1 the evolving 'polio endgame' strategy orientation for ieag 15 march 2012
TRANSCRIPT
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The Evolving 'Polio Endgame' Strategy
Orientation for IEAG
15 March 2012
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Background
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Main risks if routine OPV is continued after wild poliovirus eradication
• Cases of Vaccine-Associated Paralytic Poliomyelitis (VAPP): very rare severe adverse event, occurring in OPV recipients or a close contact.
• Outbreaks of circulating vaccine-derived poliovirus (cVDPV): very rare event; > 1 paralytic polio case with isolation of related but non-identical VDPV viruses.
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Other risk: long-term poliovirus excretors(iVDPVs: 1o immunodeficiency-associated VDPVs)
53 iVDPVs (> 6 months excretion)
8 known to excrete >5 years.
Type 2 (34) > Type 1 > Type 3
From: – Industrialized countries (22) – Middle income countries (31)– Low income countries
Immunodeficiencies linked to prolonged poliovirus excretion
cvid
agamma
ab deficient
scid
hypogamma
ICF
MHC-II def
XLA
unknown
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'After interruption of wild poliovirus, continued use of OPV would compromise the goal of a
polio-free world.Expert Consultation on Vaccine-derivedPolioviruses (VDPVs), Sept 2003, Geneva
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Evolution of the 'Post-Eradication' Timeline
0 2 4 6 8 10 12
Years
Wild virus eradication
Global Cert Comm (1995)
Certification
Expert Advisory Meeting (1998)
Certification & containment
Wild virus eradication
Last WPV case OPV cessation
ACPE (2004)VDPV elimination?Wild virus
eradicationCertification & containment
VDPV elimination & validation
Wild virus eradication
World Health Assembly (2008)
Post-OPV surveillance
Certification & containment
The 'Polio Endgame' refers to management of the
'post-eradication' risks due to OPV.
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Why is the world now rethinkingthe Polio Endgame?
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Recent developments allow a major 'rethink' of the polio endgame
• New diagnostics and experience currently suggest type 2 cVDPV is the main 'post-eradication' problem.
• New bivalent vaccine (bOPV) is proven to outperform tOPV for types 1 & 3 and a viable option to replace tOPV.
• New, very low cost 'IPV options' could allow all countries to continue type 2 immunization if they want/need to.
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Current Understanding of cVDPVs (Global)
Circulating Vaccine-Derived Poliovirus Oubreaks (cVDPVs) 2000-2010
Since 2009, 97% of cVDPV cases are due
to type 2
(& 40% of VAPP)
Type 2 (450 cases)
Type 1 (79 cases)
Type 3 (9 cases)
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Spot map of VDPVs 2011-12
Data as on 7 March 2012
YearType 1 Type 2 Type 3
Totala i c a i c a i c
2009 1 1 0 4 0 15 0 0 0 21
2010 0 0 0 2 1 2 0 0 0 5
2011 0 0 0 4 2 0 0 1 0 7
2012 1 1
Total 2 1 0 10 3 17 0 1 0 34
India: 90% of VDPVs are type 2 & 100% of
cVDPVs are type 2
Current Understanding of cVDPVs (India)
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Trend in Type 2 Polio Protection (India)
Moradabad Nov 2007(N=121)
AFP cases UPNov 08 – mid 09 (N =169)
Moradabad May 2009(N=534)
UP & BiharAug 2010(N=1280)
UP & BiharAug 2011(N=1246)
Age 6-7 mos 6-11 mos 6-7 mos 6-7 mos 6-11 mos
Type 2 56% 33.7% 75% 65% 85%
Reduced emergence of type 2 cVDPVs is associated with improving type 2 immunity
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Bivalent OPV Efficacy & Use
79.5
53.2
71
49.1
0
10
20
30
40
50
60
70
80
90
100
bOPV tOPV bOPV tOPV
Seroconversion after 2 x bOPV vs. tOPV, India, 2008-2009
Type 1 Type 3
bivalent OPV use as of Sept 2011
Introduced Dec 09-Aug 11
Planned by end-2011
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Affordable IPV options in the short-term,
Full-dose
$3
$0.6
Current price
(low volume)
< $0.3
IPV price
($ per dose)
** assumes full dose price of < US$1.5/dose at high volume
1/5th of 1 dose of IPV could be very affordable (<$0.5/dose)
1/5th fractional dose
Expected price
(high volume**)
1/5th of 1 dose of IPV can induce a response in >90% of children
0
10
20
30
40
50
60
70
80
90
100
P1 P2 P3
Response* after 1 dose
(%, intradermal IPV, Cuba)
* includes seroconversion & priming
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What are the major elements of the 'New Polio Endgame'?
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New Polio Endgame: Guiding Principles
• phased removal of Sabin viruses, beginning with highest-risk (type 2).
• elimination of VDPV type 2 in parallel with eradication of last wild polioviruses by switching from tOPV to bOPV for routine EPI & campaigns.
• early introduction of at least 1 dose of IPV to boost immunity prior to a tOPV-bOPV switch (& provide type 2 priming if further doses required).
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A new 'Endgame' strategy: parallel instead of sequential risk management
0 2 4 6 8 10 12
Years
Last wild polio case trivalent OPV cessation
VDPV elimination & validation
Wild virus eradication
Sequential risk management
Post-OPV surveillance
Certification & containment
VDPV2 elimination & validation
Post-OPV surveillance
Wild virus eradication
Parallel risk management
Certification & containment
OPV2 cessation& IPV introduction
bivalent OPV 1&3 (bOPV) cessation
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Potential Advantages of the New Approach
• accelerate eradication of type 1 & 3 wild poliovirus by routine use of bOPV (and possibly IPV)
• address >90% of the VDPV risk when global surveillance/response capacity is highest
• substantially shorten the post-eradication phase (& reduce a major source of donor/partner anxiety)
• possibly boost eradication effort with new energy & routine immunization coverage (i.e. if IPV dose at DPT3)
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Potential Disadvantages of the New Approach
• distraction to wild poliovirus eradication efforts (to stop ongoing cVDPV2s; to coordinate tOPV-bOPV switch).
• complications of adding a new vaccine (IPV) (however, GPEI has introduced many new vaccines already).
• sudden 'price shock' for donors as requires early presentation of longer-term financing requirements.
• risk of failure to stop new cVDPV2s (but, with this approach could even 'restart' tOPV temporarily if needed).
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Impact of the new Endgame Strategy on Major Cost Drivers for 2013-2018
'Core costs*' - stable
OPV campaign costs - decrease
IPV costs - additional
* staff & technical assistance, surveillance & lab, research, outbreak response, stockpiles.
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Some Implications for IPV
• IPV could be scaled up much earlier than anticipated (i.e. tOPV-bOPV switch could be prior to April 2014).
• standalone IPV would be used for the 'tOPV-bOPV switch' with hexavalent having a 'post-OPV' role (e.g. from 2017-18).
• a fractional (1/5th dose) intradermal IPV option may be essential for acceptability, cost, supply, manufacturer risk.
• the probability of expanded, longterm IPV use would increase substantially.
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Recent Developments & Next Steps
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• SAGE Nov 2011: recommended endgame strategy be based on phased, not simultaneous, Sabin strain removal.
• WHO Executive Board Jan 2012: requested endgame strategy & timeline for phased Sabin strain removal.
• SAGE Apr 2012: to discuss introduction of 1 dose of IPV at DTP3 contact in all OPV-using countries at least 6 months prior to a global tOPV-bOPV switch (as early as Apr 2014).
• World Health Assembly, May 2012: to consider a resolution on the tOPV-bOPV switch.
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Summary
• a new definition of, and strategy for, the 'endgame' may accelerate eradication & reduce long-term risks.
• depending on IPV price and strategy, the new endgame could be cost-neutral through certification.
• by emphasizing the delivery of 1 IPV dose at the DPT3 contact, the new strategy should help to strengthen the focus & coverage of routine immunization.
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Extra Slides
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Work streams Major Issues (examples)
• Phased vs. simultaneous removal of Sabin viruses
• Geographic extent and schedule for IPV use
Supply & Product Development
Surveillance & containment
Operations & logistics
• Global bOPV availability (i.e. national producers)
• Feasibility of restarting tOPV production from bOPV
• Regulatory issues, supply & price for largescale ID IPV use
• Nature of immune response & duration of priming after 1 IPV dose
• Further characterization of VDPV risks
• Criteria to validate WPV type 2 elimination; cVDPV2 elimination
• Containment requirements for type 2 after tOPV-bOPV switch
• Supplementary surveillance (incl. environmental surveillance)
• Synchronization of tOPV-bOPV switch globally
• Safe handling/destruction of residual stocks
Budget & financing
• Budget implication of IPV introduction
• Multi-year business & financing plan
Research
Policy development