update from who hq

Update from WHO HQ • W. Zhang7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting

Update from WHO HQUpdate from WHO HQ

Wenqing Zhang

5th WPR and SEAR NIC Meeting 7 – 10 June 2011 • Vientiane


Change of Network name(after adoption of WHA 64.5 on 24 May 2011)Change of Network name

(after adoption of WHA 64.5 on 24 May 2011)

GISN (WHO Global Influenza Surveillance Network)

GISRS (WHO Global Influenza Surveillance and Response System)


Update from WHO HQUpdate from WHO HQ

Selected HQ activities related to GISRS– Virus surveillance– GISRS coordination– Vaccine support– Epidemiological surveillance strategy

OEWG/PIP

IHR/RC


GISRS coverageGISRS coverage


WPR and SEAR resourcesWPR 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

#countries #countries

with NIC(s)

%population covered by

GISRS

AFR461152.90%

EMR 211286.63%

EUR534093.00%

SEAR11899.88%

PAH362296.55%

WPR281699.93%

Total195109*91.62%

*109 countries, areas and territories; 106 Member States


Virus surveillancelaboratory diagnostics

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


Virus surveillancevirus monitoring

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


Virus surveillancevirus sharing and shipping logistics

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


GISRS coordinationGISRS 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– [email protected] network hotline

Support to OEWG/PIP negotiation/discussion– Technical studies under WHA 63.1– IVTM – launched January 2011


Vaccine supportVaccine 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


Global strategy on influenza epidemiological surveillance

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


OEWG/PIPOEWG/PIP


EventsEvents

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


WHA 64.5 (24 May 2011)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


FrameworkObjective

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.


FrameworkScope

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


FrameworkVirus sharing (1)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



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



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


FrameworkSMTA 1

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


FrameworkSMTA 1

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


FrameworkSMTA 1

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


FrameworkBenefit sharing (1)Framework

Benefit 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



Benefit 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



Benefit 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


FrameworkSMTA 2

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


FrameworkSMTA 2

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


FrameworkSMTA 2

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


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




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


NIC TOR [3](under PIP Framework - for work with PIP materials)

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


IHR ReviewIHR Review


IHR review(background)

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.


DecNovOctSeptAugJulyJunMayAprMarFebJan

First RC meeting (held in Geneva)

Interim report provided to WHA by Director-General

Second RC meeting

12-14 April

mid-May

30 June -2 July

Third RC meeting 27 – 29 September

... May2010 2011

Final report provided to WHA by Director-General

mid-May

RC meeting cont. 3 –5 November

Fourth RC meeting (28-30 March) Preview document presented

5-7 January

end-Mar

RC meeting cont.

IHR review(timetable and process)

IHR review(timetable and process)


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

WHA 64.1 (20 May 2011)WHA 64.1 (20 May 2011)


SummarySummary

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

update from who hq

Documents