The Bill and Melinda Gates Foundation awards $40 million five-year grant to IVI

In December 1999, the Bill and Melinda Gates Foundation provided a grant to IVI to carry out a major program on vaccines against cholera, typhoid fever, and shigellosis - three major diseases of the most impoverished. This five year effort is titled Program for Diseases of the Most Impoverished (DOMI).

Commenting on the award, Prof. Barry Bloom, Chairman of the Board of Trustees and Dean of the Harvard School of Public Health, said "The award from the Bill and Melinda Gates Foundation is tremendously exciting. With this grant and others, the Foundation is literally revolutionizing the world of vaccine research and development. I am extraordinarily pleased that the IVI will be playing a key role in this new world." Dr. John Clemens, Institute Director, commented, "This generous gift of the Bill and Melinda Gates Foundation will dramatically change the global efforts to develop vaccines against these three diseases. To date, support in this area has been modest. The DOMI Program can be a vehicle for saving the lives of nearly 2 million individuals each year."

As the DOMI acronym implies, these diseases occur among very poor people living in the worst conditions. The diseases are rarely seen in developed countries. Therefore, the commercial market for these vaccines is quite limited. If vaccines are to be developed for these three diseases, the public sector will have to assume a greater portion of the risk involved in such development. With the gift from the Bill and Melinda Gates Foundation, IVI is trying to assume major portions of the risk of developing and deploying these urgently needed vaccines. The DOMI Program will primarily operate through subcontracts to research and technical centers in developing countries. Dr. Clemens projects that roughly 75 percent of the funds will go to these centers to support their in-country work.

The DOMI Program focuses on seven countries and certain refugee settings. The seven countries are Bangladesh, China, India, Indonesia, Pakistan, Thailand, and Vietnam. In addition, the Program will work with Me'decins Sans Frontie'res, the recent winner of the Nobel Peace Prize, in refugee populations of South East Asia and Africa. The DOMI Program is fortunate to have a strong group of collaborators in each country (see the table below).

Collaborators in the DOMI Program
(as of 08/30/00)

Bangladesh
  • The International Center for Diarrheal Disease Research, Bangladesh
China
  • Chinese Academy of Preventive Medicine
  • The Lanzhou Institute of Biological Products
France
  • Epicentre
  • Institut Pasteur
  • Me'decins Sans Frontie'res
India
  • The All India Institute of Medical Sciences
Indonesia
  • BioFarma
  • The Ministry of Health
Korea
  • Seoul National University
Pakistan
  • The Aga Khan University
Sweden
  • University of Gothenburg
Thailand
  • Mahidol University
United States
  • Harvard University
  • National Institute of Health
  • University of Maryland
  • Walter Reed Army Institute of Research
  • West Virgina University
Vietnam
  • National Institute of Hygiene and Epidemiology
  • Institute of Vaccines and Biological Substances
International
  • World Health Organization

Because of the limited commercial value of these vaccines, it is likely that local producers in developing countries will play major roles in ensuring adequate development, manufacturing and distribution of the vaccines. Therefore producers from China, India, Indonesia and Vietnam are active participants in the DOMI Program. IVI will employ its capabilities in Good Manufacturing Practices(GMP), Quality Assurance(QA) and Quality Control(QC) training and technical assistance to support these producers.

The DOMI Program also richly illustrates the unique ability of the IVI to undertake multicountry, multidisciplinary studies. These studies are essential for the successful introduction of new and effective vaccines. Single country or single issue studies can be of use, however they lack the great impact of broader studies.

WHO has agreed to participate fully in the DOMI Program. The Program secretariat has offices both in Seoul and in Geneva. Dr. Bernard Ivanoff, who has coordinated work on enteric disease vaccines for WHO, heads the WHO DOMI Program secretariat office. A meeting to launch the DOMI Program was held at WHO headquarters in February (a summary of the meeting is available from IVI upon request). This meeting was followed by meetings in Seoul in May during which collaborators presented concepts for projects they would undertake. Implementation of projects will begin later this year.

Other new support for IVI

AusAID
The Australian development agency, AusAID, made a contribution to IVI in June 2000. This important support will help IVI in its collaborations in China and Vietnam to improve both vaccine regulation and manufacture. The project is a multi-year effort carried out in three phases (see box). Collaborators include the Australian Therapeutics Goods Administration, the World Health Organization, and centers in China and Vietnam. This program will be carried out under the direction of Dr. Chung Keel Lee, Chief Officer for Technical Cooperation, IVI.

Phases of AusAID Support Project to Strengthen Regulation and Production of Vaccines in China and Vietnam

Phase-1, Assessment. There are two assessment components. The first is an independent assessment at national invitation of the regulatory functions within the National Regulatory Authority(NRA). The second part involves detailed identification of the training needs of the vaccine manufacturers.

Phase-2. NRA strengthening. NRA strengthening will include a series of training activities designed to strengthen the NRA team responsible for inspecting vaccine manufactures. Included in Phase 2 will be on-site training at manufacturing facilities to allow the NRA inspectors to perform mock audits. These on-site training activities will have the added advantage of providing real life experience for the manufacturing staff.

Phase-3. Manufacturer strengthening. This phase will specifically address the needs of the manufacturers, focusing on gaps identified in Phases 1 and 2. Such training might include an extensive equipment validation exercise, review of the management systems of the Quality Control Laboratory, review of GMP requirements for lots produced for clinical trials, and development of documentation. In the later years of the project, hands-on training will be conducted at IVI facilities.

Research capacity-building in clinical evaluation

Strengthening of the capacities of investigators in developing countries to design and conduct clinical trials and other clinical evaluations of vaccines, as well as increasing the technical expertise of National Regulatory Authorities in monitoring such evaluations, have been accorded high priority by WHO. The IVI has a strong commitment to providing formal training courses, as well as hands-on training, in vaccine evaluation to both investigators and regulatory authorities in developing countries. Recently, support for these capacity-building efforts has been committed to the IVI by Becton-Dickinson, Sartorius, SmithKline Beecham, and the Rockefeller Foundation. The first training course on vaccine evaluation to be given by the IVI will be held in Nha Trang, Vietnam, in early December, 2000. This course will be taught collaboratively by faculty from the London School of Hygiene and Tropical Medicine and the IVI, and will include participants from China, Indonesia, Pakistan, Thailand, and Vietnam.

Swedish Bacteriological Laboratory (SBL)

SBL Vaccin (formerly the Swedish National Bacteriology Laboratory) has played a leading role in the development of new-generation, killed oral vaccines against two major enteric infections afflicting developing country populations: cholera and enterotoxigenic Escherichia coli (ETEC). SBL Vaccine has recently provided financial support to the Institute for its collaboration on ongoing field trials of killed oral cholera vaccine in Vietnam and on ETEC vaccine in Egypt (see report below).

Gates Children's Vaccine Program

Japanese encephalitis (JE) is a severe infection that affects human populations throughout Asia. Several countries in Asia have completely controlled this disease with use of available vaccines. However, vaccine use is much more limited or even non-existent in the poorest countries of Asia. Moreover, surveillance mechanisms are not adequate to define the disease burden in many of these countries, complicating informed policy decisions about introduction of JE vaccines into public health programs.

IVI scientists, led by Dr. Zhi-yi Xu, have recently received a $2 million award from the Bill and Melinda Gates Children's Vaccine Program to mount a multi-country study to better define the JE disease burden in Asian countries where JE vaccines are not used or are used only to a limited extent. The program will also examine the long-term permanent neurological impairment caused by non-fatal JE infections, since these sequelae constitute a major source of the morbidity and expense of JE infections in endemic settings. Finally, the program will examine determinants of policies for the use of JE vaccines. The program will be undertaken in China, India, Indonesia, Thailand, and Vietnam.

IVI participates in GAVI

Research and Development Task Force

The Global Alliance for Vaccines and Immunization (GAVI) continues its breathtaking pace of development and success. Initially the GAVI Board established "windows" for vaccine procurement and infrastructure strengthening. Under the energetic leadership of Prof. Myron Levine of the University of Maryland, the GAVI Board approved, at its June 2000 meeting in Oslo, the formation of a Task Force on Research and Development. Dr. John Clemens, Institute Director, participated in the GAVI "Pre-Task Force" meeting convened at WHO in November 1999.

Vaccine Financing Working Group

The GAVI Working Group responsible for evaluating financing issues held a meeting at the World Bank in September 1999. Dr. Richard Mahoney, Division Head and Scientist, participated in the meeting. The meeting identified a number of important areas for study. Dr. Mahoney attended the second meeting in September, 2000.

IVI's research and technical cooperation program

Invasive Bacterial Diseases Program

Since 1997, the scientists from the IVI and UCLA have collaborated on the development of field sites for the assessment of disease burden due to invasive bacterial diseases including Haemophilus influenzae type b, Streptococcus pneumoniae and Neisseria meningitidis. The three field sites are located in Chonbuk Province, Korea, Hanoi Province, Vietnam and Guangxi Zhuang Autonomous Region, China.

Field site development has included extensive standardization of clinical diagnosis for meningitis, and standardization of the diagnosis of invasive bacteria using blood and cerebrospinal fluid culture. All data collection instruments have been standardized to ensure comparability of data collection in all three field sites.

As of June 29, 2000, the field site in Chonbuk has enrolled 495 patients under 5 years of age with suspected meningitis. In Hanoi, Vietnam, clinicians have enrolled 253 patients under 5 years of age with suspected meningitis. Demographic, clinical and other characteristics are collected at the time of enrollment for all patients. Bacterial cultures are performed in central hospitals within each of the field sites.

Quality assurance and quality control activities are carried out by local scientists in collaboration with IVI epidemiologists, database managers and biostatisticians. Standardized methods for data quality monitoring help to ensure high-quality data collection by pediatricians in each of the central surveillance hospitals and by microbiology technical staff in hospital laboratories. Technical assistance in data management and microbiological diagnosis, as well as conduct of specialized labaratory tests, is being provided by the UCLA collaborators.

The project also involves collaboration in each country with other scientists working on invasive bacterial diseases in children and antibiotic resistance of these important organisms. A complete disease burden assessment will involve other data analyses to understand the impact of invasive bacterial diseases such as pneumonia, bacteremia, arthritis, epiglottitis, peritonitis, and pericarditis.

Ultimately, this project, which is being supported by the Gates Children's Vaccine Program, Merck Sharp & Dohme, SmithKline Beecham, and Wyeth-Lederle, will provide a more complete picture of invasive bacterial diseases among infants in China, Korea and Vietnam. In particular, this project will estimate the incidence of invasive bacterial meningitis among infants and children, provide cost data regarding clinic visits, and additional disease burden data related to hospitalizations for other invasive bacterial diseases. Finally, these field sites will soon provide well- characterized populations for future evaluations of childhood vaccines for bacterial meningitis.

Field evaluations of vaccines

The Institute is collaborating on two WHO-sponsored field evaluations of two important vaccines against enteric infections. In Vietnam IVI investigators are working with scientists from the National Institute of Hygiene and Epidemiology (Hanoi), the U.S. National Institutes of Health, the University of Gothenburg, and SBL Vaccine on a program to evaluate a locally produced, killed oral vaccine against cholera. A field trial of this vaccine, being conducted in over 300,000 subjects in the central coastal city of Nha Trang, is in its fourth year of follow-up. Funding for this trial is being provided by the Swedish Agency for Cooperation in Developing Countries, the U.S. National Institutes of Health, and SBL Vaccin.

Institute scientists have also participated in an economic evaluation of this vaccine, and are providing technical assistance and training on the local production of the vaccine according to Good Manufacturing Practices.

In Egypt, Institute scientists are working with scientists from the U.S. Naval Medical Research Unit-3 (Cairo), the Ministry of Health of Egypt, the U.S. National Institutes of Health, the University of Gothenburg, SBL Vaccin, and SmithKline Beecham on a field trial of a killed oral vaccine against enterotoxigenic Escherichia coli (ETEC). This trial is the first efficacy study of an ETEC vaccine ever in infants and toddlers, who are at highest risk for ETEC diarrhea in developing countries, where ETEC infections are endemic. To date, the trial has enrolled approximately 400 subjects who are residents of Abu Homos, near Alexandria, and is in its second year of follow-up.

Vaccine Policy Studies

Dr. Richard Mahoney and Dr. Zhi-yi Xu of the IVI along with Dr. S. Ramachandran recently addressed the complex issue of the global challenge to finance the procurement of new vaccines (Ref.: The introduction of new vaccines into developing countries. 2 : Vaccine financing. Vaccine 18 : 2625-31). The paper lays out a proposal for allocating the Global Fund for Children's Vaccines initially established by a gift from the Bill and Melinda Gates Foundation. This paper is the second in a series focused on the introduction of new vaccines in developing countries. The first paper, co-authored by Dr. Mahoney and Dr. James Maynard (PATH, Seattle) helped lay the basis for the Bill and Melinda Gates Foundation Children's Vaccine Program.

 Recent publications by IVI scientists

Clemens. J. Evaluating vaccine safety before and after licensure. Bulletin of the World Health Organization. 78:218-19, 2000

Hall A, and Clemens J. Adverse reactions to vaccines in the tropics. Tropical Medicine and International Health. 5: 229-30, 2000

Duraisingh M, Jones P, Sambou I, von Seidlein L, Pinder M,. Warhurst D. Mutation of the pfmdr 1 gene of Plasmodium falciparum is associated with increased sensitivity to the antimalarials mefloquine and artemisinin. Molecular and Biochemical Parasitology 108: 13-23, 2000.

Galindo C, Acosta C, Schellenberg D, Aponte J, Roca A, Oettli A, Urassa H, Armstrong J, Kahigwa E, Ascaso E, Mshinda H, Lwilla F, Menendez C, Tanner M, Alonso P. Infant immune responses in a malaria vaccine control trial in Tanzania. Parasite Immunology (In Press).

King J, Borkowsky W, Mahidhara N, Madore D, Shapiro E, Rutstein R, Tan T, Farley J, Danker W, Nachman S, Simoes E, Flynn P, Clemens J, Hamilton R. Group-specific antibody levels surrounding invasive pneumococcol infections in children infected by human immunodeficiency virus. Jornoul of Infectious Diseases 181: 1817-21, 2000

Lin F-Y, Azimi P, Weisman L, Phillips J, Regan J, Clark P, Rhoads G, Clemens J, Troendle J, Pratt E, Brenner R, Gill V. Antibiotic susceptibility profiles of Group B streptococci isolated from neonates from 1995 to 1998. Clinical Infectious Diseases 31:76-9, 2000

Naficy A, Rao R, Holmes J, Abu-Elyazeed R, Savarino S, Wierzba T, Frenck R, Monroe S, Glass R, Clemens J, Astrovirus diarrhea in Egyptian Children. Journal of Infectious Diseases 182:685-90, 2000.

Park E, Lee YJ. Non-parametric test of ordered alternatives in incomplete blocks. Statistics in Medicine 19: 1329-37, 2000

von Seidlein L, Drakeley C, Greenwood B, Walraven G, Targett G. Risk factors for gametocyte carriage in Gambian children. American Journal of Tropical Medicine and Hygiene (In Press)

von Seidlein L, Milligan P, Pinder M, Bojang K, Anyalebechi C, Gosling R, Coleman R, Ifeanyichukwu Ude J, Sadiq A, Duraisingh M, Warhurst W, Alloueche A, Target G, Mcadam K, Greenwood B, Walraven G, Olliaro P, Doherty T. Efficacy of artesunate plus pyrimethamine-sulphadoxine for uncomplicated malaria in Gambian children: a double-blind, randomised, controlled trial. Lancet 355:352-358, 2000

Gilbert P, Self S, Rao M, Naficy A, Clemens J, Sieve analysis: methods for assesing how vaccine efficacy depends on genotypic and phenotypic pathogen variation from vaccine trial data. Journal of Clinical Epidemiology (In Press)

GMP training courses / workshops

These courses/workshops are aimed at helping both manufacturers and National Regulatory Authorities/Control Laboratories in strengthening practical knowledge for implementing Good Manufacturing Practices(GMP) principles to vaccine manufacturing and regulation. Several workshops were conducted by Dr. Chung Keel Lee of IVI.

At the request of the Government Pharmaceutical Organization (GPO), a 5-day GMP short course was held in Bangkok. Forty participants from vaccine manufacturers and the National Regulatory Authority/Control Laboratory successfully completed the course.

At the request of the National Drug Institute, Ministry of Health of Bulgaria, and of WHO, an introductory short course was held at the National Center of Infectious and Parasitic Diseases, Sofia. One hundred and seventy four individuals from various drug/biologics manufacturers and National Regulatory Authority/Control Laboratories participated in the course.

IVI conducted a training workshop at the National Institute of Vaccine & Biological Substances (IVAC). A total of fifty six trainees from IVAC, the Pasteur Institute of Nha Trang, and the National Institute of Hygiene and Epidemiology (NIHE) successfully completed the course.

WHO organized a training course for National Regulatory Authority/Control Laboratories and local vaccine producers in Iran. The course was held at Razi Vaccine and Serum Research Institute, Tehran. Twenty two participants successfully completed the course. Another training course for inspectors, sponsored by WHO/PAHO, was held at Instituto Nacional de Controle da Qualidade em Sau˘Ğde in Rio de Janeiro, Brazil. Twenty two national and regional inspectors participated. These were the first two official GMP training courses conducted by IVI as one of the WHO GTN training centers.

GMP Inspection

The World Health Organization, through its Department of Vaccines and Biologicals, provides advice to UNICEF and other United Nations agencies on the acceptability, in principle, of vaccines considered for purchase by UN agencies. Dr. Chung Keel Lee of IVI assisted in WHO's assessment of several producers by verifying that the vaccines meet specifications of the relevant UN agency and the requirements recommended by WHO, including those for GMP. The producers were:

The two manufacturers of BCG vaccine (NCIPD in Bulgaria and SSI in Denmark) and their respective National Regulatory Authority/Control Laboratories.

The three manufacturers of Hepatitis B vaccine (LG Chem., KGC and Cheil Jedang in Korea) and Korea Food & Drug Administration.

Biomanguinhos of Fiocruz and National Regulatory Authority/Control Laboratory, INCQS in Brazil.

GMP assessment on typhoid & cholera vaccine producers

IVI staff visited IVAC and NIHE in Vietnam to analyze the present status of GMP compliance in the production of typhoid and cholera vaccines. The Wuhan and Lanzhou institutes in China were visited by IVI staff for a similar purpose.

IVI continues to help Korean Food and Drug Administration (KFDA)

IVI is assisting the KFDA in several specific areas related to the evaluation, research, and regulation of biologics, including vaccines. A series of training workshops was provided to GMP field inspectors and the personnel of the Center for Biologics Evaluation & Research. A draft guide for cell substrates used for the production of biologics was generated with the guidance of IVI staff.

IVI forms Scientific Advisory Group (SAG)

Institute Director, Dr. John Clemens, appointed a distinguished Scientific Advisory Group and convened it for a first meeting in March 2000 shortly before the annual meeting of the Board of Trustees. The members of the SAG are listed in the box.

IVI SAG Members

Prof. Jan Holmgren
  University of gothenburg,
  Chairman

Prof. Michael Good,
  Queensland Institute of Medical Research,
  Brisbane

Prof. Elwyn Griffiths,
  World Health Organization,
  Geneva

Prof. Stefan Kaufmann,
  Max Planck Institute, Berlin

Dr. John La Montagne,
  National Institute of Allergy and
  Infectious Diseases, U.S. NIH

Dr. Margaret Liu,
  University of California,
  San Francisco

Prof. Sang Dai Park,
  Seoul National University, Seoul.

This first meeting was held jointly with a meeting of the Facilities Committee of the Board of Trustees. The members of the Facilities Committee are Prof. Ruth Arnon, Dr. Lars Pallesen, and Dr. Geoffrey Schild. The joint meeting participants made a number of recommendations that will help guide IVI activities.

Among other actions, the joint meeting participants encouraged

The next meeting of the SAG will take place jointly with a meeting of Facilities Committee in Seoul on April 23-24, 2001. Additionally the Facilities Committee will meet when necessary as construction of the headquarters facility proceeds.

  

Working with WHO

IVI named as member of the WHO Global Training Network

The IVI has been named as a member of the WHO Global Training Network for vaccine production and control. The IVI joins 13 other major centers throughout the world in providing urgently needed training to developing country vaccine producers and National Regulatory Authorities/Control Laboratories.

IVI to serve as part of WHO Vaccine Safety Network

In recent years, concerns about the safety of vaccines have increased in industrialized countries. Recently, these concerns were aggravated when the rhesus rotavirus- reassortant vaccine, the first vaccine to be licensed against rotavirus diarrhea, was withdrawn from the U.S. market by its manufacturer when carefully done epidemiologic studies demonstrated an association between receipt of the vaccine and the rare occurrence of intestinal intussusception, a severe and sometimes fatal condition. Unfortunately, in the vast majority of developing countries, the infrastructure is lacking for evaluating uncommon but severe side-effects. In a pair of recent articles (Clemens J. Evaluating vaccine safety before and after licensure. Bulletin of the World Health Organization 78: 218-19, 2000; Hall A, Clemens J. Adverse reactions to vaccines in the tropics. Tropical Medicine and International Health 5: 229-30, 2000), Dr. John Clemens, Institute Director, has made the case for creation of population databases in developing countries to enable epidemiologic evaluation of such potential associations. The IVI has been asked by WHO to function as part of a network of expert centers. Institute scientists have begun to make plans for creation of population-based databases in several sites in Asia.

 

Board of Trustees annual meeting

The Board of Trustees had its annual meeting March 8 - 10, 2000. Highlights of the meeting were meetings with the Prime Minister, Mr. Jong-pil Kim, the Minister of Education, Mr. Hae-chan Lee and the Acting Minister of Foreign Affairs and Trade, Mr. Ki-moon Ban of the Government of Korea. These officials reiterated the unswerving support of their government for the IVI. Prime Minister Park said, "We will do all we can to assure the success of this extraordinarily important effort to save lives. Korea is proud to host the IVI. It is one way we can thank the world for all the help we have received."

The Board took a number of important actions during its meeting. One of the first was to confirm the accession of the Sultanate of Oman to the IVI. The addition of the Sultanate of Oman brings to 33 the number of countries that are now members of the IVI.

The Board also heard a report (see story above) from the Chairman of the Scientific Advisory Group, Dr. Jan Holmgren of the University of Gothenburg. The Board expressed its strong confidence in the scientific leadership of the Institute Director, Dr. John Clemens.

Decision on Intellectual Property Rights

The Institute shall abide by the standards and obligations established by the Agreements on Trade Related Aspects of Intellectual Property Rights as Implemented by the Worls Trade Organization, taking into account the need for protection of the public sector, parrticularly in developing countries, as spelled out in resolution 52.19 of the World Health Assembly of the World Health Organization.

The Institute shall insure adequate and effective protection of intellectual property created by or furnished to the Institute and shall seek protection for such intellectual property in a timely fashon. Furthermore, the Institute shall use open and competitive processes for access to intellectual property it may hold.

The Institute shall adopt, maintain, and adhere to a written policy on intellectual property to implement this Decision.

The Board spent considerable time discussing major matters of governance. The Board expressed its desire that signatory members have the opportunity to participate fully in the affairs of the Institute. One option the Board agreed on, and which would be implemented immediately, is to strengthen and empower the Institute Support Council (see following story), which is made up of signatories of the Institute Establishment Agreement and other supporters of the Institute. The Board also decided to study the governance structures of other international organizations. As expressed by Board Chairman Bloom, "The IVI's success will be measured by the extent to which it meets the disease control needs of the member countries and other countries. Therefore, active participation of member countries is essential."

Considerable discussion was devoted to IVI policies for management of intellectual property rights(IPRs). The Board appreciates that the appropriate protection and promotion of intellectual property rights are essential for successful vaccine development. The issue facing the Board in this area is to establish policies that are enforceable. Countries enforce IPR policies through their government regulations and courts. International organizations do not have these forms of enforcement capabilities. IVI staff will be consulting broadly on this issue and will be preparing recommendations for the Board's consideration. As an interim measure, the Board approved a Decision on IPRs(see box above). In international law, a Decision taken by the Board of an International Organization is binding on the staff of the Organization.

The Board will next meet in March 2001 in Hanoi.

 

Institute Support Council (ISC) meets in conjunction with Board of Trustees

On March 10, the second afternoon of the three-day Board of Trustees meeting, the Board adjourned and the ISC had its meeting(see box). The ISC is convened by UNDP and Dr. Nay Htun, Regional Director, Bureau of Asia and the Pacific, serves as the Chair.

A representative of the Bill and Melinda Gates Foundation could not attend the meeting. However, the Foundation sent a written statement (see box).

 Attendees at ISC Meeting
Bangladesh Mr. Md Nazrul Islam
China Ms. Yao Ying
Denmark H.E. Leif Donde
Ecuador H.E. Patricio Zuquilanda Duque
Egypt H.E. Hussein E. Addel Hakim Derar
Finland H.E. Unto Turunen
Israel Mr. Ariel Shafransky
Kazakhstan H.E. Tulegen Zhukeyev
Korea Mr. Young Wan Song
Netherlands H.E. Henry J. de Vries
Pakistan H.E. Tariq Osman Hyder
Philippines H.E. Juanito P. Jarasa
Sweden Prof. Jan Holmgren
Smithkline Beecham Dr. Ralf Clemens
UNDP Dr. Nay Htun and Ms. Hyun Shin Lee
WHO Dr. Shigeru Omi

 

A number of participants made formal statements. Here are a few excerpts:

  • Mr. Young Wan Song, Director, United Nations Division, Ministry of Foreign Affairs and Trade, Republic of Korea

My government has made clear on several occasions that it will provide its unwavering support to the IVI. Even in the most difficult times economically since 1997, Korea has been providing more than half of the operating budget of the IVI, exceeding its pledge that we would cover 30% of it. When the Institute building is ready and the IVI becomes fully operational, Korea's contribution to the Institute, which stands at $1.2 million annually, will be tripled or quadrupled depending on the total operating budget.

  • Dr. Shigeru Omi, Regional Director, Western Pacific Regional Office, World Health Organization

I would also like to assure you that WHO will do all it can to support the continued growth and success of IVI. It is clear to us that IVI is an essential partner that will help WHO achieve its goal of better health for all.

  • Ms. Yao Ying, Embassy of the People' Republic of China

China is a poor country but we will do what we can to help the IVI. We earnestly hope that others with greater resources will step forward and give the IVI what it needs and deserves so that it may help children live healthy lives.

  • Dr. Ralf Clemens, Vice President, SmithKline Beecham

In the beginning many companies were hesitant to support IVI because there were concerns that it would be just another organization with the associated bureaucracy. There were also questions as to whether the IVI could actually contribute much. After much discussion, industry decided to join. I believe that industry is very pleased with the way the IVI is developing. Industry likes the sense of urgency that exists at the IVI. The IVI operates on time and carries out sound work. SmithKline Beecham will provide continuing support with both money and knowledge. SmithKline Beecham can help with production and transferring technology. SmithKline Beecham is prepared to transfer technology to developing countries, and it believes IVI can be an important partner in assuring the success of these programs. I recommend that IVI work on safety issues to reassure the public that vaccines are the most cost-effective health measure

  • Sir Gustav Nossal, Board Vice Chairman, made the following concluding remarks

I was deeply impressed and moved by the representative of China and her plea for help for the most impoverished. This leads to further reflections about what we can do to get the richer countries involved in IVI. It's a puzzlement as to why they have not provided financial support. It may have to do with lack of clarity on our part or with things we don't understand. Each country here today can help by moving in its circles to promote and advance the IVI. You can ask a few pointed questions as to why developed countries aren't helping.

Statement by the Bill & Melinda Gates Foundation to Members of the Institute Support Council of the International Vaccine Institute

Although it is not possible for a representative of the Bill and Melinda Gates Foundation to be with you today, we want to express our hope that your important deliberations in Seoul are productive. As you know, the Foundation is very suppotive of your efforts and has awarded the DOMI program with a five year, $40 million gift.

We have confidence in the leadership and staff of the Institute, and we are pleased to assist in helping DOMI fulfil its mission of providing much needed aid to impoverished communities and individuals of the world. This can and should be an extraordinarily valuable component of an overall effort to develop and introduce life-saving vaccines.

We also applaud the generosity that others have shown the Institute, including the UNDP, the Republic of Korea and vaccine industry leaders, and we hope that the Foundation's grant will act as a catalyst, encouraging others to support this critical effort.

Much work remains, and we wil continue to encourage additional entities to join in this undertaking. With a diverse and broad base of support, the Institute can become a powerful force for reducing the health burden of vaccine-preventable diseases. Congratulations, and again we wish you a constructive session.

 

Board of Trustees News

Two new members elected to Board

Kean Wang's photo (33102 bytes) Professor Kean Wang graduated from Peking Union Medical College in 1970, and received his Master degree in medicine from the Chinese Academy of Medical Sciences in 1981 and a M.Sc. in Epidemiology and Biostatistics from McGill University, Canada in 1984. For the last 16 years, Professor Wang has worked at the Chinese Academy of Preventive Medicine (CAPM) as a researcher, Deputy Chief of the Epidemiology Department, Deputy Director of the Institute of Parasitic Diseases, the Vice President and, since 1996, as the President of CAPM. Before joining CAPM, he was a medical resident at Liyang and Zhaozhou County Hospitals. In addition, Professor Wang is Chairman of Advisory Committee of the Expanded Program on Immunization, Ministry of Health, China (MOHC); Vice Chairman of the Advisory Committee on Diabetes Prevention and Control, MOHC; Vice Chairman, Advisory Committee on AIDS, MOHC; the Director of National Center for AIDS Prevention and Control; President, Chinese Association of STD and AIDS Prevention and Control; a member of the Global Commission for the Certification of the Eradication of Poliomyelitis, WHO; and the Vice President of Chinese Preventive Medicine Association. He is also on the Advisory Committee on International Health, MOHC and was a member of the Western Pacific Advisory Committee on Health Research for WHO from 1995-1998. He is a member of editorial boards of the Bulletin of WHO, Southeast Asian Journal of Tropical Medicine and Public Health as well as Vice Chairman or member of the editorial boards of several Chinese scientific journals.
Prof. Kean Wang.JPG (4449 bytes) Dr. Thamrin Poeloegnan has served as the President Director of BioFarma since 1998, when he succeeded IVI previous Board member Drs. Darodjatun. Dr. Thamrin has been with BioFarma since 1971 where he has been in charge of smallpox vaccine and animal handling. He was also head of the BioFarma Secretariat and held the posts of Director of Planning and Development and Director of Marketing. Dr. Thamrin is a graduate of the Bogor Agricultural Institute and studied animal handling management in Australia. He served on the faculty of the Bogor Institute for five years before joining BioFarma. Dr. Thamrin has been an active member of Rotary and serves on the Polio Plus Committee of the Bandung Rotary. He is married and has three children.

 

Professor Chen Chunming and Drs. Darodjatun complete terms on Board of Trustees

Professor Chen Chunming and Drs. Darodjatun completed their terms on the Board of Trustees. Professor Chen is a Professor at the Chinese Academy of Preventive Medicine and was one of the founding members of the Board of Trustees. Drs. Darodjatun was also a founding member. He moved in 1998 from heading the Indonesian vaccine manufacturer, BioFarma, to heading the national pharmaceutical company, Kimia Farma. In noting their departure, Board Chairman Barry Bloom said, "The founding members of the Board of Trustees represented a courageous group. They committed their time and energies and lent their name to an unproven enterprise. Their vision helped sustain us all."

Progress on building construction

The IVI headquarters building continues to progress toward occupancy. As seen in the accompanying photo, construction is well underway. Exterior work is to be completed by the end of 2000.

 

IVI Staff Movements

Arrivals

Camilo J. Acosta, M.D., M.Sc., trained as a medical doctor in Colombia at the Javeriana University. In Colombia, he gained 3 years experience in tropical medicine and gave clinical support to Phase 1, 2b and 3 vaccine malaria trials. Dr. Acosta holds a Master's Degree in Communicable Disease Epidemiology from the London School of Hygiene and Tropical Medicine. He has recently finalized a PhD on malaria vaccine field testing under the supervision of Dr. Pedro L. Alonso and Dr. Carlos Ascaso, at the Department of Public Health, Barcelona University. As a research scientist, Dr. Acosta worked for 4 years at the Ifakara Health Research & Development Center in Tanzania, coordinating malaria and tuberculosis intervention trials. He also provided technical assistance to the district health management team on cholera, malaria, and tuberculosis control. Before joining IVI, he held a post - doctorate position at the Municipal Institute of Medical Research in Barcelona. Dr. Acosta joined IVI as a research scientist. His main task consists of the scientific coordination of all typhoid vaccine activities within the framework of the DOMI program.

Nyambat Batmunkh, M.D., is from Mongolia and graduated from the National Medical University of Mongolia in 1998. Afterward he completed a Korean Language Course in Seoul. He is studying in the M.P.H. Course, Department of Health Management Information System at the Graduate School of Health Science and Management,Yonsei University, Seoul. He is helping the Hib Project as an Intern.

M M Hossain, M.B.B.S.; Ph.D., D.T.M.&H., A physician- epidemiologist from Bangladesh, Dr. Hossain is educated and trained in Bangladesh (M.B.B.S.), USA (Ph.D. in Epidemiology), and Thailand (D.T.M.&H.). In the past he has worked in Bangladesh, Thailand, Cambodia, USA, Pakistan, Egypt, and the United Arab Emirates. He has been involved in many infectious disease research projects at different institutions including the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) and the Center for Infectious Disease, University of Texas-Houston Medical School and School of Public Health. Dr. Hossain is a Senior Scientist at the IVI and will play a leading role in the IVI's epidemiologic studies, including coordination of cholera projects in the DOMI Program.

Nurah W. Ammat' ullah (Rosalie P. Jeter) joins IVI as a United Nations Volunteer Librarian/ Information Specialist. Born in Trinidad and Tobago, she holds a B.S. in Women's Studies from the City University of New York; a Master's Degree in Library and Information Science, and a Certificate of Advanced Studies in Archival Management from Long Island University in New York. As a Librarian, Ms. Jeter has worked in academic and research libraries throughout the New York metropolitan area. Ms. Jeter is the founding Director of Family and Community Services at the Mount Hope Masjid in the Bronx, New York where she developed an emergency food and hunger-relief program for a predominantly immigrant population. She is a member of the New York City Inter-Faith Organization, Women in Religious Leadership, which focuses on faith-based community development, and Women in Islam, a coalition of professional and social activists.

Gyoungsun Kong, R.N.,M.P.H., Before she joined IVI in June 2000, Ms. Gyoungsun Kong worked at Samsung Medical Cancer Center for 5 years as a Clinical Research Associate. Her major was Nursing Science and she finishes her Master's Degree in Public Health this summer. While studying at the Graduate School of Health Science and Management in Yonsei University, she had the opportunity to visit China and Nepal to see local health care practices.

Eunsik Park, Ph.D., was most recently a Research Statistician at the University of North Carolina, Chapel Hill. In addition to receiving a Ph.D. Degree in Statistics from Seoul National University, Dr. Park worked as a Post-doctoral Fellow at National Institute of Child Health and Human Development, U.S. NIH from March 1996 to May 1998. She has assumed the post of Statistical and Data Management Officer at IVI. She will serve as a statistician for the DOMI Program as well as other projects. She will also supervise development and implementation of data management systems.

Eunsook Park. Ms. Eunsook Park worked at Samsung Petrochemical for 10 years before she came to IVI in May. She was Administrative Manager at Samsung Petrochemical, working with the expatriates from BP Amoco Chemicals of the US and from Mitsui of Japan. She had more than two years' experience with a Dutch Company before she began her career with Samsung. She holds a Bachelor's Degree in English Language and Education. At IVI she will provide senior administrative assistance for technical cooperation programs, and she will also provide support for fund raising and Board matters.

Lorenz von Seidlein, M.D.,M.Sc., was born in Munich, Germany. Dr. Seidlein attended the Royal College of Surgeons in Ireland between 1982 and 1988. Following one year of internships in the London area, he moved to Miami, USA for 3 years of Pediatrics training. In 1992 he went to UCLA for Infectious Diseases Training including laboratory research on viral characteristics responsible for materno-fetal HIV transmission. He also worked in The Gambia, West Africa to conduct two antimalarial drug trials and returned to London at the end of 1996 to attend a one year course in communicable disease epidemiology at the London School of Hygiene and Tropical Medicine. After short assignments in Zvornic, former Yugoslavia, and Artibonite valley, Haiti, at the end of 1997 and the beginning of 1998, he went back to The Gambia in April 1998 and conducted another antimalarial drug trial which he completed in December 1998, followed by a mass drug administration trial in 1999. At IVI he will serve as the scientific coordinator of shigellosis projects with the DOMI Program.

Yong Ae Im Shin, Ph. D., joined the IVI in May, 2000 upon her retirement from the National Institutes of Health in the United States at the end of 1999. Dr. Shin's tenure at NIH spanned 35 years of service, consisting of 25 years of conducting research at the National Insititute on Aging as a Research Scientist, and 10 years as a Health Scientist Administrator supporting biomedical science research outside of NIH, as well as a Program Director at the National Institute of General Medical Sciences. During the last 7 years at NIH she was a Scientific Review Administrator at the National Institute of Dental and Craniofacial Research. Dr. Shin was born in Seoul Korea, went to United States of America in 1953 upon graduating from high school (Kyung Gi Girls High School) in 1950. She earned her Ph.D. in chemistry from the Ohio State University in 1960, and trained as a post-doctoral fellow at University of Illinois at Urbana before joining NIH. Dr. Shin currently serves as a Senior Administrative Scientist at the IVI. Her main responsibility is to oversee activities related to the DOMI Program.

Departures

Dr. Joo Yeun Kim left IVI to start a biotechnology consulting firm. Dr. Kim was an important and highly effective team member in the launch and effective management of the Invasive Bacterial Diseases in Asian Children project. Dr. Yong Soo Lee retired from the IVI in January. As a retired science journalist, he brought tremendous skills to IVI. He was responsible for IVI's Korean language publications. Ms. Kyunghee Oh and Ms. Da Eun Hyun coincidentally chose the same life path. They have moved to Canada. Ms. Oh is joining her new husband while Ms. Hyun will continue her studies.

 

Recent Visitors to IVI

January
Lorenz von Seidlein
, Medical Research Council (MRC), West Africa
Ulf Bjare, SBL Vaccine,Sweden
Camilo Acosta, Global Epidemiology, Pharma Novartis, Spain
Yong Ae Im Shin, Health Scientist, Administrator, National Institute of Dental and Craniofacial Research, NIH, USA
Seung-il Shin, Vaxgen Inc, USA
Philip Berman, Vaxgen Inc, USA
Timithy Gregory, Genetech, USA
H.E. Yahya S. H. Al-Wahaibi, Ambassador of the Sultanate of Oman, Korea
Michael Baker, Reporter, Korea
Dong Taek Cho, Professor, School of Medicine, Kyungpook National University, Korea
Ding Ding, Associate Professor, Department of Epidemiology, School of Public Health, Shanghai Medical University, China
Na-Gyong Lee, Senior Scientist, R & D Center of Bioscience, Institute of Science & Technology, Cheil Jedang Corporation, Korea.
Violaine Mitchell, Coordinator, GAVI Task Force, World Bank, USA
Kees Lucas, TNO, Netherlands
Tikki Pang, Director, RPC/EIP, WHO, Switzerland

February
Magdalene Toroansi, Counsellor, Embassy of Papua New Guinea, Korea
Sang-Dai Park, Professor, Department of Molecular Biology, College of Natural Sciences, Seoul National University, Korea
Bonita Stanton, Chairperson, Pediatrics, School of Medicine, West Virgina University, USA
Luis Herrera Martinez, Director General, Centro de Ingenieria Genetia y Biotecnologia, Cuba
Achmad Sujudi, Minister of Health, Indonesia
Sampurno, Director General of the Food and Drug Control Agency, Indonesia
Rusmono, Chairman of the Commissioners of Bio-Farma, Indonesia
Thamrin Poeloengan, President Director of Bio-Farma, Indonesia
Keun Huh, Commissioner, KFDA, Korea
Il-Sup Huh, President, KGCC, Korea
Dal-Ho Um, Executive managing Director/ Plant Manager, KGCC, Korea
Min-Taek Lee, Manager, KGCC, Korea
Yoo-Jin Kim, Chief of Regulatory Affairs, KGCC, Korea
Joel Vanderburg, WHO Country Liaison Officer, Korea
M.M. Hossain, Associate Professor, Faculty of medicine, UAE University, United Arab Emirates

March
Jean-Claude Wehrle, President, Separation Division, Sartorius AG, Germany
Maik W.Jornitz, Director of Product and Marketing Management, Separation Technology Division, Sartorius AG, Germany
Jongmin(Hohn) Kim, President, Sartorius Asia-Pacific Division, Separation Technology, Korea
D.S. Kim, Korea Area Manager, Separation Technology, Sartorius Korea Ltd., Korea.
Hans Lee, Application Engineer, Separation Technology, Sartorius Korea Ltd., Korea
Odile Leroy, Director, Corporate Clinical Program, Aventis Pasteur, France
Honghui Yang, Chief Director of Epidemiology, Guangxi Health and Antiepidemic Center (GHAEC), China
Michael F. Good, Director, Cooperative Research Center for Vaccine Technology, Queensland Institute of Medical Research, Australia
Jan Holmgren, Professor, Department of Medical Microbiology and Immunology, Goteborg University, Sweden

Stefan Kaufmann, Director, Department of Immunology, Max Planck Institute for Infection Biology, Germany.
John R. La Montagne, Deputy Director, National Institute of Allergy & Infectious Disease, National Institute of Health, USA
Margaret A. Liu, Vice President, Vaccine Research, Chiron Corporation, USA
Pil-Woo Kim, Assistant Director, United Nations Economic Affairs Division, Ministry of Foreign Affairs and Trade, Korea
Somsey Norinder, Resident Representative, United Nations Development Programme, Korea
Sang Tae Han, Former member of IVI Board of Trustees
Md. Nazrul Islam, Third Secretary, Embassy of the People's Republic of Bangladesh, Korea.
Yao Ying, Counsellor, Embassy of the People's Republic of China, Korea
H.E. Leif Donde, Ambassador, Royal Danish Embassy, Korea
H.E.Patricio Zuquilanda-Duque, Ambassador, Embassy of the Republic of Ecuador, Korea
H.E. Jauhari Nataatmaja, Ambassador, Embassy of Republic of the Arab Republic of Egypt, Korea
Ariel Shafransky, Second Secretary, Embassy of Israel, Korea
H.E. Tulegen T. Zhukeyev, Ambassador, Embassy of the Republic of Kazakhstan, Korea
U Phae Thann Oo, Minister Counsellor, Embassy of the Union of Myanmar, Korea
H.E. Henry J. De. Vries, Ambassador, Royal Netherlands Embassy, Korea
H.E. Tariq Osman Hyder, Ambassador, Embassy of the Islamic Republic of Pakistan, Korea
H.E. david Famundi Anggo, Ambassador, Embassy of Papua New Guinea, Korea
H.E. Juanito Jarasa, Ambassador, Embassy of the Republic of the Philippines, Korea
Aurelian Neagu, Counsellor, Embassy of Romania, Korea
H.E. K.C. Logeswaran, Ambassador, Embassy of the Democratic Socialist Republic of Sri Lanka, Korea
Cinar Ergin, Third Secretary, Embassy of the Republic of Turkey, Korea.
H.E. Stephen D.R. Brown, Ambassador, Embassy of United Kingdom of Great Britain aand Northern Ireland, Korea
Dauglas Whitelaw, First Secretary(Science), Embassy of the United Kingdom of Great Britain and Northern Ireland, Korea & Deputy Director, British Council, Korea
Ralf Clemens, Smithkline Beecham, Biologicals, Belgium
Somsong Rugpao, Director-General, Department of Communicable Diseases Control, Ministry of Health, Thailand
Supamit Chunsuttiwat, Acting Director, Department of Communicable Diseases Control, Ministry of Health, Thailand

April
Kazuyuki Kokubun, Second Secretary, Embassy of Japan, Korea
Hirohisa Soma, Deputy Director, Multilateral Cooperation Division, Economic Cooperation Bureau, Ministry of Foreign Affairs, Japan
Tetsushi Kondo, Desk Officer, Multilateral Cooperation Division, Economic Cooperation Bureau, Ministry of Foreign Affairs, Japan
Chris Maher, EPI Technical Officer, WHO Western Pacific Regional Office (WPRO), The Philippines
Robert Chen, Chief, Vaccine Safety & Development Activity, CDC, USA
H.E. Renier Nijskens, Ambassodor, Embassy of Belgium, Korea.




May
Rajiv Bahl, Department of Pediatrics, All India Institute of Medical Sciences, India
Zulfiqar Ahmed Bhutta, Professor of Pediatrics and Child Health, The Aga Khan University, Pakistan
Wanpen Chaicumpa, Professor of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University, Thailand
M. Kuppuswamy, Vice President, Bharat Biotech International Limited, India
Tikki Pang, Director RCP/EIP, WHO, Switzerland
Cyrus H. Simanjunta, National Institute of Health Research & Development, Ministry of Health, Indonesia
Shousun C. Szu, National Institute of Child Health & Human Development, National Institutes of Health, USA
Thomas L. Hale, Walter Reed Army Institute of Research, USA
Bernard Ivanoff, Vaccines & Other Biologicals, WHO, Switzerland
Myron M. Levine, Center for Vaccine development, School of Medicine, University of Maryland, USA
Philippe J. Sansonetti, Institut Pasteur, France
Dennis Lang, NIAID, National Institute of Health, USA
Dominique Legros, EPICENTRE, MSF, France
John Mekalanos, Professor, Harvard Medical School, Harvard University, USA
David Sack, Director, International Centre for Diarrhoeal Disease Research, Bangladesh
Dang Tuc Trach, National Institute of Hygiene and Epidemiology, Vietnam
Claire Lise Chaignat, Communicable Disease Surveillance & Response, WHO, Switzerland
Kaemthong Indaratna, Faculty of Economics, Chulalongkorn University, Thailand
Benny Kaligis, Quality Assurance Manager, P.T.Bio Farma, Indonesia
Linda Kaljee, Department of Pediatrics, University of Maryland, USA
Osman David Mansoor, Short-term Consultant, EPI Unit, WHO Western Pacific Regional Office (WPRO), The Philippines
Mark Miller, Associate Director of Research, Fogarty International Center, USA
Chris Nelson, WHO-HTP/VAB/VAM, Switzerland
Young Jack Lee, Chaired Professor, Hangyang University, Korea.
Tae Sung Park, Associate Professor, Department Of Statistics, Seoul National University, Korea
Youngdai Kim, Associate Professor, Department of Statistics, Hankook University of Foreign Studies, Korea.
Rosalie Nurah Jeter, New York
Michael Goon, Deputy Director-General, Finance and Administration, WARDA, Ivory Coast

June
Peter Andrews, Director, Centre for Drug Design and Development, The University of Queensland, Australia.
Andrew Han, CEO, IMAGEN Co., Ltd, Korea
Philip K. Ngai, Plant Manager, Hong Kong Institute of Biotechnology Ltd., Manufacturing Technology Centre, Hong Kong. 





 

 

 

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