Update from WHO HQ
Wenqing Zhang
5th WPR and SEAR NIC Meeting
7 – 10 June 2011 • Vientiane
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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 HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Update from WHO HQ
 Selected HQ activities related to GISRS
–
–
–
–
Virus surveillance
GISRS coordination
Vaccine support
Epidemiological surveillance strategy
 OEWG/PIP
 IHR/RC
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
GISRS coverage
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
# countries
# countries
with NIC(s)
% population
covered by
GISRS
AFR
46
11
52.90%
EMR
21
12
86.63%
EUR
53
40
93.00%
SEAR
11
8
99.88%
PAH
36
22
96.55%
WPR
28
16
99.93%
Total
195
109*
91.62%
Virus surveillance
laboratory 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Virus surveillance
virus 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Virus surveillance
virus 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
GISRS coordination

Expansion of GISRS
–
–
–

3rd NIC Survey – report published on WHO web and WER
–

–
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
–
–
–

A mini survey on antiviral susceptibility surveillance and sequencing capacity earlier 2010
NIC engagement in global meetings, conferences, events
–

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
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
OEWG/PIP
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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
 3 IGM

Dec 2008 – IGM and OEWG

May 2009 – IGM
 5 OEWG

May 2009 – WHA 62.10

May 2010 – OEWG

May 2010 – WHA 63.1

Dec 2010 – OEWG

Apr 2011 – OEWG

May 2011 – WHA 64.57
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
In 4 years and 4 months:
 4 WHA Resolutions
 1 IDWG
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
Objective
 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.
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
Scope
 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
Virus 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
Virus 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
Virus 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
SMTA 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
SMTA 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
SMTA 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
SMTA 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
SMTA 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Framework
SMTA 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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
IHR Review
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
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.
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
IHR review
(timetable and process)
2010
Jan
First RC meeting
(held in Geneva)
Feb
Mar
Apr
May
Jun
July
2011
Aug
Sept
Oct
Nov
...
Dec
May
 12-14 April
Interim report
provided to WHA
by Director-General
Second RC meeting
Third RC meeting
RC meeting cont.
RC meeting cont.
Fourth RC meeting (2830 March) Preview
document presented
Final report
provided to WHA
by Director-General
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
 mid-May
 30 June -2 July
 27 – 29 September
 3 –5 November
 5-7 January
 end-Mar
 mid-May
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
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Summary

GISRS – new name for GISN
–
–

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
–
–
–

Increasing expectation from MS, together with strong institutional and governmental support
Its value demonstrated and acknowledged through pandemic response
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 • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting
Update from WHO HQ • W. Zhang
7 Jun 2011 • Vientiane • WHO WPR and SEAR NIC Meeting