability

officials from the five global vaccine manufacturers and the National 

Institutes of Health to ascertain the status of candidate vaccines in the 

research pipeline. We relied on a WHO report on the anticipated licensing 

of new vaccines for data on the expected mortality from diseases that 

would be prevented through the widespread availability of these vaccines. 

To examine the factors that impede vaccine availability in the developing 

world, we interviewed officials from multilateral organizations, pertinent 

federal agencies, vaccine manufacturers, key foundations, and vaccine 

experts in academia. We also collected and reviewed documents such as 

WHO and UNICEF annual reports on immunization coverage, special 

publications on vaccines, and professional papers obtained from these 

sources. We interviewed officials responsible for vaccine issues at the Pan 

American Health Organization (PAHO), WHO, the World Bank, UNICEF, 

and the United Nations Development Program. We also interviewed 

pertinent program officials at the Centers for Disease Control and 

Prevention, the Commerce Department, the Food and Drug Administration, 

the National Institutes of Health, the State Department, and the U.S. 

Agency for International Development (USAID). We interviewed 

representatives of the Rockefeller and Gates Foundations and the vaccine 

divisions of Chiron; Merck & Co. Inc.; Pasteur Merieux Connaught; 

SmithKline Beecham; and Wyeth Vaccines and Nutrition. Finally, we 

interviewed a number of academic experts in the vaccine field who have 

been particularly active at the international level. We questioned these 

officials about their perceptions of the barriers that have impeded greater 

availability and use of vaccines by developing countries.

In addition, we collected and reviewed relevant reports, journal articles, 

and other publications that discussed key impediments to vaccine 

availability. Finally, we obtained vaccine price data from the Centers for 

Disease Control and Prevention, PAHO, and UNICEF. We interviewed 

officials at these organizations and vaccine companies to obtain insights 

into why prices changed over time. We did not independently verify the 

statistical data that were obtained from various sources.

We performed our review from July 1998 through August 1999 in 

accordance with generally accepted government auditing standards. 
Page 24 GAO/NSIAD-00-4 Vaccine Availability

Appendix II

Comments From the Centers for Disease 

Control and Prevention ApendxIi
Appendix II

Comments From the Centers for Disease 

Control and Prevention

Page 25 GAO/NSIAD-00-4 Vaccine Availability
Page 26 GAO/NSIAD-00-4 Vaccine Availability

Appendix III

Comments From the U.S. Agency for 

International Development ApendxIi
Appendix III

Comments From the U.S. Agency for 

International Development

Page 27 GAO/NSIAD-00-4 Vaccine Availability
Appendix III

Comments From the U.S. Agency for 

International Development

Page 28 GAO/NSIAD-00-4 Vaccine Availability
Appendix III

Comments From the U.S. Agency for 

International Development

Page 29 GAO/NSIAD-00-4 Vaccine Availability
Appendix III

Comments From the U.S. Agency for 

International Development

Page 30 GAO/NSIAD-00-4 Vaccine Availability
Page 31 GAO/NSIAD-00-4 Vaccine Availability

Appendix IV

GAO Contact and Staff Acknowledgments ApendxiIV

GAO Contact Lynne Holloway, (202) 512-4612

Acknowledgments In addition to Ms. Holloway, Claude Adrien, Maria Durant, Bruce Kutnick, 

Thomas Laetz, Mike McAtee, Rona Mendelsohn, and Raymond Wyrsch 

made key contributions to this report.

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