This document is an electronic version of the Institute's newsletter. To obtain a printed copy of the newsletter, e-mail the Institute providing your name & full mailing address...

Issue Number 002, May 1996

Contents

The IVI Newsletter is published by the International Vaccine Institute. It seeks to provide timely, useful information pertinent to scientists and policy-makers with an interest in vaccine science and technology development. It is distributed free of charge.

Editor: Gurinder S Shahi
Circulation Desk: Eunyoung Kim: eykim@ivi.org

The IVI Newsletter is interested in your views and perspectives. Readers wishing to submit suggestions, comments, letters to the editor, information regarding activities or events, or articles to be considered for publication may contact the Editor, The IVI Newsletter.

To be placed on the mailing list or to make address corrections, write to the Newsletter Circulation Desk.

The International Vaccine Institute
Seoul National University Campus
Shillim-Dong, Kwanak-Ku
Seoul, Korea 151-742
Tel: 82-2-872-2801; Fax: 82-2-872-2803
e-mail: Webmaster@ivi.org

Publication of this issue of The IVI Newsletter has been supported by grants from The Asia Foundation, the Republic of Korea, Quintiles (an international contract-research organization), and the United Nations Development Programme.

Return to the Top

Institute News

IVI Legal Establishment

Although the International Vaccine Institute has been functioning for over a year, it does not yet exist as a free standing, independent institution. The Institute currently operates as a project of the United Nations Development Programme. All staff members work for UNDP and not, strictly speaking, for the Institute. The Institute will only be able to do its own hiring and firing, or sign legally binding agreements on its own behalf, when it acquires, in legal parlance, a "juridical personality". Steps are currently being undertaken to legally establish the Institute - at which time it would be deemed to possess such a "juridical personality".

There are several ways for an international organization to be legally established. It can, for example, be registered as an independent, international organization in accordance with the laws of a sovereign nation. The International Center for Diarrhoeal Disease Research in Bangladesh and the International Rice Research Institute in the Philippines, for example, are legally registered only in the countries in which they are based, yet are universally recognized as independent international organizations.

Another mechanism would be for an already established international organ, such as the United Nations General Assembly, to establish the organization. Such a mechanism was used, for example, to establish the World Health Organization, and the various Bretton Woods institutions.

Yet another mechanism is for two or more sovereign nations to come together to agree to establish an international organization. Many regional organizations, such as the European Union (EU) or the Association for South East Asian Nations (ASEAN) were established in this manner, as were such independent, international organizations as the International Plant Genetic Resources Institute (IPGRI) in Rome, Italy.

These are all commonly accepted mechanisms for establishing international organizations. Nevertheless, the specifics intrinsic to each mechanism can have substantial implications for the governance, management, staffing, and potential effectiveness and impact of the institution being established. After carefully reviewing the various options, UNDP and the Government of Korea concluded that the best way to minimize potential bureaucratic encumbrances, and to guarantee the intellectual freedom and administrative flexibility that an institution like the International Vaccine Institute would require if it is to succeed, would be to establish it as an independent, international organization by intergovernmental agreement (that is, to utilize the third alternative mechanism outlined above).

The Consultative Group on International Agricultural Research (CGIAR), which UNDP has actively supported since its inception, has had a distinguished record in institution-building. The institutions which CGIAR oversees are generally considered to be very successful and have been credited with helping to fuel the green revolution in agriculture. UNDP and the Government of Korea have been so impressed by the very clear and uncomplicated process by which CGIAR oversaw the establishment of IPGRI, the latest addition to the CGIAR family of institutions, that they have chosen to use a similar approach in establishing the International Vaccine Institute.

UNDP and the Government of Korea plan for the establishment formalities for the Institute to be completed during the Summer of 1996. Several steps are involved in this process, and include:

1. Finalization of the Institute's Establishment Agreement. The Establishment Agreement, which will be open to signature by sovereign national governments and recognized international organizations, is currently the subject of last-minute review by the Legal Department of the United Nations. The agreement will outline the mission and objectives of the Institute, identify its seat, and delineate its governance and funding mechanisms. A key feature of the agreement, which it shares with the IPGRI Establishment Agreement, is that countries and institutions signing the agreement are not obligated to provide funding for the Institute beyond voluntary funding contributions.

2. Distribution of the Establishment Agreement. Copies of the Establishment Agreement and the draft Constitution of the Institute will be widely circulated. Depending on the practices of each government, decision regarding whether to sign the document will be made by the head of state, by the cabinet, or by an act of parliament.

3. Signing of the Establishment Agreement. Those governments and organizations which wish to be recognized as founders of the Institute will be invited to sign the agreement on a predetermined date which signifies the commencement of availability of the Agreement document for signing. Under international law, the Agreement may be signed by the Minister of Foreign Affairs of a sovereign country or by her/his authorized representative (who could, for example, be the country's Ambassador to the United Nations, or any other individual authorized to sign the agreement on behalf of the government). The Agreement is to be made available for signing at the United Nations in New York, where it will subsequently be permanently held in repository and be available for signing by those countries which choose to sign at a later date.

4. Legal Establishment of the Institute. The Agreement will come into force, and the Institute recognized as an independent, international organization, when three or more sovereign nations sign it.

Already, several governments have informally indicated their commitment to the mission and goals of the Institute, and their interest and willingness in signing the agreement. Legal formalities for establishment of the Institute will be completed during the Summer of 1996. UNDP and the Government of Korea believe, in the interest of openness and transparency, that the Establishment Agreement and the draft Constitution documents should be made freely available. Interested individuals may obtain copies by writing to the Institute or, alternatively, may down-load these documents from the Institute's WWW Site at http:/www.plaza.snu.ac.kr/~ivisnu/.

IVI Construction Planning Starts

A purpose-designed headquarters facility for the Institute, which will incorporate state-of-the-art research and development laboratories, is being constructed on the campus of the Seoul National University, Korea's premier academic institution.

A Construction Committee, which will oversee all phases of the design and construction of the Institute, has been established with representation from Seoul National University, the Government of Korea, and the International Vaccine Institute. It is anticipated that design and planning for the Institute, to be undertaken through competitive bidding, will be completed by mid-1996, and that the facility will be ready for occupation by early 1998.

As part of the preparatory process for construction planning, several Committee members recently toured highly regarded research and development and quality control facilities in Australia, the United Kingdom and the United States. Interested readers who have been involved in the design and planning of similar facilities, and who wish to share their experiences or offer constructive advice or caveats are invited to write to the Institute.

IVI Program Development Brainstorm Session in London

A group of prominent British scientists working on infectious diseases and vaccines met in London on 29 January, 1996, for an informal scientific brainstorming session to promote closer linkage between the British scientific community and the IVI, and to provide input to assist on-going efforts at program development for the Institute. The session was organized by Prof. Brigitte Askonas and Prof. Douglas Young (both of Imperial College, London), and Dr. Seung-il Shin (IVI). The Wellcome Trust provided financial support and kindly offered its Boardroom as the venue for the meeting. Dr. Felicity Cutts (London School of Hygiene and Tropical Medicine) graciously agreed to serve as rapporteur for the meeting.

Other experts who participated in the meeting include: Peter Beverley (Edward Jenner Institute for Vaccine Research, Compton), Mary Collins (Chester Beatty Laboratories, London), Catherine Davies (The Wellcome Trust), Gordon Dougan (Imperial College, London), Catherine Fletcher (The Wellcome Trust), Brian Greenwood (London School of Hygiene and Tropical Medicine), George Griffin (St. George's Hospital Medical School, London), Andrew Hall (London School of Hygiene and Tropical Medicine), Adrian Hill (John Radcliffe Hospital, Oxford), Kees Lucas (TNO, Leiden, The Netherlands), Andrew McMichael (John Radcliffe Hospital, Oxford), Bridget Ogilvie (The Wellcome Trust), Alan Rickinson (University of Birmingham), David Salisbury (Department of Health, London), Geoffrey Schild (National Institute for Biological Standards and Control, Potters Bar), John Stephenson (The Wellcome Trust), and Brian Thorpe (Overseas Development Administration, London). Rodney Phillips (John Radcliffe Hospital, Oxford) and Robin Weiss (Chester Beatty Laboratories, London) could not attend the session, but sent in their comments and suggestions.

Dr. Bridget Ogilvie, Director of The Wellcome Trust, opened the day-long meeting. Prof. Askonas, who chaired the first session, called on selected participants to review the state of the art of research in several major disease areas, and to highlight promising approaches for vaccine development that may be useful to consider, particularly for the new Institute. Prof. Young chaired the afternoon session. Several experts with long histories of personal involvement in field evaluations of vaccines in Africa and Asia described their experiences. Prof. Peter Beverly, recently appointed as Director of the newly established Edward Jenner Institute of Vaccine Research near Oxford, offered to "compare notes" with IVI as he works towards shaping the new British institute. There was lively discussion concerning potential areas of program focus for the Institute, as well as a consideration of key factors that would be required for success of a new international institution based in a developing country such as Korea. At the end of the day, the group made a list of recommendations for the IVI. These included the suggestions that it should maintain a strong intellectual linkage, and develop an appropriate framework for future collaborative interaction, with British research groups.

The London meeting was the second brainstorming session that was organized specifically to help the IVI staff develop its scientific and technical programs. The first such session, held in December, 1994, in New York, was attended by Barry Bloom (Albert Einstein College of Medicine), Alfred Prince (The New York Blood Center), Jerry Sadoff (Walter Reed Army Institute of Research), and George Siber (The Massachusetts Public Health Laboratory), as well as Frank Hartvelt, Timothy Rothermel, Michael Sacks, Gurinder Shahi and Seung-il Shin, all from UNDP, and Kees Lucas from the Netherlands. Until a formal scientific advisory committee is constituted, the IVI plans to regularly organize similar meetings to receive continuing scientific input as the Institute's early programs take shape. Such meetings should additionally serve as an effective means to develop cooperative linkages with scientific colleagues in different parts of the world. Minutes of the London brainstorm session are expected to be available soon, when they can be obtained from the Institute. - Seung-il Shin -

Return to the Contents page

CVI News

The Children's Vaccine Initiative (CVI) held its Fifth Consultative Group meeting at the Dante Pazzanese Institute of Cardiology Conference Center in Sao Paolo, Brazil, on October 25 and 26, 1995. The meeting was attended by over 300 scientists and policy-makers representing the wide range of institutions, agencies and corporations which constitute the CVI.

The meeting provided an opportunity to review the progress made since the World Summit for Children in 1990, and the formal establishment of the Children's Vaccine Initiative in 1991. It also provided an opportunity to reexamine CVI's direction and focus, and to redefine its role as we enter the 21st Century.

The meeting was designed to provide maximum opportunities for interaction. It provided for plenary sessions and a series of four workshops aimed at reshaping the CVI Strategic Plan. The workshop themes (convenors for each workshop are listed in brackets) include:

1. Advocacy for Immunization and Vaccine Development (Convenors: Dr. I. Arita, Mr. Andy Burness)

2. Intellectual Property Rights (Convenors: Mr. Charles Caruso, Prof. Isaias Raw)

3. Choosing Desirable Vaccines and Vaccine Combinations for the 21st Century (Convenors: Dr. S. Ramachandran, Dr. John La Montagne)

4. Financing New Vaccine Introduction (Convenors: Dr. Bjorn Melgaard, Dr. Terrel Hill)

For further information and to obtain a copy of the meeting and/or workshop reports, contact:
Dr. Roy Widdus, Coordinator, Children's Vaccine Initiative Secretariat
c/o World Health Organization, 20 Avenue Appia, CH-1211 Geneva 22, Switzerland
(Tel: 41-22-791-4369; Fax: 41-22-791-4888; e-mail: widdusr@who.ch)

Return to the Contents page

Meetings Reports

Report on SEARO Meeting on VSQ

This meeting, held in New Delhi on December 2 - 5, 1996, brought together key scientists and policy-makers from vaccine producing and non-producing countries in WHO's South East Asia Region to consider how to maintain and achieve vaccine self-sufficiency.

The meeting introduced participants to the concept of a Global Vaccine Production Initiative (see page x), wherein a Vaccine Producers' Consortium is envisaged together with several regional Control Laboratory networks. It also provided an excellent forum to consider the needs and concerns of vaccine producers, national control laboratories, and national EPI programs in the region.

The meeting also incorporated a Special Meeting to establish a Laboratory Control Network for the South East Asia region on December 4, 1996. Participants at this special meeting agreed that the National Control Laboratories (NCLs) of India (at Kasauli), Indonesia, and Thailand would be the Charter members of the Network. NCLs of Bangladesh, Myanmar, DPR Korea, and the fledgling National Institute of Biologicals of India (which will, in time, be expected to assume the role of India's national control laboratory, possibly in collaboration with the existing laboratory at Kasauli) would be observers initially.

WHO agreed to assist the Network through such support activities as:

- providing standards, cell and antisera for measles and poliomyelitis

- organizing a regional workshop on viral vaccine potency

- establishing a proficiency panel for DTP

- establishing a BCG testing proficiency system

- providing network members with guidelines for the release of newer vaccines

- developing protocols for collaborative study on diphtheria standards

- establishing suitable mechanisms for communication between network partner institutions

- planning a future workshop on in vitro methods for testing DTP

Network members also agreed that CDL Kasauli would be developed into a regional center for yellow fever testing (once certified).

The SEARO meeting on VSQ was very successful, and appears to have laid the groundwork for future close cooperation and collaboration on vaccine production, testing and supply in the South East Asia region.

Contact:Dr. Imam Mochny, CVI Adviser, SEARO/WHO (Tel: 91-11-331-7804; Fax: 91-11-331-8607)

Japanese Research Group for Vaccine Self-Sufficiency

The Research Group for Vaccine Self-Sufficiency (RGVS) met at the Japan National Institute for Health in Tokyo on December 14-15, 1995 to review work completed during 1995 and to formulate recommendations for the consideration of Japan's Ministry of Health and Welfare.

In addition to members of the RGVS, the meeting was attended by experts from other agencies including the World Health Organization Global Programme for Vaccines and Immunization (WHO/GPV) in Geneva, the WHO Western Pacific Regional Office (WPRO) in Manila, the Pan American Health Organization (PAHO) in Washington, D.C. and International Vaccine Institute (IVI) in Seoul, Korea. Experts from several Japanese universities and vaccine institutes also participated in the meeting.

During 1995, RGVS members visited China, Indonesia, the Philippines, Thailand and Vietnam to assess vaccine production. The assessments looked particularly at needs and opportunities related to quality assurance/quality control (QA/QC) and to Good Manufacturing Practices.

The meeting concluded that while substantial progress had been made in each country towards self-sufficiency, there was still urgent need for assistance with training, upgrading of facilities, and provision of advanced equipment. Such assistance is needed by manufacturers, NCAs and NCLs. Also, it was noted that none of the countries evaluated has a comprehensive strategy for accessing new vaccines that will emerge from R&D in the coming years. - Richard T. Mahoney -

For further information contact:
Dr. Isao Arita, Chairman, Agency for Cooperation in International Health
4-11-1 Higashimachi, Kumamoto City 860, Japan

Return to the Contents page

News and Views

The International AIDS Vaccine Initiative

The International AIDS Vaccine Initiative, a new global effort designed to accelerate the development of a safe and effective preventive vaccine (or vaccines) against HIV, has recently been established following a series of meetings in 1994 and 1995 which were sponsored by The Rockefeller Foundation. The meetings were attended by "scientists, public health officials, development specialists, financial experts, policy makers, industry representatives and members of the HIV and philanthropic communities".

Recognizing the continued rapid spread of the HIV epidemic (especially in developing countries), the heavy human and financial costs that the epidemic will exact (especially to poor developing countries), and the potential benefit that effective and inexpensive vaccines can bring, the Initiative's sole mandate is to work towards the development of an HIV vaccine appropriate for use where it is most needed. Among its activities, the Initiative hopes to create a more favorable environment for investment in HIV vaccine development, and is developing a targeted R&D program.

Options being considered to encourage investment focus on reducing the uncertainties and risks associated with vaccine development through such mechanisms as creating a credible market in developing countries (through, for example, the use of international loans to guarantee the procurement of products meeting specified criteria), or reducing the potential costs of liability exposure (through, for example, the establishment of a specific vaccine insurance scheme). The Initiative's R&D agenda seeks to complement on-going scientific activities, and focuses on such strategies as developing research approaches that have promise but are currently under-explored, and developing candidate vaccines from HIV subtypes found in areas of the world where the epidemic is spreading most rapidly.

The Initiative's interim secretariat is temporarily housed at premises of The Rockefeller Foundation in New York.

For Information:
International AIDS Vaccine Initiative Interim Secretariat, The Rockefeller Foundation,
420 Fifth Avenue, New York, NY 10018-2702 (Tel: 1-212-852-8349; Fax: 1-212-764-3468)

Joint Ventures involving Korean Hepatitis B Vaccine Producers: