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Update from WHO HQ

Update from WHO HQ. Wenqing Zhang. 5 th WPR and SEAR NIC Meeting 7 – 10 June 2011 • Vientiane. Change of Network name (after adoption of WHA 64.5 on 24 May 2011). GISN (WHO Global Influenza Surveillance Network) GISRS (WHO G lobal I nfluenza S urveillance and R esponse S ystem).

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Update from WHO HQ

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  1. Update from WHO HQ Wenqing Zhang 5th WPR and SEAR NIC Meeting 7 – 10 June 2011 • Vientiane

  2. Change of Network name(after adoption of WHA 64.5 on 24 May 2011) GISN(WHO Global Influenza Surveillance Network) GISRS (WHOGlobal Influenza Surveillance and ResponseSystem)

  3. Update from WHO HQ • Selected HQ activities related to GISRS • Virus surveillance • GISRS coordination • Vaccine support • Epidemiological surveillance strategy • OEWG/PIP • IHR/RC

  4. GISRS coverage

  5. WPR and SEAR resources • 3 WHO Collaborating Centres – 6 in the world • 2 Essential Regulatory Laboratories – 4 in the world • 6 H5 Reference Laboratories – 12 in the world * 109 countries, areas and territories; 106 Member States

  6. Virus surveillancelaboratory diagnostics • Advisory group • PCR WG meetings: 17-18 June 2010; 14-15 June 2011 • Protocols and manual • Diagnostic protocols being updated: review existing protocols, including H5, H7 and H9 • Serological study protocols (MN) published • WHO GISN laboratory manual published on web, hardcopy being sent to all NICs of GISRS, accompanying video being developed • Guidance for GISRS on antiviral susceptibility surveillance is being developed, a WG is planned for Nov 2011 • Quality • EQAP (PCR): panel 8 and 9 finished. Summary analysis 2010 published in WER • Guidance on use of rapid diagnostic tests updated in Sept 2010

  7. Virus surveillancevirus monitoring • Coordination of global virological surveillance • Virus evolutions potential of public health significant • D222G, I223R, AA 154-156, H275Y  virulence, antiviral susceptibility, vaccine match …. • Continuous monitoring of proportion of circulating viruses • Routine and ad-hoc TC with CCs • Weekly/bi-weekly update • Strengthening GISRS virus monitoring capacity • Antiviral susceptibility surveillance training Oct 2010 • Sequencing training Dec 2010 • Tailored training being planned for African countries

  8. Virus surveillancevirus sharing and shipping logistics • OEWG/PIP • Improving quality of virus shared with CCs • Guidance issued on using PCR vs. virus isolation and the selection of representative viruses for shipping to CCs published on Dec 2010 • WHO Shipment Fund Project • 157 shipments made since 2nd quarter of 2010, among which 34 were made by labs in WPR and SEAR • A bidding process ongoing for a new contract starting the end of July 2011 • Provision of swabs, VTM, packaging materials • Mapping shipping resources at national level, 157 countries (34 SEAR/WPR countries), update planned later this year • Support ROs and COs on 4 trainings of IATA shipping infectious substances • A review of the 6-year implementation of SPF, related challenges and solutions is being under planning with external partners, probably in 2012 • Ongoing GISRS logistics support

  9. GISRS coordination • Expansion of GISRS • 5 new NICs since April 2010: Nepal, Ghana, Vietnam (HCM), Laos and Malta • 1 new CC: CNIC Beijing • New CC development: • VECTOR, Russia; NIHRD, Indonesia • 3rd NIC Survey – report published on WHO web and WER • A mini survey on antiviral susceptibility surveillance and sequencing capacity earlier 2010 • NIC engagement in global meetings, conferences, events • Observing annual vaccine composition consultations: • Nepal (Sept 2010), Cambodia and Indonesia (Feb 2011) • Other meetings e.g. Improving influenza vaccine virus selection process June 2010; Global NIC meeting Dec 2010; surveillance consultation Mar 2011; OEWG/PIP • GISRS communication • EZCollab – informal interactive GISRS platform, encourage all NICs to register • FluNet – new page, new functions: real-time charts of selected countries, regions • GISN@who.int network hotline • Support to OEWG/PIP negotiation/discussion • Technical studies under WHA 63.1 • IVTM – launched January 2011

  10. Vaccine support • Update WHO recommendations on vaccine composition • Sept 2010 – SH 2012; Feb 2011 – NH 2011-2012 • 26-29 Sept 2011 – SH 2012 • Coordination of the development, evaluation and making available candidate vaccine reassortant viruses • Update tables on WHO web of H1N1, H3N2, B, H5N1 • Update library of candidate vaccine viruses and reagents for pandemic preparedness • Close communication with regulatory agencies and vaccine manufactures • Closer coordination of the potency reagent development and calibration • Strengthening ERL functions • Improving influenza vaccine virus selection process • Informal consultation June 2010 – report cleared, to be published • A follow up meeting is under planning for 7-9 Dec 2011 • Policy support • H5N1 vaccine stockpile • SAGE recommendations

  11. Global strategy on influenza epidemiological surveillance • Global consultation in March 2011 • Future direction • Global standards for data collection and reporting • A global influenza surveillance manual • Outline key standards of surveillance e.g. case definition, approach to surveillance and data reporting • First draft by middle 2011 • FluID (http://www.who.int/influenza/fluID) • Global epi data reporting system • Linking regional data system to FluID

  12. OEWG/PIP

  13. Events Jan 2007 – Best practice May 2007 – WHA 60.28 Jul-Aug 2007 – Interdisciplinary WG Nov 2007 – IGM Jan 2008 – IVS launched April 2008 – OEWG Dec 2008 – IGM and OEWG May 2009 – IGM May 2009 – WHA 62.10 May 2010 – OEWG May 2010 – WHA 63.1 Dec 2010 – OEWG Apr 2011 – OEWG May 2011 – WHA 64.57 In 4 years and 4 months: 4 WHA Resolutions 3 IGM 5 OEWG 1 IDWG

  14. WHA 64.5 (24 May 2011) Pandemic influenza preparedness framework for the sharing of influenza viruses and access to vaccines and other benefits(Framework) http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_R5-en.pdf

  15. FrameworkObjective • To improve pandemic influenza preparedness and response, and strengthen the protections against the pandemic influenza • by improving and strengthening the WHO Global Influenza Surveillance and Response System (GISRIS), • with the objective of a fair, transparent, equitable, efficient, effective systems for, on an equal footing: • (i) the sharing of H5N1 and other influenza viruses with human pandemic potential; and • (ii) access to vaccines and sharing of other benefits.

  16. FrameworkScope • Sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits. • NOT apply to seasonal influenza viruses or non-influenza pathogens or biological substances PIP biological materials • Human clinical specimens • Wild type viruses • Modified viruses: candidate vaccine reassortants • RNA from wild type viruses* • cDNA encompassing the entire coding region of one or more viral genes* * Operational exemption

  17. FrameworkVirus sharing (1) • Countries, through NICs and other authorized labs, to share with WHOCCs or H5 Ref Labs • In a rapid, systematic and timely manner • By providing PIP materials  MS authorizing CCs and H5 Ref Labs for onward transfer and use, subject to provisions in SMTA • NICs and other labs to ensure quality of virus shared, accompanied by other clinical and epidemiological information needed for risk assessment • NICs and other labs sharing with CCs and H5 Ref Labs on priority basis; may sharing with other party on a bilateral basis

  18. FrameworkVirus sharing (2) • Genetic sequence data • Sequence data and analysis to be shared with originating labs and among GISRS labs  in a rapid, timely and systematic manner • MS request DG to consulate Advisory Group on sharing genetic sequences and associated issues • Important transparency and access to sequences, uploaded to GenBank and GISAID • Sensitive in some instances by countries • Traceability and reporting mechanism • Use of IVTM to track the movement of PIP materials • Feedback from CCs and H5 Ref Labs, in the form of summary report to originating labs, built in IVTM • DG has authorization to modify the use of IVTM in emergencies – use of IVTM not to hinder GISRS functioning

  19. FrameworkVirus sharing (3) • Standard Material Transfer Agreements (SMTA) • SMTA1: to cover all transfers of PIP biological materials within the WHO GISRS • SMTA2: to enter into agreements with entities outside the WHO GISRS. It will cover all transfers of PIP materials to recipients for their duration

  20. FrameworkSMTA 1 • Parties: GISRS laboratories: designated or recognized by WHO under WHO TOR • Subject matter: PIP biological materials • Rights and obligations of Provider • Complies with WHO GISRS TOR • Handles PIP materials in accordance to WHO guidelines and national biosafety standards • Agrees to onward transfer and use of the materials, to all members of GISRS, on same terms and conditions under SMTA1 • Consents to onward transfer and use of the materials, to entities outside GISRS, on condition that recipient has concluded an SMTA2 • Informs WHO of shipment to entities inside/outside GISRS by recording in IVTM

  21. FrameworkSMTA 1 • Rights and obligations of Recipient • Complies with WHO GISRS TOR • Handles PIP materials in accordance to WHO guidelines and national biosafety standards • Informs WHO of shipment to entities insider/outside GISRS by recording in IVTM • In the event of further transfer within GISRS, does so in accordance with SMTA1 • Actively seeks participation from originating labs, in particular those from developing countries, in scientific studies and manuscript development associated with the PIP materials • Appropriate acknowledgements • IPR • Neither Provider nor Recipient should seek to obtain any IPRs on the PIP materials • IPRs obtained before the adoption of the Framework not affected by SMTA1 • Provider under SMTA1 may have used technology protected by IPR for the PIP materials. Any recipient of such materials acknowledges that such IPRs shall be respected • RG vaccine viruses

  22. FrameworkSMTA 1 • Acceptance • Labs already in GISRS at the time of the adoption of the Framework: Acceptance of their WHO TOR, as contained in the Framework, constitutes acceptance of SMTA1 • New labs joining GISRS after the adoption of the Framework, Acceptance of designation or recognition by WHO to become a WHO GISRS lab will constitute acceptance of SMTA1 • No further signature of acceptance is required, unless party requires otherwise

  23. FrameworkBenefit sharing (1) • PIP benefit sharing system will operate to • Provide pandemic surveillance and risk assessment and early warning information and services to all countries • Build capacity • Prioritize important benefits, such as antivirals and vaccines, to developing countries, based on assessment of public health risk and need. • Build capacity • WHO coordination

  24. FrameworkBenefit sharing (2) • Elements included in the Benefit Sharing System • Pandemic risk assessment and risk response • Provision of PIP candidate vaccine viruses • Provision of diagnostic reagents and test kits • Provision of reference reagents for potency determination of vaccines • Laboratory and influenza surveillance capacity building • Regulatory capacity building • Antiviral stockpiles • WHO stockpile • National, institutional, organizational stockpiles • PIP vaccine stockpile • Initially 150 million doses: 50 m for affected countries in containing first outbreak, 100 m to development countries once pandemic starts • WHO stockpile: size, type (composition),replenishment and operational use to be advised by experts; with associated equipment • If insufficient doses donated, DG to explore the use of sustainable funding mechanism

  25. FrameworkBenefit sharing (3) • Elements included in the Benefit Sharing System (continued) • Access to vaccines in the inter-pandemic period for developing countries • Access to pandemic vaccines • Tiered pricing • Technology transfer • Sustainable and innovative financing mechanisms • Influenza vaccine, diagnostic and pharmaceutical manufacturers will make an annual partnership contribution, the sum equivalent to 28 million – commence 2012 • DG and Advisory Group will work with industry and report annually to EB • Contribution will be used for conducting disease burden studies, strengthening laboratory and surveillance capacity, access and effective deployment of pandemic vaccines and antivirals • Advisory Group will advise the proportion of contribution for inter-pandemic and pandemic use

  26. FrameworkSMTA 2 • Parties: WHO and Recipient – entities receiving PIP materials from WHO GISRS • Subject matter: PIP biological materials • Obligations of Provider: to be agreed by parties • Obligations of Recipient: • Agree to comply with the commitment selected • For manufacturers of vaccines and/or antivirals, commit to at least two of options A1– A6 • For other non-vaccine, non-antiviral manufactures, commit to one of options: A5, A6, B1-B4 • Recipients, in addition to the above, consider other contributions • Further transfer could be done to a recipient already concluded SMTA 2, and should report to WHO. • May exchange PIP materials with any other holders of an SMTA 2

  27. FrameworkSMTA 2 • Options • A1. Donate at least 10% of real time pandemic vaccine production to WHO • A2. Reserve at least 10% of real time pandemic vaccine production at affordable prices to WHO • A3. Donate at least X treatment courses of needed antivirals for the pandemic to WHO • A4. Reserve at least X treatment courses of needed antivirals for the pandemic at affordable prices • A5. Grant licenses to manufactures in developing countries • A6. Grant royalty free licenses to manufactures in development countries or grant to WHO royalty-free, non-exclusive licenses on IPR, which can be sublicensed by WHO. • B1. Donate to WHO at least X diagnostic kits needed for pandemics • B2. Reserve for WHO at least X diagnostic kits, at affordable prices • B3. Support, in coordination with WHO, the strengthening laboratory and surveillance capacity in developing countries • B4. Support, in coordination with WHO, transfer of technology, know-how and/or processes for pandemic preparedness and response in development countries

  28. FrameworkSMTA 2 • Options • Donations of vaccines • Donations of pre-pandemic vaccines • Donations of antivirals • Donations of medical devices • Donations of diagnostic kits • Affordable pricing • Transfer of technology and processes • Granting of sublicenses to WHO • Laboratory and surveillance capacity building

  29. NIC TOR [1] (under PIP Framework - for work with PIP materials) • General conditions and activities • Under coordination of WHO • Use IVTM to record the receipt and transfer of PIP materials • Comply with SMTA 1 • Serve as key POC between WHO and the country on issues related to surveillance, laboratory diagnostics, sharing of PIP materials and important related clinical or epidemiological information • Participate WHO activities and main active communication and collaboration with other GISRS members

  30. NIC TOR [2] (under PIP Framework - for work with PIP materials) • Laboratory and related activities • Collect or process clinical specimens • Act as a collection point for virus isolates from labs within the country • Conduct testing • Ship, within one week, un-subtypable clinical specimens/virus isolates, accompanied with available geographical, clinical and epidemiological information, to a WHO CC or H5 Reference Lab • Attend trainings and build capacity • Review, maintain and strengthen influenza surveillacen in the country • Provide technical advice and support to other labs in the country

  31. NIC TOR [3](under PIP Framework - for work with PIP materials) • Information and communication • Alert WHO immediately on detection of un-subtypable viruses or unusual outbreaks of non-seasonal or ILI • Provide timely national authorities and general public with information of circulating viruses in the country • Research, scientific presentations and publications • Actively seek participation of originating laboratories/countries in research projects and manuscript development associated with PIP materials • Appropriate acknowledgement

  32. IHR Review

  33. IHR review(background) • 2008: WHA 61.2 mandates 63th WHA to review IHR (2005) in May 2010 • 2010: EB (126 session) welcomes DG's proposal to convene an IHR Review Committee (RC) in line with IHR (2005), with the aim to: • to assess the functioning of the IHR in relation to the pandemic (H1N1) 2009 and other public health events; • to review the scope, appropriateness, effectiveness, and responsiveness of global actions as well as the role of the WHO Secretariat in relation to the pandemic; • to identify and review the major lessons learnt from the global response and to recommend actions to be taken by Member States and the DG.

  34. IHR review(timetable and process) 2010 2011 May Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec ... First RC meeting (held in Geneva) • 12-14 April Interim report provided to WHA by Director-General • mid-May • 30 June -2 July Second RC meeting • 27 – 29 September Third RC meeting • 3 –5 November RC meeting cont. RC meeting cont. • 5-7 January Fourth RC meeting (28-30 March) Preview document presented • end-Mar Final report provided to WHA by Director-General • mid-May

  35. WHA 64.1 (20 May 2011) • Urges MS to support the implementation of recommendations from IHR review • 15 recommendations, grouped into short term (within 1 year), medium term (within 2 years) and long term (beyond 2 years), and by WHO led, Country led and Jointly led • Review pandemic preparedness guidance (7) [m, W] • Develop and apply measures to assess severity (8) [m, W] • Reach agreement on the sharing of viruses and access to vaccines and other benefits (14) [s, C] • Pursue a comprehensive influenza research and evaluation programme (15) [l, J] http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_R1-en.pdf

  36. Summary • GISRS – new name for GISN • Increasing expectation from MS, together with strong institutional and governmental support • Its value demonstrated and acknowledged through pandemic response • A stronger GISRS, in the changing and challenging world • through • OEWG/PIP Framework implementation • IHR review report recommendation implementation • with • improved timeliness, quality and efficiency of the Network • Linking closer to final public health products • Improved partnership • GISRS – a network, a global team • NICs are backbone • All members, NICs, CCs, ERLs, H5 Ref Labs, playing an equally important, indispensible role • WHO and public appreciations • Commitments from WHO - CO, ROs and HQ

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