EVENT REPORT. Parma, 3-4 April 2013 and 4 April European Food Safety Authority 3. European Food Safety Authority (EFSA), Parma, Italy

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1 EFSA supporting publication 2013:EN-627 EVENT REPORT Technical meetings on tools and approaches being used and developed for influenza surveillance and assessment in human and animal health with the aim of providing scientific coordination on methods for assessing the pandemic potential of animal influenza viruses 1, 2 Parma, 3-4 April 2013 and 4 April 2014 European Food Safety Authority 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT Interpretation of the origin of new human influenza strains with pandemic potential requires knowledge of the influenza gene pools in pigs and birds, as well as other animal species. In order to improve the evaluation of animal influenza viruses EFSA launched an Art. 36 project to develop a risk assessment framework aiming at a risk-based identification of influenza viruses in animals with a likely pandemic potential. The framework was developed in close cooperation with international organisations active in global influenza surveillance and data collection, including WHO, OFFLU, CDC and ECDC. Two technical meetings were organised to discuss the outcome of the grant project and to facilitate the implemententation of the framework in a future monitoring of pandemic potential animal influenza viruses. In the final discussions of these meetings participants expressed continued interest in further developing the framework and suggested that an annual status on follow-up activities should be compiled. European Food Safety Authority, KEY WORDS Animal Influenza, pandemic potential, risk assessment 1 Question No EFSA-Q Disclaimer: The views or positions expressed in this publication do not necessarily represent in legal terms the official position of the European Food Safety Authority. The European Food Safety Authority assumes no responsibility or liability for any errors or inaccuracies that may appear. 3 Acknowledgement: EFSA wishes to thank the AHAW/ALPHA Unit for the preparatory work on this scientific output and Per Have for the support provided to this scientific output and Valentina Descy, CORSER, who took care of the logistics of the first meeting. Any enquiries related to this output should be addressed to ALPHA@efsa.europa.eu Suggested citation: European Food Safety Authority, Technical meeting on tools and approaches being used and developed for influenza surveillance and assessment in human and animal health with the aim of providing scientific coordination on methods for assessing the pandemic potential of animal influenza viruses. EFSA supporting publication 2014:EN-627, 11 pp. Available online: European Food Safety Authority, 2014

2 SUMMARY Current monitoring of the influenza gene pool in humans has been useful as an alert for the emergence of new human influenza strains of public health significance. Yet, interpretation of the origins and the pandemic potential of influenza viruses also requires knowledge of the influenza gene pools in pigs and birds, as well as other animal species. A long term support for a passive monitoring network in pigs and birds is a prerequisite for obtaining greater understanding of the evolution of influenza viruses at the global level. EFSA launched an Art. 36 project to develop a risk assessment framework to assist in identifying new influenza viruses emerging in animals with a likely pandemic potential. The framework was developed in close integration with other approaches and tools being used and developed for influenza in humans and animals. It was considered important to ensure a continued contact and dialogue between EFSA, the consortium and organisations active in global influenza surveillance and data collection, including WHO, OFFLU, CDC and ECDC. Therefore, two technical meetings were organised to discuss the outcome of the grant project and to facilitate the implementation of the framework in a future monitoring of pandemic potential animal influenza viruses. The objective of the first technical meeting was to discuss the risk assessment framework, to identify relevant data sources and to discuss how this could best be implemented and combined with influenza surveillance in animals and humans. The second technical meeting was devoted to a detailed presentation of the outcome of the project and a demonstration and explanation of the risk assessment tool developed. The representative of FAO presented the FAO activities on influenza and reiterated how the risk assessment framework could possibly be integrated with FAO s EMPRES-i database. FAO collects data for almost all of the parameters required for the tool, with a current focus on H5N1, H7N9 and other zoonotic avian influenza viruses. EFSA will respond to the expression of interest put forward by FAO to seek integration of the tool with FAO s systems, particularly EMPRES-i. It is highly desirable to take steps towards complementing the Flurisk framework with estimates of the pandemic potential of influenza viruses, e.g. by linking to the CDC IRAT model and to formalise the virological risk factor rating. In the final discussion participants expressed continued interest in the project and suggested that an annual status on follow-up activities should be compiled. EFSA supporting publication 2013:EN-627 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by EFSA... 4 Terms of reference as provided by EFSA... 5 Evaluation Introduction Organisation of first meeting 3-4 April, Participants Presentations Introduction to the project WP1: Epidemiology and surveillance WP2: Risk Assessment model ESNIP OFFLU RISKSUR WHO Europe Organisation of second meeting 4 April, Participants Presentations... 9 Conclusions EFSA supporting publication 2013:EN-627 3

4 BACKGROUND AS PROVIDED BY EFSA FLURISK workshops Current monitoring of the influenza gene pool in humans has been useful as an alert for the emergence of new human influenza strains of public health significance. Yet, interpretation of the origins and the pandemic potential of influenza viruses also requires knowledge of the influenza gene pools in pigs and birds, as well as other animal species. Currently, there is an incomplete view of the influenza virus strains circulating among pigs and birds at the global level. A long term support for a passive monitoring network in pigs and birds is warranted in order to promote greater understanding of the evolution of influenza viruses at the global level. Maximum benefit of these parallel activities in the human and animal sector can only be obtained by applying an integrated approach involving both medical and veterinary networks, including the development of harmonised tools and approaches, exchange of virus strains and of sequence data and enhancing the coordination and dissemination of the findings from the human, swine and avian networks. EFSA has launched the Art. 36 project CFP/EFSA/AHAW/2011/01, under which a risk assessment framework to assess the pandemic potential of new influenza viruses emerging in animals will be developed. The project is a follow-up of the scientific opinion on monitoring for the emergence of possible new pandemic strains of influenza in animals adopted by the AHAW Panel in February A contract was signed in December 2011 (project duration 20 months) and the consortium held a kick-off meeting on February 1, With a view to the global nature of the disease, it is important that the framework is developed in close integration with other approaches and tools being used and developed in human and animal health. It is therefore considered important to ensure continued contact and dialogue between EFSA, the consortium and organisations active in global influenza surveillance and data collection, including WHO, OFFLU, CDC and ECDC. These technical meetings also intend to facilitate that the outcome of the grant project CFP/EFSA/AHAW/2011/01 can be implemented in a future monitoring of pandemic potential animal influenza viruses. The objective of the first technical meeting will be to discuss the planned risk assessment framework, identify relevant data sources and to discuss how this can best be implemented and combined with influenza surveillance in animals and humans. This meeting should be held before the 2nd interim consortium meeting. The second technical meeting should be held in conjunction with the final consortium meeting with the objective to present the risk assessment framework to the international organisations and to receive any feed-back on the proposal that might be relevant to include in the final report. EFSA supporting publication 2013:EN-627 4

5 TERMS OF REFERENCE AS PROVIDED BY EFSA The objective of the first technical meeting will be to invite experts from organisations active in global influenza surveillance and data collection (including WHO, OFFLU, CDC and ECDC) and consortium representatives to: discuss the planned risk assessment framework and underlying models under development in the Art.36 project discuss accessibility of relevant data sources to be included in the risk assessment framework discuss how the risk assessment framework can best be implemented and combined with influenza surveillance in animals and humans The objective of the second technical meeting will be to: Present the proposed risk assessment framework and draft final report as developed in the Art.36 project further discussion on how the risk assessment framework can best be implemented and combined with influenza surveillance in animals and humans EFSA supporting publication 2013:EN-627 5

6 EVALUATION 1. Introduction Following the H1N1 pandemic in 2009, EFSA issued a scientific opinion 4 on monitoring for the emergence of possible new pandemic strains of influenza in animals, adopted by the AHAW Panel in February This opinion called for the need to improve the monitoring of influenza viruses in the animal reservoir and to develop tools to assess the risk of viruses evolving from the animal reservoir with pandemic potential. Preparatory work for a risk assessment framework that could encompass the various types of information available on epidemiology and virology of influenza in both animals and humans was therefore initiated under the Art. 36 contract CFP/EFSA/AHAW/2011/01 (internal mandate EFSA-Q ) with the objective that such a framework could be used to develop integrated decision support tools that would assist in planning and implementing measures to prevent or reduce an emerging pandemic threat. A close integration of the risk assessment framework developed under the Art. 36 contract with other approaches and tools being used and developed in human and animal health internationally was considered important. Therefore, technical meetings between EFSA, the FLURISK consortium and experts from organisations active in global influenza surveillance and data collection were organised to pave the way for a constructive dialogue and to facilitate that the outcome of the FLURISK project can be implemented in a future monitoring of pandemic potential animal influenza viruses. 2. First meeting 3-4 April, 2013 The technical meeting was organised as a workshop, which allowed for a thorough discussion during the presentations Participants Gounalan Pavade (OFFLU), Diane Gross (WHO Europe), Gaelle Simon (ANSES, Ploufragan), Dirk Pfeiffer and Andy Hill (RVC, London), Ilaria Capua, Marco de Nardi and Olga Munoz (IZS Venezie), Andrew Breed and Jill Banks (AHVLA Weybridge), Adam Meijer (RIVM), Sylvie Van der Werf (Institut Pasteur, Paris), Gwen Dauphin and Sophie VonDobschuetz (FAO). Ana Afonso, Sandra Correia, José Cortinas Abrahantes, Per Have, Elena Mazzolini (EFSA) Presentations Introduction to the project M. De Nardi gave an overall presentation of the FLURISK project, covering background, objectives, project structure, key activities, integration with existing projects/organizations and workplan. The idea of having a systematic risk assessment framework grew out of the events surrounding the 2009 H1N1 pandemic and subsequent meetings held in the context of the One Health and One Flu concepts. These meetings highlighted the potential public health benefit of improved monitoring of influenza strains circulating in pigs and birds and that combining results from human and animal surveillance and strain data might lead to a better preparedness and early recognition of emerging pandemics. 4 Scientific Opinion on monitoring for the emergence of possible new pandemic strains of influenza in animals. EFSA Journal 2011;9(3):2109 [36 pp.]. EFSA supporting publication 2013:EN-627 6

7 The objective of the FLURISK project was to develop and validate an influenza risk assessment framework (IRAF) for the ranking of animal influenza A strains in their potential to cross the species barrier and cause human infection. The central questions addressed were: What is the current knowledge on the influenza virus etiology and epidemiology in pigs, birds and other animals (i.e. cats, dogs, horses)? What are the scientific community and institutional stakeholders doing in terms of influenza virus surveillance, monitoring and control? What are the scientific gaps still present to be addressed? What are the characteristics which an animal influenza A virus must possess to be potentially pandemic? How can we grade the pandemic risk posed by a given animal influenza A virus? WP1: Epidemiology and surveillance S. Von Doebschuetz presented the ongoing activities of WP1concerning the epidemiological analysis of animal influenza viruses and selection of virus strains to be included for model evaluation. This will include a description of the geographic distribution of influenza viruses, subtypes and clades since 2005 (species, gene pool, time and place), focusing on the ten animal influenza virus strains that have been selected for IRAF validation. She also described the ongoing exercise to gather information on animal influenza surveillance systems in place by submitting questionnaires to CVOs with the support of OFFLU. The main objective is to review and evaluate ongoing monitoring, surveillance and control systems in animals with the aim to review systems, tools and approaches for animal influenza surveillance and control strategies implemented globally; assess global capacity for early detection of potentially human pathogenic influenza viruses in animals; identify geographic areas and/or target species that would benefit from strengthened influenza surveillance activities; assess variation in animal influenza surveillance coverage on a global scale; identify gaps or weaknesses regarding influenza surveillance in animals. She reported that data data would be analysed according to surveillance type (active, passive, sentinel, participatory disease surveillance; objectives and purpose); surveillance frequency (continuing, by rounds; at which time of the year); Targeted disease, population and production sector; sustainability (funding sources); surveillance results (case definition; positives found; sequencing performed: yes/no, to which extent); control actions in case positives are detected and communication and reporting of results. O. Munoz described the activities undertaken to provide an overview of human influenza surveillance systems via questionnaires sent to national and international influenza centres. The data collected should provide a global overview of current monitoring of animal and human influenza viruses and surveillance systems; surveillance strategies and control programmes currently in place; surveillance EFSA supporting publication 2013:EN-627 7

8 intensity by country and variation in coverage of influenza surveillance systems worldwide. The questionnaire has been sent to National Influenza Centers and National Influenza Laboratories. The data analysis would be grouped by: Surveillance component (Human influenza) Influenza surveillance: human/animal interface Virus characterization (applied for influenza surveillance in humans and at the human/animal interface) Laboratory biosafety Quality assurance Shipment (import/export) Surveillance of other respiratory diseases Reporting of results (applied for influenza surveillance in humans and at the human/animal interface) WP2: Risk Assessment model M. de Nardi and A. Hill presented the concepts behing the risk assessment tool, which attempts to answer the question: What is the relative likelihood of human infection with a novel influenza A virus in a given spatial region given its current presence in one or more animal populations. The minimum data required to run the model includes animal population densities and information on virus strain occurrence and sequence info to enable virus score estimation. While the output should be understandable to lay persons, using the tool would still require virological and epidemiological expertise for correct interpretation. The RAF tool includes only information that is known to be of measurable effect on a species jump and produces a simple spatial framework, based on sound epidemiological science. However, there may be a potential disconnect between the availability of data and the timely running of the model. O. Munoz presented the factors used to establish the virus score and the ranking of hypothetical virus strains by expert assessment using a discrete pairwise choices approach. She stated that further work would be required to refine the current viral characterization (weighting critical points, sensitivity analysis) and to determine the most appropriate methodology to apply for data analysis ESNIP 3 G. Simon presented an overview of the studies on swine influenza performed in the European Surveillance Network for Influenza in Pigs (ESNIP 3) network (coordinated by AHVLA, Weybridge). This network is a continuation of surveillance networks that were established during previous EC concerted actions (see for further detail). In Europe, the main influenza subtypes in pigs are avian-like H1N1, reassortant human-like H3N2 and H1N2 and, since 2009 the pandemic H1N1. She emphasized that antigenic shifts by genetic reassortment is frequent in pigs and that this may involve both strains that are well-adapted to pigs and strains that are less adapted. EFSA supporting publication 2013:EN-627 8

9 The main objectives of ESNIP3 include the epidemiology of SIVs in Europe, extent of antigenic and genetic evolution of SIV and to provide insights into the public health risk of influenza in swine, especially with respect to novel and emerging viruses OFFLU G. Pavade described the main objectives of the OIE/FAO Network of expertise on animal influenza (OFFLU). OFFLU provides scientific and technical assistance, training to its members on influenza in animals and shares information with the wider scientific community. OFFLU collaborates with the WHO influenza network on issues relating to the animal-human interface, including early preparation of human vaccine and highlights and promotes influenza research needs RISKSUR D. Pfeiffer gave an overview of the newly launched RISKSUR project aiming at development and validation of conceptual and decision support frameworks and associated tools for designing efficient risk-based animal health surveillance systems WHO Europe D. Gross presented an overview of influenza surveillance in the WHO European Region. Surveillance activities are coordinated through the EuroFlu Laboratory Network, consisting of recognized national influenza centres, WHO reference laboratories and collaborating centres. Surveillance activities are performed in close collaboration with ECDC, which focues on data collection within EU, whereas WHO Europe covers the Eurasian region adjacent to EU. Epidemiological and virological data are collected to monitor incidence, virus type and subtype, disease severity, vaccine strain selection, antiviral sensitivity and to support pandemic early warning. The main data sources are based on sentinel outpatient influenza surveillance and sentinel systems for hospitalized severe acute respiratory infections (SARI). 3. Second meeting 4 April, Participants Gounalan Pavade (OFFLU), Elizabeth Mumford (WHO), Diane Gross (WHO Europe), Sue Trock (CDC), Giovanni Cattoli (IZS Venezie), Arie Havelaar (RIVM), Gaelle Simon (ANSES, Ploufragan), Andy Hill (AHVLA, Weybridge), Marco de Nardi (SAFOSO), Gwen Dauphin and Sophie VonDobschuetz (FAO), Eeva Broberg (ECDC). Franck Berthe, José Cortinas Abrahantes and Per Have (EFSA) Presentations Franck Berthe welcomed the participants and briefly explained the background for this project. Following the H1N1 pandemic in 2009, EFSA issued a scientific opinion on monitoring for the emergence of possible new pandemic strains of influenza in animals 5. This opinion called for the need to improve the monitoring of influenza viruses in the animal reservoir and to develop tools to assess the risk of viruses evolving from the animal reservoir with pandemic potential. In 2011, the One Flu Strategic Retreat 6 identified the need to develop an Influenza Risk Assessment Tool, recognizing that influenza pandemics and epidemics are unpredictable and that a better strategy is needed to respond appropriately to protect the public health. EFSA called for a risk assessment framework that could encompass the various types of information available on epidemiology and virology of influenza in 5 EFSA Panel on Animal Health and Welfare (AHAW). Monitoring for the emergence of possible new pandemic strains of influenza in animals. EFSA Journal 2011;9(3): EFSA supporting publication 2013:EN-627 9

10 both animals and humans. This project was initiated under the Article 36 of its founding Regulation (CFP/EFSA/AHAW/2011/01) and is known as Flurisk. A close integration of the Flurisk assessment framework with other approaches and tools being used and developed in human and animal health internationally is still considered important. He expressed his hope that the meeting would contribute to a constructive dialogue and facilitate that the outcome of the Flurisk project can be implemented in a future monitoring of pandemic potential animal influenza viruses. Marco De Nardi gave an overview of the Flurisk project and described the tasks of the work packages and how they linked to each other. Flurisk brought together internationally recognized research institutes and reference laboratories, international agencies and universities from veterinary and human medicine areas fostering cross-disciplinary expertise and collaborations. The project consortium was formed by six European partners that have established networks, complementary knowledge, the scientific infrastructure and the expertise to fulfil the EFSA call objectives. The project was organized in multi-disciplinary working groups and panel of experts active in four Work Packages (WP). Sophie Von Doebschuetz presented the details of WP 1. The overall objectives of WP 1 were to review animal influenza etiology and epidemiology in both animals and humans and assess current surveillance, monitoring and control strategies. Three literature reviews were conducted in order to identify virological, epidemiological and animal-human interface risk factor data to be included in the IRAF. Current surveillance, monitoring and control strategies in both animal and human populations were assessed on the basis of two global surveys targeting veterinary services and public health sector, implemented with the support of FAO, OIE and WHO, in order to collect information on influenza viruses surveillance and control systems. Regarding knowledge gaps she highlighted that no clear definition of influenza virus strains is available, non-notifiable avian subtypes are not recorded and non-seasonal human events are not recorded systematically. Andy Hill presented the development of the risk assessment framework tool (IRAF) as developed under WP 2. The WP2 main objectives were the development and validation of the risk assessment framework model and the development of a user-interface to facilitate its practical use. The project proposes a prototype risk assessment framework to spatially rank Influenza A viruses circulating in animal populations for their potential to jump the species barriers to humans. The precise risk question answered is What is the relative likelihood of influenza A virus x infecting one or more humans (compared to viruses y, z etc ) given its current presence and location in an animal population(s)?. There are two critical factors in any zoonotic transfer of pathogens: the ability of the virus to infect humans (a function of its genetic/biochemical characteristics), and the opportunity for it to do so (a function of the amount of human exposure and immunity). Considering this, the IRAF model is unique in that the ranking of viruses is dependent not only on the inherent qualities of the pathogen but also on the epidemiological factors contributing to zoonotic infection. The inclusion of data on populations, animal production systems, and on geographic location of the viruses in question, makes this prototype model the first truly risk-based assessment of the zoonotic potential of influenza A viruses globally. Due to the huge gaps in scientific knowledge and data availability, the model currently focuses solely on Avian Influenza viruses and the baseline output of the model is the opportunity map, which indicates the global suitability for a generic avian influenza virus to jump the species barrier from poultry into humans. The map provides useful information on the high-risk areas for zoonotic infection from poultry. It was considered highly desirable to take steps towards complementing the Flurisk framework with estimates of the pandemic potential of influenza viruses, e.g. by linking to the CDC IRAT model and to formalise the virological risk factor rating. A short demonstration of the tool and its user interface was given during the meeting. EFSA supporting publication 2013:EN

11 Sophie Von Doebschuetz gave an overview of FAO s activities on influenza and reiterated how the IRAF could possibly be integrated within FAO s EMPRES-i database. FAO collects data for almost all of the parameters required for the tool, currently the focus is on H5N1, H7N9 and other zoonotic avian influenza viruses. She highlighted that a number of points needs to be considered when implementing the tool: Feasibility of integration with EMPRES-i Maintaining the IRAF tool, validation and future development Safeguarding appropriate use Making it available to the international community (FAO events/training) Internal application in FAO CONCLUSIONS It was agreed that the IZSVe should continue to be the contact point for EFSA to act on behalf of all partners of the Flurisk Consortium in relation to future implementation of the tool. It was agreed that EFSA would respond to the expression of interest put forward by FAO to seek integration of the IRAF tool with FAO s systems, particularly EMPRES-i. In order to bring this forward, bilateral technical discussions will be organised. In order to explore implementation options, a formal endorsement should be obtained from the Flurisk Consortium on granting user rights to FAO for testing, validation and implementation. In the final discussion WHO, ECDC and OFFLU confirmed continued interest in the project and suggested that an annual progress status be given. It was considered highly desirable to take steps towards complementing the Flurisk framework with estimates of the pandemic potential of influenza viruses, e.g. by linking to the CDC IRAT model and to formalise the virological risk factor rating. EFSA supporting publication 2013:EN