Save the Date November 2009 The Sabin Report | Volume 11 Issue 3

World Pneumonia Day Commemorated Across the Globe

November 2, 2009 marked the first annual World Pneumonia Day created to The 2010 Albert B. mobilize efforts to fight a Sabin Gold Medal neglected disease that kills Ceremony will take more than two million children place on Tuesday, under the age of five every year. Pneumococcal Awareness Council of April 27, 2010 at the Experts (PACE) members around the world organized World Pneumonia George Washington Day events and outreach to help make it a truly global day. Several University's City View members published commentaries and articles in journals, some Room. Please check co-authored op-eds for newspapers, and others organized press events, the event listing for symposia and other activities. more information. To promote awareness and prevention of pneumonia in Bangladesh, Dr. Samir Saha, Professor and Head of the Department of Microbiology at WHO report says the Bangladesh Institute of Child Health, hosted a number of events in Dhaka, including a scientific symposium on the disease for the country's play key pediatricians and infectious disease experts. The symposium also marked role in poverty the official launch of PACE in Bangladesh. and mortality reduction In New York, a half-day Global Pneumonia Summit was convened at the Asia Society. Sabin President Dr. , and numerous PACE Council Members, spoke at the event.

Watch Global Health TV's World Pneumonia Day interview with Sabin Vice-President Dr. Ciro de Quadros here.

Rwanda deworms an estimated 4 Million Children in less than one week

Allusions of the mission In October, the Rwandan and programmatic work Ministry of Health, in of the Sabin partnership with the Rwanda Institute can be found NTD Control Program, held a throughout the World mass drug administration (MDA) campaign that Health Organization, successfully dewormed an UNICEF, and World estimated 3.2 million Bank's State of the school-age children and 1.1 World's Immunizations million pre-school age and Vaccines report children in less than one released on October week. In addition, 105,000 school-age children from six - 21, 2009. endemic districts received praziquantel. In Rwanda the entire population of nearly 9 million people is at risk of from one or more soil Vaccines are a leading transmitted helminths. cost-effective health intervention that can At the launch of the campaign, the First Lady of the Republic of Rwanda, reduce global poverty, Mrs. Jeannette Kagame, stressed the importance of interventions aimed improve overall welfare, at boosting maternal and child health. The week-long campaign provided and reduce mortality inoculations against measles as well as standard interventions delivered says the report. during "Mother and Child Health Week," including immunizations, Vaccines also play a vitamin A capsules, bednets, and family planning services. key role in achievement of the Millennium The Ministry of Health organized the campaign in partnership with Development Goals Columbia University's Access Project, the Global Fund, the Global (MDGs). Network for Neglected Tropical Diseases, the Red Cross, USAID, the World Food Program, and the World Health Organization. An essential element of Sabin's mission to Read blog post here. reduce human suffering involves the development of Manufacture of Commences at vaccines-for hookworm AERAS and Schistosomiasis-that treat or prevent Sabin Vaccine Development is partnering with AERAS Global TB Vaccine infectious and Foundation to manufacture the Na-GST-1 hookworm vaccine at their neglected tropical Rockville, MD production facility. AERAS, a non-profit product diseases. The report development partnership (PDP), funded by the Bill and Melinda Gates hails the 21st century Foundation, is primarily concerned with the development of a new as "the most productive tuberculosis vaccine, but also committed to supporting the manufacturing in the history of vaccine needs of other Gates-funded PDPs like Sabin Vaccine Development. The development." The state-of-the-art GMP-compliant facility has the capacity to produce up to global vaccine market 200 million doses of recombinant tuberculosis vaccine per year, and is has tripled, reaching geared toward vaccine production and distribution at the lowest possible over US $17 billion in cost. Both of these factors make AERAS an ideal partner in the global revenue by production of neglected tropical disease vaccines, and two lots of mid-2008, and Sabin is Na-GST-1 vaccine will be produced for toxicological and clinical use. working to add new vaccines to the growing The successful manufacture of the Na-GST-1 hookworm vaccine will be list of over 30 vaccine- an important step towards the eventual creation of a bivalent vaccine preventable diseases. candidate for hookworm. Immunization with Na-GST-1 may interfere with the ability of adult hookworms to digest hemoglobin, therefore inhibiting Read the report and their ability to feed. Investigators at Sabin's partnering organization, the learn more here. George Washington University, have shown that vaccination with Na-GST-1 reduces worm and egg burdens in dogs. In humans, this may translate into a less severe infection and to a greater extent, the breaking Heloisa Sabin of the hookworm transmission cycle. Clinical trials for this promising named Honorary candidate are scheduled to begin in in mid-2010. Trustee to the Institute Sabin Vaccine Development to Manufacture Candidate at Instituto Butantan

In September, the Sabin Vaccine Development team met with collaborator Instituto Butantan (IB) in São Paolo, Brazil for a meeting pertaining to the schistosomiasis vaccine candidate Sm-TSP-2. The major outcome was the decision to use their new cGMP facility for the manufacture of Sm-TSP-2, and both Sabin and IB agreed upon the terms of a general manufacturing agreement and production timeline. IB's commitment to the production of a schistosomiasis vaccine was evident in Mrs. Heloisa Sabin, their impressive quality system improvements. A meeting with the newly who helped establish expanded quality assurance department revealed visionary leadership the Sabin Vaccine and compliance with Agência Nacional de Vigilância Sanitária (ANVISA) Institute in 1993, was and U.S. FDA, which will be crucial in the timely review and approval for unanimously elected clinical testing. Honorary Trustee on August 26, 2009. She Brazil has the world's second largest number of endemic schistosomiasis has continuously cases. A successful transfer and production of a schistosomiasis vaccine championed the work could have a huge positive impact on the population. Brazil also currently and legacy of her late manufactures more than 80% of its own vaccines. The necessary husband, Dr. Albert requirements have been put in place to ensure an expedient technology Sabin, by promoting the transfer and execution of the manufacturing process in 2010. role of vaccines in eliminating needless deaths from PACE asks European Commission for stronger preventable and commitment to prevent pneumococcal disease treatable diseases.

Originally from Brazil, The Pneumococcal Awareness Council of Experts but currently residing in (PACE) and Michael Cashman, Member of the Washington, DC, Mrs. European Parliament, hosted a parliamentary Sabin is a notable discussion on the role of the European Union in advocate for the combating pneumococcal disease on October 5. vaccine and global Drs. Ciro de Quadros and Fred Were of PACE led health fields and the the discussion calling attention to the World Health Sabin Vaccine Institute Organization's recently released data on the global looks forward to burden of pneumococcal disease and highlighting learning from, and strategies for prevention. The event was part of a sharing, her unique two-day meeting during which PACE met with insight. members of the European Commission to discuss the need for pneumococcal prevention and to encourage further support for research, funding and policy decisions that will change the profile of Recent Scientific the disease from unknown global killer to top priority. Articles

Dr. Peter Hotez Sabin Sponsored Briefings Prompt Action in DR published two analyses Congo detailing the devastating impact of Sabin's Sustainable Immunization Financing (SIF) program hosted a neglected tropical parliamentarian briefing in Kinshasa, Democratic Republic of Congo on diseases in September 11th to call attention to the urgent need to secure sufficient Sub-Saharan Africa funding for DR Congo's health sector, and in particular for its Expanded (SSA) and member Programme of Immunization (EPI). nations of the Organization of the DR Congo allocates only 3% of its national budget to health, and its EPI Islamic Conference. remains entirely dependent on external donors to provide routine "The Neglected Tropical immunizations to its children. While the program is currently receiving Diseases and Their support from the GAVI Alliance, it has been in danger of losing that Devastating Health and support. Economic Impact on Member Nations of the As a direct result of the meeting, the Minister of Budget issued an order Organization of the for the release of funds to the GAVI Alliance, thereby fulfilling part of DR Islamic Conference," Congo's international obligations. The meeting has also sensitized and "Neglected Tropical parliamentarians--who play a large role in the budget process--to the Diseases in cost-effectiveness of EPI in promoting the health of children. While Sub-Saharan Africa: significant challenges lay ahead, Sabin remains confident that DR Congo Review of their can, and will, assume greater responsibility for financing important health Prevalence, programs like EPI. With continued collaboration and perseverance, Distribution, and remarked one participant, "financial sustainability of EPI is just around the Disease Burden," were corner." published in online open access journal PLoS Neglected Tropical Beauty Queens and Soccer Players help the Global Diseases. Network Highlight NTD Control Efforts in the

"A constitutional Americas amendment for deworming" by Dr. At the 2009 Clinton Global Hotez was also Initiative Annual Meeting, published in PLoS. former President Bill Clinton Additional articles announced a commitment by co-written by Dr. Hotez the Global Network; Inter- and published in PLoS American Development Bank; include: "Unfinished Pan American Health Public Health Agenda of Organization; the Miss in the Universe Organization; the Era of Globalization," Brazilian National Soccer "Two Years of team and other public and Providing Access to private partners to mobilize Innovation for the $30 million in support of neglected tropical disease control and elimination World's Poor...and efforts in the Americas. Counting," and "Schistosomiasis in Over 230 million people suffer from one or more disabling and disfiguring Africa: an emerging neglected tropical diseases in the Americas; however, with a firm tragedy in our new commitment from the public and private sectors, experts say it is possible global health decade." to eliminate (river blindness), lymphatic filariasis and trachoma throughout the region, as well as achieve a 75% reduction in Dr. Hotez wrote the prevalence of schistosomiasis and soil-transmitted helminths. "Neglected diseases amid wealth in the Read press release here. United States and Europe" and co-wrote "From neglected Continuing progress in two-year study of Hookworm tropical diseases to forgotten maladies" Infection in Brazilian children which were published in Health Affairs. In August, Sabin Vaccine Development passed the In September, Dr. Ciro one-year mark of the start of de Quadros published a two-year pediatric study to two pieces in Vaccine. determine the rates and "Antibiotic resistance in intensity of re-infection, Latin America: A cause following drug treatment, for alarm" and "From among children between the global to regional: The ages of 1 and 10 in a importance of hookworm endemic area of pneumococcal disease Brazil. The program has in Latin America" were successfully enrolled over 400 children in five communities. To prepare in a supplement edited the new enrollees, a team of "community preparedness" experts conducts by PACE member Ron educational sessions with children to de-mystify the process of collecting Dagan and focus on the blood and stool samples. The study will provide information on the various issues effectiveness of current deworming drugs and will obtain data to help surrounding design future hookworm vaccine trials. In addition, nutritional pneumococcal disease. assessments are being performed to estimate the impact of treating PACE members Keith helminth on this parameter. Klugman and Shabir Madhi also had an article in the same Sabin Vaccine Development Assesses the Need of a issue of Vaccine. Drug "Orphanage"

Drs. Hotez and de Quadros, et al. An "orphan" drug is a medicine that is not manufactured or marketed published "New because demand is insufficient to cover the costs of supply. Orphan Vaccines for developing drugs follow the same regulatory development path as any other drug, countries" in the but with the help of orphan status, some requirements are lessened to American Journal of keep up development momentum. For example, orphan status allows that Law & Medicine. it may not be possible to test 1,000 patients in a phase III clinical trial, as fewer than that number may be afflicted with the disease. Since the PACE has created a market for any such drug may be unprofitable, orphan status also works pair of summaries of to motivate the drug manufacturer through government incentives. These their findings on incentives may include eligibility for grants, tax credits, enhanced patent long-term sequelae and protection, and marketing rights. A few examples of the many drugs that mortality due to have been successfully developed through orphan status are drugs to bacterial meningitis and treat cystic fibrosis, phenylketonuria, and snake venom. pneumococcal infections in persons There is a new proposal to establish a functional "orphanage" for drugs with sickle cell disease targeting neglected tropical diseases (NTDs) to improve the likelihood in Africa. The "Africa that these drugs will complete the development process. At the request Review Papers," and of the Bill and Melinda Gates Foundation, Sabin Vaccine Development is links to the published currently planning to convene a meeting with experts from the FDA, the articles, will be added Gates Foundation, Sabin, and other leaders of the field to address the to the Sabin website in effectiveness of the orphanage in promoting drug development for NTDs the coming weeks. The and its appropriateness as a mechanism to do so.There are hopes that study on bacterial creating an NTD drug orphanage will advance the development of drugs meningitis has been for NTDs. published by BioMed Central, in the flagship journal BMC Medicine. Global Network Launches End the Neglect Blog The study on sickle cell disease is currently The Global Network recently launched End the Neglect, a blog which under review for serves as a broad, transparent platform through which the neglected publication by a tropical disease (NTD) community can continue to raise the profile of prestigious journal. NTDs and disseminate stories from the field. The blog will be a vital resource to educate and inform readers of the devastating impact that NTDs have on the developing world and the simple and cost-effective Upcoming interventions that can help put an end to these debilitating and deadly Meetings diseases. The Global Network encourages colleagues and collaborators around the The Sabin Vaccine world to serve as guest bloggers, and share personal stories, Institute will co-host, experiences, successes, and challenges. with the Pan American Health Organization To date, End the Neglect has featured a variety of posts, including: (PAHO), a Regional Symposium on New Pictures and local perspectives from the latest round of mass drug Vaccines in Lima, Peru administration in Rwanda; this winter. From December 1-2, 2009 An analysis of a new Resolution issued and passed by the Pan American government leaders, Health Organization on NTDs; physicians, researchers and other concerned A piece tying a New York Times article on Haiti with the importance of stakeholders will gather NTD control for poverty alleviation and the University of Notre Dame's to share the latest advocacy work; research on diseases and vaccine A guest blog post by Josh Ruxin, Founder and Director of the Access developments. Project, on the prevalence of intestinal worm infections in children.

For more information, If you are interested in submitting a guest post, email the Global Network click here. directly at [email protected] .

The year 2010 will mark the 30th Three new members join PACE Council anniversary since the Global Commission for Three new council members have recently joined PACE: Dr. Najwa Khuri- the Certification of Bulos, Head of the Division of Infectious Disease at Jordan University Smallpox Eradication Hospital; Dr. Shabir Madhi, Chair of the Department of Science and officially reported the Technology at the National Research Foundation of South Africa; and Dr. elimination of smallpox Yong-Hong Yang, Professor of Pediatrics, Beijing Children's Hospital. disease. Sabin is proud With the addition of these distinguished members, PACE is represented to co-sponsor, with by 21 members in 17 countries. FIOCRUZ, a symposium to For a full list of PACE members, click here. commemorate the 30th anniversary of smallpox eradication. The New Faces at the Sabin Vaccine Institute symposium will be held in , Brazil Nine new staff have joined from August 24-27, the Sabin Vaccine Institute 2010. since the last issue of the Sabin Report was released: For more information click here. Stephanie Hedean, Director of Strategic Partnerships and Communications, Global Network Ashly Smolyn, Program Officer, Sabin Vaccine Development Eteena Tadjiogueu, Communications Associate Anjana Padmanabhan, Communications Associate, Global Network Janet Daniels, Controller Kristina Bell, Receptionist Mark Levy, Program Coordinator, Global Network Patrick Sell, Operations Officer, Global Network Maria Bianchi, Office Manager