34 polio vaccination policy maher
TRANSCRIPT
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Polio Eradication and Endgame Strategic Plan 2013‐2018
&Implications for immunization policy
Twenty‐first Meeting of the Technical Advisory Group on Vaccine Preventable Diseases
Pan‐American Health OrganizationQuito, Ecuador, 3‐5 July 2013
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Presentation overview
• Current status of eradication• Strategic Plan 2013‐2018 & implications for immunization policy– Sequential removal of OPV (commencing with OPV2) & introduction of a routine dose of IPV
– Recent recommendations by SAGE WG on Polio• Issues surrounding policy changes
– Vaccine use, availability, & uptake– Recent GAVI board decision
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0
250
500
750
1000
1250
2007 2008 2009 2010 2011 2012 2013
Cas
esPolio, type 3 cases globally
The last WPV3 case reported had
onset in November 2012
in Nigeria
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Polio Paralyzed Children, last 6 months
• no type 3 globally
• 50% decline in endemic cases vs 2012
• HoA re‐infected & 50% of global cases
• EGY, ISR +ve sewage
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cVDPV active outbreaks, last 6 months
All recent cVDPV outbreaks are due to Type 2 virus
cVDPV2 (13 cases)
cVDPV1 (0 cases)
cVDPV3 (0 cases)
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Polio Eradication & Endgame Strategic Plan 2013‐2018 &
implications for immunization policy
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Strategic Plan, 2013‐18• Polio detection &
interruption
• Immunization systems &OPV2 withdrawal
• Containment & Certification
• Legacy Planning
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Virus detection & interruption
Last wild polio case
8
Certification
RI strengthening & OPV withdrawal
Containment & certification
Introduce IPV
Wild virus interruption
Outbreak response (esp. cVDPVs)
RI strengthening &OPV2 pre‐requisites
OPV2withdrawal
Legacy Planning
Finalize long‐term containment plans
Complete containment & certification globally
Consultation & strategic plan
Initiate implementation of legacy plan
Last OPV2 useEndgame Major
Objectives 2013 2014 2015 2016 2017 2018
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What is the new endgame approach to immunization policy?
• Sequential cessation of oral Sabin vaccine strains, starting with Sabin type 2.
• Replacing tOPV with bOPV in a synchronized manner globally as the first step in OPV cessation.
• Mitigating risk by including at least one dose of IPV in the routine EPI in addition to bOPV (starting >6 months before switch from tOPV to bOPV).
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Why is removal of Sabin viruses needed, & why start with type 2?
• 'Eradication of polio will not be complete until use of OPV ceases' – SAGE– VAPP – Risk of cVDPV development
• Despite the fact that WPV2 was eradicated in 1999, type 2 is causing polio cases:– 40% of all VAPP– Most cVDPV outbreaks and 85% of all cVDPV cases since 2000
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The highest risk: cVDPV outbreaks, 2000‐2013
Type 2 (572 cases)
Type 1 (79 cases)
Type 3 (11 cases)
14 countries have had
type 2 cVDPV
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What is the rationale for introducing a routine dose of IPV prior to OPV2 cessation?
a) Mitigate the risks of outbreak if VDPV2 or WPV2 is re‐introduced after OPV2 is stoppeda) reduce transmission
b) prevent individual cases of polio
c) provide priming to rapidly improve response to mOPV2 in an outbreak
b) boost immunity to WPV1 & 3
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What will these policy changes achieve?
• proactively address Sabin type 2 burden of paralytic disease (VAPP & cVDPV)
• ensure the gains of eradicating WPV2 forever while still pursuing the eradication of WPV1 & 3
• provide potential additional benefits– accelerate eradication of WPV1 & 3 by boosting type 1 and 3 immunity with bOPV & IPV
– provide lessons for cessation of all Sabin virus at a time when stakes are lower
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SAGE 11/2012: Decision to recommend at least 1 dose of IPV into routine schedules (risk mitigation)
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SAGE Working Group May 2013 draft recommendations on schedule for IPV*:
• 6, 10, 14 weeks or 2, 3, 4 months schedule: add IPV dose at the DPT3 contact;
• 2, 4, 6 months schedule: add IPV dose at the DPT3 contact, though DPT2 can be considered;
• countries with documented VAPP risk < 6 months of age may consider alternative schedules
* for current OPV‐only countries; the WG is not recommending to change existing schedules
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Early vs. later IPV administration
16
IPV at 4‐months: 63% seroconversion, 98% priming
Later dose (>4 mos): no evidence of seroconversion/priming gain
Earlier dose (2 mos): seroconversion falls to 35%; priming <90%
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• Remove the 40% of VAPP due to Sabin type 2
• Reduce type 1 & type 3 VAPP significantly due to IPV‐ In developing countries, up to
80% of VAPP is in children & adults over 6 months of age
Impact on VAPP (250‐500 cases/yr)
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Issues surrounding immunization policy changes
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Prerequisites for OPV2 cessation:
• Validation of persistent cVDPV2 elimination & wild poliovirus type 2 eradication
• Stockpile of mOPV2 and response protocol & capacity
• Surveillance and international notification of Sabin, Sabin‐like and cVDPV type2
• Licensed bOPV available in all OPV‐using countries
• Affordable IPV option for all OPV‐using countries
• Containment phase II for cVDPV2 and wild poliovirus type 2 and phase I for Sabin type 2
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Issue: 125 'OPV‐only' countries
IPV ONLY (47 countries)IPV/OPV (18 countries)OPV ONLY (125 countries)
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0 1,700 3,400850 Kilometers
Issue: DTP3 coverage <80%, 2009‐11
>80% (151 countries or 77%)
< 80% (43 countries or 23%)Not available
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0
10
20
30
40
50
60
70
80
90
100
BCG
DTP1
HBV3
Hib3
PnV3
HBVBDRubella
MCV1
DTP3
MCV2
HPV3Rota2/3
Malaria
IPV
Issue: outpacing historical uptake of new vaccines
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SAGE Working Group:Countries could be
prioritized (tiered) for IPV introduction based on
cVDPV risk
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Tier 1: WPV endemic + cVDPV2 emergenceTier 2: cVDPV1/3 emergence or low DPT3 for 3 yearsTier 3: Low DPT3 for at least one recent yearTier 4: Other OPV only using countries
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SAGE Working Group recommendation:
By Oct 2013: IPV supply, financing & introduction support strategy for each Tier 1 & priority Tier 2 country
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Pipelineproducts(2015‐17)
IPV pricing: Standalone IPV prices/dose
Existingproduct (2012)
Whole‐dose IM Salk IPV
US$2.75
US$1.25
Adjuvanted (1/5th) dose IM Salk IPV
US$1.00
US$0.50
Fractional (1/5th)intradermal IPV dose
US$0.50
US$0.40
NOTE: prices & timelines are best 10‐dose vial estimates at Oct 2012
• Clear policy is essential to accelerate product development and licensure and establish firm pricing
• Volume purchasing could reduce price but unlikely to get much below $1
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GAVI Board Decision (12 June):
• play lead role for IPV intro in 73 GAVI countries
• immediately communicate importance of IPV
• establish finance/supply strategy with GPEI by November 2013
• request donors to ensure financing
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Summary• The Strategic Plan 2013‐18 has implications for immunization policy potentially within the next 3 years– Cessation of OPV2 (tOPV/bOPV switch)– Introduction of a routine dose of IPV in OPV‐only countries
• The intention is to address Sabin type 2 burden of disease (VAPP & cVDPV) & to secure the gains of eradicating WPV2 forever
• IPV introduction as a risk mitigation strategy can be tiered based on risk
• There are still issues that need to be addressed & questions that need to be answered in finalizing policy
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The Americas led the world in eradicating polio…..
Now we must secure the gains for everyone