A WHITAKER GROUP PUBLICATION

NOVEMBER/DECEMBER 2009

AFRICA HEALTH NEWS
GROUNDBREAKING ADVANCES

WORLD’S LARGEST MALARIA VACCINE TRIAL LAUNCHED IN SEVEN AFRICAN NATIONS
Phase III of the largest malaria vaccine trial ever undertaken, involving up to 16,000 children in seven African countries, is underway and researchers are cautiously optimistic that the new RTS,S vaccine will represent a groundbreaking advance in the battle against one of Africa’s most deadly diseases. The vaccine, which would complement existing interventions such as bed nets and effective drug therapies, is the first malaria vaccine candidate ever to demonstrate significant efficacy during earlier trials. It is the leading vaccine candidate in the global effort by PATH Malaria Vaccine Initiative (MVI) to develop an effective malaria immunization. The vaccine is the result of a partnership between MVI, biopharmaceutical company GlaxoSmithKline Biologicals (GSK Bio), and African research institutions. Phase II studies, initiated in 2002 and conducted on more than 2,000 children in Mozambique, showed that RTS,S reduced malaria cases by 53% over an eight-month follow-up period. Other studies, published in The Lancet in 2004 and 2005, described the vaccine as effective for at least 18 months, reducing clinical malaria by 35% and severe malaria by 49%. The vaccine was also shown to be safe when used in conjunction with standard infant immunizations. “A malaria vaccine could help save countless lives and redefine the future for Africa’s children,” said Dr. Patricia Njuguna, the vaccine’s principal investigator and the chair of the Clinical Trials Partnership Committee. “Communities all across Africa are dedicated to this future and are participating to ensure that we develop a vaccine with an acceptable safety and efficacy profile.” Breadth of Trial RTS,S is the first vaccine designed specifically for African conditions. Over 800,000 Africans die each year from malaria, the vast majority of whom are children under five. By conducting the Phase III trial in seven different sub-Saharan African countries, researchers will be able to evaluate the efficacy of the vaccine in a variety of settings, with diverse patterns of malaria transmission. The trial is taking place in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The Phase III trial is the culmination of more than 20 years of research, including 10 years of clinical trials in the United States and Africa. It will evaluate the vaccine’s efficacy in two groups of children. One group, aged six to 12 weeks, will be immunized as part of their regular schedule of infant vaccinations; the second group will include children aged five months to 17 months. “This is the largest trial ever conducted in Africa of a vaccine specifically designed for use with African children. We have great appreciation for the families and children participating,” said Dr. Salim Abdulla, Director of the Ifakara Health Institute in Tanzania, one of the trial’s African partner institutions. “Development of RTS,S across Africa has

A baby is immunized with the new RTS,S vaccine during Phase II of the clinical trials. strengthened our research capacity, a legacy that will far outlast the trials.” National governments have been very involved in the trial since the beginning of the process. Each country hosting a study site has undertaken independent reviews to ensure the trial meets national safety, ethical and legal standards for medical research. In addition, an independent data and safety monitoring board oversees the entire trial with support from local safety monitors. The trial has been designed in consultation with regulatory authorities in Europe, the U.S. and African countries, in conjunction with the World Health Organization (WHO). If the vaccine meets the expected outcome, it will be submitted to regulatory authorities in 2012 together with safety and immunogenicity data. Depending on the final clinical profile of RTS,S and the timetable of the regulatory review process, the vaccine could be introduced within three to five years. In anticipation of the vaccine roll-out, MVI and GSK Bio are already working with malaria-affected countries and international institutions to ensure that an effective malaria vaccine will be readily available and affordable to those who need it most. The two organizations signed a collaboration agreement in 2001 to pursue a pediatric clinical development of RTS,S in Africa. They were joined by African research centers in five countries, with two additional African countries joining for the Phase III trial. Development of the vaccine candidate was made possible by grants of more than $200 million from the Bill & Melinda Gates Foundation to the PATH Malaria Vaccine Initiative, a global program established by the international nonprofit organization PATH to accelerate the development of malaria vaccines and ensure its availability in developing countries. So far, GSK has invested more than $300 million in the vaccine’s development and expects to invest at least another $100 million before the completion of the project.

PAGE TWO PROGRESS IN THE FIGHT AGAINST HIV/AIDS NEGLECTED TROPICAL DISEASES

NEW INFECTIONS DECLINING IN SSA AS PEOPLE LIVING WITH HIV INCREASE
The number of people in Africa who were infected with HIV in 2008 is about 15% lower than in 2001, according to a new report released in November by UNAIDS, the umbrella organization that oversees all United Nations (U.N.) AIDS programs. In 2001, when the U.N. Declaration of Commitment on HIV/AIDS was signed, 2.3 million people in sub-Saharan Africa (SSA) were newly infected with HIV. In 2008, the number has dropped by 400,000 to 1.9 million new infections. About 22.4 million people in Africa were living with HIV in 2008, the report stated, compared with 19.7 million in 2001. “The good news is that we have evidence that the declines we are seeing are due, at least in part, to HIV prevention,” said Mr. Michel Sidibé, Executive Director of UNAIDS. “However, the findings also show that prevention programming is often off the mark and that if we do a better job of getting resources and programs to where they will make the most impact, quicker progress can be made and more lives saved.” The report, which combines the results of epidemiological studies from around SSA, put the number of AIDS-related deaths in 2008 at 1.4 million. This represents an 18% decline in the rate of mortality in the region since 2004. Women and girls continue to be disproportionately affected by HIV in SSA, accounting for 60% of estimated infections. The risk of becoming infected is especially disproportionate for girls and young women. In Kenya, for example, women between 15 and 19 years old are three times more likely to be infected than their male counterparts, while 20 to 24-yearold women are 5.5 times more likely to be living with HIV than men of the same age. The report states that rapid scaling up of antiretroviral (ARV) treatment since 2004 has generated considerable public health gains. As of December 2008, 44% of Africans in need of ARV therapy (nearly three million people) were receiving it. In 2003, the WHO estimated that antiretroviral treatment was reaching just 2% of those in need. Treatment scale-up is having a profound effect on HIV mortality in many countries, studies have found. In Uganda, timely initiation of ARV therapy reduced mortality by 95% and also resulted in a 93% reduction in HIVrelated orphanhood. In Botswana, where ARV therapy coverage exceeds 80%, AIDS-related deaths fell by more than 50% between 2003

NEW PARTNERSHIPS ADVANCE NTD TREATMENTS
Distinguished experts at two forums in Washington in October pointed to public-private partnerships as key to combating neglected tropical diseases (NTD) that disproportionately affect the lives and productivity of millions of Africans. Dr. Christy Hanson, a senior public health advisor with the U.S. Agency for International Development (USAID) spoke at a gathering co-hosted by Global Health Progress (GHP), a joint initiative of research-based biopharmaceutical companies, and the journal Health Affairs, about how USAID had developed a sustainable platform for delivering critical NTD treatments by partnering with governments and the pharmaceutical industry. In an article in Health Affairs that she coauthored with Mr. Ken Gustavsen, Director, Corporate Responsibility and Global Policy Support at bio-pharmaceutical company Merck & Co, Dr. Hanson outlined disease-specific partnerships that nine drug companies have entered into to provide treatment for lymphatic filariasis, river blindness, schistosomiasis, parasitic worms, trachoma, leprosy, trypanosomiasis and Chagas disease. Dr. Hanson and Mr. Gustavsen also highlighted the work of the Partnership for Disease Control Initiatives, a loose alliance of drug companies that enables them to closer coordinate mass drug administration and address human resource burdens on affected communities and health systems. At a forum on Capitol Hill, hosted by the Tufts Center for the Study of Drug Development, that brought together experts from major research institutions, governments and the private sector, Deputy Ambassador of Malawi Mr. Kena Mphonda pointed to the successful partnerships between the Government of Malawi and Abbott Laboratories, Family Health International, GlaxoSmithKline, Merck, PharmAccess, Roche International, Johnson & Johnson, the Elizabeth Glaser Pediatric AIDS Foundation and the U.S. Centers for Disease Control (CDC) that are helping to combat diseases that are impeding Malawi’s development. Recent studies estimate that 534,000 people die each year and that 56.6 million DALYs (disability-adjusted life years) are lost annually to 13 NTDs.

In 2008, 44% of Africans in need of antiretroviral treatment received it, compared with 2% in 2003. and 2007 while the number of children newly orphaned by AIDS fell by 40%. Other findings in the report include: ■ A wide variation exists in the relationship between HIV and income. In eight African countries where surveys have been conducted - Burkina Faso, Cameroon, Ghana, Kenya, Lesotho, Malawi, Tanzania and Uganda - HIV prevalence is higher among adults in the wealthiest quintile than among those in the poorest quintile. ■ As the epidemic has evolved in SSA, the relationship between HIV infection and education has shifted. Before 1996, studies found either no association between educational level and HIV risk or found that the highest risk was among the most educated. Data collected after 1996 has tended to show a lower risk among the most educated people. ■ HIV prevalence tends to be higher in urban settings than in rural areas. The most pronounced difference in HIV prevalence is in Ethiopia, where urban dwellers are eight times more likely to be HIV-infected than people living in rural areas. ■ Many countries have greatly stepped up testing. In 2008, Botswana reported the highest proportion of people being tested in Africa (210 per 1,000). ■ HIV prevention programs may be having an impact on sexual behaviors in some African countries, where condom use has risen dramatically. In South Africa, the proportion of adults reporting condom use rose from 31.3% in 2002 to 64.8% in 2008. ■ Access to services to prevent mother-tochild HIV transmission has expanded greatly, with 45% of HIV-infected pregnant women receiving ARVs in 2008, compared with 9% in 2004.

PAGE THREE BUILDING CAPACITY MALARIA AWARENESS

SAFE BLOOD FOUNDATION SAVES LIVES AFRICAN PRIVATE
Up to 10% of the 22.4 million Africans living with HIV contracted the virus after undergoing blood transfusions. And, because of a severe shortage of safe blood in most African countries, those needing transfusions such as women in childbirth, accident victims, or children suffering from malaria-induced anemia, can be faced with the choice of foregoing the life-saving transfusion or risking HIV infection from unsafe blood. Ten years ago, New York investment banker Jeff Busch launched the Safe Blood for Africa Foundation (SBFA), with funding from ExxonMobil, Abbott Laboratories, Global Med Technologies, Johnson & Johnson and Merck & Co., to help African nations strengthen neglected safe blood services and provide the funding and support needed to make it a health priority. Since then, SBFA has provided assistance to national blood services in 35 African countries, trained over 6,000 health care technicians in safe blood handling procedures, launched educational programs that encourage young people to protect themselves against HIV infection and donate blood, and supplied millions of blood-testing kits to health facilities across Africa. Among its partners is the President’s Emergency Plan for AIDS Relief (PEPFAR), which in 2008 provided about $92.4 million to support countries as they develop or strengthen national policies and guidelines on blood safety that address their own country specific issues. The results can be measured by a sharp increase in the safe blood supply in countries where SBFA is most active. Since 2002, when SBFA began working with the Botswana National Blood Transfusion Service, the country’s safe blood supply has increased by over 100% and the HIV infection rate from donated blood has decreased from 9% to less than 2%. In Nigeria, SBFA is working in partnership with the Nigerian Ministry of Health, the U.S. Centers for Disease Control (CDC), ExxonMobil and the U.S. Agency for International Development (USAID) to establish 17 zonal blood centers. Since 2003, it has trained over 1,000 Nigerian blood service and health care staff in safe blood handling. SBFA is also working to help ensure that there are sufficient supplies of disease-

SECTOR CONTRIBUTES TO GLOBAL FUND

SBFA encourages young people to maintain healthy lifestyles and donate blood free blood in Africa. Making sure there is enough blood for treatment is as critical as ensuring that the blood that is collected is safe. There are significant health crises in many African nations because of the shortages, which are exacerbated in high HIVprevalent environments where there are higher discard rates for tainted blood. In order to encourage the participation of unpaid volunteer blood donors who are known to be of lower risk for transfusiontransmittable infections, SBFA has supported and expanded the African Club 25 Society, which combines maintenance of health lifestyles and HIV prevention with encouraging the participants, who are between 16 and 25, to become life-long blood donors. Club 25 members pledge to give blood at least 25 times while maintaining a healthy HIV-free lifestyle. With the support of SBFA, Club 25 now has over 62,000 active youth participants in 15 African countries. To build blood services capacity in Africa, SBFA supports scholarships and fundraising for grants and training programs at the African Institute for Transfusion Medicine (AITM). The purpose of AITM is to establish a sustainable and continuing professional development program in Africa for leaders, managers, clinicians and staff in blood services. SBFA’s other programs in Africa include an emergency program in the Democratic Republic of Congo (DRC); providing technical assistance, training and HIV test kits in Equatorial Guinea and supplying trained donor blood recruiters in Lesotho and Swaziland.

African private sector companies, in partnership with the hit reality television show “Big Brother Africa Revolution,” united beginning in November to raise funds for the Global Fund to Fight AIDS, Tuberculosis and Malaria. The funds are to be raised in an Africa-wide public awareness campaign and earmarked for the Global Fund’s United Against Malaria initiative. It will be the first time the African private sector has made a donation to the Global Fund. “Big Brother Africa Revolution,” now in its fourth season, is broadcast in 47 African countries. In episodes running from November 24 to November 26, the housemates in “Big Brother Africa Revolution” highlighted the critical importance of malaria prevention by installing, mending and sleeping under insecticide-treated bed nets. They also made beaded bracelets in support of United Against Malaria as part of a much larger public awareness campaign and fundraising initiative led by African companies such as South African restaurant chain Nando’s and the trans-Africa telecommunications company MTN. Fifty percent of the revenue earned by MNet, the show’s broadcaster, and its producer, Endemol South Africa, from SMS messages sent by Big Brother Africa viewers will be channeled to the Global Fund. In addition, a percentage of revenues raised from the sale of all United Against Malaria bracelets will be donated to the Fund. “M-Net believes that this is a vital and necessary initiative and so we are pleased that our Big Brother Revolution series is able to provide a continental platform where information regarding the prevention of malaria in Africa can be highlighted,” said M-Net Africa Director Biola Alabi. “It is clear that fostering greater education and understanding is a key part of the process in preventing the spread of malaria.” United Against Malaria is a partnership of prominent leaders, organizations, the private sector and sports stars that have joined forces ahead of the World Cup in 2010 in South Africa to end preventable malaria deaths. The Global Fund estimates that around 2,200 Africans die each day from malaria, 85% of them children under five years of age.

PAGE FOUR SUCCESS STORIES FROM AFRICA LEADERS IN HEALTH

NEW REPORT HIGHLIGHTS SUCCESSFUL COLLABORATIONS IN IMPROVING HEALTH
Partnerships between governments, the private sector, research institutions, funders and civil society are critical to achieving meaningful and lasting progress in addressing global health challenges, according to a new report published in November by a group of global health organizations. Case Studies for Global Health presents 30 diverse examples of health partnerships around the developing world. It is designed to be used as a tool for stakeholders seeking to build and manage partnerships to address global health challenges. It is the first time that such a broad array of health partnerships in Africa has been presented. The report was published by an alliance made up of Global Health Progress (GHP), a joint initiative of research-based biopharmaceutical companies; the Bill & Melinda Gates Foundation; the International AIDS Vaccine Initiative (IAVI); the Association of University Technology Managers (AUTM); and the World Health Organization (WHO) program Tropical Disease Research. The case studies focus on successful partnerships in four categories: access to medicines and health services, discovery and development of new drugs and vaccines, health intervention and prevention programs, and health systems strengthening and capacity building. “Although they represent diverse causes, activities and partnerships, the case studies share a common theme,” said Mr. Christopher Singer, President International of Pharmaceutical Research and Manufacturers of America (PhRMA), a founding member of GHP. “Successful programs engage partners and policymakers early, communicate openly and frequently with relevant stakeholders, and empower and involve communities.” Among the case studies included are: ■ Advance Market Commitment (AMC), which brings together donors, governments and biopharmaceutical companies to ensure the development of new vaccines for diseases prevalent in poorer countries by guaranteeing a market for the vaccines; ■ The partnership between the Global Alliance for TB Drug Development and Bayer Healthcare to develop a new first-line tuberculosis treatment; ■ The Apparel Lesotho Alliance to Fight AIDS (ALAFA), which brings together U.S. retailers and garment factories and unions in Lesotho to provide prevention and HIV test-

DR. BENJAMIN KUMBOUR MINISTER OF HEALTH, GHANA
Dr. Benjamin Kumbour, Ghana’s new Minister of Health, came into office in November with an ambitious goal: to provide universal health access to all Ghanaians by comDr. Kumbour pletely overhauling the country’s health system. His priorities include restructuring the National Health Insurance Scheme to expand it beyond its current 12.2 million members, cutting the inefficient use of resources to enable the Ministry to allocate more to health services for lower income communities, and slowing the drain of skilled health professionals from Ghana by building incentives and greater training capacity into the health system. He is also seeking to improve and expand Ghana’s health infrastructure, particularly in poorly-served rural areas. Previously Deputy Minister of Health, Dr. Kumbour has already been closely involved in the groundwork for some of the initiatives he will drive as Minister, and his prior positions as the Deputy Minister of Education and as the minority spokesperson in the Ministry of Finance have given him invaluable experience in management and finance. Dr. Kumbour recently told a gathering of health professionals in Ghana that the Ministry of Health will move away from a disease-centered approach to health care to a system that will focus on prevention and promoting health lifestyles. He said that it was particularly important to mobilize local communities and improve health infrastructure in underserved areas. Over the next few years, 21 new health centers will be built in rural areas and four existing ones upgraded to district hospitals. Further, Dr. Kumbour said he was committed to increasing Ghana’s training capacity for health workers, and has pledged to increase admissions at health training institutions, establish further clinical sites for practical training and create linkages with foreign health institutions to improve health education.

PHOTO : VANESSA VICK/CASE STUDIES FOR GLOBAL HEALTH

A laboratory technician examines an HIV candidate vaccine supported by IAVI. ing programs; ■ The partnership between the Government of Tanzania and Abbott Laboratories to build capacity in the Tanzanian health system by improving laboratory infrastructure and services; ■ The development of vaccine vial monitors by a partnership that included the WHO; global health NGO PATH; the U.S. Agency for International Development (USAID); the Global Alliance for Vaccines and Immunization (GAVI); the United Nations Children’s fund, UNICEF; and the U.S. Centers for Disease Control (CDC). The monitors indicate if a vial of vaccine has been exposed to heat. ■ The International Partnership for Microbicides (IPM), which is working to develop microbicides for women to use to avoid HIV infection; ■ The development of the RTS,S malaria vaccine by GlaxoSmithKline in collaboration with the PATH Malaria Vaccine Initiative (see story on front page); ■ A collaboration between PATH, USAID, biopharmaceutical company Boehringer Ingelheim, the Elizabeth Glaser Pediatric AIDS Foundation and the Kenyan Ministry of Health to develop a simple nevirapine delivery system for newborns. A single dose of nevirapine can prevent mother-to-child transmission of the HIV virus; ■ A partnership between the Accordia Global Health Foundation, ExxonMobil and the Ugandan Infectious Diseases Initiative (IDI) to create the Ugandan Malaria Surveillance Program; and ■ Links for Life, which promotes learning and advocacy around integrated HIV and food security programming. With pilot programs in Ethiopia and Malawi, Links for Life currently involves about 45 organizations seeking to foster advocacy at the grassroots level.
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