update on post eradication containment strategy · gap iii strategy: risk elimination, risk...

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)


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)



Plans to update containment requirements for Post Eradication IPV production guidelines


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


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


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


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


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


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)


POST ERADICATION

OUTBREAK

GAP III Strategy: Risk elimination, Risk management, and OversightPrimary Safeguards


worldwide



Manage residual risk

1o safeguards (containment)• Facility design BSL3• Substitute WPVs with Sabin• Immunize personnel• Emergency response


POST ERADICATION

OUTBREAK

GAP III Strategy: Risk elimination, Risk management, and OversightSecondary Safeguards

2o safeguards (immunity)• National routine

childhood IPV policy • High IPV coverage






worldwide


worldwide

2o safeguards (immunity)• National routine

childhood IPV policy • High IPV coverage

POST ERADICATION

OUTBREAK




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



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


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


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


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


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


THANK YOUTHANK YOU

update on post eradication containment strategy · gap iii strategy: risk elimination, risk...

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