Progress Toward Introduction of Haemophilus influenzae type b Vaccine in Low-Income Countries --- Worldwide, 2004--2007

Haemophilus influenzae type b (Hib) disease is estimated to cause 3 million cases of meningitis and severe pneumonia and approximately 386,000 deaths worldwide per year in children aged <5 years (1). Safe and effective Hib conjugate vaccines have been widely used in industrialized countries for nearly 20 years. However, primarily because of financial constraints and lack of awareness among both public health officials and the public regarding Hib disease burden and benefits of the vaccine, use of these vaccines has been low in developing countries, where most Hib disease and deaths occur.* In 2000, the GAVI Alliance (formerly known as the Global Alliance for Vaccines and Immunizations) began providing financial support for Hib vaccine in 72 countries that had a gross national income of <$1,000 (USD) per capita.^† Despite this support, before 2005, adoption of Hib vaccine by these countries remained low. In response, in June 2005, the GAVI Alliance established the Hib Initiative^§ to accelerate evidence-informed decision making regarding use of Hib vaccine in GAVI-eligible countries. During 2004--2007, the number of GAVI-eligible countries using Hib vaccine or approved to use the vaccine increased from 13 (18%) to 47 (65%).

Progress in Hib Vaccine Introduction

Countries apply to GAVI to request support for introduction of a vaccine. The application includes a financial plan, a vaccine introduction plan, and a 5-year national vaccine strategy. Applications are reviewed approximately four times per year by an independent committee, whose recommendations are later endorsed by the GAVI board. In 2004, 13 of 75 countries eligible for GAVI support for Hib vaccine were using the vaccine. By the end of 2007, 24 of 72 eligible countries were using Hib vaccine. During 2007, 23 additional countries were approved for GAVI support to introduce the vaccine (Table).

The pace of vaccine introduction has varied by region. As of December 31, 2007, approximately 80% of GAVI-eligible countries in the WHO regions of Africa (30 of 36 countries) and the Americas (five of six) had introduced or been approved to introduce Hib vaccine. In addition, four of six countries in the Eastern Mediterranean region, four of seven countries in the Western Pacific region, and one of nine countries in the South-East Asia region had introduced or had been approved to introduce Hib vaccine. Among the eight countries of the European region, one country had introduced and two had applied to introduce Hib vaccine.

Recent Worldwide Increase in Hib Vaccine Access

The estimated total number of children worldwide who received the third dose of Hib vaccine increased from 8% of the world's birth cohort in 1999 to 22% in 2006.^¶ In 2007, 17% (14 million) of the GAVI-eligible countries' birth cohort of approximately 79 million children was in countries that were using Hib vaccine, compared with 8.5% (6.8 million) of the birth cohort in 2004 (Figure).** Among the GAVI-eligible countries that had not yet applied for Hib vaccine, three (India, Nigeria, and Indonesia) constituted 34%, 8%, and 6%, respectively, of the birth cohort in GAVI-eligible countries. Indonesia has indicated intent to introduce Hib vaccine in 2009; Nigeria and India have not made a decision (Table).

Reported by: GAVI Secretariat, Geneva; Dept of Immunization, Vaccines, and Biologicals, World Health Organization, Geneva, Switzerland. The Hib Initiative, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. UNICEF, New York. London School of Hygiene and Tropical Medicine, London, England. Global Immunization Div; Div of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, CDC.

Editorial Note:

This report indicates that the number of GAVI-eligible countries that have introduced Hib vaccine has accelerated during the past 2 years. Two primary factors have contributed to this increase. First, in November 2006, WHO revised its position statement on Hib vaccine to make a stronger and clearer recommendation that Hib vaccine be included in routine vaccination programs in all countries (1). Second, the worldwide Hib vaccine supply increased with introduction of a second Hib pentavalent vaccine in 2006, alleviating certain concerns about vaccine shortages.

Because GAVI must negotiate prices with vaccine manufacturers and determine the cost at which to provide vaccines to countries, vaccine price is a major barrier to vaccine introduction. The price likely will decrease with upcoming Hib vaccine products, creating a competitive vaccine market. In certain countries, certain vaccines are available on the private market, and persons can pay for the vaccine themselves or using private insurance. However, government-funded vaccine programs help ensure availability for those who cannot pay.

The WHO-UNICEF Global Immunization Vision and Strategy focuses on helping countries develop the capacity to make informed, sustainable decisions regarding vaccine introduction (2). Using this approach, the Hib Initiative conducts country visits and regional forums to assess barriers to decision making regarding Hib vaccine and to increase awareness of existing data on Hib disease and the potential impact of Hib vaccination. In addition, because limited Hib disease data have been a barrier to vaccine introduction in certain countries, the Hib Initiative developed a targeted research and surveillance agenda focused on collecting data needed to inform vaccine policy (e.g., data regarding Hib disease burden, the effect of Hib vaccine on disease in specific regions and populations [e.g., among HIV-positive children], booster doses, and cost-effectiveness).

In 2008, more countries are expected to begin using Hib vaccine. Countries have historically introduced vaccines 6--18 months after GAVI approval; of the 23 countries that are approved by GAVI to introduce Hib vaccine (20 in 2007 and three in 2005--2006), all are expected to introduce the vaccine during 2008. Vaccine introduction in these countries would increase the number of children with access to the vaccine to 35 million (44% of the GAVI-eligible countries' birth cohort). In addition, six countries that applied in 2007 must resubmit their application in 2008, and at least eight additional applications are expected.

Several steps are required for additional progress in Hib vaccine introduction and to sustain the gains achieved. First, coordination, education, and financial support to make evidence-informed decisions are required to help countries that have not yet decided to introduce Hib vaccine, particularly for GAVI-eligible countries with large birth cohorts such as India and Nigeria. GAVI's Hib Initiative is investing in a comprehensive strategy in India to raise awareness of Hib vaccine and assist with data interpretation. Second, strong disease surveillance systems are needed to continue to document vaccine effects on disease epidemiology. Several countries with active surveillance have demonstrated high vaccine effectiveness and reduced disease burden after vaccine introduction (3--5). Third, to achieve additional reductions in morbidity and mortality from Hib disease, routine infant vaccination coverage must be high, particularly among vulnerable populations. One study estimated that the use of Hib vaccine reduced mortality for children aged <5 years by 4% in the 42 countries where 90% of pediatric deaths occurred worldwide in 2000 (6). However, increasing routine infant vaccination coverage requires strengthening of health systems and substantial commitment from countries and donors. Fourth, the current disparity in the use of Hib vaccine between lower income and higher income countries in the world should be addressed. Twenty-one of 41 (51%) lower middle-income (but not GAVI-eligible) countries, 32 of 37 (86%) upper middle-income countries, and 36 of 39 (92%) high-income countries are using Hib vaccine.^†† This disparity can be addressed through development of new financing strategies or other strategies.

The success with Hib vaccine introduction suggests that strategies used to accelerate introduction of underused vaccines in developing countries have been effective. With the availability of new vaccines such as rotavirus and pneumococcal vaccines, the approach used for Hib vaccine introduction provides a useful model to increase use of other vaccines.

References

1. World Health Organization. Strategic advisory group of experts on immunization. The WHO position paper on Haemophilus influenzae type b conjugate vaccines. Wkly Epidemiol Rec 2006;81:445--52.
2. World Health Organization; UNICEF. Global immunization vision and strategy 2006--2015. Geneva, Switzerland; 2005. Available at http://www.who.int/vaccines-documents/docsPDF05/GIVS_final_en.pdf.
3. Baqui AH, Arifeen SE, Saha SK, et al. Effectiveness of Haemophilus influenzae type b conjugate vaccine on prevention of pneumonia and meningitis in Bangladeshi children a case-control study. Ped Infect Dis J 2007;26:565--71.
4. Daza P, Banda R, Misoya K, et al. The impact of routine infant immunization with Haemophilus influenzae type b conjugate vaccine in Malawi, a country with high human immunodeficiency virus prevalence. Vaccine 2006;24:6232--9.
5. Von Gottberg A, de Gouveia L, Madhi SA, Impact of conjugate Haemophilus influenzae type b (Hib) vaccine introduction in South Africa. Bull World Health Organ 2006; 84:811--8.
6. Jones G, Steketee RW, Black RE, et al. How many child deaths can we prevent this year? Lancet 2003;362:65--71.

* Additional information available at www.hibaction.org.

^† The GAVI Alliance is a group of public and private-sector organizations that provides financial support and vaccine supplies for the 72 poorest countries of the world. Eligibility is based on having a gross national income of <$1,000 (USD) per capita in 2003. During 2000--2005, 75 countries were eligible for GAVI support. In 2006, four countries were no longer eligible and one became eligible; therefore, a total of 72 countries were eligible for support from 2006, and 72 countries is used as the denominator in this report. Additional information on the GAVI Alliance is available at http://www.gavialliance.org.

^§ The Hib Initiative is a consortium that includes the World Health Organization, Johns Hopkins Bloomberg School of Public Health, the London School of Hygiene and Tropical Medicine, and CDC.

^¶ UNICEF and WHO estimates of coverage by country, year, and vaccine. Available at http://www.who.int/immunization_monitoring/en/globalsummary/timeseries/tswucoveragedtp3.htm.

** United Nations Population Division. World population prospects. 2006 revision. Available at http://esa.un.org/unpp.

^†† World Bank. Data & statistics: country groups. Available at http://web.worldbank.org. Four countries (Cook Islands, Nauru, Niue, and Tuvalu) were excluded because they did not have a World Bank classification.

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Date last reviewed: 2/14/2008