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Expert consultation on scientific evidence linked to polio virus in Israel and Syria, Stockholm, 5 November 2013 (ECDC, November 22 2013)

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  • Expert consultation on scientific evidence linked to polio virus in Israel and Syria, Stockholm, 5 November 2013 (ECDC, November 22 2013)

    [Source: European Centre for Disease Prevention and Control (ECDC), full PDF document: (LINK). Excerpts.]


    MEETING REPORT

    Expert consultation on scientific evidence linked to polio virus in Israel and Syria, Stockholm, 5 November 2013


    Background

    In response to the recent events of wild-type poliovirus (WPV) circulation in Israel and a cluster of poliomyelitis cases in Syria, ECDC published two risk assessments for the EU/EEA on 26 September and 24 October 2013, respectively. As a further response to these two events and the recommendations presented in the risk assessments, ECDC called an expert consultation meeting on 5 November 2013.

    The focus of the meeting was to seek advice from vaccine-preventable diseases experts and polio experts in Europe on how ECDC and the EU Member States should best respond to the identified threat of wild-type poliovirus introduction and re-establishment in Europe.

    On the morning of 5 November, Deputy Chief Scientist, Dr Piotr Kramarz, welcomed the group and set the scene for the discussions. Dr Kramarz highlighted the fact that as part of its mandate, ECDC delivers scientific advice to the Member States in the field of infectious disease prevention and control. When developing advice an essential step in the process is the consultation of external experts and stakeholders in the EU/EEA.

    Dr Emilia Anis continued to set the scene with a presentation on the recent poliovirus event in Israel and the activities undertaken in the country in response to the detection of WPV in the environment. Dr Emma Huitric continued with a brief presentation of the two recent ECDC risk assessments, providing background information and the rationale for the current expert consultation.

    In its risk assessments ECDC provided a number of recommendations to Member States in the areas of immunisation, surveillance and prevention and control measures.

    To support Member States and provide scientific guidance in these areas, ECDC identified three areas of work.

    The occurrence of a new polio case in the EU/EEA may give rise to a number of different scenarios, with a combination of the following variables:


    Table 1. Possible variables in the event of a new polio case appearing in the EU/EEA

    [Polio cases - Population where cases occur - Majority (>50%) vaccinated with - Vaccination coverage]
    • One sporadic case - General population - IPV - Very high in the general population
    • One small cluster (household, closed community, etc.) - Vaccine-resistant communities - OPV - Sub-optimal in the general population
    • Cases spread throughout the community - Groups living in poor hygiene conditions - Very high but with pockets of susceptibility

    ________

    The response to one sporadic case in the general population where hygiene standards are high and vaccination coverage is good could be different to a cluster reported in a low vaccinated community living in poor hygiene conditions, or an area with large pockets of susceptible individuals.

    Taking this into consideration, the group pointed out that it was important to make an accurate assessment at national level in order to inform the decision on the type of vaccine to be used in response to a polio threat.

    Due to the high vaccine coverage and good hygiene standards, the group agreed that IPV is considered the first choice in most of the potential scenarios within the EU/EEA. Sporadic cases or small clusters in closed communities should not justify the use of OPV.

    On the other hand, the group pointed out that OPV should be taken into consideration in case of evidence of widespread WPV circulation through environmental or epidemiological surveillance.

    In order to trigger an operational plan that necessitates the use of OPV, the group advised that a threshold in terms of the number of positive sewage samples, positive stool samples, or geographical spread of samples, should be defined at the national level as part of the assessment carried out in the response plan. In general, the presence of acute flaccid paralysis (AFP) cases or of WPV in stool samples spread throughout the community or across a large geographical area could be a trigger for considering OPV use.

    Should a response with OPV be initiated, safety aspects would have to be considered as a priority. The risk of vaccine associated paralytic poliomyelitis (VAPP) is close to zero when OPV is administered to someone previously vaccinated with IPV. OPV should be administered if there is evidence that at least one dose of IPV has been received in the past. If only one dose has been received in the past, the simultaneous administration of IPV and OPV could be taken into consideration. In the absence of evidence of any past vaccination, and if logistics permit, a full sequential (two IPV + two OPV doses) vaccination course should be administered. This should be carried out according to national guidelines, possibly applying an accelerated schedule, however the group agreed that two vaccine doses should not be given less than four weeks apart.

    Shorter intervals (no less than two weeks) between doses could be considered under special circumstances after risk-benefit evaluation.

    The acceptability of OPV could be challenging, especially in a Member State with no experience of OPV use in the recent past, or in the absence of a visible threat in the media. A further challenge could arise where there is a manifestation of WPV circulation in sewage without evidence of paralytic cases. For this reason, the group agreed that communication should be an essential and integral part of national response plans. A strong consensus must be reached among all healthcare professionals involved on the policies to be implemented, in order to ensure that there is clear, consistent and transparent communication with the public. Partnerships with medical organisations, non-governmental organisations, universities and other relevant organisations have to be shown to be effective in order to improve public understanding and acceptance. In the case of targeted interventions to specific communities, local leaders should primarily be involved in communication and outreach to the public.

    The availability of OPV and regulatory aspects for its use may represent a challenge in many EU/EEA countries. National stockpiles are not the best option for several practical reasons and due to the risk of global stocks becoming depleted. Rules for access to international stockpiles, via WHO/UNICEF, and regulatory aspects for domestic use of OPV should be part of the national response plan (i.e. procurement of OPV should occur through the official international procurement system with WHO/UNICEF).


    Working group 2: EU scientific model for environmental surveillance - reviewing options

    Chairs: Assimoula Economopoulou and Daniel Palm (ECDC)

    Rapporteur: Tapani Hovi

    Working group participants: Mika Salminen; Tapani Hovi; Harrie Van de Avoort; Jacob Moran-Gilad; Katherina Zakikhany; Assimoula Economopoulou; Daniel Palm; Lucia Pastore Celentano; Niklas Danielsson; Emma Huitric.


    Defined questions for discussion
    • Given the European Regional Commission for the Certification of the Eradication of Poliomyelitis (RCC) conclusions regarding polio surveillance in Europe, should environmental surveillance of poliovirus be promoted?
    • Should EU countries implement environmental surveillance for specific groups (migrants, inadequately-vaccinated populations)?
    • Is environmental surveillance of poliovirus, as a supplement to AFP surveillance, feasible in the EU, taking into account laboratory costs, expertise and existing guidelines?
    • How should existing WHO guidelines be elaborated to help EU Member States initiate environmental surveillance (i.e. development of standards and indicators for environmental surveillance applicable across the EU)?


    Summary of discussions

    The group pointed out that each Member State needs to perform its own assessment of the risk for WPV introduction and circulation, and consequently assess the need to improve their overall polio surveillance system. Environmental surveillance is feasible and could serve as an early warning system for detecting reintroduction of poliovirus. The group suggested that ECDC could play an active role in coordinating exchange of action plans between Member States. To support capacity building, ECDC invited polio surveillance experts in the working group to discuss the opportunities for strengthening Member State polio surveillance systems, with special focus on environmental surveillance for the early detection of poliovirus circulation.


    Given the RCC conclusions regarding polio surveillance in Europe, should environmental surveillance of polio be promoted?

    During the discussions, the group agreed that each Member State needs to perform its own assessment of the risk for WPV introduction and circulation and to assess the need to improve their overall polio surveillance system. Whilst AFP surveillance is the gold standard, environmental surveillance could provide evidence for polio reintroduction at an earlier stage (as was the case recently in Israel) and thus serve as an early warning system.


    Should EU countries implement environmental surveillance for specific groups?

    As described in the WHO guidelines, environmental surveillance is likely to give the most informative results if targeting a population with sub-optimal AFP surveillance, having properties putting them at increased risk of poliovirus circulation (low vaccination coverage, evidence of recent circulation of the virus within the population or close contact with another population where the virus is circulating). Experience from a variety of surveillance approaches among the meeting participants indicated that when targeting a specific population group, environmental surveillance could be easier to conduct than enterovirus surveillance.


    Is environmental surveillance of poliovirus, as a supplement to AFP surveillance, feasible in the EU, taking into account laboratory costs, expertise, and existing guidelines?

    Environmental surveillance has shown itself to be feasible and effective as a supplement to AFP surveillance for polio. It was suggested that the use of molecular methods for environmental surveillance could reduce the laboratory costs, as it requires less specialisation and is more readily transferable and adoptable. The reference cell culture-based method would still need to be operated in parallel to confirm results, however this could be on a smaller scale. The group highlighted the fact that the cost for maintaining a comprehensive environmental surveillance system can be relatively high, given the need to perform repeated testing and practical constraints in setting up a surveillance system that covers different geographical areas. When planning to enhance national surveillance systems, decisions need to be based on whether increased effort in AFP surveillance is more cost-efficient than setting up environmental or other types of supplementary surveillance. It was re-iterated that Member States need to make their own risk assessments on the basis of these and other facts (vaccination status, polio circulation in vicinity, contact with population where poliovirus is circulating, etc.). Based on these assessments, Member States can decide if and how their surveillance systems need strengthening and, where implementation of environmental surveillance is an option, how to achieve this. Careful planning is required on how to respond to positive signals from environmental testing, especially if environmental signals are picked up before AFP cases become evident.


    How should existing WHO guidelines be elaborated to help EU Member States initiate environmental surveillance?

    Environmental surveillance is technically more complex than patient testing as conducted in AFP- or enterovirus surveillance. Experts in the group highlighted the fact that some laboratory methods for environmental testing can be standardised and validated, but the range of variables valid for a particular setting or sample-type complicates the production of guidelines covering all possible aspects. At present there is a lack of standardisation and quantitative and qualitative variants of many of the laboratory methods used for environmental testing. There are existing WHO guidelines for environmental testing from 2004, and these are currently under revision in collaboration with environmental surveillance experts and WHO.

    The group felt that ECDC did not need to develop separate guidelines for the EU countries, but could focus on areas not covered in existing polio surveillance guidelines, including:
    • Further elaboration of details on conceivable scenarios in different situations and response action options, including environmental surveillance, in cooperation with WHO and Member States;
    • Comparison of national preparedness plans and sharing of best practices on how to react in the event of poliovirus (wild-type or vaccine-derived) being detected;
    • Support of training activities for environmental and other types of polio surveillance;
    • Facilitating twinning arrangements for sample referral;
    • Direct support of polio surveillance projects or informing the European Commission of the need for funding;
    • Guidance on the interpretation of testing results and what kind of public health actions should be considered in response to positive or negative results, depending on the current situation. Actions chosen will depend on multiple situational details, such as the type of surveillance signals received as well as the type of virus detected (WPV, vaccine-derived poliovirus, Sabin, etc.).


    Working group 3: Scientific evidence to control poliovirus transmission among refugees from areas where poliovirus is circulating

    Chairs: Tarik Derrough and Elizabeth Bancroft (ECDC)

    Rapporteur: Aura Timen

    Working group participants: Anders Tegnell; Tammam Aloudat; Aura Timmen; Eran Kopel; Gregory Wallace; Tarik Derrough; Elizabeth Bancroft; Verena Kessler; Denis Coulombier; Peter Kreidl.


    Defined questions for discussion
    • Considering the current scenario of asymptomatic refugees coming to the border of an EU country, what public health measures should be taken upon entry?
    • If a clinical case of polio is diagnosed in a refugee centre, what actions should be taken?
    • If a clinical case of polio is diagnosed in a migrant or member of a family hosting a migrant from Syria, what actions should be taken?


    Summary of discussions

    Overall summary

    Working Group 3 reviewed and discussed practical measures that would need to be considered by EU/EEA Member States to ensure a) that refugees displaced in EU/EEA countries are protected from poliomyelitis at point of entry or after entry, b) that the EU/EEA population in close contact with refugees, including host families, social and healthcare workers, is protected from poliomyelitis, and c) that cases are quickly identified and contained. The populations of interest included refugees/migrants from countries with circulating WPV or countries at risk of WPV outbreaks and those in contact with these populations.


    Reaching a common understanding

    The initial discussion in the working group focused on reaching a common understanding of why the polio situation in Syria needed appropriate response measures in the EU. It was acknowledged that EU/EEA countries have experience of welcoming refugees/migrants from geographical areas were polio is endemic. Unlike refugees coming from other parts of the world, Syrian refugees may require specific attention. Syria has a highly mobile population that may be entering the EU directly and thus there may not be an opportunity for immunisation prior to entry (e.g. in transit refugee camps or as part of an on-going large-scale polio immunisation campaign). Moreover, Syria is geographically close to the EU with a relatively short-transfer time.

    As has been reported, the vaccination programme in Syria was discontinued in 2011. Prior to that date, a mixed OPV/IPV schedule was used and vaccination coverage was reported to be high. Therefore those at highest risk of acquiring or transmitting polio will be children <5 years (those who have not received any polio vaccination or those that have not received a full course of vaccination).

    The group also recognised that polio circulation/infection may not occur among Syrian refugees in the EU but among unvaccinated or under-served EU population groups. Therefore increasing coverage among the EU population is critical as well.

    The discussion focused on the situation for Syrian refugees currently entering the EU in light of the political unrest in the area.

    The group discussed the scenario of refugees arriving together in the EU/EEA who had not been through a migrant camp or did not have any documentation. In this scenario, the group highlighted that a top priority was ensuring the vaccination of all children under five years of age, unless the child had proof of vaccination. An unresolved question was the use of IPV versus OPV in this population for a variety of reasons including ease of administration, supplies and the risk associated with intramuscular injections during the polio incubation period. The need to consider administration of polio vaccination through the subcutaneous route was discussed. Host countries should ensure that the refugees have all age-appropriate vaccinations, according to the host country’s immunisation schedule. All missed vaccinations should be considered, not just polio. The group did not recommend testing serology pre-vaccination.

    The group suggested that all EU/EEA citizens who would be working with the high-risk populations should be fully immunised against polio. The group also pointed out that in light of the planned influx of refugees, all under-vaccinated populations in the EU/EEA host countries should be vaccinated.

    The group assessed that the screening of stool samples for enterovirus/polio should not be recommended, for reasons of feasibility, lab capacity, stigmatisation and limited duration of shedding. However, systematic research into stool carriage, as part of an epidemiological study, may be considered in refugee camps to better define the populations at greatest risk of incubating and transmitting poliovirus, or developing polio.

    The group agreed that enhanced clinical surveillance was needed for AFP and aseptic meningitis in the populations of interest. It also suggested that a pan-EU/EEA protocol should be developed to systematically test cases of aseptic meningitis for polio. Given that clinical surveillance of poliomyelitis is not very sensitive to identifying transmission of the virus, the group supported the use of environmental surveillance in areas where there is a high risk of polio transmission (e.g. refugee camps) or clinical disease (e.g. unvaccinated groups in host countries).

    The group felt that the responses to a positive environmental sample or a clinical polio case may differ, depending on the population affected, number of positive samples/cases, vaccination status of the population, or other considerations. Protocols need to be developed for these situations.


    Wrap-up session

    Head of Surveillance and Response Support Unit (SRS), Dr Denis Coulombier, closed the meeting, thanking all the groups for their contributions and highlighting the need for the EU/EEA to be prepared to respond to a potential polio threat. He emphasised that the situation in the Middle East was unusual and of a larger scope than expected.

    Dr Coulombier highlighted that the main scope of the expert consultation meeting had been to identify the needs and priorities (e.g. to strengthen surveillance systems for polio, enhance environmental and/or enterovirus surveillance if already in place and vaccinate pockets of susceptible individuals, refugees and asylum seekers). The meeting was essential in helping ECDC to further identify areas where it could provide evidence-based scientific advice in the areas of polio prevention and control in the EU/EEA. As a next step, ECDC would consider updating its two risk assessments and combining them in a single document with the risks and recommendations presented. ECDC would also continue to work and collaborate closely with its partners at the WHO Regional Office for Europe and the European Commission to ensure to joint efforts in the provision of guidance and support.


    Conclusions and next steps

    There were a number of important suggestions presented by the three working groups. In addition, many technical aspects were discussed which will be useful to ECDC as it continues to consider the three areas and provide scientific advice and guidance to Member States.

    The following is a summary of the key considerations and suggestions presented by the three working groups.

    Scientific evidence base for using IPV vaccination in outbreak situations in the EU/EEA:
    • IPV is considered the first choice in most of the potential scenarios within the EU/EEA;
    • In order to trigger an operational plan that necessitates the use of OPV, a national threshold should be defined in terms of number of positive sewage/stool samples, or geographical spread;
    • Should a response with OPV be implemented, safety aspects have to be considered as a priority, and even then OPV should not be administered as a first dose.


    EU scientific model for environmental surveillance - reviewing options:
    • AFP surveillance remains the gold standard for national poliovirus surveillance. The setting up of any supplementary surveillance system (environmental and enterovirus surveillance) should be evaluated at national level based on cost, efficiency and risk of polio reintroduction into the country (considering factors such as vaccination status of the general population, presence of unvaccinated pockets, poliovirus circulation in the vicinity, frequent contact with populations where poliovirus is circulating, etc.).
    • Environmental surveillance is feasible and should be considered as a supplement to national polio surveillance plans.
    • The WHO guidelines for environmental testing are currently being revised and ECDC should not duplicate or develop separate guidelines.
    • ECDC could assist with capacity-building of Member State polio surveillance systems by supporting training activities for environmental and other types of polio surveillance and by facilitating twinning arrangements for sample referral.
    • ECDC could play an active role in coordinating the exchange of preparedness plans and the sharing of best practices for action if circulating poliovirus is detected.


    Scientific evidence to control poliovirus transmission among refugees from areas where polio virus is circulating:
    • Receiving/refugee centres should assess vaccination status and vaccinate all children under five years of age from high-risk countries (e.g. Syria) on arrival in the EU/EEA against polio and other childhood-preventable diseases (unless the child has proof of vaccination).
    • There is no need for systematic stool sampling of asymptomatic individuals in receiving centres unless it is in a setting where a refugee camp/epidemiological study is being conducted.
    • It would be useful to enhance AFP surveillance and surveillance of aseptic meningitis in refugee centres and to consider environmental surveillance in high-risk areas (e.g. where there is a large concentration of refugees from high-risk areas or a large concentration of unvaccinated individuals).
    • Appropriate booster vaccines should be provided for all EU/EEA citizens who would be working with these high-risk populations.

    (...)


    References (working group 1)
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    17. Duintjer Tebbens RJ, Pallansch MA, Chumakov KM, Halsey NA, Hovi T, Minor PD, et al. Review and assessment of poliovirus immunity and transmission: Synthesis of knowledge gaps and identification of research needs. Risk analysis: an official publication of the Society for Risk Analysis. 2013 Apr;33(4):606-46. PubMed PMID: 23550968.
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    (...)


    References (working group 2)
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    2. Global Polio Eradication Initiative. Polio this week: 28 August 2013 [cited 3 September 2013]. Available at: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx.
    3. State of Israel: Ministry of Health. Polio update August 18, 2013 [cited 17 September 2013]. Available at: http://www.health.gov.il/English/News_and_Events/Spokespersons_Messages/Pages/18082013_2.aspx.
    4. World Health Organization. Department of Immunization, Vaccines and Biologicals. Polio Laboratory Manual. Geneva: WHO; 2004. Available at: http://whqlibdoc.who.int/hq/2004/WHO_IVB_04.10.pdf
    5. WHO. Report of the 27th meeting of the European Regional Certification Commission for Poliomyelitis Eradication: Copenhagen, Denmark 30–31 May, 2013: WHO Regional Office for Europe; 2013. Available at: http://www.euro.who.int/__data/assets/pdf_file/0016/200752/Report-of-the-27th-Meeting-of-the-European-Regional-Certification-Commission-for-Poliomyelitis-Eradication.pdf.
    6. World Health Organization. Department of Vaccines and Other Biologicals. Guidelines for environmental surveillance of poliovirus circulation. Geneva: WHO; 2003. Available at: http://whqlibdoc.who.int/hq/2003/WHO_V&B_03.03.pdf.
    7. Hovi T, Shulman LM, van der Avoort H, Deshpande J, Roivainen M, De Gourville EM. Role of environmental poliovirus surveillance in global polio eradication and beyond. Epidemiol. Infect. 2012 Jan;140(1):1-13.
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    9. European Centre for Disease Prevention and Control. Wild-type poliovirus 1 transmission in Israel – what is the risk to the EU/EEA? Stockholm: ECDC; 2013. Available at: http://ecdc.europa.eu/en/publications/Publications/polio-risk-assessment-transmission-in-Israel.pdf
    10. European Centre for Disease Prevention and Control. Rapid Risk Assessment on suspected polio cases in Syria and the risk to the EU/EEA Stockholm: ECDC; 2013. Available from: http://ecdc.europa.eu/en/publications/Publications/RRA%20poliomyelitis%20Syria%2021%2010%202013.pdf

    ________

    The views expressed in this publication do not necessarily reflect the views of the European Centre for Disease Prevention and Control (ECDC).

    Stockholm, November 2013

    © European Centre for Disease Prevention and Control, 2013. Reproduction is authorised, provided the source is acknowledged.


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