The Global Action Plan for Influenza Vaccines Report of the eighth meeting of the Advisory Group of the WHO Global Action Plan for Influenza Vaccines
Dubai, United Arab Emirates, 19 March 2013
Ordering code: WHO/HIS/TTI/13.1
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Contents Abbreviations and Acronyms ......................................................................................................................................... 4 1. 2. 3. Welcome and objectives ......................................................................................................................................... 5 Mapping of WHO and global activities that support GAP ........................................................................... 6 GAP partnership offices: report on activities ................................................................................................. 9 3.1 3.2 4. 5. 6. 7. CDC: Dr Joe Bresee.................................................................................................................................................................... 9 BARDA: Dr Rick Bright ......................................................................................................................................................... 10
Monitoring and evaluation of GAP objectives and activities ................................................................. 11 Interactions of PIP–GAP advisory groups ..................................................................................................... 13 Future prioritization ............................................................................................................................................. 14 List of Participants ................................................................................................................................................. 15
Report of the eighth meeting of the Advisory Group of the WHO Global Action Plan for Influenza Vaccines— 19 March 2013
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Abbreviations and Acronyms AG BARDA CDC DCVMN EPI GAP GAVI GIP GLP GPO HIV IFPMA IHR IIV IPR LAIV LMIC MCH MDG M&E NIBSC NRA PAHO PIP R&D RSV SAGE SII UN UNICEF US HHS VE VLP WHA WHO Advisory Group Biomedical Advanced Research and Development Authority Centers for Disease Control and Prevention, Atlanta, USA Developing Countries Vaccine Manufacturers network Expanded Programme on Immunization Global Action Plan for Influenza Vaccines Global Alliance for Vaccines and Immunization The Global Influenza Programme Good Laboratory Practice The Government Pharmaceutical Organization Human Immunodeficiency Virus International Federation of Pharmaceutical Manufacturers & Associations International Health Regulation Inactivated Influenza Vaccine Intellectual Property Rights Live Attenuated Influenza Vaccines Low- and middle-income countries Maternal and Child Health Millenium Development Goals Monitoring & Evaluation National Institute for Biological Standards and Control National Regulatory Authority Pan American Health Organization Pandemic Influenza Preparedness Framework Research and Development Respiratory Syncytial Virus Strategic Advisory Group of Experts on Immunization Serum Institute of India United Nations United Nations Children's Fund United States Department of Health and Human Services Vaccine effectiveness Virus-like Particle World Health Assembly World Health Organization
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1. Welcome and objectives Dr Marie-Paule Kieny welcomed members to the 8th meeting of the GAP Advisory Group. Holding the meeting back-to-back with the International Partners meeting means that AG members can discuss the efforts of both the producers and NRAs from the developing countries face to face. She reiterated the critical role of the AG in providing policy guidance to achieve the mandate of the GAP. This was all the more relevant since the GAP focuses on many areas in addition to vaccine production, such as disease burden, seasonal use and cost-effectiveness issues, and advice from the AG to ensure that activities are tailored to the goals, and to advise on the approach that the GAP should take. This meeting was also an opportunity to clarify the relationship between the AGs of the GAP and the PIP Framework and, to this end, the presence of Dr Wenqing Zhang, who participates in both groups, was very welcome. The existing mechanisms for GAP–PIP interaction, along with ways to enhance them, were on the agenda of this meeting. Dr Kieny took this occasion to thank Dr John Tam, who was attending his last GAP meeting as a WHO staff member, for his pivotal role in bringing all the work of the GAP pillars together and moving the programme ahead. Dr Jan Hendriks, an experienced technology transfer expert, has joined the GAP Secretariat on secondment from the Dutch Government and will be participating in GAP meetings from now on. Dr Bruce Gellin, in his role as Chair, looked forward to reviewing the priorities and challenges in the overall GAP programme, and particularly to hearing more about the different, yet common goals of the GAP and PIP. He also referred to several critical issues raised in the International Partners meeting that need to be addressed, either by this group or another, such as decision-making on the switch between seasonal and pandemic vaccine production.
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2. Mapping of WHO and global activities that support GAP Dr John Tam presented an advanced draft of a WHO framework covering the three GAP objectives and the activities required to achieve them, categorized by priority and status. This detailed 5-year plan shows the individual and shared responsibilities of the many stakeholders at WHO. It also includes broader issues such as partnership-building, communication, and economic analyses. Selected activities per objective were presented as follows. Objective 1: Increase seasonal vaccine use. Using the recent SAGE recommendations, WHO has been working with its regional offices to encourage Member States to develop a policy for influenza vaccination. Meetings are being held to address the specific needs of countries and regions, such as developing parallel networks to enhance the capacity of NRAs. Progress and plans included studies on the impact of seasonal vaccine, vaccine effectiveness, and adjuvants under the auspices of SAGE. Ascertaining the number of countries with a seasonal influenza vaccine policy has been hindered by the low response rate to the WHO surveys of 2006 and 2010. Thus a global report is in preparation combining data from the 2010 survey, the WHO–UNICEF Joint Reporting Form, and the VENICE Survey carried out for the European Region. The report will contain other useful information on countries that intend to procure H5N1 vaccine, the risk groups identified, and ultimately vaccine implementation levels. Effectiveness and cost-effectiveness analyses are being proposed for a number of developing countries. One of the aims of these studies is to compare investment in policy vs economic savings in health over several years. VE plans in other countries were also described. Two systematic reviews on these issues in LMIC are in press. With a view to ensuring that vaccine deployment is addressed in the updated pandemic preparedness plan, a new guidance document on pandemic vaccine deployment, based on lessons learnt from the 2009 influenza A(H1N1) pandemic, is now available on the GAP web site in all UN languages. It contains an extensive checklist to assist governments to receive and distribute vaccines, as well as a user-friendly spreadsheet that calculates a budget based on local needs. These documents have been developed in line with the needs of the PIP Framework. Global surveillance systems are being strengthened under the coordination of the Global Influenza Programme. An influenza surveillance manual and an influenza disease burden assessment manual are being finalized. A document on the global disease burden in children has been published and work is in progress on other at-risk groups. A study on disease burden of secondary bacterial infection would also be useful. In order to measure the impact of vaccination at country and regional levels, planned activities include public health impact studies, e.g. on deaths and hospitalizations averted, and a larger economic impact study to collect data from a number of key countries. Communication is a priority and many activities are under way. A communications workshop organized by the US Department of Health and Human Services has been scheduled for June 2013, and a 2-year study on vaccine hesitancy is ongoing in Pune, India, including a focus on LAIV, which will provide indicators of how to address hesitancy. This will feed into a more global understanding of vaccine hesitancy, and provide input to a new SAGE Working Group addressing vaccine hesitancy. The SAGE recommendation on pregnancy will help to promote communication on the value of influenza vaccination in risk groups. Another activity planned is to identify fears and misconceptions systematically from published work and other sources, from which evidence-based messages can be
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developed both for the general public and health professionals. These communication messages could then be tested in specific countries or those at different socioeconomic strata. Objective 2: Increase vaccine production capacity. Dr Tam noted that activities under this objective had been extensively discussed during the International Partners meeting over the previous days. Selected activities were briefly described under the topics of monitoring global vaccine production capacity and demand; providing emerging manufacturers with technical and financial support and capacity building to establish or improve influenza vaccine production; analysing vaccine technology transfer status and needs, including new approaches for technology transfer and sustainability; regulatory issues; and communication. Objective 3: R&D. The regular meetings of clinical trials of influenza vaccines and those on technologies that induce cross-protective and long lasting immunity had now been combined and a meeting was held in January 2013 in Hong Kong, China. GIP has been very active in ensuring standardization of high-growth reassortant vaccine viruses, along with CDC and different WHO Collaborating Centres. Dr Zhang noted that the needs for new generations of vaccine viruses are very different from current needs, and GIP is working closely with agencies such as CDC, manufacturers, essential regulatory laboratories and others to develop and standardize assays, etc. Once the technology is mature, it will be passed to the regulatory unit in WHO for the development of regulatory standards. Development and update of the research agenda for influenza vaccines is also a mandate of SAGE, with a particular emphasis on the development on “universal vaccines”. General discussion Support is being proposed through the PIP Framework to enhance the capacity of NRAs in grantee countries to approve the vaccines produced and increase their awareness, e.g. of lower requirements for strain change studies. In addition, Dr Zhang noted that GIP would invite NRAs of all grantee countries by turn to be observers at vaccine virus selection meetings to improve understanding of the process. In addition to the SAGE research agenda, implementation research is seeking to identify best practices, e.g. through programmes where pregnant women are traditionally vaccinated. If programmes such as MCH supported influenza vaccine, this would be strong communication for implementation. The 2-dose requirement for paediatric vaccination is more complicated, and discussions are under way with the EPI and school programmes to see how this might be integrated. Dr Kieny noted that, subject to compelling data, e.g. on pneumonia and deaths, particularly in the very young, influenza vaccination could become part of the numerous MCH initiatives to achieve MDG targets. The Chair suggested that, given the need for new partners, the GAP might reach out to programmes outside the immunization realm. Dr Tam agreed that, particularly in the light of universal influenza vaccine, other approaches were being investigated, such as family support programmes and companies in large developing countries that covered the welfare of a worker's whole family. In order to develop strategies on the switch from seasonal to pandemic vaccine production, Dr Tam promoted the key relation between supply and demand. Once countries have stratified disease burden data and policy implementation, and taking in account local production, they can then approach a consortium such as PAHO revolving fund with solid figures and negotiate their needs in advance to the benefit of all. It was pointed out that, while WHO and advisory groups, such as SAGE, the Emergency Committee of IHR, PIP AG and GAP AG can make recommendations when a pandemic comes, the options on switching seasonal to pandemic vaccine production need to have been researched in advance based on experience learnt during the H1N1 2009 pandemic and knowledge accumulated so far on influenza vaccines. The GAP AG can identify and prioritize activities that members could assume and promote, Report of the eighth meeting of the Advisory Group of the WHO Global Action Plan for Influenza Vaccines— 19 March 2013
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such as policy on seasonal–pandemic switch based on the H1N1 experience. It can also prioritize among activities for which WHO and its partners could then seek funding to ensure their implementation. While prioritization should not lead to the neglect of any activity, it was stated that many activities in the 5-year plan are already priorities within specific WHO departments. Dr Tam summarized that timelines, funding needs and monitoring would be integrated into the document, following which it will be shared with GAP partnership offices, who will then map their activities that support the GAP objectives. In this way, a global GAP work plan will be produced, providing opportunities to share progress, avoid duplication of effort and funding across the world, and ultimately accelerate production and thus access to pandemic influenza vaccine. It was agreed that the Secretariat would forward the WHO work plan by end April 2013, after which a teleconference would be organized for the AG members to provide more meaningful input on what they perceived to be priorities and gaps in approaches and activities. It was also suggested that, while the WHO work plan is essentially an internal document, it would be very useful to translate the extensive amount of work it contains into a communication tool for awareness-building and fundraising. It was emphasized that the GAP had always been based on consensus, and thus accountability rested with each stakeholder's mandate. The AG was formed specifically to advise the WHO DirectorGeneral, via the Secretariat, on the policy direction and implementation of the programme. The Secretariat would explore the possibility of an exchange between the AG Chair and the DirectorGeneral for a more direct dialogue.
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3.GAP partnership offices: report on activities Dr Tam explained the concept of GAP partnership offices as having an informal, yet recognized role based on the specific expertise of the agency. WHO created this network as a means for agencies to share what they are doing and what GAP priorities they may be able to assume, either individually as part of their mandate, or collectively within network to avoid duplications and to identify knowledge gaps that are of priority but not being addressed. 3.1 CDC: Dr Joe Bresee Within the framework of CDC's disease burden estimations and vaccine evaluations, and potential harmonization of its work plan with the GAP, Dr Joe Bresee opened a discussion on building the evidence for the use of vaccine in the grantee countries and, if this was indeed the aim, confirmation that the grantees were aiming for the domestic market. Assurance of the viability of the grantees was also needed to ensure efficient CDC investment. Dr Bright provided a briefing on the grantee selection requirements, the most important of which is government backing. The Chair agreed that a sustainability assessment might be a good indicator for CDC investment and, for geographical coverage, help to initiate discussions to see if access to influenza vaccine in GAVI-eligible countries may be of value. Regarding the criteria for where burden of illness studies are carried out, Dr Zhang informed the group that 10% of the 70% PIP partnership contributions for preparedness activities will be used to support disease burden studies. The criteria for selection of countries is that a surveillance system is in place, and GAP grantees in developing countries will be considered as a priority for inclusion in these studies. The package of support for preparedness activities will also include NRA strengthening and significant support to laboratory and surveillance capacity. The final draft of a work plan implementing the partnership contribution, being discussed with the PIP advisory group, is expected to be available for the upcoming PIP AG meeting. The GAP grantee countries are also considered in other efforts such as cooperative agreements with CDC. In this respect, Dr Bresee noted that CDC agreements are based on the premise that the country's business plan is focused on the domestic, and not the international market; whereas WHO looks at each grantee on a case-by-case basis. CDC strategy for the coming years The CDC international programme was initiated with the aim of focusing on (1) building the case for influenza vaccine in mid-income countries, e.g. SII and GPO's LAIV, depending on clarified risks and timelines; (2) direct support to vaccine manufacturers or studies that would resolve critical issues that could impede GAP progress. Looking forward, CDC will continue support disease and economic burden studies in mid-income countries, and increasingly invest in understanding the impact of vaccination in developing countries. Following the GAVI approach to use vaccine introduction projects to create value for MCH, CDC is focusing on determining the effect of vaccine programmes on birth rates. A parallel study is determining the economic burden for a variety of populations in mid-income countries. In low-income countries, CDC will study the economic burden of low birth weight of premature babies, with a view to showing the economic impact of vaccine. Support to GAP would largely continue as before, except for grantees that were not expected to succeed in producing a vaccine. Given that CDC investment decisions are usually made in May, any pertinent information in this regard would be appreciated soonest.
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The Chair suggested that the MCH platform would be a good opportunity to demonstrate the potential of introducing an immunization programme for pregnant women, combined with RSV burden of illness studies, which CDC performed. 3.2 BARDA: Dr Rick Bright Much of BARDA's work focused on GAP objectives 2 and 3, and it was remarkable that the capacity of the grantees had risen to 280M doses. BARDA is fully committed to sustain funding until 2016 and hit the target of 400–500M doses. BARDA's domestic investments have led to the significant achievement of licensure of the Novartis cell-based vaccine. The important next step of a large-scale production facility will lead to substantial increased capacity. BARDA has also invested heavily in its Centres for Innovation in Advanced Development and Manufacturing sites, three of which will allow rapid response capacity for vaccines and contribute to the research and technology needed to advance next generation vaccines. Another major programme for BARDA is its investment in recombinant-based vaccines, such as the Protein Sciences insect cell-based VLP vaccine and two other vaccines in late stage clinical trials. The next substantial project, a coordinated effort among several arms of the HHS, is to identify potential universal vaccine candidates which, despite the many unknowns, even the terminology, point to a few candidates that warrant further investigation in the early stages of development. A final area presented was BARDA's significant investment in an international partnership with industry, WHO, NIBSC and HHS agencies on the influenza vaccine manufacturing improvement initiative, which provides funds to improve technology yields, speed, more stable backbones, as well as better release, potency and sterility assays. Dr Zhang asked BARDA about its interest in supporting a system for standardization of candidate vaccine viruses for LAIV, given the increasing commercial interest in this technology. Systems for IIV are streamlined, but despite efforts in Russia and CDC, there is a need for a similar system for LAIV, e.g. strain selection, high-growth reassortants, etc. It would be useful if GAP partnership offices could assume such a task. Dr Zhang explained the process for reassortment of potential wildtype viruses, a streamlined and rapid network but limited to two laboratories that have GLP capacity for classical, but not reverse genetic reassortment, which can only be carried out in WHO collaborating centres. It was noted that, while new producers can obtain the same vaccine viruses as the major manufacturers, they are less able to improve the growth of their vaccines and less likely to obtain regulatory approval from the countries. To this end, the BARDA initiative to increase knowledge that would lead to higher growth vaccines would be made available to all manufacturers. The Chair asked BARDA to circulate documents on the very useful presentation to the AG. BARDA summarized that two major barriers to success of the GAP programme were regulatory harmonization and, most importantly, the ability to develop markets for sustainability; in this last respect, the AG was exhorted to make a formal recommendation to the Director-General to draw attention to this aspect.
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4. Monitoring and evaluation of GAP objectives and activities Claudia Nannei and Erin Sparrow presented the draft of a monitoring and evaluation framework to measure implementation of GAP objectives. The framework is based on indicators to track actions and outcomes towards achieving the three GAP objectives. This first report was developed to test the availability of 2006 baseline data, the feasibility of data collection, calculation of indicators and their usefulness for monitoring developments. Indicators were also chosen for their validity, reliability, sensitivity, ease and affordability. The AG was invited to comment on the appropriateness of the indicators, methods and data sources in order to refine the process. Each intermediate and outcome indicator per GAP objective was reviewed, along with proposed modifications, areas of concern and suggestions to improve the analyses. Some indicators, for example, had been revised to reflect the proportion of countries per region attaining a given outcome; some were considered too vast to yield meaningful results; but the majority of limitations concerned the data. While sources such as CDC and the DCVMN – and even the PIP – could provide input, the data were often difficult to obtain, incomplete due to unpublished data and/or confidentiality or not globally representative. In addition, baseline data from 2006 were often unavailable; data are not always collected through a structured mechanism; and in some instances geopolitical changes make baseline and current data incomparable. From 2013, the WHO-UNICEF Joint Reporting Form will include a question on influenza vaccine policies and coverage for all risk groups. Objective 1: The forthcoming Communications meeting in June 2013 will be an occasion to brainstorm on tools that might serve as useful indicators. The number of countries reporting to FluNet could be considered as an indicator. Countries vaccinating at least one at-risk population could be clarified to refer to SAGE recommendations and/or those included in the national vaccination policy. Objective 2: Assumptions on the need for 2 doses and a 10.77X seasonal–pandemic conversion need to be revisited. New data will be available from a survey of all manufacturers on their adjuvant plans, and more data is expected from the DCVMN and others. Intermediate indicator 2.ioci.4 is redundant given the outcome indicator 2.oci.2 requiring NRAs to meet WHO vaccine prequalification standards. Objective 3: The R&D landscape is constantly evolving, with some technologies falling off the table. BARDA will continue to update product advancements, and those under development in countries such as China and India will be added. BARDA will work with Secretariat to refine the criteria and definitions of antigen-sparing technologies. Consideration might be given to relating the number of candidate vaccines to an ideal number, perhaps by reflecting an inventory of "degree of readiness", although it is difficult to publicly track ongoing research. It was suggested that a separate table be created on universal vaccines once a definition is agreed, and that the number of patents could serve as a useful indicator. The Secretariat noted that the Excel spreadsheet of clinical trials currently published on the web would be developed into a more user-friendly database. General AG comments Monitoring requires surveillance systems to be in place. Some definitions, criteria and language need to be refined. It was queried whether any WHA resolution covers the collection of burden of disease data. Distinguish between, and standardize numbers, percentages and coverage goals, e.g. for essential personnel and at-risk populations. SAGE recommendations on priority risk groups, as well as the need to develop markets, should be embedded in indicators across all GAP objectives.
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AG members were invited to reflect on the M&E framework and get back to the Secretariat with any further comments. The Secretariat, for its part, would continue to work on the indicators in line with the comments made today.
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5. Interactions of PIP–GAP advisory groups Dr William Ampofo noted that, similar to the GAP AG, members of the PIP AG advised the DirectorGeneral on an annual basis on implementation of the PIP Framework. Four meetings and a teleconference had been held and several documents had been posted on the WHO PIP web site, including a FAQ that explains the background, structure, mechanisms and aims of the PIP Framework. The PIP AG works with the Secretariat on Standard Material Transfer Agreements (SMTA2) with manufacturers and other entities outside the Global Influenza Surveillance and Response System (GISRS). Another major area of focus is the partnership contributions, agreed by Member States under WHA resolution 64.5 between WHO and manufacturers. Donations for the first partnership contribution for 2012 have reached US$18 Million, largely instrumental by IFPMA, which have set the tone for what might be expected each year. The PIP-AG has advised that the partnership contributions would be allocated to 70% for preparedness and 30% for response activities. Dr Tam gave examples of the affectation of PIP 70/30 funds, the timing of donations and the obligatory and voluntary parts of the contributions. PIP discussions continue on implementation of partnership contributions, best use of funds and the development of indicators. Other agenda items are to assess the term of reference of GISRS and how it can benefit from the partnership, and ensuring open consultations with industry and civil society. This may open opportunities for investment in countries by GAP partners. Dr Ampofo explained that countries were selected based on transmission zones and the impact on neighbouring countries. The PIP AG had developed four areas of overlapping focus, including risk communication. Deployment would be a significant problem, and thus GAP technical support, especially for product and project management, would be extremely useful.
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6.Future prioritization It was agreed that the WHO 5-year strategic plan would be shared with AG members for their comments. The strategic plan then needs to be turned into an implementation plan and, to this end, sub-groups might usefully be formed to review and follow-up priorities per GAP objective. Each element would in addition complement the work of the PIP Framework and a WHA review in 2016.
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7.List of Participants MEMBERS Dr William Kwabena Ampofo, Senior Research Fellow & Head - Virology, Noguchi Memorial Institute for Medical Research, Legon Accra, Ghana Dr Daniel Camus, Institut Pasteur de Lille, Lille, France Dr Supamit Chunsuttiwat, Senior Medical Officer, Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand (Unable to attend) Dr Bruce Gellin, Director, National Vaccine Programme, Department of Health and Human Services, Washington, DC, United States of America (unable to attend) Dr Hiroyuki Hori, Deputy Director, International Affairs Division, Ministry of Health, Labour and Welfare, Tokyo, Japan Dr Rosanna Lagos, Coordinadora, Centro para vacunas en Desarollo-Chile, Hospital de Niños Roberto del Rio, Santiago, Chile Dr Firdausi Qadri, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh Dr Daniel Reynders, Head of Service, International Relations, Federal Public Service, Brussels, Belgium (unable to attend) Dr Amine Slim, Head, Microbiology Department, National Influenza Centre, Charles Nicolle Hospital, Tunis, Tunisia (Unable to attend) Professor Hongjie Yu, Director, Division for Infectious Disease, Chinese Center for Disease Control and Prevention, Beijing, People's Republic of China(Unable to attend) OBSERVERS Dr Joseph S. Bresee, Commissioned Corps (Medical OFC), Centers of Disease Control, Atlanta, United States of America Dr Rick Bright, Deputy Director, Influenza Division, Office of Biomedical Advanced Research & Development Authority (BARDA), US Department of Health and Human Services (HHS), Washington, United States of America WHO SECRETARIAT Ms Florence Barthelemy, Team Assistant, Technology Transfer Initiative, Geneva, Switzerland Ms Kay Bond, Consultant, Geneva, Switzerland (Rapporteur) Dr Martin Friede, Scientist, Technology Transfer Initiative, Geneva, Switzerland Dr Marie-Paule Kieny, Assistant Director-General, Innovation, Information, Evidence and Research, Geneva, Switzerland Ms Claudia Nannei, Technical Officer, Public Health, Innovation and Intellectual Property, Health Systems and Innovation, Geneva, Switzerland
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Mr James Pfitzer, Technical Officer, Technology Transfer Initiative, Geneva, Switzerland Ms Erin Sparrow, Project Officer, Technology Transfer initiative, Health Systems and Innovation, Geneva, Switzerland Dr John Siu Lun Tam, Technical Officer, Initiative for Vaccine Research, Geneva, Switzerland Dr Wenqing Zhang, Scientist, Influenza, Hepatitis and PIP Framework (HIP), Health Security and Environment, Geneva, Switzerland
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WHO/HIS/TTI/13.1 Report of the eighth meeting of the Advisory Group of the WHO Global Action Plan for Influenza Vaccines— 19 March 2013
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