Influenza Virus Traceability Mechanism for viruses with pandemic potential

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1 Influenza Virus Traceability Mechanism for viruses with pandemic potential SARINET AND REVELAC-I FOURTH ANNUAL MEETINGS PUNTA CANA, DOMINICAN REPUBLIC, MAY 2017 TUESDAY MAY S. Jackson, C Fuster, M Samaan,T Besselaar 1

2 Presentation outline To review the history of IVTM and relationship with PIP Framework To describe the use of IVTM: Registered and public users Records within the 6 WHO regions Records within the Americas Search and analysis functions of IVTM Training and tutorials Access to IVTM and WHO IVTM contact Challenges and solutions 2

IVTM Goal and Objectives System that records the transfer and movement of PIP Biological Materials (PIP BM) within and to parties outside the WHO GISRS.

To allow users to see the results of analyses and tests carried out with PIP BM 3.

3 IVTM Goal and Objectives System that records the transfer and movement of PIP Biological Materials (PIP BM) within and to parties outside the WHO GISRS. Goal to increase the transparency of GISRS activities of PIP Biological Materials Objectives: 1. To allow users to track the transfers of PIP biological materials 2. To allow users to see the results of analyses and tests carried out with PIP BM 3. To allow users to trace the geographic transfer of PIP biological materials (Geotrace) 4. To allows users to view the Derivation Tree for the same. IVTM, is envisioned by Member State as an efficient, userfriendly and cost-effective system. 3

4 To consider when shipping PIP BM Legal aspects Legal aspects Legal aspects Timeliness Traceability ( IVTM) Shipping conditions National and international regulations 4

5 Importance of Registering Materials and Shipments in IVTM 1. It is a requirement under the PIP Framework: GISRS labs Terms of Reference Use the WHO IVTM to record the receipt and transfer of PIP biological materials ( Guiding Principle 8, Annex 5) SMTA 1 2. Allows users and all stakeholders to trace the movement and use of all PIP material 3. GISRS laboratories that do not record receipt and shipment of PIP materials are in breach of the TORs and SMTA 1 4. Allows WHO to track transfers of PIP materials to Non-GISRS laboratories and/or manufactures that have not yet signed an SMTA 2 with WHO 5

6 GISRS-Global efforts growing Birth of GISN 1952 Virus monitoring Vaccine composition recommendation WHOCCs 59 NICs/42 countries Accumulating knowledge of influenza epidemiology WHOCCs 108 NICs/76 countries Risk assessment WHOCCs 112 NICs/83 countries HPAI H5N1 Diagnostics Antiviral susceptibility monitoring WHOCCs 121 NICs/93 countries HPAI- H5N1 IVTM (traceability) H1N1pdm WHOCCs 143 NICs/113 countries H5 (N=1,6,8) H7- (N=1,2,3,7,9 H8N4 H9N2 6 World Health Organization W Zhang

7 Genesis of Influenza Virus Traceability Mechanism (IVTM) May 2007 The World Health Assembly adopted resolution WHA60.28 "Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits" inter-alia requested the Director-General to convene an intergovernmental meeting on this topic. WHO was mandated to : The Intergovernmental Meeting (PIP-IGM) IVTM interim operational system "establish a technical and feasible system as soon as possible within WHO to track all shared H5N1 and other potentially pandemic human viruses and parts thereof..p Pending the functioning of such traceability mechanism, an interim mechanism providing full disclosure of information on transfer and movement of virus shall be made operational immediately." In response, an interim mechanism with limited functionality was rapidly developed with core WG and external developers and became operational on 22 January The interim mechanism traces influenza specimens and viruses with pandemic potential, and the related analyses and outcomes. 7

8 WHO-Influenza Virus Traceability Mechanism (IVTM) Longer term system development Time lines Sept 2008: Ottawa Workshop. Nov 2008: WHO WG January 2009: The technical parameters Developed plan of action for longer term on IVTM using best practices. NIC survey constituted the baseline for finalising IVTM requirements WG constituted of 15 experts from GISRS labs who would be end-users. WG develops specifications for IVTM system learning from experiences of online interim system, user needs and mandate for tracking system Develop timelines for IVTM Recommends development of IVTM internally with WHO IT experts. The technical parameters, requirements and specifications of the IVTM were developed and consolidated through a broad WHO-lead consultative process. Monitoring, review and update s -development of access to genetic sequences through IVTM. 8

9 Pandemic influenza preparedness Framework PIP biological materials 9

10 Recording of PIP BM in IVTM Total materials recorded to as of May 25, 2017= 1290 Total shipments and materials recorded as of May 25, 2017 =

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13 Within the Americas Recording of PIPBM in IVTM Canada, Mexico and the USA The Americas have recorded 295 original viruses in IVTM. This included the documentation of Influenza A/Mexico/7218/2012 (H7N3) isolated from a human and detected in Mexico in 2012 which was recorded in IVTM by CDC Atlanta. These 295 viruses have been shared among GISRS and non-gisrs laboratories 707 times. 13

14 Recording of PIPBM in IVTM The Americas 14

15 Sharing of PIPBM within the Americas 912 PIPBM have been shared with: Brazil (H5,H7), Canada (H3,H5,H7) Peru and the USA (H1,H2,H3,H5,H6,H7 and H9) 15

16 IVTM Home Page Public users Registered users 16

17 Geotrace 17

18 Search 18

19 Search results 19

20 Data entry only for registered users 20

21 Derivation tree 21

22 IVTM Updates Addition of designation for variant viruses Addition of variables for: Accession numbers Genomic Data Base Link for corresponding accession numbers Quality control alerts for incorrect entries 22

23 Shipments of PIP BM Within GISRS SMTA 1 (Annex 1) GISRS labs share PIP BM with other GISRS labs as required by SMTA 1 GISRS labs must record receipt and further transfers of PIP BM to other GISRS labs in the IVTM Outside GISRS Partnership Contribution or SMTA 2 (Annex 2) A non-gisrs entity (ex: company, research institutions) requesting PIP BM must sign an SMTA 2 with WHO or contribute to the PC GISRS labs include a notice with shipments to non-gisrs entities by accepting the shipment the entity agrees to conclude an SMTA 2 GISRS labs must record transfers of PIP BM to non-gisrs entities in the IVTM PIP Secretariat uses the IVTM to determine which entities received PIP BM and must sign an SMTA 2 with WHO 23

24 BENEFIT SHARING In exchange for access to PIP BM, non-gisrs entities are required under the SMTA 2 or contribute a benefit to GISRIS The benefit options, described in the PIP Framework, reflect the nature and capacity of the different recipients of PIP BM Required: Manufacturers of vaccines, antivirals and other products (ie: diagnostic test kits) must contribute certain benefits Voluntary: Non-commercial recipients (ex: university labs) are requested to contribute a benefit To date, through the SMTA 2s WHO has secured access to vaccines, antivirals and diagnostic test kits and PC funding Total number of SMTA 2 s concluded Vaccine & Antivirals: Diagnostics: Academic & Research 24

25 Access to IVTM Request username and password IVTM database manager Christian Fuster: Webpages IVTM: GISRS: PIP Framework: 25

26 IVTM Current practice WHO CCs register shipments received on behalf of NICs and create source material WHO CCs register onward shipments of source materials and materials created from original source materials Ideal Practice All GISRS laboratories register shipments of human samples infected with influenza viruses of pandemic potential made within and outside GISRS 26

27 Challenges and Potential Solutions 1. PIP-BM Virus sharing Communication to raise awareness with countries for sharing viruses with pandemic potential Development of operational guidance on virus sharing under PIP RO to communicate with countries with poor/non sharing of zoonotic influenza viruses 2. Use of IVTM by NICs On-line and physical training Communication with countries 27

28 PAHO Avian Influenza in the Americas - (H5-H7), Outbreaks overviewhttp://ais.paho.org/phip/viz/ed_hpai.asp 28

29 Acknowledgements IVTM users National Influenza Centre s WHO ERL s WHO CC s The GISRS Team The PIP Team 29

Brief history of the development of the Framework on Sharing influenza viruses and access to vaccines and other benefits

Brief history of the development of the Framework on Sharing influenza viruses and access to vaccines and other benefits The Intergovernmental (IGM) Process Since the late 1940's, WHO has coordinated a