The IVI Newsletter - December 1997

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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.

Governing Board of Trustees Installed;
Search Initiated for First Institute Director

The International Vaccine Institute has officially become an independent, international organization. The Establishment Agreement for the Institute, which was opened for signature in October 1996 at the United Nations in New York, came into force on May 29, 1997, when the United Nations received the third instrument of ratification for the Agreement from the Republic of Uzbekistan. The Republic of Korea and Sweden had ratified it earlier.

Twenty-eight countries and the World Health Organization have, thus far, signed the IVI Establishment Agreement. Instruments of ratification have now been deposited at the United Nations from China, Mongolia, the Republic of Korea, Sweden, Uzbekistan, Vietnam, and the World Health Organization.

The Constitution of the International Vaccine Institute provides for a Governing Board of Trustees consisting of up to 17 members: 10 members elected at large, 1 member elected upon nomination by the United Nations Development Programme (UNDP), 2 members appointed by the World Health Organization (WHO), 2 members appointed by the Republic of Korea, and 2 ex officio members (the Executive Secretary of the Children's Vaccine Initiative and the Institute's Director).

All standing members of the UNDP Advisory Board of Trustees for the Institute agreed to serve on the Institute's Board. Prof. Ruth Arnon, Prof. Barry Bloom, Prof. Chen Chunming, Drs. Darodjatun, Dr. Demissie Habte, Dr. Adolfo Martinez-Palomo, Dr. Lars Pallesen, Dr. V. Ramalingaswami and Dr. Geoffrey Schild all served on the UNDP Advisory Board and will serve as members at large of the Institute's new Governing Board. They have been joined in this capacity by Sir Gustav Nossal, President of the Australian Academy of Science and Chairman of the joint Scientific Advisory Group of Experts (SAGE) of the Children's Vaccine Initiative and the Global Programme on Vaccines (World Health Organization).

Prof. Wan-Kyoo Cho, who served on the UNDP Advisory Board, has been appointed to represent the Government of Korea on the Institute's Board together with Mr. Dae Won Suh, who is Director-General of the United Nations and International Organizations Bureau of Korea's Ministry of Foreign Affairs. Prof. Cho also serves as Chairman of the Korean IVI Support Committee, a voluntary group of prominent private citizens.

The World Health Organization appointees who will serve on the Board are Dr. Sang Tai Han, Regional Director of WHO's Western Pacific Region, and Dr. Uton Muchtar Rafei, Regional Director of WHO's South East Asia Region.

The United Nations Development Programme has nominated Dr. Nay Htun, Assistant Administrator and Director of UNDP's Regional Bureau for Asia and the Pacific (RBAP) to the Institute's Board. Mr. Nay Htun will also serve as founding Chairman of the Institute Support Council.

Dr. Jong-Wook Lee, Executive Secretary of the Children's Vaccine Initiative and Director of WHO's Global Programme on Vaccines and Immunization (GPV), and the Institute Director (who is yet to be named), will serve as the two ex officio members of the Board.

The inaugural meeting of the Board was held on October 8, 1997, in Seoul, Korea. Prof. Barry Bloom was elected Chairman of the Board, Sir Gustav Nossal was elected Vice-Chairman, and Dr. Lars Pallesen became the Treasurer. The Board agreed that the position of Secretary would go to the Institute's Director, when he/she is appointed. A major highlight of the Board meeting was the handing over of governance responsibility for the Institute from UNDP to the Board, immediately after the Board was formally constituted.

Priority issues which the Board addressed during its 3-day meeting included the policies and procedures for operation of the Institute as an independent entity, the search process for identifying the Institute's first Director, the draft Strategic Plan for the Institute, and the Institute's plan of work for 1998. The Board also constituted several committees, including a Program Committee to be co-chaired by Dr. Demissie Habte and Dr. Geoffrey Schild and a Finance Committee to be co-chaired by Drs. Darodjatun and Dr. Lars Pallesen.

For the interim period until the Institute Director takes up her/his position, the Board appointed Prof. Cho as Executive Trustee-in-Residence to provide guidance and supervision for day-to-day operation of the Institute. It also appointed Dr. Seung-il Shin as Chief Operating and Scientific Officer and Dr. Richard Mahoney as Chief Administrative and Development Officer.

The first meeting of the Institute Support Council (ISC), which was convened by UNDP as part of its on-going commitment to ensure the long-term sustainability and success of the Institute, took place in Seoul on the morning of October 11, 1997. Among those present were representatives in Seoul from Australia, Bangladesh, Cote d'Ivoire, France, Germany, India, Myanmar, Norway, Romania, Slovakia, Sweden, the United States and Uzbekistan. Rhone-Poulenc (the parent company of Pasteur Merieux Connaught) also sent a representative.

It is envisaged that the ISC, which is to be chaired by UNDP as founder of the Institute, will evolve, in time, into an important mechanism to enable Institute supporters to help shape the direction and focus of the Institute's activities, to ensure that these are consistent with priority concerns and needs in developing countries, and to provide support (financial and in-kind) for the work of the Institute.

Membership of the ISC will be open to all signatories of the IVI Establishment Agreement, prospective signatories, donor institutions (bilateral and multilateral agencies, foundations, etc), industry, and other interested parties.

The meeting started with a brief description by Mr. Nay Htun of UNDP of the process leading up to the establishment of the Institute. Prof. Barry Bloom and Sir Gustav Nossal then went on to elaborate on the vision of the Institute. Dr. Seung-il Shin followed up with a discussion of the Strategic Plan of the Institute and its various programs and initiatives.

Base support for the Institute comes, of course, from Korea's generous gift to the world in the shape of providing a state-of-the-art R&D facility for the Institute and providing for 30% of its annual operating costs (in fact, the Korean Government, recognizing that substantially more resources are required in the earlier phases of operation have kindly provided substantially more than 30% of the budget for 1996 and 1997. UNDP will provide at least $1.5 million between 1998 and 2000. The Institute's budget is anticipated to reach about $9 million by 2000. Contributions from Industry, which already represented some 10% of 1997's budget, is anticipated to rise to about 20% of the Institute's budget by 2000. Other funders (including multilateral donors, development banks, foundations and private individual donors) are being sought to help meet the Institute's additional funding requirements. Participants at the ISC meeting noted that this requirement was very small in comparison to the potential impact of the Institute.

Several participants spoke to express their interest and support for the initiative at the ISC meeting.

Dr. Ahmed Meer of the US Embassy advised that the Institute maintain a "non-discriminatory public access" policy for any information generated in the work of the Institute.

The representative of Cote d'Ivoire commented that the Institute's programs appeared to be focused on Asia - and asked if it would also work with countries in other regions. He was assured that it would.

Dr. JW Lee, Executive Secretary of CVI indicated that he has been involved in several major donor group meetings, and that he was very heartened by the warmth and enthusiasm which IVI was receiving from national representations in attendance. His experience had seldom been this happy, he added.

It was a great start for IVI's ISC. The challenge will now be to translate the high level of intellectual and moral support into financial and in-kind support. Indications suggest this should be quite feasible since several signatories and prospective signatories have already informally signaled their intention to make significant contributions to the Institute.

A key priority during the Board meeting was the launch of the search process for the Institute's first Director. The Board of Trustees believes that this search is sufficiently important that the Executive Committee has agreed to serve as the search committee.

Selection of a visionary Director with excellent scientific credentials and leadership capabilities will be key to ensuring the long term success and sustainability of the Institute.

Advertisements seeking candidates for the post of Institute Director were released in early November in several major international publications. The announcement can also be found on the Institute's World Wide Web site at http://www.ivi.org.

Interested members of the international community are invited to submit applications or names of potential candidates. The Executive Committee also expects to directly approach strong prospective candidates to encourage their application. All applications will, of course, be treated with strictest confidence.

With formal establishment of the Institute as an independent international organization now completed, it is now necessary that a Headquarters Agreement between the IVI and the host country, the Republic of Korea. The Agreement will, among other things, outline the privileges and immunities to be accorded the Institute in its host country. Of special note is the commitment of the Government of Korea, as host country, to build and equip a state-of-the-art permanent facility for the Institute, and to provide 30% of the Institute's annual operating budget.

The Institute has been operating as a project of the United Nations Development Programme (UNDP) through the United Nations Office for Project Services (UNOPS). In accord with its independent status, the International Vaccine Institute is in the process of setting up its own administrative and financial capabilities. Once these capabilities are in place, the Institute will be ready to formally separate from UNDP sometime in mid-1998.

The Institute has developed a draft Strategic Plan outlining the direction and focus of its work for the next 3 years.

The plan was reviewed and approved by the Board at its October meeting, and is now available for circulation to interested persons. The full text of the Plan can also be found on the Institute's World Wide Web site (http://www.ivi.org). Interested readers may also obtain a copy by writing to the Institute or sending an e-mail request mailto:(address:Webmaster@ivi.org).

The construction of the International Vaccine Institute's permanent facilities took further steps towards becoming a reality with the selection of a design for the Institute by the IVI Construction Committee, an expert committee appointed by the Seoul National University Planning and Support Committee for the IVI. Following an open competition in which 5 different designs for the Institute were evaluated, the design submitted by a consortium consisting of Samwoo Architects (Seoul, Korea) and Payette Associates (Boston, the United States) was selected.

After further consultations and revisions the final design concept was completed in June, 1997. Detailed architectural drawings based on the Samwoo/Payette design were completed in mid-October. It is anticipated that construction work will begin within the next few months. The building is scheduled to be completed in early 2000.

The picture below is a bird's eye view of the proposed Institute building. The main building will house the laboratories, animal facilities, a library and meeting rooms. A separate building, connected to the main building, will house the Institute's pilot plant facility capable of producing small test lots of vaccine for testing and evaluation purposes, and will also serve as a training center.

The Korean IVI Support Committee has been established at the initiative of Prof. Wan-Kyoo Cho to enable prominent Koreans to play an active role in generating support for the Institute in Korea. Members of the Committee are:

Member of the IVI Board; and President of the Korean Academy of Science and Technology

(Former President of Seoul National University and Former Minister of Education)

Prof. Dong Sung Cho, Professor, College of Business Administration, Seoul National University

Hon. Choo-Nyun Chung, President and Chief Executive Officer, Yonhap Television News

Prof. Won Shik Chung, President, Korea National Red Cross (Former Prime Minister)

Prof. Soong-Jong Hyun, President, Korean Committee for UNICEF (Former Prime Minister)

Mr. Moon-Kyu Kang, Director, Asian Institute for Civil Society Movements; and Co-Chairman, Korea Council of Citizens' Movements

Dr. Young-Hoon Kang, Chairman, The Sejong Foundation (Former Prime Minister)

Prof. Chong-Un Kim, President, Korea Research Foundation (Former President of Seoul National University)

Mr. Jaison Kim, Publisher, "The Samtoh" (Former Speaker of the National Assembly)

Dr. Un Young Kim, Chairman, The Presidential Council on Science and Technology

Prof. Chang Soon Koh, Professor, College of Medicine, Seoul National University

Prof. E. Hyock Kwon, Chairman, Sungkyun Kwan University (Former President, Seoul National University)

Amb. Sang Ock Lee, President, The United Nations Association of the Republic of Korea (Former Minister of Foreign Affairs)

Mr. Kwan-Shik Min, Director, Asia Institute for Public Policy (Former Speaker of the National Assembly and Former Minister of Education)

Prof. Choong Hyun Paik, Professor, College of Law, Seoul National University

Dr. Shang-Hi Rhee, Member of Parliament, Korean National Assembly (Former Minister of Science and Technology)

Prof. Chang-Soon Yoo, Chairman, Daishin Economic Research Institute (Former Prime Minister)

The International Vaccine Institute organized a brainstorming meeting on May 29, 1997, with leading scientists in Korea to consider future directions for the Institute, and the potential for mutual cooperation and collaboration in areas of common interest. The meeting was part of wide-ranging consultations held by the Institute in the course of strategic planning.

The meeting started with a discussion of the goals and objectives of the meeting by Dr. Seung-il Shin, Project Leader, IVI. This was followed by a review of future directions for the Institute by Dr. Demissie Habte, Chair of the Program Committee of UNDP's Advisory Board of Trustees for IVI, and thoughts on the nature of the relationship between Korea and the International Vaccine Institute by Prof. Sang-Dai Park of Seoul National University.

Discussions focused on three major areas: the scientific agenda of the Institute, Korean perspectives on the Institute, and ideas for cooperation and collaboration between the Institute and Korean scientists and institutions.

A summary report on the meeting is available from the Institute (Webmaster@ivi.org) and from the Institute's World Wide Web site (http://www.ivi.org).

As part of its initiatives to improve the quality of locally produced vaccines, GPV/VSQ is developing a global Training Network. The major objective of the Training Network is that all vaccines used in national immunization programmes are of known good quality by the year 2000, or after. The Training Network will provide resources to vaccine producers who meet the minimum criteria and to National Control Authorities and Laboratories. Its activities are supportive of the Vaccine Production Consortium and the Regional Laboratory Control Networks being developed through VSQ.

The Training Networks consist of several institutions providing training in priority areas for vaccine production and control using approved syllabus and standardized documentation materials. The first priority areas for training are: Good Manufacturing Practice, Good Laboratory Practice, quality control testing methodologies, animal husbandry, short courses in vaccine production for control staff, and licensing criteria.

Basic policy for the operations of the Network is set by an Advisory Committee on Training (ACT), which is composed of representatives from each of the training centers in the network. At present, the ACT includes representation from institutions in Australia, Indonesia, India, Japan, Mexico, the Netherlands, the United Kingdom and the United States. WHO staff serve as the secretariat to the ACT.

Review Committees in each training area are appointed by WHO on the advice of the ACT. Serving as advisors to WHO, they provide guidance to prospective training centers in developing course curricula, and advise WHO on the standardization and certification of training courses and documentation in each area. Review Committees have been established to date for all curricula areas with the exception of licensing. Approved curriculum materials have been prepared for GMP and QC test methodologies, and the four centers established to date in these areas are accepting trainees.

GPV, with support from its partners in the effort to improve vaccine quality, has already adopted a policy which limits funding to support technical inputs, either consultants or equipment, to those vaccine producers located in countries which have already established independent and competent National Control Authorities, defined as those assuring the six critical functions for vaccine quality control; written criteria for licensing vaccines, use of clinical data in licensing decisions, lot-by-lot release of vaccines, use of clinical data in licensing decisions, regular inspections for compliance with GMP, postmarketing surveillance for vaccine-related adverse events and efficacy. VSQ intends to implement an analogous policy regarding access to training in the WHO-certified courses of the Training Network for vaccine production and quality control. Thus, access to this training will not be accorded to vaccine producers in countries without National Control Authorities exercising all six critical control functions. Priority for training for National Control Authority staff will decrease as a country assures fewer of the national control functions.

All trainees must have evidence of government commitment and support to these training activities. This commitment could be reflected by some or all of the following: planned physical plant improvements, purchase of new equipment, support for in-house training, willingness to provide services in return for training such as receiving trainees, testing of samples, participating in collaborative studies, information sharing, and development of regional reference materials.

Training activities commenced in the fourth quarter of 1996. Applications for further training are now being processed and evaluation of completed training is in progress.

Mr. Peter Evans
Chief, VSQ/GPV
Tel: 41-22-791-4193 ; Fax: 41-22-791-4192 ; E-mail: evansp@who.ch

More than 30% of the world's children below five years received oral polio vaccine (OPV) in polio campaigns conducted throughout south Asia during December 1996, the first National Immunization Day (NID) round, and January 1997, the second National Immunization Day round. Countries participating in this massive event included six SEARO member states including Bangladesh, Bhutan, India, Myanmar, Nepal, and Thailand, one EMRO (Eastern Mediterranean Region) member, Pakistan, and one Western

Pacific Region member, China. Through these extensive coordinating efforts involving adjoining countries and regions, over 250 million children received OPV.

Synchronization of NIDs in neighboring countries increases the impact of these mass immunization campaigns by expanding the "epidemiologic block" targeted for interruption of poliovirus transmission. The polio virus, which causes paralysis in children, knows no borders and can easily be transmitted by travellers and other migratory populations from one country to another. When NIDs are conducted synchronously, polio-endemic countries are less likely to re-introduce disease into adjoining countries that have just conducted NIDs.

NIDs are the only proven immunization strategy to enable polio endemic countries to eliminate polio. On these days, all children under five years of age are vaccinated with oral polio vaccine (OPV) regardless of their previous vaccination status. The goal of this intensive vaccination schedule is to attain global eradication of polio by 2000.

Since NIDs must be conducted during the low season of disease transmission, Democratic People's Republic of Korea (DPR Korea), Indonesia, Maldives and Sri Lanka from SEARO conducted NIDs at different periods during the year.

During 1996, 934 cases of polio were reported in SEAR, representing approximately half the reported cases globally. Only 48 cases were reported from countries outside India (31 from Bangladesh, six each from Indonesia and Myanmar, three from DPR Korea, and one each from Nepal and Thailand). Despite estimates that 10-30% of polio cases are reported globally, these data highlight the need for India to control and eradicate polio rapidly if the world target is to be reached.

In fact, India has seen substantial progress in polio eradication - cases have consistently declined - from 28,264 in 1987 to 6,028 in 1991 to 3,263 in 1995 to just 886 in 1996. This remarkable reduction in cases is largely attributable to the effectiveness of NIDs.

In all, a total of 121 million children are targeted to receive polio vaccination in India during the NIDs in 1996/97. 118 million children (98%) were immunized on December 7, 1996 - the number represents the largest single day immunization event in a single country in history - exceeding the previous record of 93 million achieved in India on January 20, 1996.

This record breaking success was largely due to extensive strategic planning by the Government of India. Over 2.6 million health workers and volunteers staffed 650,000 vaccination posts nationwide. Each vaccination post was staffed by at least one trained health worker and three volunteers.

Volunteers played a substantial role in ensuring the success of the NIDs. In Bangladesh, for example, it was estimated that one in every 250 Bangladeshi participated in some voluntary capacity in relation to their NID. Coordination among volunteers and Government authorities was also critical to reach the children dispersed in over 3,000 islands nationwide. In all countries, members of Rotary International played major roles - not only through the provision of financial support, but also by coordinating efforts with government authorities by transporting vaccines in their vehicles and staffing many vaccination posts.

As much as 80% of the necessary funds to support the NIDs were provided by SEARO member countries themselves. International agencies contributed to the effort included the Australian Agency for International Development (AusAID), British Overseas Development Authority, US Centers for Disease Control, DANIDA, Germany's KFW, Japan International Cooperation Agency, Rotary International, USAID, UNICEF and WHO.

Two key challenges to achieving SEAR's goals remain: achieving polio eradication requires that NIDs are sustained yearly over several years, and that the system of disease reporting be strengthened significantly in order to identify, report and investigate all cases of acute flaccid paralysis. Ultimately, this is the only way to ensure that polio will be eradicated before the year 2000. All cases of acute flaccid paralysis (AFP) in children aged less than 15 years should be reported and investigated. Each case must have two (2) stool specimens collected for culture within 14 days on the onset of paralysis.

Dr. Imam Mochny
WHO SEAR
Tel: 91-11-331-7804 ; Fax: 91-11331-8607 ; E-mail: mochny@who.ernet.in

1. SEAR Press Release: National Immunization Days - Milestones for Polio Eradication (SEA/PR/1251), 17 Jan 1997

IVI Initiates a Major Epidemiological Study on Invasive Bacterial Diseases in Asia

Invasive bacterial diseases of childhood account for substantial mortality, morbidity and health care expenditures. In all areas of the world where this has been carefully studied, Haemophilus influenzae (Hi), Streptococcus pneumoniae (Sp) and Neisseria meningitidis (Nm) have been found to cause the majority of childhood bacterial infections. Diseases caused by these bacteria include meningitis, sepsis, pneumonia, otitis, sinusitis, cellulitis, pericarditis, septic arthritis, and osteomyelitis. Even with the availability of effective antimicrobial therapy, as much as 33% of infected children died from invasive bacterial infections, and up to 50% of children suffered permanent sequelae. Some serious disabilities include hearing loss, defects in language acquisition, mental retardation, motor abnormalities, seizure disorders, and vision impairment. The health care cost in caring for the acute illness and the permanent disabilities resulting from the illness is considerable. Since permanent disabilities are not uncommon even with effective treatment, prevention of these diseases should be the solution.

Vaccination remains a practical and most cost-effective method of disease control. Polysaccharide conjugate vaccines against Haemophilus influenzae type b (Hib) are already licensed in many countries and promising polysaccharide conjugate vaccines for Sp and Nm are likely to become available within three years. However, vaccine availability should not automatically lead to vaccine usage. One must weigh disease burden and vaccine efficacy against available resources to determine its utility to a population.

Hib is among the leading cause of invasive childhood bacterial diseases wherever this problem has been studied. One of every 200-500 children under age 5 worldwide will contract the disease. According to currently available epidemiologic data, three highly effective conjugate vaccines against Hib (PRP-T, PRP-OMP and HbOC) are being used as part of routine childhood immunizations in more than 20 nations. In the countries that have recently initiated routine Hib immunization, incidence of Hib disease has decreased by more than 85%. And in those nations that have well-established Hib immunization programs, a greater than 95% decrease in the incidence of Hib diseases is commonly observed. This remarkable decrease occurs despite less than complete immunization of the pediatric population. In the US, this translates to an estimated saving of more than $200 million dollars in health care costs per year.

Asia has half of the world's children, and many Asian countries have the economic resources to initiate comprehensive Hib immunization programs if necessary. However, the incidence of Hib diseases in Asia has not yet been established because there have been no definitive population-based studies of invasive Hib disease. The few hospital-based surveys completed to date have tended to suggest surprisingly low disease rates. Many explanations have been put forth to account for this apparent low incidence of disease, including the possibility that invasive Hib disease is largely an Occidental ailment that Asian children do not tend to contract. However, closer scrutiny of the reported studies show that the majority are retrospective or hospital-based studies, with little or no attempt to define the study population or to assure case detection. As a consequence, widely variable annual disease incidences (ranging from less than 1 per 100,000 to 19 per 100,000 children under 5 years of age) have been quoted from different institutions. These numbers probably underestimate the true incidence of Hib diseases in Asia since there were no proactive efforts to seek out all cases. Clearly, a prospective, population-based, surveillance will better define Hib disease burden in Asia.

The Children's Vaccine Initiative (CVI) has issued a "Global Agenda to Expedite Prevention of Hib Disease." The World Health Organization (WHO) recently published a "Generic Protocol for Population-Based Surveillance Studies of Haemophilus influenzae type b" and called for accelerated international action on Hib disease burden studies. A meeting organized by AMP in Indonesia in December 1996, as well as the CVI Global Agenda, had also identified the urgent need for definitive Hib epidemiological studies in Asia.

Worldwide Incidence of Invasive Hib Disease in Children Under 5 Years of Age,
Prior to the Introduction of Hib Vaccines

Region	Years	Hib Meningitis	All Hib Disease
Australia/New Zealand	1985-87	25-53	39-92
US/Canada	1959-91	40-69	67-130
Europe	1985-90	15-26	33-60
Israel	1985-90	18	34
Africa	1980's	36-60	NA
South Africa	1989-90	15-25	21-43
Asia	1990's	1.3-1.9	1.9-27

In response to these calls for action, and working closely with CVI and WHO, the International Vaccine Institute has developed a series of definitive Hib epidemiological studies in Asia. With little extra effort or expense, the studies on Hib will also evaluate disease burden for S. pneumoniae and N. meningitidis infections. These studies represent the Institute's first major research effort in the region.

The study will be a two year, population-based, epidemiologic surveillance intended to ascertain the incidence and characteristics of invasive bacterial diseases in 4 to 6 countries in East Asia. The primary purpose of this disease burden study is to evaluate the need for use of Haemophilus influenzae type b conjugate vaccines in Asian infants.

The studies will be carried out with the collaboration of local investigators in each country. IVI will help train personnel from the partner institutions in epidemiological methods and population-based surveillance. Development of such collaborative partnerships is an important long-term goal of the Institute. These studies also demonstrate the importance of IVI's role as a collaborator with vaccine manufacturers in promoting expanded use of high priority vaccines in both the public and private sectors. Most importantly, the results of such studies should be of value to physicians, local and national health authorities, and international health agencies.

The Institute and the UCLA Center for Vaccine Research developed a study protocol that will be used at all study sites. The use of a common study protocol will ensure that data from all study sites will be comparable. UCLA will also provide laboratory, epidemiology and data management support for the project. In addition, colleagues at US NIH, WHO/GPV, CVI, industry, and many others have contributed to the study protocol to ensure the quality of the study design. The Institute will continue to seek expert advise to ensure proper execution of the study to meet all the stated research objectives.

2. Dr. John La Montagne, National Institute of Allergy and Infectious Diseases, National Institutes of Health, USA

3. Dr. Kim Mulholland, Global Programme on Vaccines and Immunization/World Health Organization, Geneva, Switzerland

4. Dr. Jay Wenger, Children's Vaccine Initiative and US Centers for Disease Control, Geneva, Switzerland

It is anticipated that 4 to 5 studies will be conducted throughout Asia. Invitations to participate in the IVI sponsored study were sent to our partner institutes in China, Indonesia, Korea, Malaysia, Myanmar, Philippines, Thailand, Singapore and Vietnam.

The Advisory Committee will select the study sites using a novel approach. Since IVI has developed the study protocol, there is no need for interested investigators to submit a study proposal. Instead, each site will be evaluated by its ability to implement the study. A study questionnaire was developed in conjunction with the protocol to measure this ability. Information solicited by the questionnaire include:

2. The quality of the proposed surveillance system and its integration with the existing health care delivery system;

3. Availability of laboratory facilities and technical expertise of its personnel;

4. A well defined population for study surveillance with accurate census data for the proposed population;

Selected sites will be visited to determine feasibility of each site based on the submitted questionnaire. The Advisory Committee will make final site selection after the site visits.

After the study sites have been determined, IVI will appoint a Steering Committee to oversee implementation of the study. The committee will include the principal investigator of each study site, members of the Advisory Committee, representatives of study sponsors, and a small number of consultants.

The preparatory phase of the project is expected to last approximately 8 to 10 months. (See timeline for anticipated schedule of the project.) The Institute provided initial funding to start the project. Support for the preparatory phase has come largely from USAID and industry sponsors (Merck Sharp & Dohme, Pasteur-Merieux, SmithKline Beecham and Wyeth-Lederle). The organization and funding of the first meeting of the Advisory Committee has been provided by US NIH, WHO, USAID and the Secretariat of the CVI.

Anticipated Study Timeline

Study concept formulated by IVI:1995-1996
Study proposal approved by IVI Advisory Board of Trustees: February 1997
Study Advisory Committee constituted: March 1997
Draft of study protocol and site selection criteria: March-April 1997
Advisory committee review of study protocol and site selection criteria: May 1997
Invitation for study proposals issued to interested investigators in Asia: June 1997
Briefing conferences and consultation with interested investigators: July-August 1997
Deadline for receipt of site proposals: September 1997
Initial review of site proposals by Advisory Committee: October 1997
Site visits to short-listed study sites: January 1998
Study procedure manual completion: February-March 1998
Data collection instrument and database preparation: January 1998
Final Study site selection: January 1998
Study Steering Committee to be appointed: February 1998
Training workshop for study participants: February-March 1998
Training workshop in laboratory techniques: February-March 1998
Initiation of surveillance: Spring 1998

Protocols for the study can be obtained by writing to the Institute. It will also be available through IVI's web site after final selection of the study sites.

As part of the effort to develop the International Vaccine Institute's program in economic and policy research and development, the Institute has been working in collaboration with Coopers and Lybrand, the international management consulting firm, on research projects in Indonesia and Thailand to study economic and policy considerations for introduction of new and improved vaccines into developing countries.

In the course of the studies, interviews were conducted with leading policy-makers and opinion leaders (public and private sector), and data from a wide variety of sources, including independent analyses and specially commissioned consumer omnibus surveys, were collected. The information collected thus far provides a good picture of the dynamics of decision-making and the national priorities and concerns of each country. The assessments point to the need for better epidemiology and surveillance information gathering, as well as improved capability in the assessment of the potential economic implications of new vaccines.

The studies have found that the role of the private sector in vaccine supply and delivery in both countries was substantially greater than had previously been estimated - nearly 25% in Thailand, and close to 10% in Indonesia for EPI vaccines. The private sector role for non-EPI vaccines is much higher in both countries. All indications suggest a growing role for the private sector in the delivery of preventive services, including vaccines, in both countries, and a growing potential for policy-makers to better integrate private sector service providers into national health plans. Additionally, the growing role of health insurance providers (in Thailand) and the potential future contribution of managed care organizations (in Indonesia) will enable limited public resources to be freed up for reallocation to improving the range and quality of vaccines available to the least well-off members of society.

The omnibus surveys conducted as part of these projects yielded very interesting data regarding people's perception of vaccines. There was, for example, found to be considerable price sensitivity regarding the decision by individuals to purchase and use vaccines. In Thailand, for example, 48% of urban dwellers were willing to purchase Hepatitis B vaccine at the current market price of 1,575 baht (about $60) per course. The proportion went up 87% when the price was halved, implying that urban consumers were willing and able to pay for vaccines, and that either bringing the price down, or providing a subsidy on the purchase of vaccines (through, for example, insurance reimbursement programs) could substantially increase the proportion of consumers able and willing to pay for their own vaccines. The Institute and Coopers and Lybrand are in the process of preparing case study reports for both Indonesia and Thailand in collaboration with national policy-makers. These will be made available, when completed, both as text publications and on the Institute's World Wide Web site.

In connection with these studies, the Institute is also involved in organizing a regional consultation for Asia and Pacific countries on the economic and policy considerations for introducing new and improved vaccines in collaboration with the Children's Vaccine Initiative and, possibly, the World Health Organization. It is anticipated that representatives of Ministries of Public Health, vaccine producers (if applicable), National Economic Planning Boards (or equivalent) and Ministries of Finance from Asia-Pacific countries will be invited to participate in the consultation, which will take place in March/April 1998, in Bangkok, Thailand, under the auspices of Thailand's Department of Communicable Disease Control.

This consultation will provide an opportunity to discuss the application of economic and policy tools for analysis to rationalize decision-making for new and improved vaccines, and to consider financing options to enable equity of access to the benefits of new vaccines.

Several changes have occurred to the list of suppliers approved by WHO for supply of vaccines to UNICEF and other United Nations organizations.

BioFarma, Indonesia's sole public sector vaccine producer, is now accepted as a supplier of measles and polio vaccines. Over the last several years, with technical assistance and support from JICA (the Japan International Cooperation Agency) and from Dutch RIVM, BioFarma has made substantial progress in improving its viral vaccine production capability with the construction of state-of-the art facilities for measles and viral vaccine. Drs. Darodjatun, President-Director of BioFarma, expressed great satisfaction that BioFarma is now an international supplier of vaccines, and informed The IVI Newsletter that BioFarma has already made several shipments of vaccines to other countries, including providing 4 million doses of polio vaccine to North Korea in August, 1997.

Korea Green Cross Corporation (KGCC) is now approved as a UNICEF supplier of plasma-derived Hepatitis B vaccine, while LG joined the ranks of approved suppliers of recombinant Hepatitis B vaccine. Korean supply to UNICEF was temporarily suspended during 1996 when WHO recommended that no supplier from Korea be accepted unless necessary changes were made to the operation and structure of Korea's National Control Authority. This led to the suspension of supply even of vaccine from Cheil which had been approved in 1992. Subsequently, the Korean authorities responded by introducing major changes in biologicals control procedures. These changes satisfied WHO and led to the reinstatement of Cheil and the addition of KGCC and LG as vaccine suppliers.

List of Suppliers of Vaccines Approved for Sale to UN Agencies [June, 1997]*

*based on information provided at the "WHO Workshop on the Role of National Control Authorities in Ensuring the Quality of Vaccines" in Manila, The Philippines from Aug. 25-29, 1997.

Participants at a Bellagio Conference on "The Global Supply of New Vaccines" organized jointly by CVI and the Rockefeller Foundation circulated the statement below following the conference:

The high cost-effectiveness of immunization and its unparalleled contribution to the reduction of infant and child mortality in the world needs greater recognition. The opportunity now exists to prevent at least an additional one to two million child deaths each year, and potentially millions more in the next decade. Existing but severely underused vaccines (such as those against hepatitis B, Haemophilus influenzae type b, rubella, and yellow fever) must be moved into appropriate use wherever needed. Other vaccines (for example, rotavirus, pneumococcal and meningococcal conjugate vaccines) against major killers of children may rapidly become available. A new "global era" in vaccine development is at hand and other innovative new technologies will soon offer further advances.

The establishment of a commercially viable vaccine market in developing countries is recognized as a long term goal for which approaches should be actively sought. For the supply of vaccines to the poorest countries, UNICEF's procurement function will play a critical role for the foreseeable future.

Because of the different economics surrounding new vaccines, actually attaining the reduction in childhood death, disability and suffering they make possible will entail different approaches including:

- full implementation of the UNICEF/WHO strategy for targeting supply assistance for new vaccines to only those countries in greatest need (defined in terms of the UNICEF/WHO banding strategy as countries falling in bands A and B). Tiering of prices offered by manufacturers - an implicit part of the strategy, made possible by economies of scale and production experience - at the earliest feasible opportunity will accelerate worldwide control of infectious diseases and its affordability, and thus has broad benefits. Broad communication to achieve acceptance of this strategy is essential;

- protection of, and respect for, intellectual property, which in turn serves as a stimulus for further innovation, in line with the WTO TRIPS agreement;

- involvement in global supply of various types of producers to meet vaccine needs, all of which, to ensure their viability, will need to secure access to new technologies, whether through negotiated strategic alliances, licensing agreements, or research and development;

- acceptance that vaccine quality cannot be compromised, if safety, effectiveness and public confidence are to be maintained, and assurance of this quality must be independently overseen by well-functioning national control authorities;

- earlier forecasts of demand for new vaccines, based inter alia on epidemiological criteria;

- pro-active management to ensure that vaccines will be developed to prevent diseases in developing countries for which there is no adequate commercially attractive market;

- advocacy to raise awareness among decision makers and populations, in both industrialized and developing countries, donor and international agencies of the high value of vaccines, in terms of both health and economic benefits;

- mobilization of substantially greater resources for vaccine introduction, supply and utilization, especially in developing countries; and

- unprecedented levels of collaboration among the diverse contributors to vaccine development, supply, quality and delivery - in particular, between the public and private sectors in achieving their shared goal of providing the best vaccines possible to improve the health of the world's population.

These efforts will necessarily be complex and interrelated. Consensus, coordination and recognition of complementary objectives among potential contributors will be required for effective implementation. A new active relationship is urgently needed. Therefore, the CVI Secretariat should:

1. Design new structures or mechanisms whereby all potential contributors can be involved in achieving the above objectives. These structures must create a sense of commitment and shared goals among potential participants.

3. Through discussions with those having the authority to commit institutional resources, seek the involvement of all potential contributors and stakeholders in achieving these aims.

For further information, contact:
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

WHO Workshop on the Role of National Control Authorities in Ensuring the Quality of Vaccines

WHO's Western Pacific Regional Office (WPRO) brought together representatives from countries in the region to participate in a meeting on the role of national control authorities in ensuring the quality of vaccines. The countries represented fell essentially into 2 groups: countries which produce vaccines (these included Australia, China, Japan, Korea and Vietnam) and those which do not currently produce vaccines (including Malaysia, the Philippines and Singapore).

The meeting considered the roles and responsibilities of national control authorities (NCAs) in both circumstances. The participants reviewed the current operation of their respective NCAs with respect to ensuring vaccine quality. All the NCAs represented at the workshop undertake appropriate critical functions as defined by WHO, namely:

5. regular inspections of compliance with good manufacturing practice (GMP); and

However, the degree to which these functions are actually performed is variable and there are significant constraints to the full implementation of these functions in a number of countries.

The following major constraints were identified as affecting one or more of the NCAs represented:

1. a general lack of vaccine-specific expertise and experience within the NCA, but particularly with respect to product licensing, lot release and GMP inspection;

2. a lack of ready access to a vaccine testing laboratory independent of the vaccine manufacturer; and

3. an inadequate legislative framework to support the functions, responsibilities and authority of the NCA, particularly with respect to regulatory independence.

2. in-country reviews of NCA structure and function in selected countries, to develop recommendations to strengthen the operation of the NCA;

3. improved communication between the NCAs within the region to allow for rapid exchange of information and technical expertise; and\

4. practical training of NCA staff in specific areas, either in-country or at appropriate NCAs.

Dr. Chris Maher, WHO WPR
Tel: 63-2-528-9970 ; Fax: 63-2-521-1036 ; e-mail: maherc@who.org.ph

Singapore's BioProcess Technology Center organized a highly successful four day workshop on "Cell Culture BioProcess Technology" which was held at the Science Hub of the Singapore Science Park. The International Vaccine Institute was pleased to cooperate with the Bioprocess Technology Center in organizing the workshop, which was expertly coordinated by Ms. Lily Chan and Ms. Florence Chua (BTC) and Dr. Sooyoung Stanford Lee (IVI). Faculty for the workshop included leading experts from industry and academia, and included individuals associated with Amersham-Pharmacia-Biotech, B.Braun, Coopers & Lybrand/Marc J Consulting, the International Vaccine Institute, Millipore, the National Vaccine Institute, Schering-Plough, the University of Minnesota, and Wyeth Lederle-Praxis.

The workshop focused on the current issues and new technological advances in cell culture technology. Strong emphasis was placed on the application of cell culture bioprocess technology for the production of biopharmaceuticals such as viral vaccines. The workshop which attracted 37 participants including scientists working in biotechnology research and development, process development scientists, production managers, process design engineers and others who need to keep ahead of the issues and latest developments in cell culture bioprocess technology.

The range of subjects covered in the workshop included cell culture process, viral infection process, cell and viral seed banking process, media development, process development and process optimization, downstream processing, formultation/final product presentation, scale-up and facility design considerations, as well as regulatory and cGMP considerations.

For further information, please contact:
Lily Chan, Deputy Director
BioProcess Technology Center, National University of Singapore
Tel: 65-772-6619 ; Fax: 65-775-4933 ; E-mail: btcchanl@leonis.nus.sg

Dr. Hai-Feng Huang is a pediatric infectious disease specialist who received his medical degree at the University of California, San Francisco (UCSF) and his training in pediatrics and in infectious disease at the Harbor Medical Center, University of California, Los Angeles (Harbor-UCLA). Dr. Huang, a US citizen, hails originally from Taiwan and moved to the United States at the age of 9. He joined the Institute staff in June, 1997.

Dr. Huang's primary responsibility will be to coordinate the Institute's multi-national study on epidemiology of invasive childhood bacterial infections. He will work closely with principal investigators at each study site to implement this multi-center study.

Dr. Huang enjoys reading science fiction and builds computers in his spare time.

Mr. Gupta is a Computer Science Specialist who holds a Bachelor's degree in science and a Masters degree in mathematical statistics. Prior to joining the Institute in September, 1997, he worked for Rail India Technical and Economic Services as Deputy General Manager, where he was responsible for the computerization of various operations including feasibility studies, systems analysis and design, software development, implementation and training. His experience includes setting up a computer center and providing training for computer operations and programming to the Iraqi Republic Railway Establishment.

Mr. Gupta, an Indian national, joins the Institute as a United Nations Volunteer. He will be responsible for maintaining and developing the Institute's computer network and internet communications capability.

Dr. SooYoung Stanford Lee, IVI's Senior Scientist and Head for Technical Programs, left the Institute in September to take up a new appointment as Manager of Bioprocess Development at Schering-Plough Research Institute in New Jersey, USA.

Dr. Lee was responsible for coordinating construction planning on behalf of the Institute and played an important role to ensure that the Institute's design will be consistent with its future needs. Dr. Lee was also involved as a faculty member for the Institute's training workshops in Bandung and Beijing, and served as a faculty member for the Workshop on Cell Culture Bioprocess Technology, organized by the Bioprocess Technology Center in Singapore in collaboration with the Institute, in October 1997.

Gurinder, IVI's Head of Program Development, played a key role during the site selection and board nominations processes of the Institute's establishment while serving with UNDP in New York before moving to Seoul in January 1995 as a member of the Institute's senior management team. He has been responsible for overseeing the build up of partnership links between the Institute and leading centers of excellence in Asia, for information dissemination activities of the Institute (including publication of this Newsletter), and for coordinating IVI's training and capacity-building activities.

Gurinder will serve as Principal Consultant at Coopers & Lybrand/Marc J Consulting Healthcare and Pharmaceutical Industries Practice. He will also be Executive Director and Coordinator of the newly established International Molecular Biology Network (IMBN) for Asia and the Pacific Rim. In addition to taking on these new responsibilities, Gurinder will continue to coordinate the planning and organization of the meeting on Economic and Policy Considerations in New Vaccine Introduction which the Institute is organizing in Thailand next March/April in association with the Department of Communicable Disease Control of the Thai Ministry of Public Health.

The Institute now has a completely new Web site (URL for the home page is http://www.ivi.org). The site provides information regarding the Institute and its various programs and initiatives, as well as links to a growing number of other interesting vaccine-related sites. It also provides a book review section, and a discussion forum is under construction. Why not come visit our site? Feel free to share your comments and suggestions for improving the site and making it more responsive to your needs.

The Institute's Web site already haslinks to over 200 vaccine-related Web sites throughout the world. Some particularly interesting sites include:

The DNA Vaccine Page [http://www.genweb.com/Dnavax/dnavax.html] is an attractive site provides fairly comprehensive access to information regarding DNA vaccine research and development. It includes information on conferences, news, scientific information and an excellent selection of links.

The US Centers for Disease Control and Prevention (CDC) site [http://www.cdc.gov] provides up-to-date information on travelers' health, training and employment opportunities, research funding possibilities (in the US), scientific information, epidemiological surveillance data, health statistics, laboratory information on communicable diseases, and a variety of other interesting information.

The World Health Organization 's Global Programme for Vaccines and Immunization (GPV) site [http://www.who.ch/programmes.gpv/gpv_home.htm] has a "Latest News" section, and includes several full text newsletters. It also provides information regarding the Children's Vaccine Initiative, and contains the text of the book "State of the World's Vaccines and Immunization".

All the Virology on the WWW [http://, by the Garry Lab seeks to provides links to a large number of virology-related Web sites that might be of interest to virologists, and others interested in learning more about viruses. It has an index to virus pictures on the web, The Big Picture Book of Viruses (which also functions as a resource for viral taxonomy). A collection of some of the best Online Virology and Microbiology Courses available can also be found here. If you're interested in books you can access its Virology Bookshop, an on-line microbiology and virology bookstore with discounts for users. It even provides links to Virology Dictionaries.

Outbreak [http://www.outbreak.org/ cgi-unreg/dynaserve.exe/index.html] is an interesting on-line information service addressing emerging (and remerging) infectious diseases. This site is also well worth visiting.

Do check out the Institute's Web site and these other interesting sites - and let us know if there are sites to which you feel we should set up links to!

The International Vaccine Institute plans to set up a discussion forum on vaccines on its Web site. Topics currently available for reaction and feedback include:

For each topic, a brief position paper to initiate discussion will be made available. Respondents will also be able to review the perspectives posted by others and make their views known. But don't be constrained by the topics we have developed. Write to the webmaster with your suggestions for topics (write a position paper for it too) - you might just find your topic listed!

One of the aims of the International Vaccine Institute is to collect and disseminate vaccine-related information. The Institute invites publishers and authors to send us their latest books devoted to vaccines, immunology and infectious diseases.

If you would like to review any of these books (or other books of vaccine-related interest), please write or send an e-mail to Andree Manuel, Information Services Officer, International Vaccine Institute (amanuel@plaza.snu.ac.kr or Webmaster@ivi.org) with particulars of the book you wish to review. The review will be published on our web site and, possibly, our newsletter. For further information regarding the book review program, check out our web site at (http:/ /www.ivi.org)

The Institute hosted the following visitors between November 1, 1996 and November 30, 1997:

Mr. Armando Alvarez ( Embassy of Mexico, Korea), Dr. John Barton (Stanford Univ., USA), Ms. Claudiana Betancourt (Ambassador's wife, Embassy of Ecuador, Korea), Mr. George Blumberg (Samsung Europe Headquarters), Dr. Jane Broughan (Wyeth-Lederle Vaccine & Pediatrics, USA), Prof. Steven Chung (Univ. of Hong Kong, China), Dr. Ron Dagan (Soroka University Medical Center, Israel) Dr. Don Francis (Genentech Inc., USA), Dr. Bruce Gellin (National Institute of Allergy & Infectious Diseases, National Institute of Health, USA), Dr. Ramesh Govindaraj (Harvard Univ. of Public Health), Prof. Cunsan Guo (Sino-Danish Biomedical Postgraduate Training Center, China), Mr. Frank Hartvelt (SEED, UNDP, USA), Drs. Maman Hidayat ( Bio Farma, Indonesia), Dr. Maurice Hilleman ( Merck Institute for Therapeutic Research), Prof. Fotis Kafatos ( European Molecular Biology Laboratory, Germany), Dr. Vera Kallmeyer (Aviron, USA), Dr. David Kim (CDC, Atlanta, USA), Dr. Yosef Kimhi (Institute of Molecular & Cell Biology, National University of Singapore, Singapore), Dr. John La Montagne (National Institute of Allergy & Infectious Diseases, National Institute of Health, USA), Mr. Charles Lim (Pharmacia Biotech, Malaysia), Dr. Alicia L. Lingao (Philippine Council for Health Research and Development, The Philippines), Dr. C. J. Lucas (Netherlands Organization for Applied Scientific Research), Dr. James Maynard ( PATH, USA), Mr. S. Ahmed Meer ( U.S. Embassy, Korea),Dr. Kathrin Muhlermann (Institute for Medical Microbiology, University of Berne, Switzerland), Dr. William Muraskin (Queens College, City Univ. of New York, USA), Mr. Dennis Normile (Science, Japan), Dr. Remigio M. Olveda (Research Institute for Tropical Health),

Dr. Shigeru Omi ( WHO Western Pacific Regional Office, The Philippines), Dr. Akira Oya (Japan National Institute of Health, Japan), Mr. Hugh Purser ( National Science and Technology Board, Singapore), Dr. S. Ramachandran (Anna University, India), Dr. James S. Robertson (NIBSC, UK), Mr. Timothy Rothermel (UNDP, Palestine), Prof. Philip Russell (Johns Hopkins University, USA), Dr. Albert Sasson (UNESCO, France), Dr. Victor Shi (A. M. Pappas & Associates, Singapore), Mr. Ma Shiliang ( Chinese Academy of Preventive Medicine, China), Prof. M. Siniscalco (Calgary University, Italy), Dr. Yoshifumi Takeda ( International Medical Center of Japan, Japan), Dr. Elaine Walker (Therapeutic Goods Administration Laboratories, Australia), Prof. Joel Ward (Harbor-UCLA Medical Center, USA), Dr. Cao Xu (Wellbond Group Ltd., Hong Kong), Dr. Jian-Guo Xu (Institute of Epidemiology & Microbiology, China), Prof. Zhi-Yi Xu (Shanghai Medical University, China), Dr. Pacita L. Zara (Philippine Council for Health Research and Development, The Philippines).

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

New Trends in Vaccine R&D- Adjuvants, Delivery Systems and Antigen Formulations

Contact: M.L. Drye
Institute Pasteur, Euro Conferences
28, rue du Docteur Roux
75724 Paris Cedex 15, France
Fax: 33-1-4061-3405 ; e-mail: ldrye@pasteur.fr

Contact: Susanne Koch, PhD
Waldstr. 11
53721 Siegburg, Germany
Tel: 0049-2241-56882 ; Fax: 0049-2241-56484 ; email : susanne.koch@metronet.de

Contact: International Society for Infectious Diseases
181 Longwood Av.
Boston, MA 02115 USA
Tel (617) 277 0551

First Annual Conference on Vaccine Research Basic Science- Product Development- Clinical and Field Studies

Contact: NFID, Suite 750
4733 Bethesda Ave
Bethesda, MD 20814-5228, USA
Fax: (301) 907-0878 ; Tel: (301) 656-0003 ; E-mail: kkantelo@aol.com

Contact: Institute Pasteur
28, rue du Docteur Roux
75724 Paris Cedex 15, France
Fax. 33-1-4061-3405

Contact: Prof. Felicidad Cua-Lim
7 Roosevelt St, GH West
San Juan, Metro Manila 1502
Tel: 63-2-722-1433 ; Fax:63-2-722-0202

Institute News	IVI Staff News
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Meeting Reports

Vaccine	Eligible Suppliers
BCG	Behringwerke, Conpharma (Sofia), Japan BCG, Medeva, Pasteur-Merieux-Connaught, Statens Seruminstitut Copenhagen
DTP	Behringwerke, CSL, Pasteur-Merieux-Connaught, Serum Institute of India, Swiss Serum
DT	Behringwerke, CSL, Human, Pasteur-Merieux-Connaught, Biocine, Serum Institute of India, Swiss Serum
TT	Behringwerke, CSL, Human, Pasteur-Merieux-Connaught, Biocine, Serum Institute of India, Swiss Serum
OPV	Behringwerke, Biocine, BioFarma, Pasteur-Merieux-Connaught, SmithKline
Measles	Biocine, BioFarma, Eisai, Intervax (Institute of Immunology, Zagreb), Medeva, Pasteur-Merieux-Connaught, Serum Institute of India, SmithKline, Swiss Serum
Hepatitis B	Cheil Foods and Chemicals, Korea Green Cross Corporation, LG, SmithKline