Report of the Ninth Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine

Transcription

1 Report of the Ninth Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers Geneva, Switzerland, 17 November 2016

2 Ordering code: WHO/HIS/TTi/17.4 This publication is available on the internet at: World Health Organization 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization ( Suggested citation Report of the Ninth meeting with international partners on prospects for influenza vaccine transfer to developing country vaccine manufacturers held in Geneva, Switzerland, 17 November World Health Organization; 2017.]. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at Sales, rights and licensing. To purchase WHO publications, see To submit requests for commercial use and queries on rights and licensing, see Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. ii

3 CONTENTS ABBREVIATIONS AND ACRONYMS... iv SESSION 1. INTRODUCTION AND UPDATES... 1 Opening: taking stock of the tech transfer programme, successes and challenges, and lessons learnt... 1 Take home messages from the GAP III meeting and discussion... 1 SESSION 2: PRESENTATIONS BY MANUFACTURERS WITH PRODUCTS IN RESEARCH/CLINICAL STUDIES... 1 BCHT (China)... 1 Butantan (Brazil)... 2 GPO (Thailand)... 2 Serum Institute of India (India)... 2 Torlak (Serbia)... 3 IVAC (Vietnam)... 3 SESSION 3. CONTINUING SUPPORT TO MANUFACTURERS... 3 International proficiency study of the single radial immune diffusion test (SRID) for manufacturers and regulators from developing countries... 3 Continuation of Chemistry Manufacturing and Control (CMC) and clinical trial support (PATH) 3 BARDA presentation international programme... 4 Future technical support to vaccine manufacturers (influenza and beyond)... 4 Conclusion... 4 ANNEX 1: PROGRAMME... 5 ANNEX 2: LIST OF PARTICIPANTS... 6 iii

4 ABBREVIATIONS AND ACRONYMS BARDA BCHT CMC FDA GAP GMP GPO HHS IDRI IIV IND IVAC LAIV MDCK R&D SII TIV US WHO Biomedical Advanced Research Development Authority Changchun BCHT Biotechnology Co. (People s Republic of China) Chemistry Manufacturing and Control Food and Drug Administration Global Action Plan for Influenza Vaccines good manufacturing practice Governmental Pharmaceutical Organization Department of Health and Human Services (US) Infectious Disease Research Institute inactivated influenza vaccine investigational new drug Institute of Vaccines and Medical Biologicals live attenuated influenza vaccine Madin-Darby canine kidney cell line research and development Serum Institute of India trivalent inactivated influenza vaccine United States World Health Organization iv

5 8th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers SESSION 1. INTRODUCTION AND UPDATES The Ninth Meeting of International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers was held on 17 November 2016 in Geneva, Switzerland. The meeting was chaired by Dr James Robertson. The programme and list of participants are provided in Annex 1 and 2; the presentations are available on the World Health Organization (WHO) website ( Opening: taking stock of the tech transfer programme, successes and challenges, and lessons learnt Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation, extended a warm welcome to all participants. She commented on the considerable progress made at the grantee manufacturers and thanked partners for their support. As a result of this programme more than 1 billion doses will be added to global pandemic production capacity by She stressed the important work ahead in consolidating and sustaining the progress made to date. Take home messages from the GAP III meeting and discussion Bruce Gellin, Chair of the final WHO consultation on the Global Action Plan (15-16 November 2016), noted that much progress had been made towards achieving the GAP objectives, and a significant proportion of those advances had been aided by the establishment of influenza vaccine manufacturing in developing countries with the help of technology transfer. The GAP target to increase global production capacity to 10 billion doses of pandemic influenza vaccine had yet to be met. While GAP had concluded, it was hoped and intended that efforts to support vaccine production in developing countries would continue. Challenges include sustaining seasonal influenza vaccine demand for the current level of production capacity to be maintained and expanded. Demand for seasonal vaccines has slowed down in some regions over the past few years, and participants at the GAP consultation had spent extensive time discussing why that had occurred and questioning the dogma on which pandemic vaccine preparedness efforts have been based. Currently, there are limited tools and resources with which to respond to a pandemic. There is a pressing need for novel and improved influenza vaccines- and a pressing challenge is to carry out major R&D to develop next-generation vaccines... SESSION 2: PRESENTATIONS BY MANUFACTURERS WITH PRODUCTS IN RESEARCH/CLINICAL STUDIES BCHT (China) Jinchang Wu provided an overview of the influenza vaccine development at BCHT, China. Major milestones included the transfer of the Russian LAIV technology from the Institute of Experimental Medicine and WHO in 2012; Investigational New Drug (IND) application filing in September 2013; IND approval in August 2015; and clinical trials for a trivalent LAIV vaccine beginning in March of this year. Phase I and phase II trials have been concluded and a phase III trial is underway. Earlier studies to evaluate safety and efficacy showed robust immune responses to a single vaccination in ferrets. BCHT intends to reach registration by and to obtain WHO prequalification as soon as possible so as to gain access to international markets. The phase III trial will enrol healthy children and adolescents aged 3 to 17 to assess safety, efficacy and immunogenicity of one dose of the vaccine in. Final results are expected towards the end of BCHT has a new state-of-the-art plant under construction which will include an LAIV facility with a capacity of eggs per day. 1

6 Butantan (Brazil) Ricardo Oliveira reported that the Brazilian Regulatory Agency had required Butantan to perform a prospective study to evaluate the safety and immunogenicity of its seasonal influenza vaccines from 2013 to 2015 as a post-licensing requirement. The study population consisted of 169 healthy adults (men and non-pregnant women) and 130 elderly (over age 60). The results showed that the seasonal vaccines were safe and immunogenic for both groups. Products currently in research include an adjuvanted split virus H7N9 vaccine. Support is being provided by the US Biomedical Advanced Research Development Authority (BARDA), the Infectious Disease Research Institute (IDRI) and WHO. Preclinical tests were carried out in ferrets and three industrial batches were subsequently produced. Formulation and filling is anticipated in Butantan is also developing a quadrivalent vaccine which they plan to test in clinical trials in 2017 depending on demand from Ministry of Health. GPO (Thailand) Ponthip Wirachwong reported that GPO, a state enterprise, has the long-term goal of establishing and sustaining the capacity to manufacture up to 10 million doses of WHO prequalified seasonal inactivated influenza vaccine (IIV), which could be converted to produce 60 million doses of pandemic vaccine (IIV and LAIV); and of supporting national and regional influenza pandemic preparedness through contributing to stockpiles of pre-pandemic vaccine. A recent phase I/II study evaluated the safety, efficacy, and immunogenicity of GPO s seasonal TIV in healthy adults. The results indicated that the vaccine is safe and immunogenic. A clinical phase III trial is in preparation. Target groups for the vaccine are pregnant women, people with chronic diseases, and healthcare personnel. A new manufacturing plant for vaccine production is currently being built and is expected to begin producing commercial vaccines in The establishment and sustainability of influenza vaccine production in Thailand is taking place under favourable conditions including: Government support of US$ 42 million for the industrial-scale manufacturing plant; a supportive policy environment and supportive national healthcare system; and an annual market for seasonal influenza vaccine of 3.5 million doses. Among the challenges facing the company are the need for a guaranteed supply of Specific Pathogen Free (SPF),the supply of vaccine quality eggs and further technical development to strengthen R&D and production capabilities. Assistance is needed, for example, in transferring from pilot to industrial production. Serum Institute of India (India) Suresh Jadhav presented SII s experience in the development of their influenza vaccine programme. Challenges in early development included the sourcing of eggs and vaccine viruses, the development and optimization of manufacturing processes, and pre-clinical studies. SII had explored both IIV and LAIV during the H1N1pdm09 pandemic before selecting LAIV for further development. During the H1N1 pandemic they licensed both an IIV and LAIV. Their H1N1 LAIV was WHO prequalified in November In 2014 they licensed their seasonal trivalent LAIV and received WHO prequalification in September Post-licensure clinical trials of their seasonal LAIV have included completed efficacy studies in Bangladesh and Senegal, an ongoing efficacy study in Delhi, India, and an ongoing immunogenicity and safety trial in Gambia. Results to date indicate that the vaccine is safe and effective. New influenza vaccines under development include a liquid egg-based trivalent seasonal vaccine; a liquid egg-based quadrivalent seasonal vaccine; and a liquid cell-culture-based quadrivalent seasonal vaccine. The use of cell-culture production would overcome the issue of sourcing eggs. 2

7 8th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers Sustainability has become a major concern for influenza vaccine manufacture by SII. Demand for the H1N1 LAIV had been high during the H1N1 pandemic but then significantly declined resulting in SII destroying 6 million doses of unused vaccine. Money has been lost, which has had to be compensated for by sales of other products. Without a market, it is not clear if production can be sustained, and it would help to have the government contribute some funding to keep factories online and operating. Torlak (Serbia) Svetlana Filipovic Vignjevic presented Torlak s progress in influenza vaccine development. Torlak has developed a split inactivated trivalent influenza vaccine. Phase I clinical trials were conducted in The vaccine was found to be safe, well-tolerated, and immunogenic. The phase III trial would start this month and a license will be requested in The vaccine will be used first among the elderly and later expanded to other high-risk groups. The long-term aim is to produce doses annually to meet the demand within Serbia. At full scale production, the facility could produce 1.4 million doses of TIV, which would translate to 4.2 million doses of a monovalent pandemic vaccine. With the addition of an adjuvant this capacity could be further increased. Torlak plans to initiate nonclinical studies of an adjuvanted split pandemic vaccine in IVAC (Vietnam) Le Kim Hoa presented the influenza vaccine development at IVAC. Since joining the project in 2007, IVAC has built a GMP-certified influenza vaccine manufacturing plant as well as a chicken farm, and has established a process for the production of whole killed monovalent vaccines and split inactivated seasonal vaccine. They have completed phase I and II clinical studies for an A/H5N1 vaccine, with a phase III to commence shortly. A phase I clinical trial of a split seasonal vaccine has been conducted with good preliminary results, and phase II/III clinical trials are expected to commence in early SESSION 3. CONTINUING SUPPORT TO MANUFACTURERS International proficiency study of the single radial immune diffusion test (SRID) for manufacturers and regulators from developing countries Laszlo Palkonyay provided an update on the study which aims to assess the effectiveness of hands-on WHO training workshops carried out under GAP in the field of quality control for inactivated seasonal influenza vaccines produced since Since 2012 WHO, supported by the US FDA, has been supporting capacity of developing country national regulatory agencies and national control laboratories to regulate vaccines with an emphasis and focus on influenza through providing training. The proficiency study is due to commence in 2016 with test antigens, reagents, and the study protocol to be distributed to participants. Tests will be performed at the participants laboratories and at the National Institute for Biological Standards and Control, and the report will be published. Continuation of Chemistry Manufacturing and Control (CMC) and clinical trial support (PATH) Francesco Berlanda Scorza outlined the support that PATH had provided, with financial support from BARDA, to manufacturers in the GAP initiative, related to CMC, clinical trials, pharmacovigilance and regulatory functions. 3

8 Among these efforts were support to IVAC in designing clinical trials for split inactivated trivalent influenza vaccine and for whole virion inactivated A/H5N1 monovalent pandemic vaccine as well as pharmacovigilance support; support to Torlak with clinical activities related to seasonal vaccine development; support to VABIOTECH with MDCK cell line characterization and process development; cooperation with SIIL on MDCK cells (including commercial licensure and cell characterization), and liquid formulation development for the final product, a cell-culture-based quadrivalent LAIV; collaboration with Butantan on CMC and other activities, including process validation and manufacturing of TIV seasonal vaccine, pharmacovigilance support and assistance in prequalification submission; and support to BCHT on downstream activities such as process and yield optimization and formulation, and on a clinical development plan and on preparation of a new manufacturing facility. BARDA presentation international programme Julie Schafer reminded participants that as the international technology-transfer programme and GAP concludes, the gains made over the past decade must be sustained in the face of serious challenges. It is necessary for all involved to deal with the difficult issues of creating and sustaining demand for influenza vaccines; and that further effort is needed in encouraging and working with government programmes, keeping in mind the sometimes convoluted relationships between governments and private markets. It also is important to see what recommendations for the future come out of the conclusion of GAP. Enormous progress had been achieved over the decade-long international technology transfer partnership effort, and that outcome illustrated a core BARDA belief that money alone is not enough; what companies and countries need is sustained cooperative effort and international teamwork. Future technical support to vaccine manufacturers (influenza and beyond) Martin Friede noted that more than US$ 50 million had been provided to manufactures in the programme, which given the enormity of the undertaking, wasn t a great deal of money. The fact that WHO supported these programmes encouraged Governments to provide domestic support for influenza vaccine development and production. As the decade-long international partnership project now came to a close, WHO will continue to provide expert advice and information. The sustainability challenges facing developing country vaccine manufacturers will require steps to capitalize on the know-how, technology, expertise and facilities that now exist to augment incomes from vaccine production with other products such as biotherapeutics. Manufacturers should study local and regional markets and needs to see what opportunities are present. They may be able to use their infrastructure and filling lines for goods other than vaccines; they may be able to manufacture veterinary vaccines along with human vaccines; and they may be able to hire themselves out to conduct clinical trials for other potential medications. Although most producers came into the field for public health reasons, the bottom line is money, and it is important to be thinking of marketing in other areas. Developing-country manufacturers have accomplished the hard work of building up their factories and attaining the needed expertise; now it is up to them to find ways to retain their capacities for producing influenza vaccines. Martin Friede acknowledged the fundamental role of all of the partners who had contributed financially and technically to the success of the programme. Conclusion The Chair of the meeting, James Roberston, noted that the enthusiasm and dedication shown during the many technology-transfer projects had been admirable and it is clear that there is a continuing desire to make good vaccines. GAP itself may be closing, but in whatever form develops the family of vaccine developers and manufacturers will go on. 4

9 8th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers ANNEX 1: PROGRAMME Chair: Dr James Robertson SESSION 1: INTRODUCTION 9:00 9:30 Opening: taking stock of the tech transfer programme, successes and challenges, and lessons learnt (Dr Marie-Paule Kieny) Take home messages from the GAP III meeting and discussion (Dr Bruce Gellin) SESSION 2: PRESENTATIONS FROM MANUFACTURERS WITH PRODUCTS IN RESEARCH/CLINICAL STUDIES 9:30 10:30 BCHT (Dr Jinchang Wu) Butantan (Dr Ricardo das Neves Oliveira) GPO (Dr Ponthip Wirachong) 11:00 12:00 IVAC (Dr Le Kim Hoa) SII (Dr Suresh Jadhav) Torlak (Dr Svetlana Filipovic-Vignjevic) SESSION 3: CONTINUED SUPPORT TO MANUFACTURERS 13:00 13:55 International proficiency study of the SRD test for manufacturers and regulators from developing countries (Dr Laszlo Palkonyay) PATH presentation continuation of CMC and clinical trials support (Dr Francesco Berlanda Scorza) BARDA presentation international programme (Ms Julie Schafer) Future technical support to vaccine manufacturers (influenza and beyond) (Dr Martin Friede) 13:55 14:30 Wrap-up 5

10 ANNEX 2: LIST OF PARTICIPANTS PARTICIPANTS/OBSERVERS Dr Atika Abelin, Director, Public Affairs (IFPMA IVS policy member), Sanofi Pasteur, Lyon, France Ms Paula Barbosa, Manager, Vaccines Policy, International Federation of Pharmaceutical Manufacturers & Associations, Geneva, Switzerland Dr Francesco Berlanda Scorza, Project Director, Influenza vaccines, PATH, Seattle, United States of America Dr Joseph S. Bresee, Chief, Epidemiology and Prevention Branch, Influenza Division, Centers for Disease Control and Prevention, Atlanta, United States of America Professor Daniel Camus, Lille Pasteur Institute, Lille, France Mr Christopher Chadwick, International Health Analyst, Office of Pandemics and Emerging Threats, US Department of Health and Human Services (HHS), Washington, United States of America Dr Nicolas Collin, Head, Vaccine Formulation Laboratory, University of Lausanne, Epalinges sur Lausanne, Switzerland Dr Nancy J. Cox, Consultant, Atlanta, United States of America Dr Dr Ricardo das Neves Oliveira, Butantan Institute, São Paulo, Brazil Dr Do Tuan Dat, Director, The Company for Vaccines and Biological Production No. 1 (VABIOTECH), Ha Noi, Viet Nam Dr Martine Denis, Consultant, Mandelieu la Napoule, France Dr Armen Donabedian, Senior Programme Manager, Vaccine Advance Development, Biomedical Advanced Research and Development Authority (BARDA), Washington DC, United States of America Dr Matthew Downham, Associate Director, Flu Manufacturing Sciences & Technology, Medimmune, Liverpool, United Kingdom of Great Britain & Northern Ireland Dr Thai Huu Duong, Vice Director, Production, Institute of Vaccine and Medical Biologicals, Nha Trang, Viet Nam Dr Othmar Engelhardt, Principal Scientist, National Institute for Biological Standards and Control, Health Protection Agency, Potters Bar, United Kingdom of Great Britain and Northern Ireland Mr Ralf Fehrenbach, Managing Director, Fehrenbach Consult SPRL, Meux, Belgium Dr Svetlana Filipovic-Vignjevic, Assistant Director, Institute of Virology, Vaccines and Sera Torlak, Belgrade, Serbia Dr Chris Fox, Senior Scientist/Principal Investigator, Infectious Disease Research Institute, Seattle, United States of America Dr Donald P Francis, Executive Director, Global Solutions for Infectious Diseases, South San Francisco, United States of America Dr Juliman Fuad, Production Director, PT Biofarma (Persero), Bandung, Indonesia Dr Bruce Gellin, Director, National Vaccine Programme, Department of Health and Human Services, Washington, United States of America Mr Jan T. Hendriks, Institute for Translational Vaccinology, Bilthoven, Netherlands Dr Le Kim Hoa, Vice Director, Quality Control and Quality Assurance, Institute of Vaccine and Medical Biologicals, Nha Trang, Viet Nam Mr Chuong Huynh, Interdisciplinary Scientist /Project Officer (COR-III), Division of Influenza, Biomedical Advanced Research and Development Authority (BARDA), Washington, United States of America Dr Luis Guillermo Francisco Ibarra Ponce de Leon, General Director, Laboratorios de Biologicos y Reactivos de Mexico, Mexico DF, Mexico Dr Suresh S. Jadhav, Executive Director, Quality Assurance & Regulatory Affairs, Serum Institute of India Limited (SIIL), Pune, India Dr Markhabat Kassenov, Head of Laboratory, Research Institute for Biological Safety Problems (RIBSP), Gvardeiskiy, Kazakhstan Dr Berik Khairullin, Deputy Director, Research Institute for Biological Safety Problems, Gvardeiskiy, Kazakhstan 6

11 8th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers Dr Igor Krasilnikov, Deputy Director, Saint-Petersburg Institute of Vaccines and Sera, Saint- Petersburg, Russian Federation Dr Rosanna Lagos, Coordinator, Centre for Developing Vaccines - Chile, Children Hospital Roberto del Rio, Santiago, Chile Dr Fernando Lobos, Director, Business Development, Sinergium Biotech, Garin, Argentina Dr Kutub Mahmood, Scientific Director, Vaccine Development Global Program, PATH, Seattle, United States of America Dr Morena Makhoana, Deputy Chief Executive Officer, Biovac Institute, Pinelands, South Africa Dr Raul Yanko Montano Chavez, Director, National Institute of Virology, Laboratorios de Biologicos y Reactivos de Mexico (BIRMEX), Cuautitlán Izcalli, Mexico Dr Ida Nurnaeni, Head of Department, Influenza Vaccines Department, PT Biofarma (Persero), Bandung, Indonesia Mr Adrian Onu, Scientific Director, Cantacuzino Institute, Bucharest, Romania Dr Hicham Oumzil, Head, Virology Department, National Institute of Hygiene, Rabat, Morocco Dr Sonia Pagliusi, Executive Secretary, Developing Countries Vaccine Manufacturers Network (DCVMN), Nyon, Switzerland Dr Laszlo Palkonyay, Consultant, Geneva, Switzerland Mr Kittisak Poopipatpol, Influenza Vaccine Plant Manager, The Government Pharmaceutical Organization, Bangkok, Thailand Dr James S Robertson, Independent Consultant, St Albans, United Kingdom of Great Britain and Northern Ireland Professor Larisa Georgievna Rudenko, Head, Department of Virology, Institute of Experimental Medicine, Saint-Petersburg, Russian Federation Dr Carla Magda Santos Domingues, EPI Manager, Secretaria de Vigilância em Saúde, Ministério da Saúde, Brasilia, Brazil Dr Kellen Santos Rezende, Consultant, Brasilia, Brazil Ms Julie Schafer, Chief of Staff, Biomedical Advanced Research & Development Authority, Department of Health and Human Services, Washington, United States of America Dr Jane Seward, Partnership for Influenza Vaccine Introduction (PIVI), The Task Force for Global Health, Decatur, United States of America Ms Muriel Socquet, Programme Manager - VAC, PATH, Grand Saconnex, Switzerland Dr Jaspal Sokhey, Consultant, New Delhi, India Dr Vera Stoiljkovic, Managing Director, Institute of Virology, Vaccines and Sera Torlak, Belgrade, Serbia Mr Sit Thirapakpoomanunt, Director, Viral Division, The Government Pharmaceutical Organization, Bangkok, Thailand Mr Patrick Tippoo, R&D Manager, Biovac Institute, Pinelands, South Africa Professor Han van den Bosch, ATHENA Institute, Free University, Amsterdam, Netherlands Professor Sylvie van der Werf, Head, Unité de Génétique moléculaire des Virus respiratoires, Institut Pasteur, Paris, France Mrs Elly van Riet, Institute for Translational Vaccinology, Bilthoven, Netherlands Dr Roland Ventura, Vaccine Formulation Laboratory, University of Lausanne, Epalinges, Switzerland Dr Rahnuma Wahid, Senior Program Officer, Vaccine Development, PATH, Seattle, United States of America Dr Yajun Wang, Director, LAIV Department, Changchun BCHT Biotechnology Co., Changchun, People s Republic of China Professor John Martin Watson, Deputy Chief Medical Officer, Department of Health, London, United Kingdom of Great Britain and Northern Ireland Dr Jerry Weir, Director, Division of Viral Products - Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, United States of America Dr Ponthip Wirachwong, Director of Biological Research Group, Research and Development Institute, Government Pharmaceutical Organization, Bangkok, Thailand Dr Jinchang Wu, Director R&D, International Affairs, Changchun BCHT Biotechnology Co., Changchun, Jilin, People's Republic of China 7

12 WHO/HEADQUARTERS SECRETARIAT Dr Marie-Paule Kieny, Assistant Director-General, Health Systems and Innovation Technology Transfer initiative, Essential Medicines and Health Products Ms Florence Barthelemy, Team Assistant Dr Gary Grohmann, Technical Officer Ms Myriam Grubo, Technical Officer Ms Erin Sparrow, Project Officer Mr Guido Torelli, Programme Manager Mr Alan Sternberg, Rapporteur Essential Medicines and Health Products Ms Claudia Nannei, Technical Officer, Public Health, Innovation and Intellectual Property WHO Health Emergencies Programme Ms Anne Huvos, Legal Officer Initiative for Vaccine Research, Immunization, Vaccines and Biologicals, Family, Women's and Children's Health Dr Martin Friede, Coordinator Dr Birgitte Giersing, Technical Officer WHO/REGIONAL AND COUNTRY OFFICES SECRETARIAT Professor Bartholomew Akanmori, Immunization and Vaccine Development Programme, WHO African Region, Brazzaville, Republic of Congo Dr Maria Luz Pombo, Regional Adviser on Vaccines and Biotechnological Products, WHO Region of the Americas, Washington, DC, United States of America Ms Pernille Jorgensen, Technical Officer, Influenza & other Respiratory Pathogens (IRP), Division of Communicable Diseases and Health Security, WHO European Region, Copenhagen, Denmark Dr Erica Dueger, Medical Officer, Influenza Surveillance, WHO Western Pacific Region, Manila, Philippines Dr James Heffelfinger, Technical Officer for New Vaccines, WHO Western Pacific Region, Manila, Philippines Dr Felipe Dias Carvalho, Consultant for Health Technologies Innovation and Development, WHO Country Office, Brasilia, Brazil Dr Emilia Cain Harari, Expanded Programme on Immunization, WHO Country Office, Mexico, Mexico 8