january 2005 polio eradication initiative nvac meeting february 9-10 2005 polio eradication: global...

January 2005 Polio Eradication Initiative

NVAC MeetingNVAC Meeting February 9-10 2005February 9-10 2005

Polio Eradication: Polio Eradication: Global Progress and Global Progress and

Post-Eradication StrategiesPost-Eradication Strategies

Polio Eradication Initiative

2February 2005

PurposePurposeFor NVAC to:

Be informed and aware of key decisions and progress toward polio eradication.

Support US participation in the global stockpile and response and access to mOPV

Support WHO's efforts to stop the proliferation of wild polioviruses for IPV production and program to assess safety and efficacy of Sabin-IPV

Endorse plans for a NAS meeting on antiviral agents


3February 2005

OverviewOverview

Status of global polio eradication

Post-eradication era: policies, strategies, products


4February 2005

1988

350 000 cases

125 countries

Progress by End 2004Progress by End 2004

2004

1227 cases (as of 02 Feb 05)

6 + 11 countries


5February 2005

Reported Polio Cases'Reported Polio Cases'Comparison of 2002–2004*Comparison of 2002–2004*

0

300

600

900

1200

1500

1800

Asia & Middle East Africa

200220032004

Reported Polio Cases

*Data as of 01 Feb 2005


6February 2005

Impact of 'Intensification', AsiaFocal Transmission in 2004

Pakistan/Afghan India6 NIDs + 8 rounds in high risk areas 6 NIDs + 8 rounds in high risk areas


7February 2005

Challenge: tenacious viral transmission and ‘fatigue’ (public and staff)

Planned response: Use of type 1 monovalent

OPV in Egypt and parts of India by May 2005

‘Underserved’ strategy

Integration with other interventions

Prospects – Asia & EgyptProspects – Asia & Egypt

Protection after 1 dose of mOPV vs. tOPV

(for type 1 polio)

42

81

0

25

50

75

100

tOPV mOPV


8February 2005

Impact of OPV Suspension, NigeriaImpact of OPV Suspension, NigeriaPoliovirus Spread, 2004Poliovirus Spread, 2004

Nigeria 781 cases

Transmission re-established in 5 polio-free

countries

Wild virus type 1

Wild virus type 3

?


9February 2005

SummarySummary

India & Egypt: will intensify activities & add mOPV1 to stop polio during the 2005 low season.

Africa: rapid progress possible, if• NID quality improves & is sustained,• large-scale, synchronized activities continue,• surveillance gaps are addressed.


Post-OPV Cessation Post-OPV Cessation Policies/ProductsPolicies/Products

February 2005


11February 2005

Priority of Post-OPV Cessation Priority of Post-OPV Cessation PlanningPlanning

".. to manage the risk of paralytic disease caused by any polioviruses among current and future generations of children."*

[Elimination of risk not possible!]

*WER 2004;39:349-355.

January 2005


Outbreaks of Circulating Vaccine-Outbreaks of Circulating Vaccine-Derived Polioviruses (cVDPVs)Derived Polioviruses (cVDPVs)

Philippines Philippines 20012001

3 cases3 cases

Hispaniola Hispaniola 20002000

22 cases22 cases

MadagascarMadagascar20022002

4 cases4 cases

ChinaChina20042004

2 cases2 cases

Egypt* 1988-9332 cases

* Based on retrospective analysis of isolates.

January 2005


13February 2005

iVDPV & Long-Term iVDPV & Long-Term Excretion: WHO RegistryExcretion: WHO Registry

24 iVDPVs, including 22 long term excretors

2 currently known to excrete

7 type 1, 16 type 2, 1 type 3

cases have been from: Europe (9), USA (7), Japan (1), Argentina (1), Kuwait (1), Taiwan (1), Iran (1), Ireland/Zimbabwe (1), Thailand (1)

Immunodeficiencies linked to persistent poliovirus infections

cvid

agamma

ab deficient

scid

hypogamma

ICF

MHC-II def

XLA

unknown

January 2005


14February 2005

Risks of Polio After 'Eradication'Risks of Polio After 'Eradication'

VAPP 2-4/million birth cohort 250-500stable

iVDPV 24 identified <1 decreases

(since 1963)

cVDPV 1* per year 10increases

IPV sites 1 accident (1990s) <1 decreases

Lab accident 1 investigation NKdecreases

Deliberate 0 NK unknown

Frequency Annual Evolution Risk to date burden over time

*based on current understanding

After interruption of wild poliovirus,continued use of OPV will compromisethe goal of a polio-free world.

Expert Consultation on Vaccine-derived

Polioviruses (VDPVs), Sept 2003, Geneva

January 2005


15February 2005

Policy DecisionPolicy DecisionCessation of OPV for routine immunization Consensus of September 2003

(endorsed in September 2004) meeting

Risks > benefits in absence of wild poliovirus

Expectation of countries and stakeholders

High opportunity & financial costs of continued OPV.

Timing: must occur while population immunity & surveillance sensitivity (for cVPDV emergence) are high.

January 2005


16February 2005

Prerequisites for Prerequisites for OPV CessationOPV Cessation

Appropriate containment of all polioviruses.

Global surveillance & notification capacity.

mOPV stockpile & response mechanism.

Coordinated cessation of OPV.

'Post OPV' immunization policy in place.

January 2005


17February 2005

Routine Immunization Policy Routine Immunization Policy

Discontinue OPV (as recommended)

Remaining options:– Discontinue all polio vaccination

– Replace OPV with IPV (country, region or globally)

– Develop a new polio vaccine

January 2005


18February 2005

Polio Vaccine Use Worldwide, 2004

IPV only

IPV/OPV

OPV onlyThe boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO 2005. All rights reserved


19February 2005

Current WHO Statement on IPV

Most important considerations:Risk of importation / spread of wild PV

Vaccination coverage (IPV mostly direct effects)

January 2005


20February 2005

Products Pursued Products Pursued & Rationale I& Rationale I

mOPV– Finish eradication in most difficult areas

(anticipate licensure in Spring 2005 for mOPV1)

– Serve as principle stockpile vaccine

Antivirals– Clear chronic excretion among long-term excretors

– Available for post-exposure prophylaxis

– Option for outbreak control (example: pandemic flu)

January 2005


21February 2005

Sabin-IPV– Facilitate containment– Serve as "warm-base" for restart OPV production– Minimize the proliferation of new wild poliovirus

amplification sites– Facilitate the replacement of all wild poliovirus in

vaccine production (longterm objective)– “The AACPE (AdHoc Advisory Committee on Polio

Eradication) is encouraged by the prospect of a potentially effective IPV using Sabin poliovirus strains, and urges acceleration of studies to demonstrate safety and protective efficacy.…” (WER 2004, 79,401-8)

Products Pursued Products Pursued & Rationale II& Rationale II

January 2005


22February 2005

Timelines depend primarily on interruption of wild poliovirus.

Policy directions will be reviewed as new data becomes available.

OPV Cessation StrategyOPV Cessation Strategy

January 2005


23February 2005

Use mOPV for 'outbreaks'

Implement 'BSL3 / polio' for Sabin

Schematic: Risks & TimelinesSchematic: Risks & TimelinesMain Risk

Years after last wpv

Containment

Vaccines

Surveillance

0 1 2 4 53

cVDPV emergenceInadvertant

wpv release

Undetectedwild

polio

iVDPV &/or IPV accident

Implement 'BSL3 / polio' for WPVs'Final' IPV Procure decisions stockpile

Add 'suspectpolio' to IHR

Potential Target Datefor OPV Cessation

'Dangerous pathogen' lab & surveillance practices


24February 2005

Summary/ConclusionsSummary/Conclusions

OPV cessation prerequisite for maintaining eradication, elements:– Poliovirus detection & notification

– Stockpile & emergency response

– Long-term containment

– National immunization policy decisions

Key is to manage the risks (no ‘risk free’ option)

January 2005


25February 2005

PurposePurposeFor NVAC to:

Be informed and aware of key decisions and progress toward polio eradication.

Support US participation in the global stockpile & response and access to mOPV

Support WHO's efforts to stop the proliferation of wild polioviruses for IPV production and program to assess safety and efficacy of Sabin-IPV

Endorse plans for a NAS meeting on antiviral agents


26February 2005

THANK YOU!THANK YOU!


27February 2005

EXTRA Slides-EXTRA Slides-Polio Eradication StatusPolio Eradication Status


28February 2005

Selected Key MilestonesSelected Key MilestonesShort-term (24 months): License monovalent OPV & establish response mechanism. Limit sites of wild poliovirus amplification (incl. IPV sites). Consensus on long-term containment (GAP ed. III). Introduce 'National Guidelines for OPV Cessation'.

Medium term (24-60 months): Align surveillance/diagnostics with that of

dangerous pathogens.

Long-term: Promote use of Sabin strains only for IPV manufacture.

October 2004January 2005


29February 2005

Ongoing WorkOngoing Work

Risks measurement & management iVDPVs: prevalence, re-introduction risk, clearance strategies

(IgG, antivirals) cVDPV: define highest risk areas & potential strategies

(e.g. limited pulses, IPV) IPV sites: define biosecurity 'gains' with Sabin; for new producers Lab stocks: verify survey/inventory process; Stockpiles: size of mOPV stockpiles; role of IPV; restart capacity

(5 year period)

IPV introduction define country expectations re future polio immunization model impact (esp. in terms of cVDPV emergence) determine whether specific conditions warrant a WHO IPV recommendation protective efficacy of Sabin-IPV

January 2005


30February 2005

Potential World Health Assembly Potential World Health Assembly Resolutions (May 2005)Resolutions (May 2005)

1. OPV Cessation: consensus on globally coordinated OPV cessation as key goal of the eradication initiative.

2. Containment (future handling of polioviruses): consensus on need for safe storage at secure biosafety levels for Sabin, vaccine-derived & wild polioviruses after OPV cessation.

3. Outbreak Response (reintroduction of polioviruses): consensus on the need for vaccine stockpile and international controls, & mechanism for responding to polio outbreak should one occur.


31February 2005

Framework for National Framework for National Guidelines Guidelines

for OPV Cessationfor OPV Cessation1. Rationale for OPV Cessation

2. Containment activities for OPV Cessation

3. Surveillance before, during & after OPV Cessation

4. Stopping routine use of OPV

5. Polio vaccine stockpiles & outbreak response

6. Implications of IPV introduction

January 2005


32February 2005

Summary/Conclusions IISummary/Conclusions II

Prevention of wild poliovirus amplification sites of paramount importance

Development of mOPV, antiviral agents, and Sabin-IPV is integral part of post-OPV cessation planning

January 2005


33February 2005

Show me the money….Show me the money….for 2005-2008for 2005-2008

2005 Financial Resource Requirements: $ 615m Contributions (Received/Projected): $ 515m Funding Gap: $ 100m

2006-2008 Financial Resource Requirements: $ 805m Stockpile: $ 250m


34February 2005

Sudan Sudan as of as of 18 Jan 0518 Jan 05

Sudan had 112 cases.Sudan had 112 cases.

Undetected circulation for Undetected circulation for several years.several years.

Four rounds of NIDs planned Four rounds of NIDs planned for the first half of 2005. for the first half of 2005.

Recently negotiated days of Recently negotiated days of tranquility so that all children tranquility so that all children could be reached.could be reached.

Concern about spread to Concern about spread to Ethiopia, Eritrea, Uganda, Ethiopia, Eritrea, Uganda, Kenya and other countries.Kenya and other countries.


35February 2005

Challenge: largest outbreak in recent history. Suspension of activities in Cote d’Ivoire Low population immunity in

affected areas Possible spread to Ethiopia,

DRC and other parts of E. Africa

Response: New WHO/UNICEF team in Nigeria Improved NID quality Improved AFP surveillance Involvement of religious and local leaders

Prospects – AfricaProspects – Africa

Synchronized Synchronized NIDs, 2004-5NIDs, 2004-5


36February 2005

ChallengesChallenges

Funding gap – G8 and new donors

Gaps in quality – both SIAs and surveillance

Security/conflicts – polio ceasefires

Burnout – recognition, incentives, staff support

Political commitment, particularly in India, Pakistan and Egypt


37February 2005

Conclusions and Recommendations Conclusions and Recommendations of the Ad Hoc Advisory Committee on of the Ad Hoc Advisory Committee on

Poliomyelitis Eradication, 21-22 Sept, 2004Poliomyelitis Eradication, 21-22 Sept, 2004

Interrupting WPV transmission– Global program priorities

– Enhancing the impact of SIAs

– Measures to limit the international spread of wild poliovirus

Plans for globally coordinated cessation of use of OPV


38February 2005

OverviewOverview

Overriding priority

Risks of poliovirus infection

Policy decision

Prerequisites

Products pursued & rationale

Summary & conclusions

January 2005

january 2005 polio eradication initiative nvac meeting february 9-10 2005 polio eradication: global...

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