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Efficient response to highly dangerous and emerging pathogens at EU level [EMERGE] [677066] - Joint Actions
Project abstract

The human population is confronted with emerging and re-emerging infectious pathogens that can cause serious cross-border outbreaks. A recent example is the Ebola outbreak requiring strong diagnostic, clinical, and public health measures in Europe and abroad in order to get this incident under control. The JA EMERGE is in compliance with the European policy (Decision No 1082/2013/EU) where the need for an efficient, rapid and coordinated response to high threat pathogens is defined. The JA EMERGE comprises a European network with more then 40 diagnostic laboratories focused on risk group 3 bacteria and risk groups 3 and 4 viruses. It will act in a so-called inter-epidemic mode (IEM) which can be activated and switched into an outbreak response mode (ORM) on request by the Health Security Committee in order to direct all activities to the outbreak management. A number of other laboratory networks, institutions and agencies are contributing to the management of cross-border infectious outbreaks. EMERGE will provide a platform for establishment and consolidation of a common, coordinated and effective response to infectious disease outbreaks at EU level and abroad (WP4). State of the art and new diagnostic methods for high threat pathogens, including in-house and commercial kits, will be evaluated for their applicability and recommended in outbreak situations when suitable (WP5). External quality assurance exercises will ensure best approaches for laboratory responsiveness in outbreak situations (WP6). These activities must be supported by an appropriate training to share best practices of diagnostics and bio-risk management (WP7). In conclusion, the general objective will be to ensure efficient response to serious emergent and re-emergent cross-border events by reinforcing the existing EU network of BSL 3 and BSL 4 laboratories which are already active in the field of identification of dangerous bacterial and viral human pathogens.

Summary of context, overal objectives, strategic, relevance and contribution of the action

The human population is confronted with emerging and re-emerging infectious pathogens that can cause serious cross-border outbreaks. A recent example is the Ebola outbreak requiring strong diagnostic, clinical, and public health measures in Europe and abroad in order to get this incident under control. The JA EMERGE is in compliance with the European policy (Decision No 1082/2013/EU) where the need for an efficient, rapid and coordinated response to high threat pathogens is defined. The JA EMERGE comprises a European network with about 40 diagnostic laboratories focused on Risk Group (RG) 3 bacteria and RG 3 and 4 viruses. It is acting in a so called interepidemic mode (IEM) which can be activated and switched into an outbreak response mode (ORM) on request by the Health Security Committee in order to direct all activities to the outbreak management. Other laboratory networks (e.g. the EVD-LabNet), institutions and agencies are also contributing to the management of cross-border infectious outbreaks. EMERGE is providing a platform for establishment and consolidation of a common, coordinated and effective response to infectious disease outbreaks at EU level and abroad. State of the art and new diagnostic methods for high threat pathogens, including in-house and commercial kits, are evaluated for their applicability and recommended in outbreak situations when suitable. External quality assurance exercises (EQAEs) ensure best approaches for laboratory responsiveness in outbreak situations. These activities must be supported by an appropriate training to share best practices of diagnostics and bio-risk management. In conclusion, the general objective is to ensure efficient response to serious emergent and re-emergent cross-border events by reinforcing the existing EU network of BSL 3 and BSL 4 laboratories which are already active in the field of identification of dangerous bacterial and viral human pathogens.

Methods and means

The horizontal Work Packages (WPs) comprise Coordination, Dissemination, and Evaluation of the Joint Action (JA) ensuring the implementation of the project as planned and budgeted. A pro-active visibility is provided to laboratory staff and first line health professional responders in case of outbreaks. In addition, the scientific community, public health experts and politicians are provided with information on the progress of the JA by the regularly published newsletters, presentations held during conferences, publications in journals and further appropriate dissemination channels like personal contacts and direct approaching of stakeholders. All WPs are designed to pursue their specific objectives in an interepidemic mode (IEM) and in an outbreak response mode (ORM). Upon activation by the Health Security Committee (HSC), the coordinator ensures the switch from IEM to ORM which has not been the case during the first and second reporting period (June 2015 - May 2017). Together with the Steering Committee (SC), an ORM Working Group (WG) was established. The ORM WG is meant to cope with outbreak management during ORM. A continuous evaluation assesses whether the right and relevant information is distributed and the right target groups are approached.

Work performed during the reporting period

A short summary outlining the work performed during the 2nd reporting period is given below - detailed descriptions are part of the report.

During the 2nd reporting period, the first periodic report was delivered as scheduled in the Grant Agreement, 31 July 2016. The Consortium Agreement was signed by all partners of the JA, except for the new Romanian partner (INC). EMERGE is usually and currently directed to work on preparedness and planning of outbreak management, defined as interepidemic mode (IEM). In case of an outbreak, coordinator and co-coordinator will ensure the reliable activation of the network, i.e. the switchover from IEM to ORM (outbreak response mode), supported by the Steering Committee (SC). A plan for transition from IEM to ORM was developed and approved by the SC.
The second EMERGE meeting took place in Thessaloniki in October 2016.

For external communications of activities different means are used comprising the EMERGE website, newsletters, flyer and presentations at conferences. A 2nd newsletter was prepared and published; the 3rd newsletter is in preparation.

Evaluation reports for progress of achieved Milestones and Deliverables were generated in January 2016 and April 2016, a presentation on progress was delivered in September 2016 and a report generated in March 2017. The technical meeting in Berlin and the 2nd project meeting in Thessaloniki were evaluated with a questionnaire to ascertain the quality and impact of the meetings. A report was generated for each of the evaluations highlighting the areas of success as well as areas for improvement.

The report on the inventory of EU funded projects and networks which enables identification of areas for collaboration was further completed and finalized. The report includes a short description of networks and EU funded projects with activities that could be involved in the response management of cross-border health threats. The focus is primarily on provision of laboratory support, which can be quite diverse, given the diversity of cross-border threats that are potentially involved. A publication of survey B presenting the data and conclusions was drafted and submitted to Eurosurveillance and is currently under review. The survey A report has been drafted and will be submitted for publication in the beginning of period 3. An outbreak scenario was provided, using six sessions of information. The scenarios were used on 30 November 2016 at an Outbreak, Preparedness and Response Coordinators meeting, organized in Amsterdam, to gain insight in the extent to which information is exchanged among the attending networks and organizations.

For the Assessment of target pathogens of the next project year, WP5 leader INMI disseminated different questionnaires among all partners with the aim of:
1. Setting up the list of agents on which to perform the activities for the second year of the project (i.e. EQAEs)
2. sharing the survey on "criteria selection" with all partners (the previous one was disseminated only among the SC) to assign a score to each agent and eventually redefine the pathogens with highest score (as decided during the meeting in Thessaloniki)
3. verifying the availability of human samples to perform Ab detection in order to implement serology of agents relevant for our project
4. implementation of new diagnostic tests for pathogens with cross-border potential

Besides, a second survey has been circulated among partners to assess the benefits of EMERGE for the partner laboratories.

All participants of the first bacterial and viral EQAEs received certificates evaluating their performance. Further, individual and overall results were discussed during the 2nd EMERGE meeting in Thessaloniki, October 2016. The second round of EQAEs was already performed, results are under evaluation.
Training needs and offers were identified and the training programme has started. Evaluation (post course assessment) of the trainings is continuously implemented by mea

The main output achieved so far and their potential impact and use by target group (including benefits)

The network of partner laboratories comprises public health laboratories, veterinary laboratories, and military laboratories. These laboratories represent the main target groups. Target groups are also informed through the website, the EMERGE leaflet, a bi-annual newsletter, presentations on scientific and public health conferences, further specifically organized meetings with relevant networks, and personal exchange. Additionally, other relevant networks were contacted for possible cooperation during the Outbreak, Preparedness and Response Coordinators meeting in Amsterdam. The involved network coordinators are, now, better informed of activities already existing in other networks. Duplications can be avoided and the opportunity to compare results and procedures with other European (ERINHA-2) and non-European infrastructures/networks (GHSAG) is provided.
The EMERGE activities and outcomes have shown that the JA is having a positive long-term effect on the performed quality of diagnostic laboratories. EQAEs and training served to improve the potential for responsiveness of the partner laboratories in outbreak situations. The EQAE certificates were used by partner laboratories for accreditation purposes. The JA can already now ensure the interoperability between the partner laboratories and other institutions (e.g. D4.1 and MS16) and when it comes to the diagnostics of highly pathogenic bacteria and viruses.
As a matter of fact, single Member States would not be able to develop a coordinated European preparedness and readiness to respond to pathogens naturally spreading across political borders. Moreover, the EMERGE network is not just the sum of the participating laboratories but considerably benefits from the generated synergies among the partners, as could be shown by the results of the recently conducted survey (as attached to the report).

Achieved outcomes compared to the expected outcomes

A strategic, long-lasting vision, able to merge and optimize existing resources and capabilities and to create new knowledge, is necessary to support Europe in the event of severe cross-border epidemics. In many countries considerable gaps still exist and several issues are unresolved to support evidence-based clinical guidelines, and patient management protocols. Effective transnational preparedness and response requires the setting-up of cooperative relationships prior to an event, regardless of the origin or type of the potential infectious disease threat. The EMERGE JA has the potential to deliver these impacts by taking advantage of its extraordinary capability to mobilize European and international resources, its partners’ longstanding experience in coordinating such disparate efforts, and by their high and recognized level of scientific expertise. The dissemination of results of the project activities such as meeting reports, exercise reports and approved procedures will be discussed during periodical meetings, taking into account issues such as the sensitivity of the content of reports.
The main expected outcomes are outlined below:
• Production of protocols and/or guidelines by the interaction of relevant networks or agencies, including ECDC, for outbreak management based on the continuous assessment of emerging and re-emerging infectious pathogens that have a potential to cause cross-border outbreaks (IEM) and supporting the interoperability of networks (WP4) and development of specific recommendations for diagnostic approaches in close interaction with WP5-7 (ORM).
• Increase of diagnostic capabilities for high treat pathogens (during IEM) and application of best practice approaches for diagnostics in outbreak situations, especially supporting Member States without the required laboratory capacities/capabilities (during ORM) (WP5).

• Assessment of status quo and recommendations for improvement and maintenance of laboratory capabilities and the high quality for diagnosis of highly pathogenic viral and bacterial agents, and for the diagnosis of pathogens in “unknown” samples in an inter-laboratory approach by EQAEs (IEM) and establishment of quality assurances of diagnostics in cross-border infectious outbreaks (ORM), provision of reference material in case of both modes (WP6).
--> 4 EQAEs were carried (2 viral EQAEs and 2 bacterial EQAEs). The identified diagnostic gaps and ways of improvement were addressed during 2 specific meetings (for the viral part in Rome, for the bacterial part in Berlin) and one general meeting in Thessaloniki. Certificates on the performance were dispatched to all participants for the first round of EQAEs.
• Validation and improvement of biorisk management in partner laboratory (IEM) and beyond (ORM) (WP6).
--> Application of the Biorisk Management in Handling of High Consequence Risk Group 3 and 4 Agents (ECL-Biorisk) developed during the previous JA QUANDHIP – identification of gaps  Training on Biosafety & Biosecurity, e.g. provided by the RKI.
• Identification of synergies between the existing repositories of reference strains of the JA and different providers of appropriate reference material on highly pathogenic agents of risk group 3 and 4 (WP6).
--> This process is ongoing, further usages of the reference material needs to be discussed and will be under legal consideration.
• Improvement of the European capability to detect highly pathogenic agents by training (IEM) and application of ad-hoc training directed to outbreak causing highly pathogenic agents (ORM) (WP7).
--> A training programme based on identified needs has been developed. It includes 16 training courses within the four specified areas: biorisk management, laboratory methods, diagnostic algorithms and field diagnostic laboratory methods. So far, 13 courses provided by six partners were held for a total of 46 trainees.
For the second reporting period, it was foreseen to provide eight deliverables

Dissemination and evaluation activities carried out so far and their major results

Listed in the following section are the dissemination activities carried out and presented at various events during the first and second reporting period of the JA EMERGE:

• 10-06-2015 VIROGENESIS meeting in Leuven, Belgium
• 18/19-06-2015 EDUFLUVAC workshop in London, United Kingdom
• 22-06-2015 PREPARE meeting in Antwerp, Belgium
• 08-09-2015 COMPARE meeting at Schiphol, The Netherlands
• 09-09-2015 PREPARE meeting in Antwerp, Belgium
• 23/24-09-2015 COMPARE meeting in London, United Kingdom
• 28-09-2015 PATHSEEK meeting in Rotterdam, The Netherlands
• 12 to 14-10-2015 Ebola meeting, EMERGE presentation, Luxembourg (Giuseppe Ippolito)
• 18/19-11-2015 ECDC expert consultation on ECDC strategy on WGS in Stockholm, Sweden
• 25/27-11-2015 ANTIGONE/PREDEMICS meeting in Rotterdam, The Netherlands
• 30-11 to 02-12-2015 WHO consultation on Anticipating Epidemics in Geneva, Switzerland
• 10/11-12-2015 WHO consultation on MERS R&D, development of a global MERS R&D roadmap in Geneva, Switzerland
• 20-01-2016 COMPARE meeting in Copenhagen, Denmark
• 2/2016 Presentation and discussion of EMERGE evaluation of the European Ebola labs in Africa, Senegal
• 01-02-2016 RKI News, presentation JA EMERGE
• 03/2016 three-day ECCMID Arbo-virus course in Thessaloniki, Greece
• 08/10-03-2016 COMPARE meeting in Copenhagen, Denmark
• 22/23-03-2016 Conference on Global Health Security, Lyon, France
• 09 to 12-04-2016 ECCMID 2016, Amsterdam, The Netherlands (Carla Nisii)
• 20 to 22-04-2016 PREPARE meeting Madrid, Spain
• 25/26-04-2016 EVAg meeting in Rotterdam, The Netherlands
• 26 to 29-04-2016 15th Medical Biodefense Conference, Munich, Germany
• 10-05-2016 Livestock Forum in Barcelona, Spain
• 13/14-05-2016 EVDLabNet meeting in Stockholm, Sweden
• 08/09-11-2016 28th GHSAG-LN meeting, Winnipeg, Manitoba, Canada
• 30-11-2016 Outbreak Preparedness and Response Coordinators meeting, Amsterdam, The Netherlands
• 14/16-02-2017 ECDC Expert consultation on ranking and prioritizing EIDT for preparedness, Stockholm, Sweden
• 15-03-2017 Final meeting of PANDEM project, Brussels, Belgium
• 05/07-04-2017 Ebola MoDRAD 3rd workshop on outbreak management, Porton Down, United Kingdom
• 10-05-2017 ERINHA workshop for the scientific community and potential users, Brussels, Belgium
• 15-06-2017 Public Health Conference: Preparedness, Alert and Response: Lessons Learned in Europe from Last Cross-Border Health Infectious Threats, organized by CHAFEA and ISCIII, Madrid, Spain

Representation of EMERGE by peer-reviewed journal articles:
• C. Nisii, R. Grunow, A. Brave, G. Ippolito, D. Jacob, P. Jureen, B. Bartolini, A. Di Caro; EMERGE Viral Pathogens Working Group: Prioritization of High Consequence Viruses to Improve European Laboratory Preparedness for Cross-Border Health Threats. Adv Exp Med Biol. 2017;972:123-129. doi: 10.1007/5584_2016_152
https://www.ncbi.nlm.nih.gov/pubmed/28032326

• C. Nisii, D. Vincenti, F.M. Fusco, J. Schmidt-Chanasit, C. Carbonnelle, H. Raoul, M. Eickmann, R. Hewson, A. Brave, S. Nuncio, M. Paz Sanchez-Seco, B. Palyi, Z. Kis, S. Zange, A. Nitsche, A. Kurth, M. Strasser, M.R. Capobianchi, A. Ozin, P. Guglielmetti, C. Menel-Lemos, D. Jacob, R. Grunow, G. Ippolito, A. Di Caro: The contribution of the European high containment laboratories during the 2014-2015 Ebola Virus Disease (EVD) emergency. Clinical Microbiology and Infection, 2017 Feb;23(2):58-60
http://www.sciencedirect.com/science/article/pii/S1198743X16302270