WHO 20 March 2014 Withdrawal of OPV type 2 in India Implementing the Polio Endgame Strategy Meeting of India Expert Advisory Group for Polio Eradication 2013 2014 2015 2016 2017 2018 ID: 554820
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Slide1
Dr Sunil BahlWHO20 March 2014
Withdrawal of OPV type 2 in India Implementing the Polio Endgame Strategy
Meeting of India Expert Advisory Group for Polio EradicationSlide2
2013 2014 2015 2016 2017 2018
Virus
detection & interruption
Target last
wild
polio
case
Certification
RI strengthening
& OPV withdrawal
Containment & certification
Introduce
IPV; withdraw OPV2
Wild virus
interruption
Outbreak response
(esp.
cVDPVs
)
RI strengthening & OPV2 withdrawal preparations
OPV 1 & 3withdrawal preparations
Legacy Planning
Finalize long-term containment plans
Complete containment
& certification globally
Consultation & strategic plan
Initiate implementation of legacy plan
Last OPV2 use
1
Objective
2
3
4
Major Objectives of
Polio
Eradication & Endgame Strategic Plan
2013-2018Slide3
Rationale for OPV type 2 withdrawal (switch from trivalent OPV to bivalent OPV)
Currently, the risks associated with the type 2 component of tOPV outweigh the benefitsSince 1999, type 2 wild poliovirus has not been detectedThe type 2 component of tOPV:
Causes more than 90%
of
vaccine-derived polio viruses (VDPVs)Causes approx. 40% of vaccine-associated paralytic polio (VAPP) casesInterferes with the immune response to poliovirus types 1 and 3 in tOPV
3Slide4
Inactivated Polio Vaccine (IPV) introduction in RI
Bivalent OPV (bOPV) licensure & availability for use in RISurveillance & mOPV2 StockpileContainment of type 2 polioviruses
Verification of elimination of wild poliovirus type 2 (WPV2)
5 Preparedness Criteria for OPV2 withdrawal Slide5
National IPV introduction plan (August 2014) – key elements
Policy decision
Oversight & Coordination mechanism
Vaccine requirement
Vaccine formulations/ availabilityCold chain Capacity building
Advocacy, communication & social mobilizationInjection safety & waste managementAEFI surveillance
Monitoring & evaluationRecording & reportingRoles of stakeholdersAddressing challengesIntroduction timelines Slide6
Percent seropositive
Impact of IPV vs. OPV booster in OPV vaccinated sero-negative children 9 months of age
N=346Slide7
Age: 6-9 months
OPV primed children
Single dose of IPV given at day 0 of study
Blood collected at baseline & 28 days
Percent seropositive
N= 862Slide8
0
10
20
30
40
Day 31
Day 35
Day 42
No Vaccine
bOPV
IPV
No Vaccine
bOPV
IPV
No Vaccine
bOPV
IPV
P1 excretion after day 28 challenge (%)
6-11 months
5-6
yrs
10-11
yrs
N=990
50%
75%
IPV reduced fecal excretion for poliovirus types 1 and 3 between 38.9-74.2% and 52.8-75.7%, respectively, compared to control
After challenge with vaccine viruses, the reduction in fecal excretion was also greater in children who received an additional dose of IPV prior to
challenge,
than children who received an additional dose of bOPV
*
Hamid
Jafari
et al
. Efficacy
of inactivated poliovirus vaccine in
India.
Science 345, 922 (2014);Slide9
*http
://dx.doi.org/10.1016/S0140-6736(14)60934-XSlide10
Study summary
Poliovirus type 2
1
st
dose seroconversion
63%
Priming
98%
1
st dose seroconversion & priming99%
Cumulative two-dose seroconversion
100%
Single full dose IPV in OPV naive 4-month old infants sero-converts 63% and primes 98% infants against type 2.
N= 310Slide11
VAPP number
Year
In 1992,
single-dose
IPV at 3 months
In 2006,
IPV-only
scheduleSlide12
Early versus later IPV administration
12
Baseline (4-month IPV dose)
:
63% seroconversion, 98% priming; 99% seroconversion & primingLater administration (potential gains):?seroconversion (>63%), ?priming (>98%)Earlier administration (potential losses):seroconversion decreased (32-39% vs 63%)
2-dose IPV studies suggest priming also lower by early IPV(<90% seroconversion)Slide13
NTAGI recommendations (June 2014)Introduction of IPV under routine immunization in 2015
Single, full dose of IPV at DPT3/OPV3 contact (14 weeks of age or later)IPV dose in addition to OPVDecision consistent with SAGE recommendations for IPV use
Nationwide introduction of single dose of IPV in RI in October 2015
Introduction
of IPV
– Policy decisionSlide14
Introduction of IPV : Oversight & Coordination MechanismSlide15
Target population: 27 million (birth cohort)Annual vaccine requirement for 1st year: Birth cohort + wastage + buffer = ~40 million doses
Cost: 10 dose vial: 1 USD/dose5 dose vial: 1.9 USD/dose1st year requirement of IPV to be supported by GAVI Alliance
Introduction of IPV -
V
accine requirementSlide16
Vaccine formulations: Single dose, 5 dose & 10 doses formulationsFormulations currently licensed in India: pre-filled single dose, single dose vials, 10 dose vials
5 dose vials under consideration for licensureOpen vial policy to be applicable A mix of different formulations may have to be used during 1st year considering the large requirement and limited availability of different formulations
Introduction of IPV: Vaccine formulations/availabilitySlide17
National cold chain assessment carried out in 2014-15Additional cold chain space required to manage IPV at state, district and sub-district levels worked out Cold chain capacity being increased at national/state/ district/ sub-district stores to meet the requirements
Bulk space of central and state stores being increased & procurement of deep freezers, ILRs, solar direct drives for district/sub-district vaccine storage points underwayNational Cold chain and vaccine management plan developed and being implemented to improve vaccine managementIntroduction and scale-up of pentavalent vaccine in states freeing up cold chain space
Introduction of IPV: Cold chain availabilitySlide18
Training modules under developmentOne day operational/communication training for ANMs/ASHAsIndependent monitoring of quality and completeness of trainings
Introduction of IPV: Capacity
building of health staffSlide19
Communication strategy for IPV introduction developedAdvocacy efforts with various stakeholders an integral part of the strategy
Sensitization of medical professionals through Indian Medical Association & Indian Academy of Pediatrics has begunSocial Mobilization Network for polio to be engaged for mobilization of communities in UP, Bihar and West BengalMedia sensitization plan being developed
Introduction of IPV: Advocacy
, communication & mobilizationSlide20
Injection safety protocols as per RI guidelinesInjection safety to be part of the training module being developed for health workersWaste management
as per “Biomedical waste management & handling rules”
Introduction of IPV: Injection
safety and waste managementSlide21
Revised national guidelines on AEFI surveillance & causality assessment finalizedCapacity building of national and state committees on causality assessments planned
District level trainings planned to ensure systematic reporting & investigation of all AEFI casesCapacity building of state spokespersons to handle media queries an integral part of planIntroduction of IPV: Strengthening AEFI surveillanceSlide22
Standardized checklists for new vaccine introduction to be used for assessment of preparedness in all districts/states National and state observers/partners to be involved with monitoring
progress of activitiesState and District Task forces to ensure preparedness & implementation at state and district levels is per timelines and protocolNational level monitoring by Vaccine Introduction Working Group
Introduction of IPV: Monitoring
&
evaluationSlide23
Recording & reporting tools being modifiedMother & Child Protection card revised to include IPVReporting formats and Health Management Information System (HMIS) being modified to capture data on IPV
Introduction of IPV: Recording & reportingSlide24
Introduction of IPV: Role
of partner agenciesWHO
Evidence for policy
Planning & Operational support
Capacity buildingMonitoring preparedness & implementationUNICEF & other SM Net Partners
Communication strategy development
Communication & media, social mobilization & capacity developmentCold chain supportMonitoringROTARYAdvocacyIEC activitiesOperational supportOTHERS
Engaging state & local bodies for information dissemination & advocacyEngaging IMA/IAP particularly in private sectorSlide25
Introduction of IPV - Addressing key challengesSlide26
NTAGI approval
Plan development
Advocacy/Communication
Preparedness assessment
National Orientation followed by cascade to state/district/block training
IPV LAUNCH
2014
2015
IPV introduction timeline, India
Oversight by VIWG/state & district task force
IPV supply
Monthly state & district task force meetings
IPV licensure & procurementSlide27
Inactivated Polio Vaccine (IPV) introduction in RI
Bivalent oral polio vaccine (bOPV) licensure & availability for use in RISurveillance & StockpileContainment of type 2 polioviruses
Verification of elimination of wild poliovirus type 2 (WPV2)
5 Preparedness Criteria for OPV2 withdrawal Slide28
Licensure of bOPV for use in routine immunization under processEPI vaccine trial conducted : 5
arm study to assess efficacy of bOPV vs tOPV (with or without IPV) when given in EPI scheduleTrial report submitted by manufacturer to DCGITimeline for procurement of bOPV being worked out considering procurement lead timetOPV procurement and supply to be adjusted to ensure no stock-outs prior to switch from tOPV to bOPV
& minimal surplus stocks post-switch
Criteria 2:
bOPV licensure and availability for use in RI Slide29
Arm
Sample size:
180 subject
in each arm
A B
C
D EPoliovirus typetOPVtOPV+IPV at 14 wkbOPVbOPV
+ IPV at 14 wkbOPV+ IPV at 14 & 18 wkType 1 %99.499.498.8
99.4
99.4Type 2 %98.299.423.878
83
Type 3 %91.699.498.899.498.8
An additional dose of IPV in arm E at
wk
18 significantly boosted the immunity against poliovirus type 2 (to 97% at wk 19), exhibiting the priming effect of the first IPV doseIndia EPI polio vaccine trial:Seroprevalence after OPV doses given at birth and 6,10 & 14 wk
Study conducted in Pune, Hyderabad, Visakhapatnam, 2013-14Slide30
Inactivated Polio Vaccine (IPV) introduction in RI
Bivalent oral polio vaccine (bOPV) licensure & availability for use in RISurveillance & mOPV2 StockpileContainment of type 2 polioviruses
Verification of elimination of wild poliovirus type 2 (WPV2)
5 Preparedness Criteria for OPV2 withdrawal Slide31
Essential to maintain sensitive AFP surveillance system to ensure timely detection of WPV, VDPV and sabin viruses
Targeted expansion of environmental surveillance to supplement AFP surveillanceGlobal mOPV2 stockpileMaintain preparedness for type 2 outbreakImmediate type 2 notificationOutbreak response as per global guidelines
Criteria 3:
Surveillance and Stockpile
Additional sites
in Mumbai
Hyderabad
Existing environmental
surveillance sites
Expansion plans
in
2015Slide32
Inactivated Polio Vaccine (IPV) introduction in RI
Bivalent oral polio vaccine (bOPV) availability for use in RISurveillance & mOPV2 StockpileContainment of type 2 polioviruses
Verification of elimination of wild poliovirus type 2 (WPV2)
5 Preparedness Criteria for OPV2 withdrawal Slide33
Phase I: Preparation for containment of poliovirus type 2National laboratory survey and poliovirus type 2 inventory; Destruction of unneeded poliovirus type 2
materials in non-essential facilities; Transfer of needed poliovirus type 2 materials to essential facilities; Designated essential facilities obtain certification for containmentPhase IIa: Containment of wild poliovirus type 2 (WPV2) All WPV2 are contained in essential facilities that have been certified in Phase I
Phase
IIb: Containment of OPV/Sabin type 2 polioviruses All OPV2/Sabin2 are contained in essential facilities that have been certified in Phase I. Criteria 4: Containment of type 2 polioviruses
National Task Force for laboratory containment lead by ICMR Slide34
Inactivated Polio Vaccine (IPV) introduction in RI
Bivalent oral polio vaccine (bOPV) licensure & availability for use in RISurveillance & mOPV2 StockpileContainment of type 2 polioviruses
Verification of elimination of wild poliovirus type 2 (WPV2)
5 Preparedness Criteria for OPV2 withdrawal Slide35
Last wild poliovirus
type 2 case,
India
WPV2
24/10/1999
Aligarh (UP)
Criteria 5: Verification of elimination of WPV2Slide36
PLAN
Establish management structure, National Switch Validation Committee (NSVC)
Develop National Switch Plan
PREPARE
tOPV inventory, adjust delivery
Secure funding, monitoring plan
2015
2016
Key components of
tOPV to bOPV switch planPREPAREAdjust tOPV ordersOrder bOPV
PREPARELast tOPV deliveryLaunch communication strategy
PREPARELast tOPV delivery to peripherySwitch monitors identifiedIMPLEMENTTrain monitorsTrain health staffDistribute bOPVSWITCH PERIODVALIDATEtOPV disposalValidation by switch monitorsReport to NSVC
Validation by NSVC
World Health Assembly
SAGEConfirmation of switch datesSlide37
Addressing challengesSlide38
Introducing IPV in RI 6 mths prior to switch
Conducting 2 NIDs with tOPV in qtr 1, 2016Improving routine immunization coverage through system strengtheningCatch- up campaigns (Mission Indradhanush)
Addressing challenges: Achieving high type 2 immunity prior to tOPV to
bOPV
switch
Moradabad
UP2007
AFP cases UP2008–09Moradabad UP2009
UP & Bihar
2010UP & Bihar
2011
UP &Bihar2012
Bihar, MP & Mumbai 2014
Age
6-7 mo
6-11
mo
6-7
mo
6-7 mo
6-7 mo
6-7
mo6-7
mo
Type 1
78%
96.5%
99%
98%
98.5%
95.2%
97.3%
Type 2
56%
33.7%
75%
65%
85%
88.3%
97.9%
Type 3
69%
42.6%
49%
77%
88.2%
81.8%
86.9%Slide39
Periodic Sero-surveys
: To assess the seroprevalence to poliovirus serotypes Mucosal immunity study: To assess level of mucosal immunity against all three poliovirus types in the adolescents and adult age groups
mOPV1/IPV EPI polio vaccine study:
To assess immunogenicity and safety of mOPV1/IPV when given in EPI schedule
Proposed research studiesSlide40
Is the national preparedness plan for IPV introduction appropriate and adequate?
Is preparedness for type 2 withdrawal on track in India?
Does the IEAG agree with the proposed research studies? Slide41Slide42
Backup slides researchSlide43
Findings of recent studies on IPVOne dose of IPV provides significantly high humoral immunity in OPV primed children, especially against
type 2 (Côte d'Ivoire study and Moradabad IPV study, India, 2009)Single dose of IPV given in OPV primed children boosts mucosal immunity in all age groups (Moradabad mucosal immunity study 2011)One dose of IPV provides excellent immunity base (sero-conversion and priming) (Cuba study 2010)Slide44
IPV Study Moradabad (2009)
IPV (IM) GSK
IPV (IM) Panacea
Single dose of IPV given in OPV primed children, closes humoral immunity gap, especially for type 2Slide45
Single dose of IPV given in OPV primed children, substantially boosts mucosal immunity in all age groups (6-11 months, 5 and 10 years) – effect larger than with a dose of bOPV
Mucosal immunity study Moradabad-2011
Day 3
Day 7
Day 14
Proportion of subjects excreting P1 after bOPV challengeSlide46
Cuba study 2010
One dose of IPV provides excellent immunity base against all three serotypes (nearly 100% seroconversion or priming for all serotypes)Slide47
Summary of existing information on poliovirus immunity 3 to 4 tOPV doses (SIAs plus RI) provide high immunity against type 2
bOPV provides better protection for type 1 and type 3 than an equivalent number of tOPV dosesOne dose of IPV provides effective boost to humoral and mucosal immunity to all 3 types in OPV immunized children One dose of IPV provides immunologic priming in > 95% children against all 3 serotypesSlide48
P1
P2
P3
Excretion of poliovirus at day 7 (week 19)
after tOPV challenge at week 18 in arms A,B & D
Inference:Good mucosal response for type 1 & type 3 across all three arms
Poor mucosal response against type 2 for children receiving bOPV7 days after challenge28 days after challengeSlide49
VAPP number
Year
In 1992,
single-dose
IPV at 3 months
In 2006,
IPV-only
schedule