update on post eradication containment strategy · gap iii strategy: risk elimination, risk...
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Update on post eradication containment strategy
Seventh WHO/UNICEF Consultationwith OPV/IPV Manufacturers and NRAs
30 October 2008
2 Global Polio Eradication Initiative
Overview of GAPIII
– development process
– risk / consequence assessments
– guiding principles
– strategy
– timeline
Overview of Biorisk management standard for essential poliovirus facilities
Risk assessment for OPV stockpile
Topics covered in previous meeting (2007)
3 Global Polio Eradication Initiative
Overview of GAPIII
– development process
– risk / consequence assessments
– guiding principles
– Strategy
– Timeline – Overview of Biorisk management standard for essential poliovirus facilities
Risk assessment for OPV stockpile
Topics for 2008
(update on new developments)
(update on new developments)
(update on new developments)
Plans to update containment requirements for Post Eradication IPV production guidelines
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Purpose: To minimize the post eradication risk of reintroducing wild polioviruses and Sabin strains from the laboratory to the community, at a time when OPV use has stopped.
POLIO ERADICATION CONTAINMENT POLICYGlobal Action Plan, 3rd edition
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After wild poliovirus eradication, polioviruses will still be needed to maintain a polio-free world:
• Vaccine production
• Stockpiles
• Vaccine quality assurance
• Diagnostic reagent production
• Reference
• Research (diagnostics, anti-virals, etc.)
Essential longterm needs for polioviruses
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The 61st WHA requests the Director General:
[for the post eradication era]…to develop appropriate strategies and products for managing risks, including safer processes for IPV production and affordable strategies for its use…
61st World Health Assembly resolution on longterm poliovirus risk management
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Implications for GAPIII:
Formally acknowledges goal of safer and more affordable IPV production
Safeguards revised and re-organized
Timing of safeguard implementation adjusted
61st World Health Assembly resolution on longterm poliovirus risk management
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Global Action Plan to minimize poliovirus risks (GAP III): Updated strategy
Eliminate risk through destruction & prohibition of poliovirus materials except in essential facilities in a minimum number of countries
Manage remaining risk in essential facilities with:
- primary safeguards of containment
- secondary safeguards of immunity
- tertiary safeguards of location
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Post eradication poliovirus facilities
worldwide
POST ERADICATION
OUTBREAK
GAP III Strategy: Risk elimination, Risk management, and OversightOversight
Risk eliminationReduce number of WPV facilities
worldwide (<20 by time of OPV cessation)
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POST ERADICATION
OUTBREAK
GAP III Strategy: Risk elimination, Risk management, and OversightPrimary Safeguards
Post eradication poliovirus facilities
worldwide
Risk eliminationReduce number of WPV facilities
worldwide (<20 by time of OPV cessation)
Manage residual risk
1o safeguards (containment)• Facility design BSL3• Substitute WPVs with Sabin• Immunize personnel• Emergency response
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POST ERADICATION
OUTBREAK
GAP III Strategy: Risk elimination, Risk management, and OversightSecondary Safeguards
2o safeguards (immunity)• National routine
childhood IPV policy • High IPV coverage
1o safeguards (containment)• Facility design BSL3• Substitute WPVs with Sabin• Immunize personnel• Emergency response
Risk eliminationReduce number of WPV facilities
worldwide (<20 by time of OPV cessation)
Manage residual risk
Post eradication poliovirus facilities
worldwide
Post eradication poliovirus facilities
worldwide
2o safeguards (immunity)• National routine
childhood IPV policy • High IPV coverage
POST ERADICATION
OUTBREAK
1o safeguards (containment)• Facility design BSL3• Substitute WPVs with Sabin• Immunize personnel• Emergency response
Risk eliminationReduce number of WPV facilities
worldwide (<20 by time of OPV cessation)
GAP III Strategy: Risk elimination, Risk management, and OversightOversight
3o safeguards (facility location)
WPV facilities in "lowtransmission" areas:
• High standard of hygiene• Closed sewage systems
secondary effluent treatment
Safeguards recognize different level of consequences between WPV and Sabin re-introduction: Wild poliovirus = primary, secondary, and tertiary / Sabin poliovirus = primary & secondary
Reduce consequences
National and International accreditation
33 o for WPVo for WPV
Manage residual risk
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Stockpile risk assessment should be linked to tender process. If conducted now and tender delayed for a long period, risk assessment findings likely to be out of date (change in facilities, procedures, etc.)Tender likely to occur after a major shift in current poliovirus epidemiology (example: global interruption of WPV1 circulation)A major shift in poliovirus epidemiology is proposed as the trigger for conducting OPV stockpile risk assessments
Update on OPV stockpile risk assessmentUpdate on OPV stockpile risk assessment
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Current requirements:– WHO Technical Report Series, no 926, 2004.
"Guidelines for safe production and quality control of inactivated poliomyelitis vaccine manufactured from wild polioviruses"
– TRS926 predates GAPIII and does not address SabinIPV
Plan:– Update WHO TRS926 to align it with GAPIII in 2009– End 2009, submit proposed document for review and
adoption by ECBS at their meeting in 2010
Update on IPV containment guidelinesUpdate on IPV containment guidelines
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GAP III GAP III –– phases phases Phase I
• Survey and inventory of all biomedical facilities with WPV materials• Destruction of unneeded materials
National WPV transmission
stopped
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Polio endemic (n=4)
Polio reinfected (n=7)
Conducting survey (n=14)
Reporting completion of survey & inventory (n=168, 78%)
Not started containment (n=22)
Status of wild poliovirus containment(Phase I survey & inventory per GAPII)
• over 200,000 laboratories surveyed • ~600 facilities with wild poliovirus identified
EUR: PHASE I COMPLETE
AMR: GOAL TO COMPLETE PHASE I IN 2008. BRAZIL IS CHALLENGE
WPR: ONLY CHINA AND JAPAN REMAIN. WILL COMPLETE IN 2008
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GAP III GAP III –– phases phases Phase I
• Survey and inventory of all biomedical facilities with WPV materials• Destruction of unneeded materials
National WPV transmission
stopped
Phase IIMajor change in poliovirus
epidemiology • National policy on post eradication/OPV cessation poliovirus retention
Risk Elimination
Most CountriesMost Countries
Risk Management
Countries with essential facility & Countries with essential facility & specified safeguardsspecified safeguards
1 year w/o polio
reported globally
Phase III Phase III
• WPV retention is prohibited• Plan for OPV cessation
• Primary, secondary, and tertiarysafeguards for all WPV facilities
• Nat'l & Int'l accreditation• Plan for OPV cessation
At the time of global OPV
cessation
Phase IV• Poliovirus retention prohibited
Phase IV• Primary and secondary
safeguards for Sabin facilities• Nat'l & Int'l accreditation
Post VAPP/VDPV elimination: 1st, 2nd, 3rd safeguards for Sabin viruses or switch toalternate strains if available
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THANK YOUTHANK YOU