United States General Accounting Office GAO Report to Congressional Requesters October 1999 GLOBAL HEALTH Factors Contributing to Low Vaccination Rates in Developing Countries GAO/NSIAD-00-4 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 Page 1 GAO/NSIAD-00-4 Vaccine Availability Page 2 GAO/NSIAD-00-4 Vaccine Availability United States General Accounting Office National Security and Washington, D.C. 20548 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 Page 3 GAO/NSIAD-00-4 Vaccine Availability B-283270 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 burden 3 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. Page 4 GAO/NSIAD-00-4 Vaccine Availability B-283270 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. Page 5 GAO/NSIAD-00-4 Vaccine Availability B-283270 Immunization Rates Immunization rates for the six WHO-targeted diseases in many of the poorest countries of the world are substantially lower than the global Are Lower Than the average of 82 percent. In some countries, coverage has declined in recent Global Average in years. Moreover, few developing countries have included vaccines recently recommended by WHO for inclusion in national immunization programs. Many Poor Countries Shortfalls in Coverage for Although five countries 6 in other regions have coverage rates among the Older Vaccines 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. Page 6 GAO/NSIAD-00-4 Vaccine Availability B-283270 Figure 1: Overall Immunization Coverage Rates for Countries, Grouped by Region, 1991-97 100 Overall percent of coverage 90 80 70 60 50 40 30 20 10 0 1991 1992 1993 1994 1995 1996 1997 CEE EA LA ME SA SSA 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 Page 7 GAO/NSIAD-00-4 Vaccine Availability B-283270 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. Page 8 GAO/NSIAD-00-4 Vaccine Availability B-283270 Figure 2: Immunization Coverage Rates in the Poorest Countries, With and Without Conflict, 1991-97 70 Overall percent of coverage 60 50 40 30 20 10 0 1991 1992 1993 1994 1995 1996 1997 Non-conflict Conflict 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). Page 9 GAO/NSIAD-00-4 Vaccine Availability B-283270 Coverage for New Vaccines Efforts by WHO to encourage countries to incorporate additional vaccines Is Limited 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. 10 Most 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. 11 Bhutan, Gambia, Kiribati, Maldives, Tuvalu, and Vanuatu. 12 In 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. Page 10 GAO/NSIAD-00-4 Vaccine Availability B-283270 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 Four principal factors have limited vaccine availability in developing countries: (1) inadequate health infrastructure, (2) the relatively higher Impede Vaccine cost of vaccines recommended recently by WHO, (3) insufficient Availability in information on disease burden and vaccine efficacy, and (4) changing priorities of international donors. The extent to which these factors impede Developing Countries vaccine availability varies by country, although some patterns exist across countries. 13 Tetanus 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. 14 There are 46 countries/territories in PAHO, spanning Canada, Central America and the Caribbean, South America, and the United States. Page 11 GAO/NSIAD-00-4 Vaccine Availability B-283270 Inadequate Infrastructure Countries must have systems that can safely and effectively deliver Impedes Immunization vaccines. WHO uses several indirect measures to assess countries’ capability to implement vaccine immunization programs. These measures, Efforts 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). Page 12 GAO/NSIAD-00-4 Vaccine Availability B-283270 Figure 3: Immunization Coverage Rates for Measles and Tuberculosis in Sub-Saharan Africa, 1991-97 90 Percent of coverage 80 70 60 50 40 30 20 10 0 1991 1992 1993 1994 1995 1996 1997 TB Measles 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 Page 13 GAO/NSIAD-00-4 Vaccine Availability B-283270 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 Another factor inhibiting the availability of newer vaccines in developing Vaccines Limit Their 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 Availability 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 15 Vaccine 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. Page 14 GAO/NSIAD-00-4 Vaccine Availability B-283270 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 Governments and donors need accurate information that can serve as a Impedes Investment in basis for deciding how much to invest in immunization programs. Surveillance data are crucial in assessing the impact of individual diseases, Vaccines and Immunization determining whether existing disease reduction targets are being met, and Programs deciding where resources should be targeted for maximum impact. In 16 UNICEF 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. 17 This is the price negotiated by PAHO for hepatitis B vaccine in 1998. Page 15 GAO/NSIAD-00-4 Vaccine Availability B-283270 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 18 UNICEF 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. Page 16 GAO/NSIAD-00-4 Vaccine Availability B-283270 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. Page 17 GAO/NSIAD-00-4 Vaccine Availability B-283270 Shifting Priorities of In the 1970s and 1980s, after WHO created the Expanded Program on International Donors 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 19 These are programs designed to deal directly with the special health needs of children and mothers, including those aimed at improving immunization, nutrition, and sanitation. 20 Polio 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. 21 All USAID figures are fiscal year obligations. Page 18 GAO/NSIAD-00-4 Vaccine Availability B-283270 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, 1990-98 200 Dollars in millions 180 160 140 120 100 80 60 40 20 0 1990 1991 1992 1993 1994 1995 1996 1997 1998 Immunization funding Of which, vaccine procurement 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. Page 19 GAO/NSIAD-00-4 Vaccine Availability B-283270 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 22 The European Union Initiative, which purchases vaccines for several countries in western Africa, does not provide support for the purchase of more recently recommended vaccines. Page 20 GAO/NSIAD-00-4 Vaccine Availability B-283270 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 21 GAO/NSIAD-00-4 Vaccine Availability Appendix I Objectives, Scope, and Methodology Appendx Ii 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 Page 22 GAO/NSIAD-00-4 Vaccine Availability Appendix I Objectives, Scope, and Methodology 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 23 GAO/NSIAD-00-4 Vaccine Availability Appendix II Comments From the Centers for Disease Control and Prevention Appendx Ii Page 24 GAO/NSIAD-00-4 Vaccine Availability Appendix II Comments From the Centers for Disease Control and Prevention Page 25 GAO/NSIAD-00-4 Vaccine Availability Appendix III Comments From the U.S. Agency for International Development AppendxIi Page 26 GAO/NSIAD-00-4 Vaccine Availability 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 Appendix IV GAO Contact and Staff Acknowledgments Appendx iIV 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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Global Health: Factors Contributing to Low Vaccination Rates in Developing Countries
Published by the Government Accountability Office on 1999-10-15.
Below is a raw (and likely hideous) rendition of the original report. (PDF)