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AFRICA HEALTH NEWSA WHITAKER GROUP PUBLICATION NOVEMBER/DECEMBER 2009

G ROUNDBREAKING A DVANCES

WORLDS LARGEST MALARIAVACCINE TRIAL LAUNCHEDN SEVEN AFRICAN NATIONShase III of the largest malaria vaccine trial ever undertaken, involv-

ng up to 16,000 children in seven African countries, is underway andesearchers are cautiously optimistic that the new RTS,S vaccine willepresent a groundbreaking advance in the battle against one of Afri-as most deadly diseases.

e vaccine, which would complement existing interventions such

s bed nets and effective drug therapies, is the rst malaria vaccine can-idate ever to demonstrate signicant efficacy during earlier trials. Its the leading vaccine candidate in the global effort by PATH Malaria

Vaccine Initiative (MVI) to develop an effective malaria immunization.e vaccine is the result of a partnership between MVI, biopharma-eutical company GlaxoSmithKline Biologicals (GSK Bio), and Africanesearch institutions.

Phase II studies, initiated in 2002 and conducted on more than 2,000hildren in Mozambique, showed that RTS,S reduced malaria cases by 3% over an eight-month follow-up period. Other studies, publishedn e Lancet in 2004 and 2005, described the vaccine as effective for ateast 18 months, reducing clinical malaria by 35% and severe malaria by 9%. e vaccine was also shown to be safe when used in conjunction

with standard infant immunizations.A malaria vaccine could help save countless lives and redene the

uture for Africas children, said Dr. Patricia Njuguna, the vaccinesrincipal investigator and the chair of the Clinical Trials Partnership

Committee. Communities all across Africa are dedicated to this futurend are participating to ensure that we develop a vaccine with an ac-eptable safety and efficacy prole.

readth of Trial

RTS,S is the rst vaccine designed specically for African conditions.Over 800,000 Africans die each year from malaria, the vast majority of whom are children under ve. By conducting the Phase III trial in sev-n different sub-Saharan African countries, researchers will be able tovaluate the efficacy of the vaccine in a variety of settings, with diverseatterns of malaria transmission. e trial is taking place in Burkinaaso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.

e Phase III trial is the culmination of more than 20 years of re-earch, including 10 years of clinical trials in the United States and Af-ica. It will evaluate the vaccines efficacy in two groups of children. Oneroup, aged six to 12 weeks, will be immunized as part of their regularchedule of infant vaccinations; the second group will include childrenged ve months to 17 months.

is is the largest trial ever conducted in Africa of a vaccine speci-ally designed for use with African children. We have great apprecia-on for the families and children participating, said Dr. Salim Abdulla,

Director of the Ifakara Health Institute in Tanzania, one of the trialsAfrican partner institutions. Development of RTS,S across Africa has

strengthened our research capacity, a legacy that will far outlast the als.

National governments have been very involved in the trial sincebeginning of the process. Each country hosting a study site has underten independent reviews to ensure the trial meets national safety, ethiand legal standards for medical research. In addition, an independedata and safety monitoring board oversees the entire trial with suppfrom local safety monitors. e trial has been designed in consultatiowith regulatory authorities in Europe, the U.S. and African countriesconjunction with the World Health Organization (WHO).

If the vaccine meets the expected outcome, it will be submittedregulatory authorities in 2012 together with safety and immunogenity data. Depending on the nal clinical prole of RTS,S and the titable of the regulatory review process, the vaccine could be introduwithin three to ve years.

In anticipation of the vaccine roll-out, MVI and GSK Bio are alreworking with malaria-affected countries and international institutioto ensure that an effective malaria vaccine will be readily availableaffordable to those who need it most. e two organizations signed collaboration agreement in 2001 to pursue a pediatric clinical develment of RTS,S in Africa. ey were joined by African research centein ve countries, with two additional African countries joining for Phase III trial.

Development of the vaccine candidate was made possible by grof more than $200 million from the Bill & Melinda Gates Foundatto the PATH Malaria Vaccine Initiative, a global program establishby the international nonprot organization PATH to accelerate the d velopment of malaria vaccines and ensure its availability in developcountries.

So far, GSK has invested more than $300 million in the vaccines velopment and expects to invest at least another $100 million before

completion of the project.

A baby is immunized with the new RTS,S vaccine during Phase IIthe clinical trials.

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P AGE TWO

P ROGRESS IN THE F IGHT A GAINST HIV/AIDS

NEW INFECTIONS DECLINING IN SSA ASPEOPLE LIVING WITH HIV INCREASEe number of people in Africa who were in-ected with HIV in 2008 is about 15% lowerhan in 2001, according to a new report re-

eased in November by UNAIDS, the um-rella organization that oversees all United

Nations (U.N.) AIDS programs.In 2001, when the U.N. Declaration of Com-

mitment on HIV/AIDS was signed, 2.3 mil-on people in sub-Saharan Africa (SSA) wereewly infected with HIV. In 2008, the numberas dropped by 400,000 to 1.9 million new in-ections. About 22.4 million people in Africa

were living with HIV in 2008, the report stat-d, compared with 19.7 million in 2001.

e good news is that we have evidencehat the declines we are seeing are due, at leastn part, to HIV prevention, said Mr. Michelidib, Executive Director of UNAIDS. How-ver, the ndings also show that preventionrogramming is o en off the mark and that if

we do a better job of getting resources and pro-rams to where they will make the most im-act, quicker progress can be made and moreves saved.

e report, which combines the results of pidemiological studies from around SSA, puthe number of AIDS-related deaths in 2008 at.4 million. is represents an 18% decline inhe rate of mortality in the region since 2004.

Women and girls continue to be dispropor-onately affected by HIV in SSA, accountingor 60% of estimated infections. e risk of ecoming infected is especially disproportion-te for girls and young women. In Kenya, forxample, women between 15 and 19 years oldre three times more likely to be infected thanheir male counterparts, while 20 to 24-year-ld women are 5.5 times more likely to be liv-ng with HIV than men of the same age.

e report states that rapid scaling up of ntiretroviral (ARV) treatment since 2004 has

enerated considerable public health gains. Asf December 2008, 44% of Africans in needf ARV therapy (nearly three million people)

were receiving it. In 2003, the WHO estimatedhat antiretroviral treatment was reaching just% of those in need.

Treatment scale-up is having a profoundffect on HIV mortality in many countries,tudies have found. In Uganda, timely initia-on of ARV therapy reduced mortality by 95%nd also resulted in a 93% reduction in HIV-elated orphanhood. In Botswana, where ARVherapy coverage exceeds 80%, AIDS-related

eaths fell by more than 50% between 2003

and 2007 while the number of children newly orphaned by AIDS fell by 40%.

Other ndings in the report include: A wide variation exists in the relationship

between HIV and income. In eight Africancountries where surveys have been conducted- Burkina Faso, Cameroon, Ghana, Kenya, Le-sotho, Malawi, Tanzania and Uganda - HIVprevalence is higher among adults in thewealthiest quintile than among those in thepoorest quintile.

As the epidemic has evolved in SSA, therelationship between HIV infection and edu-cation has shi ed. Before 1996, studies foundeither no association between educationallevel and HIV risk or found that the highestrisk was among the most educated. Data col-lected a er 1996 has tended to show a lowerrisk among the most educated people.

HIV prevalence tends to be higher in ur-ban settings than in rural areas. e most pro-nounced difference in HIV prevalence is inEthiopia, where urban dwellers are eight timesmore likely to be HIV-infected than people liv-ing in rural areas.

Many countries have greatly stepped uptesting. In 2008, Botswana reported the high-

est proportion of people being tested in Africa(210 per 1,000). HIV prevention programs may be having

an impact on sexual behaviors in some Africancountries, where condom use has risen dra-matically. 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-to-child HIV transmission has expanded greatly,with 45% of HIV-infected pregnant womenreceiving ARVs in 2008, compared with 9% in2004.

In 2008, 44% of Africans in need of antiretroviral treatment received it, compared

with 2% in 2003.

Distinguished experts at two forums in Was

ington in October pointed to public-privapartnerships as key to combating neglecttropical diseases (NTD) that disproportioately affect the lives and productivity of mlions of Africans.

Dr. Christy Hanson, a senior public headvisor with the U.S. Agency for InternatiDevelopment (USAID) spoke at a gatheco-hosted by Global Health Progress (GHa joint initiative of research-based biopharceutical companies, and the journal Healt fairs, about how USAID had developed a tainable platform for delivering critical Ntreatments by partnering with governmeand the pharmaceutical industry.

In an article in Health Affairs that sheauthored with Mr. Ken Gustavsen, DirecCorporate Responsibility and Global PoSupport at bio-pharmaceutical company Mck & Co, Dr. Hanson outlined disease-spepartnerships that nine drug companies hentered into to provide treatment for lymphic lariasis, river blindness, schistosomiparasitic worms, trachoma, leprosy, trypasomiasis and Chagas disease.

Dr. Hanson and Mr. Gustavsen also hilighted the work of the Partnership for DiseControl Initiatives, a loose alliance of companies that enables them to closer codinate mass drug administration and addrhuman resource burdens on affected commnities and health systems.

At a forum on Capitol Hill, hosted byTu s Center for the Study of Drug Develment, that brought together experts from m jor research institutions, governments and private sector, Deputy Ambassador of MaMr. Kena Mphonda pointed to the succes

partnerships between the Government of Mlawi and Abbott Laboratories, Family HeInternational, GlaxoSmithKline, Merck, PmAccess, Roche International, JohnsonJohnson, the Elizabeth Glaser Pediatric AFoundation and the U.S. Centers for DiseControl (CDC) that are helping to comdiseases that are impeding Malawis devement.

Recent studies estimate that 534,000 pedie each year and that 56.6 million DA(disability-adjusted life years) are lost annuto 13 NTDs.

NEW PARTNERSHIPSADVANCE NTDTREATMENTS

N EGLECTED TROPICAL D ISEASES

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P AGE T

B UILDING C APACITY

SAFE BLOOD FOUNDATION SAVES LIVESUp to 10% of the 22.4 million Africans liv-ing with HIV contracted the virus after un-dergoing blood transfusions. And, becauseof a severe shortage of safe blood in most

African countries, those needing transfu-sions such as women in childbirth, acci-dent victims, or children suffering frommalaria-induced anemia, can be facedwith the choice of foregoing the life-savingtransfusion or risking HIV infection fromunsafe blood.

Ten years ago, New York investmentbanker Jeff Busch launched the Safe Bloodfor Africa Foundation (SBFA), with fund-ing from ExxonMobil, Abbott Laborato-ries, Global Med Technologies, Johnson &Johnson and Merck & Co., to help Africannations strengthen neglected safe blood ser- vices and provide the funding and supportneeded to make it a health priority.

Since then, SBFA has provided assistanceto national blood services in 35 Africancountries, trained over 6,000 health caretechnicians in safe blood handling proce-dures, launched educational programs thatencourage young people to protect them-selves against HIV infection and donateblood, and supplied millions of blood-test-ing kits to health facilities across Africa.

Among its partners is the PresidentsEmergency Plan for AIDS Relief (PEPFAR),which in 2008 provided about $92.4 mil-lion to support countries as they develop orstrengthen national policies and guidelineson blood safety that address their own coun-try specific issues.

The results can be measured by a sharpincrease in the safe blood supply in coun-tries where SBFA is most active. Since 2002,when SBFA began working with the Botswa-na National Blood Transfusion Service, thecountrys safe blood supply has increased by

over 100% and the HIV infection rate fromdonated blood has decreased from 9% toless than 2%.

In Nigeria, SBFA is working in partner-ship with the Nigerian Ministry of Health,the U.S. Centers for Disease Control (CDC),ExxonMobil and the U.S. Agency for Inter-national Development (USAID) to establish17 zonal blood centers. Since 2003, it hastrained over 1,000 Nigerian blood serviceand health care staff in safe blood handling.

SBFA is also working to help ensure thatthere are sufficient supplies of disease-

SBFA encourages young people to maintainhealthy lifestyles and donate blood

free blood in Africa. Making sure there isenough blood for treatment is as critical asensuring that the blood that is collected issafe. There are significant health crises inmany African nations because of the short-ages, which are exacerbated in high HIV-prevalent environments where there arehigher discard rates for tainted blood.

In order to encourage the participationof unpaid volunteer blood donors who areknown to be of lower risk for transfusion-transmittable infections, SBFA has sup-ported and expanded the African Club 25

Society, which combines maintenance of health lifestyles and HIV prevention withencouraging the participants, who are be-tween 16 and 25, to become life-long blooddonors.

Club 25 members pledge to give blood atleast 25 times while maintaining a healthy HIV-free lifestyle. With the support of SBFA, Club 25 now has over 62,000 activeyouth participants in 15 African countries.

To build blood services capacity in Af-rica, SBFA supports scholarships and fund-raising for grants and training programs at

the African Institute for Transfusion Medi-cine (AITM). The purpose of AITM is toestablish a sustainable and continuing pro-fessional development program in Africafor leaders, managers, clinicians and staff in blood services.

SBFAs other programs in Africa includean emergency program in the Democrat-ic Republic of Congo (DRC); providingtechnical assistance, training and HIV testkits in Equatorial Guinea and supplyingtrained donor blood recruiters in Lesothoand Swaziland.

African private sector companies, in pa

nership with the hit reality television shBig Brother Africa Revolution, united ginning in November to raise funds for tGlobal Fund to Fight AIDS, Tuberculosis aMalaria.

e funds are to be raised in an Africa-wipublic awareness campaign and earmarkedthe Global Funds United Against Malariatiative. It will be the rst time the African vate sector has made a donation to the GlFund.

Big Brother Africa Revolution, nowits fourth season, is broadcast in 47 Afrcountries. In episodes running from Noveber 24 to November 26, the housemates in Brother Africa Revolution highlightedcritical importance of malaria preventioninstalling, mending and sleeping under inticide-treated bed nets. ey also made beadebracelets in support of United Against Malas part of a much larger public awareness cpaign and fundraising initiative led by Afrcompanies such as South African restauchain Nandos and the trans-Africa telecmunications company MTN.

Fi y percent of the revenue earned by Net, the shows broadcaster, and its produEndemol South Africa, from SMS messsent by Big Brother Africa viewers wichanneled to the Global Fund. In additiopercentage of revenues raised from the of all United Against Malaria bracelets widonated to the Fund.

M-Net believes that this is a vital and essary initiative and so we are pleased thatBig Brother Revolution series is able to vide a continental platform where infortion regarding the prevention of malaria

Africa can be highlighted, said M-Net ADirector Biola Alabi. It is clear that fostegreater education and understanding is a part of the process in preventing the spreamalaria.

United Against Malaria is a partnershiprominent leaders, organizations, the privsector and sports stars that have joined foahead of the World Cup in 2010 in South rica to end preventable malaria deaths.

e Global Fund estimates that aroun2,200 Africans die each day from malaria, of them children under ve years of age.

AFRICAN PRIVATESECTOR CONTRIBUTESTO GLOBAL FUND

M ALARIA A WARENESS

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P AGE F OUR

LEADERS IN H EALTH

P REPARED AND D ISTRIBUTED BY T HE W HITAKER G ROUP

D R. BENJAMIN K UMBOURM INISTER OF H EALTH , G HANA

Dr. Benjamin Kum-bour, Ghanas new Minister of Health,

came into office inNovember with anambitious goal: toprovide universalhealth access to allGhanaians by com-pletely overhaulingthe countrys health system.

His priorities include restructuringthe National Health Insurance Scheme toexpand it beyond its current 12.2 milliomembers, cutting the inefficient use of resources to enable the Ministry to allocat

more to health services for lower incomcommunities, and slowing the drain oskilled health professionals from Ghanby building incentives and greater training capacity into the health system. He also seeking to improve and expand Ghanas health infrastructure, particularly ipoorly-served rural areas.

Previously Deputy Minister of HealthDr. Kumbour has already been closely in volved in the groundwork for some of thinitiatives he will drive as Minister, anhis prior positions as the Deputy Ministeof Education and as the minority spokesperson in the Ministry of Finance havgiven him invaluable experience in management and nance.

Dr. Kumbour recently told a gatheringof health professionals in Ghana that thMinistry of Health will move away fromdisease-centered approach to health carto a system that will focus on preventioand promoting health lifestyles.

He said that it was particularly important to mobilize local communities andimprove health infrastructure in under-served areas. Over the next few years, new health centers will be built in rurareas and four existing ones upgraded tdistrict hospitals.

Further, Dr. Kumbour said he wacommitted to increasing Ghanas training capacity for health workers, and hapledged to increase admissions at healttraining institutions, establish furtheclinical sites for practical training ancreate linkages with foreign health insttutions to improve health education.

artnerships between governments, the pri-vate sector, research institutions, funders andivil society are critical to achieving meaning-

ul and lasting progress in addressing globalealth challenges, according to a new reportublished in November by a group of globalealth organizations.

Case Studies for Global Healthpresents 30 di-verse examples of health partnerships aroundhe developing world. It is designed to be useds a tool for stakeholders seeking to build and

manage partnerships to address global healthhallenges. It is the rst time that such a broadrray of health partnerships in Africa has beenresented.

e report was published by an alliance

made up of Global Health Progress (GHP), aoint initiative of research-based biopharma-eutical companies; the Bill & Melinda Gatesoundation; the International AIDS Vaccinenitiative (IAVI); the Association of Univer-ity Technology Managers (AUTM); and the

World Health Organization (WHO) programTropical Disease Research.

e case studies focus on successful part-erships in four categories: access to medicinesnd health services, discovery and develop-

ment of new drugs and vaccines, health inter-ention and prevention programs, and healthystems strengthening and capacity building.

Although they represent diverse causes,ctivities and partnerships, the case studieshare a common theme, said Mr. Christo-her Singer, President International of Phar-

maceutical Research and Manufacturers of America (PhRMA), a founding member of GHP. Successful programs engage partnersnd policymakers early, communicate openly nd frequently with relevant stakeholders, andmpower and involve communities.

Among the case studies included are: Advance Market Commitment (AMC),

which brings together donors, governmentsnd biopharmaceutical companies to ensurehe development of new vaccines for diseasesrevalent in poorer countries by guaranteeingmarket for the vaccines; e partnership between the Global Al-

ance for TB Drug Development and BayerHealthcare to develop a new rst-line tubercu-osis treatment;

e Apparel Lesotho Alliance to FightAIDS (ALAFA), which brings together U.S.etailers and garment factories and unions in

Lesotho to provide prevention and HIV test-

NEW REPORT HIGHLIGHTS SUCCESSFULCOLLABORATIONS IN IMPROVING HEALTH

S UCCESS S TORIES FROM A FRICA

P HOTO : VANESSA V ICK /C ASE S TUDIES FOR G LOBAL H EALTH

A laboratory technician examines an HIV candidate vaccine supported by IAVI.

ing programs; e partnership between the Government

of Tanzania and Abbott Laboratories to build

capacity in the Tanzanian health system by improving laboratory infrastructure and ser- vices;

e development of vaccine vial moni-tors by a partnership that included the WHO;global health NGO PATH; the U.S. Agency for International Development (USAID); theGlobal Alliance for Vaccines and Immuniza-tion (GAVI); the United Nations Childrensfund, UNICEF; and the U.S. Centers for Dis-ease Control (CDC). e monitors indicate if a vial of vaccine has been exposed to heat.

e International Partnership for Micro-bicides (IPM), which is working to developmicrobicides for women to use to avoid HIVinfection;

e development of the RTS,S malaria vaccine by GlaxoSmithKline in collaborationwith the PATH Malaria Vaccine Initiative ( seestory on front page);

A collaboration between PATH, USAID,biopharmaceutical company Boehringer In-gelheim, the Elizabeth Glaser Pediatric AIDSFoundation and the Kenyan Ministry of Healthto develop a simple nevirapine delivery systemfor newborns. A single dose of nevirapine canprevent mother-to-child transmission of theHIV virus;

A partnership between the Accordia Glob-al Health Foundation, ExxonMobil and theUgandan Infectious Diseases Initiative (IDI)to create the Ugandan Malaria SurveillanceProgram; and

Links for Life, which promotes learningand advocacy around integrated HIV and foodsecurity programming. With pilot programs inEthiopia and Malawi, Links for Life currently involves about 45 organizations seeking to fos-

ter advocacy at the grassroots level.

Dr. Kumbour