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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
Polio Eradication Initiative
3February 2005
OverviewOverview
Status of global polio eradication
Post-eradication era: policies, strategies, products
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
?
Polio Eradication Initiative
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.
January 2005 Polio Eradication Initiative
Post-OPV Cessation Post-OPV Cessation Policies/ProductsPolicies/Products
February 2005
Polio Eradication Initiative
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
January 2005 Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
27February 2005
EXTRA Slides-EXTRA Slides-Polio Eradication StatusPolio Eradication Status
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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.
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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.
Polio Eradication Initiative
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
Polio Eradication Initiative
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
Polio Eradication Initiative
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
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