SABIN VACCINE INSTITUTE Partnering for a Healthier World
TABLE OF CONTENTS
02 Letter from the Chairman and CEO 03 Message from the President 05 The Sabin Story 06 Why We Fight Diseases of Poverty 08 2010 in Review 11 Measuring Success Program Updates 12 Vaccine Advocacy and Education 16 Vaccine Development 20 Global Network for Neglected Tropical Diseases Profiles 24 Profile 1: NTD Vaccine Development 26 Profile 2: Ending the Neglect in Burundi 28 Profile 3: Immunization Financing in Cambodia 30 Our Partners 32 Board of Trustees and Staff 34 Financials 36 Sabin Scholar Awards and Appointments 37 In Memoriam
To reduce needless human suffering from vaccinepreventable and neglected tropical diseases by developing new vaccines, advocating for increased use of existing vaccines, and promoting expanded access to affordable medical treatments. 2
Sabin Annual Report 2010
Letter Dear Sabin Supporters: We are pleased to present the Albert B. Sabin Vaccine Institute’s 2010 Annual Report and to share with you our most significant developments since our last letter. As this report makes clear, the breadth and scope of Sabin’s three principal programs have grown significantly as we continue to play a leadership role in the global fight against vaccine-preventable and neglected tropical diseases (NTDs). While progress continues to be made in bringing new vaccines and treatments to the market, there remains a large gap in getting life-saving interventions to the world’s poorest people. Millions of children still die each year because they are not being vaccinated. Nearly 1.4 billion people remain trapped in poverty, in part because they do not have access to medicines —many of which are donated by pharmaceutical firms—that offer effective treatment against the seven most prevalent NTDs. To avoid drug resistance problems in the future and provide definitive, longterm solutions, vaccines for some of these diseases must be developed. Sabin exists to bridge these gaps by providing poor and underserved communities around the world with better access to vital medical treatments and vaccines. Sabin continues to pioneer the development of low-cost vaccines to prevent human hookworm, schistosomiasis, and other diseases. Our unique vaccine product development partnership (PDP), which involves collaborators from across the globe, including Brazil, Australia, and China, recently grew in stature and scope through a new affiliation with Baylor College of Medicine (BCM) and Texas Children’s Hospital (TCH), which now host the PDP. The addition of these prestigious institutions and their financial support will enable us to significantly expand our capacity to develop and deliver vaccines for a range of diseases affecting the poorest people around the globe. In addition, our partnership with these two worldrenowned institutions provides an important link between our research and treatment initiatives and the BCM/TCH network of pediatric centers of excellence across Africa. 2
from the Chairman and CEO
Sabin’s Vaccine Advocacy and Education initiative advances policies that improve access to vaccines which prevent transmission of a multitude of infectious diseases. Spurred on by our Sustainable Immunization Financing program, seven of 15 target countries increased their immunization budgets and nine countries began writing new immunization financing legislation. The Coalition against Typhoid, a new program launched in 2010, quickly became a major resource for countries seeking to develop implementation policies and secure funding for World Health Organization (WHO) prequalified typhoid vaccines. Another core initiative, the Global Network for Neglected Tropical Diseases, expanded its advocacy and resource mobilization for integrated NTD treatment programs, also known as mass drug administrations or MDAs. Through MDAs, for approximately $0.50 per person, we can treat and prevent up to seven NTDs for a year. Working with a range of international partners, we developed regional funds that will efficiently channel donations to NTD control programs in Africa, Latin America, and the Caribbean. To further these initiatives and programs, we formed an affiliate in the United Kingdom, Sabin Foundation Europe. Its leaders will focus on expanding awareness and support of the Sabin mission throughout Europe. Sabin plays a unique and vital role in providing solutions to the health burdens of the world’s poor and we will remain at the forefront of the fight against diseases of poverty. We truly appreciate your generous contributions, which are the foundation of our success, and look forward to working with you to overcome these global challenges in the years to come. Sincerely,
Morton P. Hyman Chairman of the Board of Trustees
Michael W. Marine Chief Executive Officer
Dear Friends: As you will read in the pages that follow, 2010 was particularly notable for our efforts to control and ultimately eliminate neglected tropical diseases, the most common afflictions of the world’s poorest billion people. In the area of research and development, our vaccine development program and PDP—the Sabin Vaccine Institute Product Development Partnership—advanced three new “anti-poverty vaccines” to combat NTDs. The two antigen components of our human hookworm vaccine were successfully manufactured and we submitted regulatory filings in the U.S. and Brazil prior to anticipated clinical testing in Brazil. Our schistosomiasis vaccine will also soon be manufactured and we launched efforts to make a new Chagas disease vaccine. We continue to be deeply grateful to the Bill & Melinda Gates Foundation and the Brazilian Ministry of Health for their unwavering support of the hookworm vaccine, now joined with a major co-investment from the Dutch Ministry of Foreign Affairs. For the schistosomiasis vaccine, the ongoing support of the Blavatnik Family Foundation, and Mort and Chris Hyman, and now the National Institute of Allergy and Infectious Diseases of the U.S. National Institutes of Health, has been absolutely critical. We are equally grateful for the new support of the PDP by the Carlos Slim Health Institute in Mexico to begin efforts for a new therapeutic vaccine for Chagas disease and related infections. Our expansion into additional vaccines beyond hookworm and schistosomiasis coincides with the relocation of our vaccine development laboratories to Houston, Texas. In September 2011, our product development laboratories moved to a state-of-theart, 20,000 square foot facility at the Feigin Center of Texas Children’s Hospital and Baylor College of Medicine, located in the renowned Texas Medical Center (TMC), the world’s largest medical center. Texas Children’s Hospital and Baylor College of Medicine will become major investors in the Sabin Vaccine Institute PDP.
from the President
Relocating the vaccine program to TMC will allow our team of a dozen scientists and support staff to embark on new collaborations for vaccine discovery, delivery, and testing, at a world-class institution in a major gateway city to Latin America. Both the hookworm and schistosomiasis vaccines will undergo clinical development and ultimately industrial scale manufacture in Brazil, and we plan to develop a Chagas disease vaccine in Mexico. In the area of policy and delivery, our Global Network for Neglected Tropical Diseases, under the direction of Dr. Neeraj Mistry, continues to make great progress in elevating the profile of these conditions, and we look forward to revealing some innovative approaches to “get the word out” about these conditions in the coming months. At the same time, Dr. Ciro de Quadros leads an incredibly effective effort to expand global access of all major childhood vaccines as well as to ensure that the “decade of vaccines” meets its ambitious targets. With the move of the Sabin vaccine development labs to Houston, I will also become the founding Dean of a new National School of Tropical Medicine, the first of its kind in the United States, at Baylor College of Medicine. I invite you to come and visit our labs in Houston, Texas and enjoy one of the most culturally vibrant and international cities in the U.S.! Warmest regards,
Peter J. Hotez, MD, PhD President, Sabin Vaccine Institute
Sabin Annual Report 2010
The Sabin Story In 1993, the Albert B. Sabin Vaccine Institute was founded in honor of one of the most influential scientists of the 20th century. Over time, Sabin grew into a leading advocacy and scientific organization dedicated to developing lifesaving vaccines and expanding access to existing vaccines and medicines for the poorest people around the world. Since its inception, Sabin has placed a premium on the value of partnerships for addressing complex global health challenges. Our three main programs —the Sabin Vaccine Institute Product Development Partnership, the Global Network for Neglected Tropical Diseases, and Vaccine Advocacy and Education— fulfill distinct, yet complimentary, missions to achieve better health for the world’s poor. We work closely with a wide range of entities—including global policymakers, development agencies, program implementers, and academic institutions—to deliver effective and sustainable health solutions. Our mission has evolved over the past 18 years to meet the emerging needs of a rapidly developing world still plagued by preventable diseases. We remain focused on creating the first vaccines for devastating diseases that affect over a billion people living in poverty. While those vaccines are in development, we expanded our scope of work to include advocating for and facilitating the use of existing drugs to treat the seven most prevalent neglected tropical diseases (NTDs). This allows us to meet immediate human needs until new vaccines can be developed. Far too many children die each day from diseases that can be prevented. From the first day Sabin opened its doors, we have championed increased access to existing vaccines for a range of deadly yet preventable
Honoring a lifetime of scientific achievement by pioneering new health solutions for the world’s poor.
diseases by working with leading health agencies, pharmaceutical companies, and senior government officials to expand the demand for and reduce the price of these lifesaving vaccines. Ultimately, governments must prioritize immunization policies and adopt measures for vaccination programs to be paid out of their own national budgets. To help meet these sustainability goals, Sabin works with low-income countries to strengthen and pay for immunization programs themselves. As researchers, scientists, and advocates, we understand that making a positive impact on global health outcomes requires time, but we are still driven to make a difference now. So we are exploring new channels of communication to tell the story of NTDs and encourage diverse groups to collaborate on solutions. We are encouraging government leaders to increase funding and to consider new approaches to financing immunization programs. And we are continually expanding our partnerships to ensure that a multitude of perspectives are considered. It is in this way that we honor the legacy of Dr. Sabin while continuing to deliver on the promise of a healthier future for millions of people around the world.
Dr. Albert B. Sabin
Sabin Annual Report 2010
Why we fight diseases of poverty
At a cost of approximately 50 cents, per person per year, we can provide protection from seven of the most common NTDs for an entire year.
Diseases of poverty are aptly named: they affect people living in extremely poor conditions and trap people in a cycle of poverty because they leave children unable to learn and undercut adults’ ability to work productively. They disproportionately target infants and young children, prevent children from ever reaching their full potential, and keep mothers from having healthy pregnancies. When pneumococcal virus, or typhoid, or schistosomiasis strikes a child or parent, a family is destabilized. When these diseases occur at endemic levels, as they frequently do, the development of an entire nation can stall. We believe that access to vital medicines and vaccines should be a basic service that governments guarantee for their people; and that populations free from the burden of preventable diseases are better equipped to focus successfully on building their societies. The tools to fight many of the worst diseases already exist, but tragically remain out of reach for many of those who need them. Sabin works with global partners at the highest levels of government, business, and society to break down the logistical and financial barriers to delivering existing lifesaving vaccines and treatments. We leverage the generosity of pharmaceutical industry partners who have donated billions of dollars of NTD medications by encouraging national governments to undertake annual, low-cost mass drug administrations (MDAs) to treat and eliminate NTDs as a public health threat. We also fill a critical market gap by pioneering the research and development of new, affordable vaccines to prevent the NTDs with the highest health burden.
Sustainable results require an unwavering, long-term commitment to see the end of these diseases. We know most can be controlled and eventually eliminated for a relatively low cost and in a period of time that is measured by years, not decades or lifetimes. We also have emerging evidence that the effects of treating NTDs can have widespread positive impact on efforts to reduce the rates of infection of HIV/AIDS, malaria and tuberculosis. Our job is to educate, eliminate barriers, and lead scientific discovery on behalf of nearly two billion people still affected by NTDs and vaccine preventable diseases. Our goal is to help them achieve a life worth living.
The Sabin Vaccine Institute PDP is a one-of-a-kind organization. Its science is absolutely novel and unique, and the potential of its work to impact public health in the world’s poorest countries is unparalleled.
Physician-in-Chief Texas Children’s Hospital 6
2010 In Review
Summary of our accomplishments
We pushed boundaries by
W e increased funding for fighting DISEASES OF POVERTY by
Encouraging more than 50 countries to introduce pneumococcal vaccines 1. into their national immunization programs Creating a major advocacy program to promote universal access for typhoid vaccines Making significant progress in the development of a schistosomiasis vaccine and two hookworm vaccine antigens, registering one with the U.S. Food and Drug Administration for Phase 1 clinical trials Supporting NTD control programs in Rwanda and Burundi that delivered more than 16 million treatments1.during mass drug administration campaigns 1.
We connected with
500,000 web site visitors and posted 415 blog entries
4,600 Twitter followers
We expanded our impact by cultivating
More than 100 partners
Raising nearly $20 million in new funding for vaccine development, advocacy for vaccine access, and expansion of NTD treatment programs around the world Creating and expanding regional funds in Africa and Latin America and the Caribbean Leveraging $2.18 million through partners such as the Inter-American Development Bank, Fundacion Mundo Sano, and University of Notre Dame, directed to control programs in Latin America Helping to persuade the U.S. government to raise NTD funding from $25 million in 2009 to $65 million in 2010 We spread the word through 535 news articles 13 broadcast appearances 10 op-eds 21 journal articles 71 panel/key speaking opportunities Nearly 200 meetings with global policymakers
Operational or program partnerships in 40 countries
MEASURING SUCCESS R educing the global prevalence of typhoid fever, pneumococcal disease, meningococcal disease, human papillomavirus, pertussis, polio, measles, rotavirus, and rubella
Encouraging greater integration between neglected tropical disease (NTD) control and other health programs such as water and sanitation, HIV/ AIDS and malaria prevention programs
Achieving World Health Organization prequalification for at least two typhoid vaccines
Raising $250 million from G8/G20 governments and other sources to support NTD mass drug administration
Promoting the creation of a supply and distribution system for two, first-ever dengue fever vaccines to be introduced over the next several years Successfully implementing vaccine immunization finance legislation and funding mechanisms in 15 pilot countries
The partnership developed over the last few years between the Global Network and PAHO and the Inter-American Development Bank has led to significant gains for a number of Latin Americaâ€™s most vulnerable populations. Together we have supported several countries to design and carry out needed surveys for NTDs in neglected communities, map and model diseases, develop national integrated plans of action for NTDs and obtain deworming tablets to help keep many young children healthier and in school.
Among the key milestones we are working toward are:
Developing and institutionalizing regional funding mechanisms in Africa, Latin America and the Caribbean, and Asia Supporting ongoing pharmaceutical donation programs for vital NTD medicines and ensuring the effective use of these critical donations
Bringing vaccine candidates for human hookworm, schistosomiasis and other NTDs through phase 3 clinical trials, licensure, and large scale manufacture Increasing the level of awareness of the adverse impact of NTDs and what can be done to control them among general populations and policymakers Promoting the creation and execution of national government, multi-year plans for NTD mass drug administration in all endemic countries
Regional Advisor for Parasitology and Neglected Tropical Diseases Pan American Health Organization (PAHO) 10
Sabin Annual Report 2010
VACCINE ADVOCACY AND EDUCATION
Rubella virus... Text to come
Saving lives through better access to existing vaccines Speakers at the 9th International Rotavirus Symposium in Johannesburg, South Africa organized by Sabin Vaccine Institute
Following on a century of steady advancements in medical and vaccine science, the Bill & Melinda Gates Foundation has heralded the next ten years as the â€œDecade of Vaccines,â€? underscoring the imperative to extend access of low-cost, effective vaccines to all populations. At Sabin, we believe access to vaccines is a basic human right, on a par with access to safe drinking water. We capitalize on a rich history of vaccine expertise to advocate at the highest levels of government, in the private sector, and among civil society, to develop sustainable access to lifesaving vaccines for all people.
Rubella Virus, US Department of Health and Human Services
Our Vaccine Advocacy and Education program is one of the only groups in the world bringing leaders together to tackle the complex issues that prevent vulnerable populations from receiving the vaccines they need to live healthy, productive lives. We serve as an independent, honest broker as groups with different agendas seek common ground for the sake of better vaccine policies. We focus our advocacy and education attention on diseases that already have proven vaccines available, but which are not currently accessible to those who need them. Among these diseases are typhoid fever, pneumococcal disease, meningococcal disease, human papillomavirus, pertussis, polio, measles, rotavirus, and rubella. Together, these diseases account for more than three million preventable deaths annually. Dengue fever is another focus area. No vaccine for dengue presently exists, although the disease affects more than 100 countries worldwide and imposes a significant economic burden on governments and individuals. No drugs are available to prevent or treat dengue infections, making the need for a widely accessible vaccine all the more urgent. Several dengue vaccines are in development, and Sabin is leading the advocacy work of the Dengue Vaccine Initiative to prepare governments for their swift introduction to affected communities. Beyond preventing high levels of mortality, morbidity, and disability, controlling these diseases helps communities lift themselves out of poverty by ensuring that kids stay healthy and in school, and parents stay productive. Eliminating the threat of disease also strengthens political stability and greater social justice, two crucial elements of vibrant societies.
Sabin Annual Report 2010
In response to a major gap in advocacy for typhoid vaccines, the Bill & Melinda Gates Foundation awarded Sabin a three-year, $3 million grant to serve as the secretariat for the Coalition against Typhoid (CaT), a global forum of health and immunization experts dedicated to improving access to low-cost typhoid vaccines in poor communities around the world. We at Sabin believe it is important to challenge the existing, heavily donor-dependent immunization financing practices followed by many national governments in the developing world. We do this by taking a “bottom-up” approach, working with national government officials, parliamentarians, and the domestic private sector through our Sustainable Immunization Financing (SIF) program. We encourage governments to use their immunization programs as vehicles to improve their budgeting and financial management capacities. The SIF program documents and disseminates best practices and arranges peer exchanges among the 15 SIF pilot countries.
During 2010, seven of the SIF countries increased their immunization budgets and nine countries began writing new immunization financing legislation. Passing this legislation will ensure that immunization budgets are protected by law. Though there has been progress with immunization financing, much remains to be done. By 2010, the 15 SIF pilot countries were financing just $11 of the $30 needed to provide a child with the basic immunization package. The SIF program will focus increasingly in the coming years on implementation—taking the best practices to scale and finding local capacity to build solutions on a country-specific basis.
Bill Gates, David Oshinsky, Pulitzer Prize-winning author of “Polio: An American Story,” and Dr. Ciro de Quadros, Sabin’s Executive Vice President
In 2010, the Vaccine Advocacy and Education team led efforts to create greater attention on the prevention of pneumonia and diarrheal diseases. The Pneumococcal Awareness Council of Experts (PACE) hosted a symposium for officials from the Eastern Mediterranean region to increase access to pneumonia and diarrheal disease vaccines. At this conference, country representatives agreed on the need for the region to form a funding mechanism and pledged to work together to develop one. PACE also played a key role in successfully advocating to make pneumococcal vaccines available at affordable prices throughout the developing world. Since PACE’s inception in 2006, over 50 countries introduced pneumococcal vaccines in their national immunization programs. In August 2010, in conjunction with Fogarty International Center of the U.S. National Institutes of Health, the Bill & Melinda Gates Foundation, and Brazil’s Fundação Oswaldo Cruz (FIOCRUZ), Sabin convened a 30th anniversary symposium on smallpox eradication to discuss the global campaign and how its lessons and legacies relate to current global health priorities.
2011 Highlights: Vaccine Advocacy and education
I n collaboration with the Coalition against Typhoid (CaT), the World Health Organization (WHO) granted prequalification for the first typhoid vaccine. This is a major advancement toward universal access for typhoid vaccines, as it allows the United Nations Children’s Fund (UNICEF), other UN agencies, and the Pan American Health Organization (PAHO) Revolving Fund to procure the vaccine. WHO prequalification also is a prerequisite for GAVI Alliance support. he Dengue Vaccine Initiative was officially T launched to focus on introducing and maintaining a pipeline of vaccine candidates. The DVI is a consortium consisting of the International Vaccine Institute, the WHO, the International Vaccine Access Center at Johns Hopkins University, and Sabin Vaccine Institute.
The SIF program held its first International Colloquium in Addis Ababa, Ethiopia, where more than 100 delegates representing ministries of health and finance from 18 African, Asian, and Latin American countries convened to discuss sustainable immunization financing strategies, initiatives, and achievements. I n partnership with Universidad Peruana Cayetano Heredia, Sabin convened a two-day training session in Lima, Peru, for 30 global health journalists from 17 countries in the Americas.
Sabin Annual Report 2010
VACCINE DEVELOPMENT Sabin’s vaccine development program marked its 10-year anniversary in 2010. More than one billion people around the world live at risk of hookworm and schistosomiasis infection. Typically, those affected by these diseases are among the planet’s poorest people, providing little financial incentive for traditional vaccine makers to tackle these problems. In 2000, Sabin led a group of committed organizations from around the world to form a product development partnership (PDP) to fill this gap. In its first decade, the Sabin PDP established itself as a leader in the adaptation of the PDP model for NTD vaccine production of “anti-poverty vaccines.” The PDP has leveraged world-class clinical testing and process development resources from such partners as FIOCRUZ and Instituto Butantan in Brazil; James Cook University in Australia; London School for Hygiene and Tropical Medicine in the United Kingdom; The Institute for Parasitic Diseases, Chinese Centers for Disease Control and Prevention; and The George Washington University in the United States. Recently we made a major expansion to the PDP through an affiliation with Baylor College of Medicine and Texas Children’s Hospital, where our product development labs will be located as of September 2011. The move includes a $40 million commitment over ten years by Texas Children’s Hospital and Baylor College of Medicine. In 2010, the PDP completed preparation of an Investigational New Drug (IND) application for the Na-GST-1 hookworm vaccine antigen. Sabin submitted the IND application for the Na-GST-1 vaccine to the U.S. Food and Drug Administration (FDA) in January 2011 and will begin Phase I
Pioneering NTD vaccine development
clinical trials later in the year. In addition to the work completed on Na-GST-1 in 2010, significant progress was made in developing the manufacturing process of a second hookworm vaccine antigen, Na-APR-1. Of note, cell banks were produced to manufacture this antigen in tobacco plants in collaboration with the Fraunhofer Center for Molecular Biotechnology. Because its victims are among the poorest people in the world, hookworm disease remains unknown to many in developed economies even though it affects nearly 600 million people. Hookworm is an intestinal parasite that causes internal blood loss leading to iron-deficiency anemia and protein malnutrition, particularly in pregnant women and children. Chronic hookworm infection in children contributes to physical and intellectual impairment, learning difficulties and poor school performance. Hookworm is a serious global concern contributing to an estimated 43 percent reduction in future wage earnings in affected areas. In December 2010, the Sabin PDP was awarded a four-year grant in the amount of 5.9 million euros ($8.5 million) from the Dutch Ministry of Foreign Affairs to continue development of a hookworm vaccine. The Sabin Vaccine Institute is confident that this grant and continued support from many other organizations and individuals, including the Bill & Melinda Gates Foundation and the Brazilian Ministry of Health, will one day result in a safe, low-cost, and effective vaccine for hookworm.
Sabin Annual Report 2010
While working toward a vaccine to prevent hookworm disease, the program also adapted its novel approach for other diseases afflicting poor people around the world. Using the PDP blueprint, Sabin also conducted work to develop vaccines to prevent schistosomiasis and malaria in 2010, and advanced a Chagas disease vaccine initiative. Schistosomiasis, like hookworm, causes anemia, impairs physical growth, and limits cognitive development. It also can cause severe damage to the internal organs of its victims. It is estimated that over 200 million people around the world are afflicted by schistosomiasis.
The Sabin PDP is developing a promising vaccine antigen identified as Sm-TSP-2 that will target the main cause of intestinal/liver schistosomiasis, Schistosoma mansoni. We completed production of antigen cell banks and are transferring the manufacturing technology for this vaccine to two partners: Instituto Butantan in Brazil and Aeras in the United States. Vaccine development is a process that can take many years to produce a safe and efficacious candidate for human use. The past several years marked a period of tremendous exploration and discovery for the Sabin PDP team. As a result, we are on the path to delivering the world’s first vaccines for hookworm, schistosomiasis, and Chagas disease.
2011 Highlights: Vaccine Development
Relocated the laboratories of Sabin Vaccine Development from The George Washington University to Baylor College of Medicine and Texas Children’s Hospital. The move and the accompanying budget support of $40 million dollars over ten years represent a major, new investment to develop vaccines for the world’s poor. The priorities are to continue our cutting edge work on hookworm and schistosomiasis vaccine development. The first new targets will be to accelerate the Sabin PDP’s work on a vaccine for Chagas disease.
Utilizing plant-based expression technology, Sabin collaborated with iBio, Inc. and the Fraunhofer Center for Molecular Technology to successfully manufacture the Na-APR-1 hookworm vaccine, which will be tested in an animal toxicology study in the second half of 2011 and will enter clinical trials in 2012. Received a two-year, $12 million grant from the Bill & Melinda Gates Foundation (BMGF) to fund continued development of the Na-GST-1 and Na-APR-1 hookworm vaccines through Phase 1 clinical trials. Prior to this grant, BMGF had funded our hookworm vaccine research from 2000 to 2010.
Freshwater snails carrying the parasite Schistosoma
Sabin Annual Report 2010
global network FOR Neglected Tropical Diseases Imagine feeling as though you have just donated a pint or two of blood, every day for the rest of your life. Or that you are slowly losing your eyesight because your eyelashes are curling inward and scratching your corneas with every blink. What would it feel like to go through life with limbs so swollen that you are no longer able to use them? The reality is that nearly one in six people around the world suffer from these and other life-altering symptoms caused by the seven most common neglected tropical diseases (NTDs). NTDs are a group of 17 parasitic and bacterial diseases that together are a greater health burden than malaria and tuberculosis, and rival that of HIV/AIDS. Another reality: we can treat and prevent the seven most common NTDs for approximately $0.50 per person per year.
Promoting mass drug administration for NTDs
Many of those afflicted by NTDs are children—half a billion in all. Many others are young girls and pregnant women. Generation after generation of people living in the poorest parts of the world who are unable to escape poverty because NTD-induced anemia saps the strength needed to be productive students or workers, or because they are physically disfigured and debilitated. Established in 2006, the Global Network for Neglected Tropical Diseases (Global Network) advocates highly cost-effective and proven mass drug administrations (MDAs) to treat and prevent NTDs. Over the past year, we have strengthened our partnerships with country governments, international non-profit organizations, and major pharmaceutical corporations to expand the availability of these MDAs to those who need them.
One of the Global Network’s most important activities focuses on the creation of regional funding mechanisms in our three priority regions—Latin America and the Caribbean, Africa and Asia—to deliver programmatic funding in support of MDAs in a more cost-effective and impactful way. We established the Latin America and the Caribbean (LAC) NTD Initiative, a partnership between the Global Network, the Inter-American Development Bank (IDB), and the Pan American Health Organization (PAHO), that supports projects which are integrated and community-based. These projects go beyond immediate curative measures to include long-term solutions that tackle the social and environmental determinants of disease transmission, including improved access to clean water and sanitation systems. In 2010, the LAC NTD Initiative designed eight projects in five different countries (Brazil, Guyana, Haiti, Mexico, and Guatemala). These projects will close the gaps in health equity among indigenous communities, while working toward NTD elimination. In Africa, we partnered with Geneva Global, a private philanthropy consultancy with a founding commitment from Legatum Foundation to establish the End Neglected Diseases (END) Fund. The END Fund is
a visionary roadmap for corporate and philanthropic engagement to deliver multi-sectoral solutions that can set Africa on the path to NTD control. It expands the pool of financiers of NTD control projects beyond donor countries and traditional funders. The END Fund began with the goal of raising $100 million to provide effective interventions that reduce the prevalence of the seven most common NTDs in sub-Saharan Africa. Over the next several years, it will provide the capital resources needed to address the region’s NTD burden as well as the technical capacity to collaborate with national governments and health and development organizations operating on the ground to bring scalable treatment options to those at risk. In addition, the Global Network expanded its operations into Asia last year by laying the groundwork for targeted and deliberate multi-regional funding and advocacy efforts. We began a relationship with Deworm the World in India that promises to deliver significant opportunities for collaboration in 2011 and we strengthened our partnership with the World Health Organization’s (WHO) Western Pacific Regional Office and South-East Asia Regional Office in support of deworming and lymphatic filariasis elimination efforts. Sabin Annual Report 2010
The Global Network also supports programs to ensure that country-led efforts to control NTDs are implemented at the national level. In May 2010, ongoing national NTD control programs in Rwanda and Burundi successfully completed their third year of operations, accounting for the delivery of 16.5 million treatments during MDAs that year alone. The drug deliveries, which were conducted during the Mother and Child Health Week campaigns, reduced disease prevalence and intensity in both countries. In Rwanda, the overall average cost per child treated was an estimated $0.14, while the overall cost per anemia case prevented was estimated to be $5.13, just one indicator of the value of MDAs as an inexpensive and highly cost-effective health intervention. Due to the project’s high return on investment, funding for both programs was extended for another year. During the same period, we partnered with four WHO regional offices to support the development of national plans for NTD control in Asia, sub-Saharan Africa, and the Americas. These plans provide a critical framework for coordinating various diseasespecific efforts at the country level and with the implementing organizations. Furthermore, they serve as a forecasting tool to access drug donations and as the basis for proposals to present to potential donors.
In our broader advocacy efforts, we strengthened the Global Network’s outreach strategy to the U.S. Congress, the White House, and targeted G8 and G20 countries. Over the past several years, our advocacy efforts have contributed to the establishment of the U.S. Agency for International Development’s NTD Program, the inclusion of NTDs in President Obama’s Global Health Initiative, and the 70 percent increase in drug donations commitments from the pharmaceutical industry. Fighting NTDs continues to be acknowledged as an important aspect of reaching the Millennium Development Goals (MDGs) and was recognized in the United Nations 2010 MDG Summit’s official outcome document. Additionally, through briefings and special events, one-on-one meetings with decision-makers, expanded online communications, and targeted global health correspondence, we made the case for controlling and eliminating NTDs to nearly 200 key policymakers in 2010. Despite the severe economic downturn, the U.S. government increased its spending on NTD control in 2010 to $65 million, up from $25 million in 2009.
2011 Highlights: Global Network
The United States Congress approved $77 million for the USAID NTD Program, reflecting the highest funding level for NTD control and elimination by the U.S. government since the inception of the program. Coordinated with the Burundi and Rwanda Ministries of Health to transition mass drug administration programs to government control, providing NTD treatment to over eight million people over the past four years. Launched the first demonstration project of the Latin America and the Caribbean (LAC) NTD Initiative in Chiapas, Mexico.
This project is co-funded by the Chiapas State Government, FEMSA Foundation and the LAC NTD Initiative, and will treat more than 132,000 people at risk for NTDs over the next year. Released a white paper entitled “A Call to Action: Addressing Soil-transmitted Helminths in Latin America and the Caribbean,” directed to regional policy makers and public health advocates.
The [NTD] disease burden has been easy to ignore, as it affects people with little political voice and low visibility on national and international agendas. The immense suffering caused by these diseases is often endured in silence, accepted as an inevitable consequence of being poor… Today, instead of waiting for these diseases to gradually vanish, a community of partners is deliberately vanquishing them. Some of the recent progress, viewed against such a long and notorious history, is stunning.
Director-General of the World Health Organization 22
Profile 1 ntd Vaccine development December 2005
Sabin continues to make significant progress in its efforts to develop the first vaccines for human hookworm and schistosomiasis, two diseases that together plague hundreds of millions of people. Our product development partnership (PDP) fills an important market gap by collaborating with worldclass research and development institutions to create ultra low-cost vaccines for poor populations.
EXPLORATORY STAGE: 2-4 years. Goal: identify natural or synthetic antigens.
Na-APR-1, an adult-stage hookworm protein, selected as second candidate vaccine antigen against hookworm.
Na-GST-1, an adult-stage hookworm protein, selected as candidate vaccine antigen against hookworm.
Sabin Vaccine Institute begins work on a candidate vaccine antigen, Sm-TSP-2, against schistosomiasis, discovered by scientists from the Queensland Institute of Medical Research.
June 2011: Manufacture of Na-APR-1.
November 2009: Manufacture of Na-GST-1.
4th Quarter of 2011: Scheduled manufacture of Sm-TSP-2.
PRIMARY SAFETY STUDY (TOXICOLOGY):
August 2011- February 2012: Planned primary safety study for Na-APR-1.
July-December 2010: Conducted primary safety study for Na-GST-1.
2011-2012: Planned primary safety study for Sm-TSP-2.
INVESTIGATIONAL NEW DRUG (IND) APPLICATION: Application required by the FDA in order to begin clinical testing. The IND application describes the manufacturing and testing processes, summarizes the laboratory reports, and animal testing, and describes the proposed clinical trial.
2nd Quarter 2012: Planned IND submission for Na-APR-1.
January 2011: Sabin Vaccine Institute submits IND application for the clinical development of the Na-GST-1 hookworm vaccine.
4th Quarter 2012: Planned IND submission for Sm-TSP-2.
September 2011: Planned Phase 1 Clinical Trial of Na-GST-1 in USA.
2nd Quarter 2013: Planned Phase 1 Clinical Trial of Sm-TSP-2.
Once the IND application has been approved, the vaccine undergoes three phases of testing. PHASE 1 clinical TRIALS: This first attempt to assess the candidate vaccine in humans involves a small group of adults, usually between 20-80 subjects. Goals are to assess the safety of the candidate vaccine and determine the type and extent of the immune system response.
4th Quarter 2012: Planned Phase 1 Clinical Trial of Na-APR-1.
PHASE 2 clinical TRIALS: A larger group of several hundred individuals participates in Phase 2 testing. The goals of Phase 2 testing are to study the candidate vaccine’s safety, immunogenicity, and potential to have a biological impact on infection (also referred to as a “proof-of-concept” study).
2016: Planned Phase 2 Clinical Trial of Na-APR-1 (co-administered with Na-GST-1).
PHASE 3 clinical TRIALS: Conducted within a much larger group of thousands to tens of thousands of people. Testing for safety as well as efficacy.
2018: Planned Phase 3 Clinical Trial of Na-APR-1 (co-administered with Na-GST-1).
September 2011: Planned Phase 1 Clinical Trial of Na-GST-1 in Brazil.
2016: Planned Phase 2 Clinical Trial of Na-GST-1 (co-administered with Na-APR-1).
2018: Planned Phase 3 Clinical Trial of Na-GST-1 (co-administered with Na-APR-1).
2014: Planned Phase 2 Clinical Trial of Sm-TSP-2.
2016: Planned Phase 3 Clinical Trial of Sm-TSP-2.
Sabin Annual Report 2010
Profile 2 ending the neglegt in burundi The prevalence rate of intestinal worms has decreased significantly; schistosomiasis decreased from 6.4 percent to 3.6 percent, bringing it below the public health hazard level. Trachoma has been mapped and the International Trachoma Initiative, along with other partners, is considering the provision of sight-saving interventions. In addition, thousands of community health workers and laboratory technicians have been trained to identify NTD infections and administer drugs to fight them. Burundi, lush and green, is known fondly as “the Land of a Thousand-and-One Hills.” A decade of violence that began in 1993 shattered the nation, claiming 300,000 lives and displacing nearly one million people. Poverty rates rose, with the number of people living on less than a $1 per day increasing from 35 percent in 1992 to more than 67 percent in 2005. Not unexpectedly, NTDs thrived in this environment. By 2005, in some districts, schistosomiasis and hookworm affected over 40 percent of the population. With the notable exception of the African Programme for Onchocerciasis Control (APOC), which worked with the Ministry of Health to control onchocerciasis (aka river blindness), Burundi lacked the needed systems and infrastructure to treat NTDs. In 2008, with funding from the Legatum Foundation, an alliance formed between the Global Network, the Ministry of Health, CBM International, Geneva Global, and the Schistosomiasis Control Initiative to build on APOC’s ongoing efforts. The partnership implemented the nation’s first mass drug administration (MDA). In the initial year, more than 1.8 million Burundians received medicine to treat NTDs, many for the first time. After three years, seven integrated MDAs (campaigns providing vaccinations, bed nets, micronutrients, and other medicines), and more than three million people treated, Burundi has achieved remarkable milestones. 26
Burundi’s government was central in this effort, paying for the salaries and office space of the Burundi NTD team; not taxing the imported drugs; adopting a national NTD policy; and developing a five-year plan with the goal of controlling and eliminating NTDs in Burundi. Going forward, these efforts will strengthen the government’s ability to control NTDs with less donor assistance. The partners are also addressing the lack of access to clean water and adequate sanitation, both significant problems in Burundi and the main cause of high re-infection rates. With a government committed to NTD control and elimination, millions of Burundians have the promise of a better future. For Burundians like village chief Leonard Madina, NTD treatments provided a new lease in life. When he returned to Burundi’s Rutana Province at the end of the civil war, the country’s health system was in shambles. He was soon suffering from the debilitating symptoms of onchocerciasis, which scarred and distended his legs, causing him tremendous pain and preventing him from wearing the rubber boots he needs to work in the rice fields. Today, thanks to the help of community health workers, Chief Madina and his fellow farmers have received the NTD treatments they need to allow them to support their families.
“Before the medicine, people couldn’t work and cultivate the fields. Thanks to the medicine, the community is back to work, and we are moving forward.” Leonard Madina, Village Chief, Rutana Province
Sabin Annual Report 2010
Profile 3 immunization financing in Cambodia The SIF program engages countries through a high-level advocacy process. Advocacy begins with parliamentary briefings where elected officials learn from their counterparts in other governments how their own national immunization program is performing and how it is currently financed. Advocacy often extends to regional officials who prepare and manage provincial immunization budgets. Sabin sustains collective action through frequent peer exchanges in which key counterparts share best practices with each other.
Sabinâ€™s Vaccine Advocacy and Education program has developed a niche expertise in the area of immunization program financing. Using an approach that leverages collective action, the Sustainable Immunization Financing (SIF) program engages leaders in ministries of health, ministries of finance, parliaments, and the private sector to develop sustainable financing solutions for national immunization programs. The goal is to reduce external dependencies and assure country ownership of the programs. As the number of recommended childhood vaccines increases and the number of children continues to grow, countries face a corresponding increase in immunization program costs. Current vaccine prices have not decreased substantially and additional valuable vaccines are entering the market. Low-income governments have three choices: let their populations get sick, remain dependent on external aid, or find sustainable domestic financing.
Examples of these best financing practices include quarterly analysis and reporting of immunization program expenditures, legislation earmarking new revenue sources for vaccines, and the development of national immunization trust funds. During 2010, Cambodian government officials and parliamentarians attended three Sabin-sponsored briefings along with their counterparts from Nepal and Sri Lanka. Each event generated a resolution calling on the governments to increase and safeguard immunization financing. The parliamentarians subsequently introduced the resolutions in their home parliaments. Each country is currently crafting supporting legislation. In addition, Sabin sponsored a series of provincial briefings where Cambodian parliamentarians learned firsthand how the immunization program is financed and managed. According to Cambodiaâ€™s national immunization program manager, Dr. Svay Sarath, Ministry of Health officials were hesitant to meet with parliamentarians. The SIF advocacy work changed this. Today, Cambodian Ministry of Health, Ministry of Finance, and parliamentarian counterparts are working together to find their best sustainable immunization financing solutions.
Prior to the Sabin/SIF initiative, Cambodia health officials rarely met with members of Parliament to discuss immunization policies. Now we see increased collective action between leaders in the ministry of health, ministry of finance and Parliament, which has led to a more effective understanding of the importance of immunization.
Cambodia National Immunization Program Manager 29
Our success is the direct result of the generosity, insights and leadership of our global partners. We appreciate the collaboration and support that the following organizations and
individuals have provided to Sabin Vaccine Institute as we seek to provide life-changing health solutions to millions of people worldwide.
Edmond de Rothschild Foundation [United Kingdom]
African Programme for Onchocerciasis Control
International Emerging Infections Program [Nepal]
Aga Khan University [Pakistan]
The Emory Global Health Institute
International Trachoma Initiative
Agence de Médecine Préventive [France]
FEMSA Foundation [Mexico]
International Vaccine Access Center at the Johns Hopkins University
Baylor College of Medicine
Fraunhofer Center for Molecular Biotechnology
Oxford University Clinical Research Unit at the Hospital for Tropical Diseases [Vietnam] Oxford Vaccine Group at the University of Oxford [United Kingdom] Pan American Health Organization PATH MVI
Bharat Biotech [India]
Fundação Oswaldo Cruz [Brazil]
International Vaccine Institute [South Korea]
The Bill & Melinda Gates Foundation
Fundación Mundo Sano [Argentina]
James Cook University [Australia]
Johnson & Johnson
Philippine Foundation for Vaccination [The Philippines]
Blavatnik Family Foundation
The Campbell Family Foundation
Geneva Global, Inc.
Carlos Slim Health Institute [Mexico]
George Link Jr. Charitable Trust
Legatum Foundation [United Arab Emirates]
The George Washington University School of Medicine and Health Sciences
Liverpool School of Tropical Medicine [United Kingdom]
CBM International Center for Research and Advanced Studies of the National Polytechnic Institute [Mexico]
GlaxoSmithKline [United Kingdom]
London School of Hygiene and Tropical Medicine [United Kingdom]
Changing Our World
Governments and Parliaments of Cambodia, Cameroon, Democratic Republic of the Congo, Ethiopia, Kenya, Liberia, Nepal, Mali, Nigeria, Madagascar, Rwanda, Senegal, Sierra Leone, Sri Lanka, and Uganda
Chiapas State Government [Mexico]
Government of the Municipality of Recife [Brazil]
Children Without Worms
Helen Keller International
National Institute of Parasitic Diseases [China]
Covington & Burling
The Horace W. Goldsmith Foundation
Nepal Paediatric Society [Nepal]
Morton and Chris Hyman
Novartis International AG [Switzerland]
Center for Vaccine Development at the University of Maryland Center for Vaccine Development [Mali]
Crucell Deworm the World Dubai Cares [United Arab Emirates] The Earth Institute at Columbia University
Eisai Co., Ltd. [Japan]
Inter-American Development Bank
iBio, Inc. IMA World Health Instituto Butantan [Brazil]
Mectizan Donation Program Merck & Co, Inc. Ministry of Foreign Affairs, Government of the Netherlands Ministry of Health, Kingdom of Jordan
Novartis Vaccines Institute for Global Health [Italy]
Price Family Foundation, Inc.
U.S. Centers for Disease Control and Prevention U.S. National Institutes of Health U.S. National Institutes of Health, Fogarty International Center United Nations Children’s Fund The United Nations Foundation United Nations Relief and Works Agency United States Agency for International Development Universidad Peruana Cayetano Heredia [Peru]
Public Health Development and Research Center, Integrated Rural Health Development Training Center [Nepal]
University of Cincinnati
The Rockefeller Foundation
University of Notre Dame
Rotary Club of Kathmandu-North [Nepal]
University of the Witwatersrand [South Africa]
University of Yucatan [Mexico]
Wellcome Trust [United Kingdom]
Schistosomiasis Control Initiative at Imperial College, London [United Kingdom]
University of Jordan [Jordan] University of Kansas
Wellcome Trust Sanger Institute [United Kingdom]
Serum Institute of India
The World Bank
Shantha Biotech [India]
World Health Organization
The Social Investment Consultancy [United Kingdom]
World Health Organization Regional Office for Africa
Task Force for Global Health
World Health Organization South-East Asia Regional Office
Texas Children’s Hospital U.S. Army Walter Reed Institute of Research
World Health Organization Western Pacific Regional Office
Sabin Annual Report 2010
Board of trusteEs
The Sabin Vaccine Institute is grateful for the activism and generosity of its Board of Trustees, composed of international leaders in business, civil service, academia and philanthropy.
As of July 2011
Morton P. Hyman Chairman Louis Z. Cooper, MD Former President of the American Academy of Pediatrics Allan L. Goldstein, PhD Professor in the Department of Biochemistry & Molecular Biology at The George Washington University School of Medicine Rt Hon Baroness Helene Hayman Immediate Past Lord Speaker of the House of Lords, United Kingdom Parliament Axel Hoos, MD, PhD Medical Lead in Immunology/ Oncology at Bristol-Myers Squibb Kevin L. Reilly Former Chairman of the Board of VaxGen, Inc. Gary Rosenthal Partner in The Sterling Group, L.P; Chairman of the Board of Trustees of Texas Childrenâ€™s Hospital Philip K. Russell, MD Past Chairman Major General, U.S. Army Medical Corps (Ret.)
Marc Shapiro Non-Executive Chairman of Chase Bank of Texas; Chairman of the Board of Trustees of Baylor College of Medicine.
Michael W. Marine, Ambassador (Ret.) Chief Executive Officer
Sabin Vaccine Institute PDP
Alisa Swidler Chair, The Walkabout Foundation
Peter Hotez, MD, PhD President and Director of Sabin Vaccine Institute PDP
Peter L. Thoren Executive Vice President of Access Industries
Ciro de Quadros, MD, MPH Executive Vice President and Director of Vaccine Advocacy and Education
Michael E. Whitham Secretary and Treasurer Founding partner of the law firm of Whitham, Curtis, Christofferson & Cook
Neeraj Mistry, MD, MS Managing Director, Global Network for Neglected Tropical Diseases
Heloisa Sabin Honorary Trustee
Brian Davis, CPA Chief Operating Officer
Maria Elena Bottazzi, PhD Director, Product Development Baylor College of Medicine Texas Childrenâ€™s Hospital David Diemert, MD, FRCP(C) Director, Clinical Trials Marva Loblack, MS, MBA Director, Quality Assurance & Regulatory Global Network for Neglected Tropical Diseases Michelle K. Brooks Director, Policy Richard J. Hatzfeld Director, Communications Marcia de Souza Lima, MD Director, Programs and Operations Vaccine Advocacy and Education Ana Flavia Carvalho, MBA, MPH Associate Director Mike McQuestion, PhD, MPH Director, Sustainable Immunization Financing Christopher B. Nelson, PhD, MPH Director, Coalition Against Typhoid Secretariat
Sabin Annual Report 2010
FINANCIAL Condensed Statement STATEMENTS of Activities For the years ended December 31, 2010 and December 31, 2009
For the years ended December 31, 2010 and December 31, 2009
Grants, contributions and other support received
Future portion of grants as of year-end
Revenue and Support
Investment income TOTAL
Condensed Statement of Financial Position 2010
Cash, equivalents and other current assets
Liabilities and Net Assets Expenses
Program services General, administrative and fundraising TOTAL Excess of revenues, commitments and support over expense
Accounts payable and accured expenses
Temporarily restricted net assets
Total net assets
Other liabilities 1,891,292
Total liabilities Unrestricted net assets
Total liabilities and net assets
Sabin's Board of Trustees and executive leadership are fully committed to responsible and effective stewardship of donor funding. For the second consecutive year, Sabin received Charity Navigator's highest rating possible for consistently executing our mission in a fiscally responsible way.
2010 functional expense allocation:
11% General, administrative and fundraising
The financial statements presented have been summarized from Sabin's audited financial statements. Sabinâ€™s full audit report, completed by Rogers & Co, LLP, is available at www.sabin.org.
2010 program expense allocation:
41.5% 26.3% Sabin Vaccine Development
Vaccine Advocacy Global Network and Education
0.2% Other programs
Sabin Annual Report 2010
Sabin Scholar Awards and Appointments Sabin’s prominence in the field of vaccine and global health advocacy is recognized in part by the awards and appointments that our leadership receives and through the presentation of the Sabin Gold Medal, which we award each year to the scientist whose peers believe best reflects Dr. Albert Sabin’s lifelong work of developing vaccines to meet humanitarian needs. Sabin President Dr. Peter Hotez selected to lead the American Society of Tropical Medicine and Hygiene Dr. Peter Hotez was elected President of the American Society of Tropical Medicine and Hygiene (ASTMH), one of the world’s leading organizations promoting global health through the prevention and control of infectious and other diseases affecting poor communities. Additionally, Dr. Hotez was appointed as a member of the National Institutes of Health (NIH) Council of Councils and was awarded the Abraham Horwitz Award for Excellence in Leadership in Inter-American Public Health by the Pan American Health and Education Foundation (PAHEF). Coupled with his guest speaking opportunities as the John Ring LaMontagne Lecturer at the National Institutes of Health and the Stanley Plotkin Lecturer at the Fondation Merieux, these honors and appointments highlight the breadth of Dr. Hotez’s contributions in developing solutions to diseases of poverty.
The following represent some of the appointments and awards that Sabin received and conferred since 2009.
Dr. Ciro de Quadros honored by the Pan American Health Organization and the Spanish Royal Academy of Medicine
Dr. Ciro de Quadros received a special award by the Pan American Health Organization (PAHO) at the 50th annual meeting of the PAHO Directing Council. The award recognized the public health contributions Dr. de Quadros has made in the Americas and his involvement in the creation of PAHO’s Revolving Fund for Vaccine Procurement. Additionally, Dr. de Quadros was presented with the Premio Carlos IV for Research in Public Health award by the Royal Academy of Medicine of Spain honoring his work in the development and promotion of activities related to improving public health and progress of biomedical research.
Sabin Gold Medal Award
Dr. John D. Clemens, DirectorGeneral of the International Vaccine Institute (IVI), became the 16th recipient of the Albert B. Sabin Gold Medal Award. Dr. Clemens is a world-renowned expert in vaccine development and evaluation in developing countries and is best known for leading the first efficacy trial of an oral vaccine against cholera at the International Center for Diarrheal Disease Research in Bangladesh. During the cholera study, Dr. Clemens discovered that the cholera vaccine was highly effective at protecting women and children and that the vaccine provided “herd immunity,” representing two revolutionary breakthroughs. He has also conducted studies of vaccines against numerous other diseases, including typhoid fever, tuberculosis, measles, and Japanese encephalitis, throughout Asia, Africa and the Americas.
The Sabin Vaccine Institute said goodbye to a dear friend and leader early in 2011 when our founding chairman, Dr. H.R. Shepherd, passed away. This report is dedicated to his legacy.
Sabin Annual Report 2010
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