The IVI Newsletter - November 1996

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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.

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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.

Representatives of 12 member states of the United Nations and the representative of the World Health Organization met in Conference Room number 8 at the United Nations General Assembly building in New York on October 28, 1996, to sign the agreement to establish the International Vaccine Institute.

In opening the Signing Ceremony for the Establishment, Mr. James Gustave Speth, UNDP's Administrator, said, "The International Vaccine Institute will fill a great need. It will be the world's only international research centre devoted to vaccines for developing countries, and should serve as a catalyst to ensure that the benefits generated by new technology will lead to healthier lives and livelihoods, especially for the poor."

Countries which signed the agreement on October 28 were: Bangladesh, Bhutan, Indonesia, Kazakhstan, Republic of Korea, Monglia, the Netherlands, Panama, Romania, Thailand, Viet Nam and Uzbekistan. Deputy Director-General Dr. Hu Ching-Li signed on behalf of the World Health Organization. The Agreement will be available for signature by other interested states and international organizations over the next two years. The Secretary-General of the United Nations serves as its Depositary.

The occasion was witnessed by observers from a number of interested member states including Australia, France, Germany, Japan, the Philippines, Poland and Singapore. Prof. Barry Bloom (Chairman, UNDP Advisory Board of Trustees of IVI), Prof. Wan-Kyoo Cho (Chairman, Korean Committee for IVI), Dr. Las Pallesen (Director, Statens Seruminstitut, Denmark), Dr. Jong Wook Lee (Director, Global Programme on Vaccines and Immunization, WHO, and Executive Secretary, Children's Vaccine Initiative), Prof. Sang Dai Park (Chairman, IVI Planning and Support Committee of Seoul National University), and Dr. Roy Widdus (Coordinator, Children's Vaccine Initiative) were among the special guests at the Ceremony.

The agreement comes into force when three or more sovereign nations ratify it. This is likely to occur before the end of 1996. Sovereign states and international organizations which wish to sign the Agreement should contact the Treaty Section of the United Nations in New York.

Notes: Senegal signed the Establishment Agreement on October 30, and the Philippines signed on November 5. The total number of signatory countries as we went to press stood at 14.

The International Vaccine Institute is organizing 3 major events in mid-November: a meeting of the Institute's Network Coordinating Group on November 13, the IVI Symposium on November 14, and the Board of Trustees meeting from November 15 to 18.

The Network Coordinating Group's inaugural meeting is expected to result in the formal establishment of the "brain" behind the Institute's network of partner institutions. As conceived, the Network Coordinating Group (NCG) will provide a forum to consider and develop the various programs and initiatives of the Institute, particularly as they relate to the concerns of the Institute's network partner institutions. They will also consider how best to pool the capabilities, skills and resources possessed by each institution towards meeting common concerns and achieving common objectives.

Representatives of the following institutions (the majority of which were represented at the IVI Regional Consultation in May, 1995) will attend the NCG meeting:

The meeting is expected to focus on determining the criteria for IVI Network membership, and on developing a plan of work for 1997/98 for the collaborative network.

Construction planning for the permanent facilities of the International Vaccine Institute took a step forward in October 1996 when prospective architects/engineers were invited to submit proposals for the design of the state-of-the-art research and development facilities.

Over the past several months, ideas regarding the design of the Institute have taken shape through consultations with leading scientists and visits by members of the IVI Construction Committee (made up of representatives of the Korean government, Seoul National University, and the International Vaccine Institute) to centers of research and development excellence in Australia, the United Kingdom and the United States. The Institute will likely establish laboratories for research in such areas as immunology, virology, bacteriology, parasitology, and discovery research, in addition to developing its capabilities for epidemiology and surveillance, and for pharmacoeconomic and policy analysis. It will also include a small pilot plant for training and small batch production of antigens and related biological products, and animal holding facilities for small mammals.

It is anticipated that the contract to design the Institute will be awarded by January, 1996, and that it would take approximately six months to complete the design process. Ground-breaking for construction will likely take place in Summer, 1997, after which construction will begin in earnest. The facilities are expected to be completed by 1999, which would enable the Institute to occupy its permanent facilities in time for the new millennium

As recently as the 1960s, epidemics of poliomyelitis struck as many as 20,000 people, many of them children, each year in the United States. It often led to paralysis or death.

Dr. Jonas Salk developed a vaccine against poliomyelitis in 1955. This was a killed vaccine administered by injection - injected polio vaccine (IPV). Dr. Albert Sabin subsequently developed a live attenuated orally administered vaccine - oral polio vaccine (OPV). Both vaccines increase immunity against polio, but only OPV prevents the recipient from carrying and possibly spreading the "wild" virus. Hence, OPV began to replace IPV as the vaccine of choice in 1961.

OPV was extremely successful in controlling poliomyelitis, which was eliminated from the United States in 1978. By 1990, poliomyelitis was virtually eliminated from the Americas using OPV and a highly effective strategy of national immunization days (NIDs), which has since been replicated with great success in national immunization programs throughout the world.

Since polio elimination in the Americas, the only cases of poliomyelitis in the region have been due to infection caused by the live attenuated polio virus in OPV itself. The US, for example, has seen, since 1979, about 8 to 10 cases of polio each year caused by OPV. IPV, on the other hand, being a killed vaccine, carries no risk of causing poliomyelitis.

Currently, the practice in the US is to administer three doses of OPV by age two. In June, 1996, a US Centers for Disease Control and Prevention (CDC) Advisory Panel recommended a change in vaccination policy whereby infants would be administered two doses of IPV in the first four months of life, followed by two doses of OPV to be administered between ages one and six.

CDC announced in mid-September that it had accepted the Advisory Panel's recommendation, and that it was issuing a new guideline recommending the change to IPV/OPV vaccination. The guideline will come into effect in 1997.

An Associated Press news release quoted CDC Director David Satcher as saying, "Since 1979, the only polio we have had in this country has been due to the vaccine itself. That's what we are trying to solve." Using IPV and OPV according to the guidelines is expected to halve the risk of contracting polio from the oral vaccine.

Using both vaccines would cost the United States government about $14.7 million more a year than just OPV alone. "We think that's a price worth paying," Dr. Walter Orenstein of CDC's National Immunization Program told Associated Press.

CDC expects that the new policy will remain in force over the next three to five years, after which it intends to recommend a switch to IPV alone.

Editor's Note: Recognizing the potential influence and impact of the US CDC move on vaccination policy in other countries, we asked our colleagues at the World Health Organization's GPV (Global Programme and Vaccines and Immunization) for their reaction. Dr. Harold Hull of GPV's polio eradication team provided the following response:

I would say that we are disappointed that the US has taken this move at this time, but recognize that there are differences in our approaches. WHO is focused primarily on the global eradication of polio, on preventing the estimated 70 000 cases of paralytic polio which still occur. The US has stopped transmission within its borders, and is focused on preventing the 8-10 cases of vaccine associated polio which occur each year in the US.

We had previously expressed our concerns about the proposed schedule change on two grounds. One, it might stimulate other countries where polio remains endemic to adopt a similar policy. The academic community in a number of developing countries have pushed for the use of IPV based on prior recommendations of the United States Institute of Medicine which called for the US to switch to IPV. The change in the US schedule will, I think, strengthen their voices. If an endemic country would adopt a mixed schedule, it would be expensive and has the potential to damage the polio eradication effort by making less vaccine available to vaccinate the poorest, most difficult to reach children who often represent the major reservoir of wild virus infection.

Our second concern was that with a fiscally conservative [US] Congress that an either/or scenario might develop - with the expensive new schedule pitted against polio eradication. This has not developed to date. In fact, funding for global polio eradication activities by the US Government is increasing.

We note several points: first, vaccine-associated polio is truly rare. Second, the new schedule will not prevent all cases of vaccine-associated polio. Third, in the final analysis, we feel that the global eradication of polio is the best solution to vaccine-associated polio. After eradication is certified, vaccination will stop. There will be no cases of vaccine-associated polio anywhere in the world and the cost will be zero. Global eradication will also prevent all cases of polio due to wild virus.

The Institute's training and education activities got off to a solid start with two well received courses - the first, on quality assurance, good manufacturing practice, and quality control (QA/GMP/QC) in Bandung, Indonesia, and the second on vaccine production management in Beijing, China. Both events were well attended with 39 participants/observers at the Bandung meeting and 49 participants at the Beijing meeting.

Sustainability is seen as a key issue for developing country vaccine producers. Some experts believe that many developing country facilities will have to close operations in the coming years because they will not be able to access modern technologies or because their facilities will no longer be considered acceptable. A key to assuring sustainability is the extent to which the facilities can attain internationally recognized capabilities in terms of QA, GMP, QC, and access to modern technologies and know how for production of new and improved vaccines. Unless developing country producers can meet the exacting demands of modern biologicals production and quality control, they are unlikely to be sustainable as vaccine manufacturers.

The training workshops on QA/GMP/QC and on Vaccine Production Management were, hence, aimed at helping developing country vaccine manufacturers gain the necessary competence and skills to help themselves develop effective strategic and action plans to become more sustainable. Such effort on the part of manufacturers would have many benefits, not least among which would be enabling them to become more attractive for mutually beneficial partnerships with leading vaccine producers. This would be a particularly effective means to gain access to new technologies.

The IVI/UNIDO/Bio Farma Training Workshop on QA/GMP/QC for Vaccine Manufacture in Developing Countries was held on the premises of Perum Bio Farma in Bandung, Indonesia, from July 8-15, 1996. Perum Bio Farma, Indonesia's national vaccine production institute, is recognized to be amongst the best managed and operated public sector vaccine producers in the world. It is a member institution of the Institute's Network Coordinating Group.

A total of 39 participants/observers from 13 countries were invited to participate in the workshop. They included: Brazil, China, Croatia, Hong Kong, India, Indonesia, Iran, Korea, Malaysia, Mexico, South Africa, Thailand, Vietnam. Faculty consisted of leading experts in production technology for biological products. Core Faculty for the Workshop included Ms. Nina Merchant and Mr. Nik Cucakovich. They were supported by Dr. Zoltan Csizer (UNIDO), Dr. Benny Kaligis (Perum Bio Farma) and Dr. Sooyoung Stanford Lee (IVI). Dr. David Magrath, formerly Chief of Biologicals at the World Health Organization, served as Technical Advisor. The workshop was expertly hosted by the staff of Perum Bio Farma.

The Director-General of Indonesia's Food and Drug Administration, Dr. Anton Fric (who represented Dr. Uton Rafei, Regional Director of WHO's South East Asia Regional Organization), and Drs. Darodjatun (President-Director of Perum Bio Farma, and a member of the IVI Board of Trustees) attended the opening ceremony for the workshop.

The workshop was intended for senior management staff of vaccine production facilities with responsibility for QA/GMP/QC (it was aimed particularly at Quality Assurance managers), and for senior managers of National Control Laboratories (NCLs). It sought to provide managers with an understanding of the key issues in current QA/GMP/QC, and was designed to equip them with the tools and skills to develop effective action plans towards upgrading and improving their institutional QA/GMP/QC standards and capabilities. Participants were advised on the need for their institutions to take full technical and financial responsibility for bringing about appropriate change that they themselves identified. The workshop incorporated write-ups, lectures, case studies, open discussions, group assignments, site visits and demonstrations. Faculty made itself available throughout the workshop for discussion and consultation.

The workshop focused on key issues in GMP for vaccine manufacture. Topics covered included:

The various topics were discussed in the context of developing a strategic approach to achieving GMP, the so-called GMP Action Plan (see box).

Participants also considered issues in implementing effective GMP Action Plans, including, for example, the pros and cons of establishing GMP Task Forces made up of representatives from different areas of operation of their respective institutions, and the challenges which need to be overcome for successful action. It was emphasized that the development of an effective action plan would require a substantial investment in time and resources, and that it could easily take two years or more for effective implementation of all aspects of GMP - especially when such changes as facility renovation, updated equipment, and staff training and skills enhancement were called for. On the other hand, it would be possible to make substantial changes in documentation, approaches to validation, and in operational procedures almost immediately. Such action could potentially bring substantial benefit at minimal cost.

Prior to attending the workshop, participants were asked to submit write-ups identifying strengths, weaknesses and opportunities which they saw in their respective institutions in relation to GMP. These write-ups enabled faculty to get a good sense of the concerns and circumstances faced by each participant and his/her institution. This allowed some customization of the workshop in response to specific needs and concerns.

The facility design workshop provided an excellent opportunity for participants to think through key issues and concerns in facility design for GMP. Such issues included:

After covering the fundamentals of facility design, participants were divided into 4 groups on the third day of the workshop, each of which was assigned to design a vaccine production facility for either 10 million or a 100 million doses of either oral poliomyelitis vaccine (OPV) or Diphtheria, Pertussis, Tetanus vaccine (DPT). They were advised to utilize the ideas and inputs discussed each subsequent day of the course in their planning consideration. On the final day of the workshop (Day 8), each group presented its design for representations on the facilities designed by each group were made.

Indonesia's Minister of Health, Dr. Sujudi, kindly officiated at the closing ceremony and presented certificates to each of the participants.

Participants generally reported that they found the workshop extremely useful and seemed to find the facility design exercise particularly beneficial. One participant, for example, reported that she now saw her own facilities with new eyes, and realized many ways in which facilities, practices and procedures could be improved. Several participants also reported that they felt much more confident now in their ability to troubleshoot and rectify problem areas in their own facilities.

Participants filled out evaluation questionnaires at the end of the workshop. The mean score of their evaluations (on a scale of 0 to 10) are summarized below:

Approximately 4 weeks subsequent to the course, participants were asked if their institutions had either taken, or intended to take, any action as a consequence of their participation in the workshop. Most indicated that their institutions now had a better appreciation for what it would require to achieve internationally acceptable standards of GMP. Many also said that their institutions had agreed to implement several improvements in approach to documentation and validation, for example, in accordance with what was learnt at the workshop. Several institutions were also in the process of establishing GMP Task Forces and initiating the process of developing GMP Action Plans. It is to be anticipated that substantial improvements in operation and practice are likely to result from these efforts by the various institutions.

The Institute intends to follow up the training course by working with those vaccine manufacturing facilities which request its assistance and advice in helping them in their efforts to improve GMP.

In addition, on the basis of feedback from participants, the Institute is looking into the feasibility of developing courses on such specific topics as validation issues, and bioprocess technology issues in vaccine production - for example, cell culture technology and fermentation technology.

GMP Action Plan

The GMP Action Plan is a tool which managers could utilize to help provide a systematic framework for reviewing their institutional strengths and weaknesses, and developing an effective course of action. A generic plan might contain the following:

Executive Summary

Introduction

Statement of GMP Goals, Objectives and Targets

Review of Existing Situation (analysis of strengths, weaknesses and opportunities)

Facilities - Description of existing facilities

Equipment - Status

Staff

Qualifications and Capabilities

Access to Skills Enhancement and Training Opportunities

Organization of staff - Roles and Responsibilities

Practices and Procedures

Documentation

Validation

Operational Procedures

Other Related Matters

Funding

Access to Reference Standards

Access to Technical and Regulatory Requirements

Certification of Facility - National or International (WHO)

Recommended Strategy for Achieving cGMP Compliance

Facilities

Retrofit or new

Multiproduct or dedicated

Site for new facility

Equipment

Upgrade

Automation

Containment

Scale-up

Staff

Qualifications and Capabilities

Access to Skills Enhancement and Training Opportunities

Organization of Staff - Roles and Responsibilities

Practices and Procedures

Documentation

Validation

Reorganization of Operational Procedures

Other Related Matters

Access to Funding

Access to Reference Standards

Access to Information

Availability of Technical Support

Proposed Work Plan, time lines, use of Consultants and/or Engineering Firms

Funding Considerations

The Management Training Course was held at the Sino-Danish Postgraduate Biomedical Training Center of the National Vaccine and Serum Institute, Beijing, China from September 8-13, 1996. The Training Center is an excellent facility with lecture rooms, small meeting rooms, laboratories, and housing and dining facilities which manages about 40 courses per year. Being on the campus of one of China's major vaccine production facilities also provided an opportunity for site visits and interaction with production staff.

In all, the course attracted 50 participants and 18 faculty. Several faculty came from leading vaccine producers around the world with others coming from premiere public and private institutions. Faculty came from Austria, Belgium, Canada, China, France, India, Singapore, and the U.S. The trainees were from vaccine producers in 13 different countries: Bangladesh, Brazil, Cameroon, China, Croatia, Cuba, India, Indonesia, Korea, Philippines, South Africa, Thailand, and Viet Nam.

UNDP's Deputy Resident Representative in China and Dr. Chen Chunming, the past president of the Chinese Academy of Preventive Medicine attended the opening ceremony. Dr. Chen is also a member of the IVI Advisory Board of Trustees.

The overall objective of the course was to provide training that would be helpful to vaccine production facility managers in updating and/or creating strategic plans for their institutions. The methodology to achieve this objective involved lectures, case studies, working groups, and evening homework. The focus was on how production facilities can develop plans that will assure their sustainability in the near and long term.

A clear strategic plan is one of the most essential tools of good management. A good strategic plan should have a positive impact on management and should help to make the organizations better partners with other manufacturers with whom they may wish to or already have formed joint ventures.

Each of the lecturers prepared a document or slides/transparencies before the meeting and the total documentation is roughly about 500 pages. A condensed form of these materials is in preparation.

Additional presentations were made that summarized recent successful programs of major improvement at vaccine production facilities in India and Indonesia and an effort to develop a national regulatory authority in India. These case studies gave participants real-life examples of how developing country producers can improve their organizations.

A great deal of time was spent in working groups where trainees attempted to complete partially finished strategic plans of fictional vaccine production facilities. The fictional facilities were patterned after known facilities in developing countries but certain information was modified slightly, e.g. population size of the country, number of employees in the facility. The trainees could then attack the plans without having to worry about national or personal sensitivities. Each of the four groups had a separate plan. The course ended with each group presenting to the other groups, and the faculty, the results of their efforts. It appears that this portion of the course was eminently successful based on numerous comments of the participants and the vigorous and committed participation they exhibited.

The Minister of Health of China and the President of China's National Corporation for Biological Products kindly attended the closing ceremony and presented certificates to each of the participants.

The Institute will follow up this training course by working with vaccine manufacturing facilities to help them update or create institutional strategic plans. Invitations have already been received from several institutes in China, from two institutes in Vietnam, and from a facility in Cuba. Follow up was initiated immediately after the course when IVI staff visited the Wuhan Institute of Biological Products and the Shanghai Institute of Biological Products. Because strategic planning is a continuing process, the course follow up is one way in which the IVI will maintain an ongoing interaction with the institutes.

In addition to the direct follow up of the course itself, there is also the opportunity to follow up with additional training courses. The trainees indicated that the course needed to be followed with courses on specific topics. Of particular interest would be courses on market assessment and projection and on financial management. Another topic of great interest would be on technology transfer management. IVI staff are prepared to develop and execute these course if sufficient resources can be identified.

Strategic Plan

The Training Course emphasized the need for a well conceived institutional strategic plan in effective management of vaccine production facilities. Such a plan might have the following major elements:

Mission Statement
Goals
Situation Analysis

Market Assessment

Technology Assessment

Personnel Assessment

Financial Assessment

Regulatory Environment Assessment

Objectives (short-term and long-term)
Management Plan

Market Plan

Technology Plan

Personnel Plan

Financial Plan

Regulatory Management Plan

Evaluation Plan

From its inception, the Children's Vaccine Initiative has convened an annual "Consultative Group" (CG) meeting which seeks to include all who work towards expanding and improving global vaccination efforts. The meeting brings together individuals from the entire spectrum which constitutes the CVI, including: representatives of research institutes, national immunization programs, international organizations, the development assistance/donor community, industry, non-governmental organizations and academia.

This year's CG meeting, the sixth in the series, will take place in Dakar, Senegal on December 9 and 10, 1996. As always, the meeting will cover a wide range of topics of global significance. It will also address issues of particular relevance to Africa and developing countries.

Dr. Jong Wook Lee, Executive Secretary, CVI, describes the goals of the CG meeting as follows: "It is hoped that each participant in the meeting will be able to return to his or her country, institution, or company, with a further appreciation for recent developments in the field of vaccines and immunization, and with an increased commitment to push for progress. Participants should also leave with fresh, new ideas for addressing issues of particular concern, or interest, obtained from the workshops and interactions with other related fields."

This year's meeting will, for the first time, include the presentation two special awards CVI Awards. These are the CVI Pasteur Award for recent contributions in vaccine development, and the CVI Jenner Award for recent contributions in immunization.

For further information, contact: CVI Secretariat, c/o World Health Organization, 20 Avenue Appia, 1211, Geneva 27, Switzerland (Tel: 41-22-791-4799, Fax: 41-22-791-4888, e-mail: cvi@who.ch)

The World Health Organization and the United Nations Children's Fund (UNICEF) have jointly produced the first-ever State of the World's Vaccines and Immunization. The publication focuses on the global vaccine situation - highlighting the successes which have been achieved, and identifying some of the most critical future challenges.

The report provides a comprehensive survey of the current vaccine situation in 5 succinct chapters. It is well written and includes many useful and insightful boxes - and keeps very much to the tradition of international publications such as UNICEF's State of the World's Children or the World Bank's World Development Report. It is an excellent publication which is well worth reading.

One small omission, which would have been extremely useful, is the lack of comparative data showing immunization rates in each country, analyses of infectious disease mortality, the mix of public and private sector supply of vaccines in each country, comparisons of procurement versus production, etc. Experience has shown that such comparative data often encourages countries to perform better and to seek to achieve standards of health care and access to services achieved in other countries. Such data helps make practices and priorities transparent and clear - it is often provided by countries themselves, and causes important and fundamental questions to be asked about resource allocation and getting more impact on investment.

It is to be hoped that future editions would begin to carefully examine the wealth of data that is available to our colleagues at WHO and UNICEF that would clearly demarcate the need for future investment.

World Health Organization, Global Programme for Vaccines and Immunization, 1211 Geneva 27, Switzerland

This publication is also available on the internet: http://www.who.ch/programmes/gpv/gpv_home.htm

Foreword

State of the World's Vaccines and Immunization

"Immunization is now entering a new era. Advances in technology are enabling the development of a whole range of both new and improved vaccines. Currently, new vaccines are being developed against more than 60 different diseases. Until recently, only the most visionary researcher would have considered some of these diseases to be vaccine-preventable.

These new and improved vaccines are not put into general use as fast as they could be. One of the major concerns is that price is still considered to be a major obstacle. There is a need to work closely with the vaccine industry to ensure that commercial interests are carefully balanced against the need to provide equal access to vaccines for all the world's children.

The issue is not only the price of vaccines but their enormous value for children, families, and society in averting premature death or the huge costs of lengthy hospitalization.

If our organizations and our partners can give the world a better understanding of the value of vaccines and immunization, the success of the past twenty years in saving millions of children=s lives will be dwarfed by the successes of the next two decades"

Ms. Carol Bellamy (Executive Director, UNICEF) and Dr. Hiroshi Nakajima (Director-General, WHO)

The 14th Edition of the Jordan Report, an annual publication of the United States National Institute of Allergy and Infectious Diseases was released at the end of September, 1996.

In keeping with its tradition of excellence, the 1996 edition provides a very lucid summary of the current status of vaccine development for a large variety of infectious diseases, and lists the vaccines currently licensed in the United States. This edition also summarizes the list of AIDS vaccines undergoing experimental trials, and the strategies being used to develop AIDS vaccine candidates.

This year's Jordan Report includes nine feature articles written by prominent leaders in public health and immunology. These include articles on:

Philip J. Baker, PhD, Editor, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Solar Building, Room 3A05, Bethesda, MD 20892-7630 (Tel: 1-301-496-7728; Fax: 1-301-402-2508; e-mail: pb26o@nih.gov)

Preface

The Jordan Report (1996)

"The expansion of our knowledge of the immune system and the development of protective immunity has enabled us to progress from the relatively crude vaccines of the past to well-defined acellular vaccines for the prevention of pertussis, as well as nucleic acid (DNA) vaccines to generate immunity against tuberculosis, influenza, and other infectious diseases...Thus, vaccines always will be a major component in the development of effective strategies to combat new threats to the public health, such as emerging infectious diseases and the increased incidence of infections caused by antibiotic-resistant strains of bacteria."

John La Montagne PhD, Director, Division of Microbiology & Infectious Diseases, NIAID

The World Health Organization's Global Programme for Vaccines and Immunization published, in June 1996, the first issue of Vaccine & Immunization News. The newsletter is a useful and practical source of information. The first issue includes a series of very interesting articles including:

This first issue of Vaccine & Immunization News ends with a useful listing of recent GPV Publications. The newsletter, which is edited by John Maurice (who also edits the CVI Forum for the Children's Vaccine Initiative - see below) is informative and well worth reading (its free!).

For further information, contact: Editorial Office, Vaccine and Immunization News, GPV/WHO ; 20 Avenue Appia, 1211 Geneva 27, Switzerland (Tel: 41-22-791-4802; Fax: 41-22-791-4192; e-mail: gpv@who.ch)

"Why another newsletter? The answer is simple. We in the GPV want as many people as possible to know about our work on vaccines and immunization. Not because we feel our work is important - we do, of course - but because we feel vaccines are important and becoming appreciated by more and more people who realize how easily and inexpensively vaccines can reduce deaths and suffering from disease." - Dr. Jong Wook Lee, Director, GPV/WHO ; Editorial (Issue 1), Vaccine & Immunization News

Issue 11 of the CVI Forum is dedicated to taking a closer look at the relationship between public and private sector institutions working in the vaccine arena, and asks the very pertinent question regarding this crucial relationship: discord or dialogue?

The analysis of the relationship between public and private sector institutions provided in this issue is among the most comprehensive on record on this important subject. If you don=t already receive CVI Forum, it is certainly well worth getting listed on the CVI mailing list.

For more information, contact: Editorial Office, CVI Forum, CVI Secretariat ; c/o World Health Organization - 1211 Geneva 27, Switzerland (Tel: 41-22-791-4799; Fax: 41-22-791-4888; e-mail: cvi@who.ch)

Dr. Maurice Hilleman, Director of the Merck Institute of Therapeutics, informed the Chairman of the Board that he intended to retire from the Board, "for personal and work reasons", as of the next Board meeting in November, 1996.

Dr. Hilleman, who was appointed to the Board in November 1994, has served with distinction, and provided a much appreciated private sector perspective. Dr. Hilleman reassured the Institute, nonetheless, that he continues to support the effort for vaccine research and development to ensure effecive supply of vaccines globally.

Dr. Hilleman will be a keynote speaker at the IVI Symposium in November, 1996, where he will speak on the subject "From Cowpox to DNA Vaccines:....". The Institute, in recognition of his distinguished service, will award him with a plaque of appreciation during the Board meeting in Seoul, Korea.

Dr. David Magrath, formerly Chief of Biologicals at WHO, passed away peacefully on August 20, 1996, after a courageous battle with cancer. He was much respected by those who had the opportunity to work with him for being a man of honor and conviction. He believed always in doing what he felt was the right thing.

David saw the potential of an international vaccine institute early, long before it became fashionable. He understood how such an institution might contribute to helping to build up expertise and competence in developing countries, and was committed to the concept of networking and collaboration which fired early efforts of the Institute. He participated actively in several seminal brainstorm discussions on the feasibility and potential future role of the Institute.

Through the Children's Vaccine Initiative, David worked in collaboration with Seung-il Shin and Gurinder Shahi, as part of the so-called "Planning Group for Asia". He foresaw the need for close cooperation between the regional offices of WHO, UNICEF and the future institute - and helped put in place the conceptual basis for what has evolved into the Institute's Network Coordinating Group.

Even in retirement, David was committed to helping the Institute achieve its objectives. He served as technical advisor for our Bandung workshop on QA/GMP/QC and provided much needed insight and perspective. David's desire for cooperation and collaboration will always live on as an intrinsic part of the spirit that drives the International Vaccine Institute!

Ms. Kim (keyyoung@plaza.snu.ac.kr ) joined IVI in April, 1996. A graduate of Seoul National University , she majored in English Language and Literature. Prior to joining IVI, she spent several years teaching English. She also worked briefly as a secretary at the UNDP Office in Seoul. Ms. Kim enjoys sports - she loves swimming and is also a very good skier.

Dr. SooYoung Stanford Lee - Senior Scientist and Head, Technical Planning and Operations

Dr. Lee is an American citizen with a PhD in Biochemical Engineering from Cornell University, he has over 15 years of extensive industrial R&D and manufacturing experience in the biotechnology and vaccine industries. Prior to joining IVI in July, 1996, he was in charge of a viral vaccine process development laboratory at Wyeth Lederle Vaccines and Pediatrics (WLVP), Pearl River, New York. He is responsible for day-to-day management of scientific and technical input for the design, construction and equipping of the Institute's headquarters facility being built in Seoul, Korea. He is also in charge of the Institute's technical assistance to developing country vaccine manufacturers on such issues as facility design, vaccine production process development, and good manufacturing practices (cGMP) production.

Ms. Manuel (amanuel@plaza.snu.ac.kr) is United Nations Volunteer from Spain who joined the Institute in November, 1996. She holds a bachelors degree in Biology from the University of Seville, and a masters degree in information studies from the University of North London. Prior to joining IVI, Ms. Manuel served as Library Coordinator at the Andalusian School of Public Health, and has also worked previously as a Spanish Translator for the World Health Organization in Geneva. She speaks English, French, Portuguese and Spanish. Ms. Manuel will take responsibility for setting up the Institute's library and archives, and will be involved with designing and maintaining the Institute's informational databases. Ms. Manuel is a nature lover who enjoys mountain hiking.

The Institute hosted the following visitors between May 1, 1996 and October 31, 1996:

Dr. Tony Adams (Commonwealth Department of Health and Family Services, Australia), Prof. Ken-ichi Arai (University of Tokyo, Japan), Dr. Baruch Blumberg (Fox Chase Cancer Philadephia, USA), Ms. Hae wol Cho (KNIH, Korea), Dr. Jae So Chung (Access Pharma Council, Korea), Dr. George Morgan Davis (Academy National Sciences of Philadelphia, USA), Mrs. Heather Foley , Prof. William R. Folk (University of Missouri-Columbia, USA),

Dr. Demissie Habte (International Centre for Diarrhoeal Disease Research, Bangladesh), Dr. Peter Jay Hotez (Yale University School of Medicine, USA), Prof. Hideo Ikeda (University of Tokyo, Japan)

Mr. Takashi Ishihara (University of Tokyo, Japan), Prof. Tong H. Joh (Cornell University, USA), Prof. H.D. Kim (University of Missouri-Columbia, USA) , Prof. Kiyoshi Kita (University of Tokyo, Japan), Prof. Kwang Ho Ko (Seoul National University, Korea), Dr. Jean Lariviere (International Health, Ottawa, Canada), Dr. Chi-Jen Lee (United States Food and Drug Administration, USA), Dr. Cheng-hsiung Lu (National Institute of Preventive Medicine, Taiwan), Prof. Hisao Masai (University of Tokyo, Japan), Dr. Anthony Mire-Sluis (National Institute of Biological Standards and Control, United Kingdom), Prof. Yoshikazu Nakamura (University of Tokyo, Japan), Dr. Qingdong Qi (Ministry of Health, P.R. China), Dr. Satish D. Ravetkar (Serum Institute of India, India), Prof. Tatsuo Shioda (University of Tokyo Japan), Prof. Michael W. Steward (London School of Hygiene & Tropical Medicine, United Kingdom), Mr. Shinichi Tamura (Sosei Co. Ltd. Japan), Mr. Ken Tominaga (Tomy Seiko Co. Ltd, Japan), Prof. Sumiko Watanabe (University of Tokyo, Japan), Dr. Testuo Watanabe (Asahi Chemical Industry Co. Ltd, Japan), Mr. Graham Wright (International Centre for Diarrhoeal Disease Research, Bangladesh), Dr. Shu-Hua Xiao (Chinese Academy of Preventive Medicine, P.R. China), Prof. T. J. Yoo (University of Tennessee, USA), Dr. Wang-Don Yoo (Cheil Foods & Chemical, Korea), Prof. Mitsuaki Yoshida (University of Tokyo, Japan), Dr. Feng Zheng (Chinese Academy of Preventive Medicine, P.R. China).

WHO's Control of Tropical Diseases (CTD) has recently established a Dengue Page which provides information regarding dengue and dengue hemorrhagic disease. Incorporated in the site is a 15 page color brochure entitled "Preventing dengue and dengue hemorrhagic fever - a fact sheet for municipal and community leaders." (The brochure can be read using Acrobat Reader software which can be downloaded for free on the Web from such sites as http://www.adobe.com).

For further information, contact: Dr. A.B. Knudsen, Scientist/Medical Entomologist WHO/CTD/FIL (DEN); e-mail: knudsen@WHO.CH

A meeting on Methods to Assess Vaccination Policy Options was held in Geneva on October 21-22, 1996, drawing together specialists in economics, epidemiology, immunization delivery and health decision-making.

The meeting was aimed at obtaining broad agreement on standardized methods for assessing new vaccines and other policy options to help CVI collaborators in setting priorities at global, regional and country levels. The methods proposed will be available for review in early 1997. --Roy Widdus, CVI

For further information, contact: Mark Miller, CVI Secretariat (Tel: 41-22-791-4799;Fax: 41-22-791-4888; e-mail: millerm@who.ch)

The Children's Vaccine Initiative convened a meeting in October, 1996, which brought together 7 major vaccine companies, the World Health Organization and UNICEF to discuss steps needed to bring the benefits of vaccines against Haemophilus influenzae type b (Hib) to developing countries as soon as possible. Many necessary actions were identified to speed control of Hib pneumonia and meningitis which may claim over 500,000 children's lives each year: these will be undertaken by many different CVI collaborators including WHO/GPV, WHO's Child Health and Development Division, PATH, the US CDC, national immunization programs and the CVI Secretariat. An international meeting on Hib vaccination has been planned for mid-1997 which will bring together a wide range of additional organizations and individuals to discuss knowledge of Hib disease burden and how to expedite Hib vaccination wherever appropriate. --Roy Widdus, CVI

For further information, contact: Jay Wenger, CVI Secretariat (Tel: 41-22-791-4799;Fax: 41-22-791-4888; e-mail: wengerj@who.ch)

The CVI Task Force on Strategic Planning met at the United States National Institutes of Health (NIH) on October 31 and November 1, 1996. The Task Force agreed on the establishment of two new CVI Working Groups. One group, the CVI Working Group on Advocacy and Information Exchange, will address issues of advocacy for vaccines and immunization. The second group, the CVI Working Group on Vaccine Demand, Supply and Financing, will, among other things, be concerned with long-term financing to ensure adequate supplies of vaccines.

The Task Force also agreed to begin the development of a detailed document laying out the goals that are achievable with vaccines in the next 15 to 20 years and the resources that will be required to achieve those goals. The Task Force will have its next meeting in conjunction with the CVI Consultative Group meeting to be held in Dakar, Senegal in December. --RTM

For further information, contact: CVI Secretariat (Tel: 41-22-791-4799;Fax: 41-22-791-4888; e-mail: cvi@who.ch)

The International Vaccine Institute is crossing a critical threshold. While still a "work in progress", it has begun to move from being a project of UNDP to becoming an independent international institution. As the Institute is weaned from its UNDP "mother" and learns to stand on its own, it faces tremendous challenges.

The Institute's gestation period has been eventful, and sometimes even difficult. Nevertheless, with support of friends and colleagues at UNDP, the Government of Korea, WHO, UNICEF, UNIDO, industry and many institutions around the world which saw the Institute as one of the first tangible fruits of the CVI, the Institute has begun to establish the basis for a successful future.

The Institute's first training workshops have been well received, and provide an indicator of the potential contribution which it could make towards helping developing country institutions help themselves. The Institute has made substantial progress in establishing links with key centers around the world. The Institute appears also to be building a solid basis for cooperation and collaboration with industry, as exemplified by the Beijing workshop on vaccine production management where representatives of major international vaccine producers worked closely with staff of the Institute, UNIDO, and other interested institutions (including the US FDA) to provide needed insight and advice to developing country vaccine manufacturers.

The extent to which the Institute fulfils its potential will depend very much on how its efforts are supported by those who have a stake in international vaccine-related science and technology development. A critical element in the success and future impact of the Institute will be the extent to which it is able to find ways to work complementarily and effectively with its partner institutions and with others who recognize the need for innovative new ideas and approaches in the arena of infectious disease and vaccinology.

There is much we can do collectively to strengthen the ability of developing countries to "ensure that the benefits generated by new technology will lead to healthier lives and livelihood, especially for the poor. -GSS

The IVI Newsletter will post information regarding meetings, conferences, and workshops which may be of interest to scientists and policy-makers in Asia.

Institute News	Transitions
OPV or IPV/OPV?	IVI Visitors
IVI Training Workshop	IVI Staff
Editor's Opinion	Internetworking
CVI News	Meeting Reports
Publications of Note	Meeting Planner