The switch from trivalent to bivalent oral polio vaccine - PowerPoint Presentation

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The switch from trivalent to bivalent oral polio vaccinePlanning and Implementation

July 2015

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ContentsPolio Endgame Objective 2Rationale for switching from tOPV to bOPVDates and timelines around the SwitchGuidance for implementation:PlanPrepareImplementValidate2Slide3

Objectives of the Polio Eradication & Endgame Strategic Plan 2013-20183Slide4

4Objective 2 of the plan addresses the Endgame through three distinct stages

Before end

2015

2016

2019-2020

Ongoing STRENGTHENING of routine immunization servicesSlide5

tOPV

b

OPV

5Slide6

Rationale for switching from trivalent OPV to bivalent OPV Currently, the risks associated with the type 2 component of tOPV outweigh the benefits

Since 1999, naturally occurring type 2 wild poliovirus has not been detectedThe

type 2 component of tOPV:

Causes more than 90% of vaccine-derived polio viruses (VDPVs)Causes

up to approx. 30

%

of

vaccine-associated paralytic polio (VAPP) cases

Inte

rferes

with immune response to

poliovirus types

1 and

3 in tOPV

6Slide7

Type 2 component of tOPV is responsible for >97% of all circulating vaccine derived poliovirus (cVDPV)

in recent years

*as of 10 June 2015; case count will be updated regularly

(current numbers: http

://

www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

)

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Key dates around the switch8May 2015

World Health Assembly endorsement of the process and tentative timelinesSeptember

2015National Switch Plans finalized

October 2015Strategic Advisory Group of Experts (SAGE) will assess the epidemiology of persistent type 2 cVDPVs

and confirm the switch date

December 2015

*

At least 1 dose of IPV introduced

into routine immunization programmes in all countries

April 2016

The Switch:

replace

tOPV with bOPV

globally.

tOPV

should no longer be used anywhere in the world in routine immunization or SIAs.

May

2016

All

tOPV

should be disposed of as soon as possible after the switch. All countries should have validated the completion of the switch by 15 May.

*

Some countries

at relatively low risk of polio outbreaks may not introduce

IPV until

2016 due to supply constraints

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Global synchronization and planningAll 156 OPV-using countries and territories must switch within a 2-week switch window (from 17 April to 1 May)Globally synchronizing the switch

reduces the risk of re-emergence of type 2 cVDPV re-emergence or outbreaks from the use of tOPV

Implications for tOPV supply planning:

tOPV stocks needed for national routine immunization only until April 2016

Countries should coordinate with their relevant supplier to plan around the switch

The last in-country distribution of tOPV should take place

4 weeks before

the switch

date

Important to avoid tOPV

stock-outs in the weeks

before the

switch

Countries

should immediately enhance stock

monitoring and management

capacity

Implications

for

bOPV

:

3-6 months of supplies of

bOPV

should be planned for and received in countries from

January 2016 onwards

New

bOPV

stocks

should be kept

at central

level, stored separately until distribution

Supply may be distributed

to vaccination

points

starting 2 weeks

before the

national switch date

Countries should not switch before the global switch window!

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National Switch DayCountries will select one day during the 2-week switch window as their National Switch Day. On this day, countries will:Remove

and dispose of tOPVBegin use of

bOPV

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National

Validation

Day

2 weeks after

the National Switch Day, countries will

schedule a National Validation Day

. All tOPV must be withdrawn by this date

All

tOPV

must be fully disposed of as soon as possible after the switch daySlide11

Proposed* Switch Window and Validation11

*Exact dates of the Switch Window will be confirmed by SAGE in October 2015

The collection of tOPV from the cold chain must be validated by this dateSlide12

Example of switch dates in a country12

All tOPV

must

be withdrawn from the cold chain and validation completed by this date

Two week window for independent monitoring

Stop use of tOPV and remove from cold chain. Begin use of bOPV on the same daySlide13

Components of a successful switch13

Site

Visits

Monitoring

Process Monitoring

Reporting

Timing

Storage

Collection of

tOPV

Site

selection

Disposal methods

Procurement

Cold chain

plan

bOPV

supply

Training

&

C

omms

Stock inventories

Procurement

Smaller

deliveries

tOPV

supply

Validation

Monitoring

Reducing excess while avoiding stock-outs

Minimizing time that tOPV & bOPV are in cold chain together

Ensuring tOPV is not used after the Switch

Making sure milestones are met

Ensuring national withdrawal of tOPV

Waste

Mgmt

Safely disposing of all tOPVSlide14

Shared responsibilities  a successful switch

Global/Regional

Support Supply

Validation Motivation & discussion Ensuring global supply

Global

tOPV

withdrawal

Scientific guidance Regulatory

Communications

Technical and financial support

Country Effort

Planning

Preparation

Validation

Oversight committees Supply management

Recall from service

Budget

bOPV

licensing

Disposal

National Plan

Waste

mgmt

Supply Training

Monitoring Communications

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Establish management structureEstablish National Switch Validation Committee

Conduct situational analysis

Conduct first tOPV inventory to inform forecasting and procurement planning

Draft national switch plan and communications plan (finalize by end of Sept 2015)

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Proper planning will help ensure:Successful recall of tOPV & introduction of bOPV in April 2016Minimize tOPV wastage after the switch

Continuity of vaccination (

i.e., avoidance of tOPV stockouts before the switch and bOPV stockouts

after the switch)Validation that country is free of tOPV

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National Switch Plans should

be finalized and approved by the ICC by

end September

,

2015Slide17

Management and Operational Oversight17Slide18

National and Regional Switch CommitteesPRIOR TO SWITCH:National and Regional Switch Management Committees Plan, manage, and oversee the implementation of the switch activitiesInteragency coordination committee (ICC) or a similar body - can be modelled after campaign management

Oversee Switch Support Teams who help execute recall and destruction

AFTER THE SWITCH DAY: National Switch

Validation Committee: Independent body authorized to validate the switch

Oversees

Switch Monitors

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Switch Support Teams and Switch MonitorsPRIOR TO SWITCH:Switch support teams Individuals hired or delegated by the national authorities to carry out preparatory and implementation activities related to the switch except validation AFTER THE SWITCH DAY:

Independent switch monitors Individuals hired to validate

the withdrawal of tOPV Should be independent from the switch planning and preparation process

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Situational AnalysisLicensingOPV supply & distributionWaste managementCommunications and training needs

Experience with previous recallsResources

Management and operational oversight

Budget

Work plans and timelines

Supply and distribution

Logistics

Monitoring

Training and communication

National Switch Plan

by end of Sept 2015

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Update tOPV procurement plan and inventoryPlan bOPV procurement and distributionEstablish support mechanisms

Secure budget

Set up switch support teamsFinalize communications plan, develop training materials and conduct briefings

of key stakeholders

Manage logistics (cold chain capacity assessment, waste disposal strategy)

Develop

a monitoring framework

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bOPV procurement and distributionTo minimize the time that both bOPV and tOPV have to be in the cold chain together:Plan for bOPV to be delivered 2-3 months prior to the switchDistribute bOPV to the periphery two weeks prior to the switch

Remove all tOPV from the cold chain at all levels on switch daySelf-procuring countries may need to conduct additional activities when developing their procurement plans, tenders and contracts with suppliers.

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Waste managementNational planners should develop and communicate a tOPV collection and disposal plan for the countryDisposal plans should be in accordance with national legislation and existing regulations, where applicable. If national legislation does not provide clear guidance, the following methods, in order of priority, are considered safe.

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Co-Incineration

Encapsulation

Protected Sanitary Landfill disposal

Functional incinerator sites that are large enough (i.e. hospital or industrial sized) and able to treat health care waste by operating at temperatures between 900 and 1200°C

Available landfills or pits where hard containers (such as metal drums) in which vials have been encased in immobilizing materials (e.g. cement, bituminous sand, or clay) can be disposed of safely.

Accessible landfill sites that are fenced off and inaccessible to the public and free of visible illegal recycling activities

Preferred for both rural and urban areas

For rural areas only

For rural areas onlySlide25

Communications and Training

General objectives:

Build understanding and awareness of the switch among key stakeholders

Support accurate and consistent messaging

Support switch implementation, e.g. training health workers and logisticians

Be ready to manage any communications risks associated with the switch

A range of generic materials are available for adaption and use:

Overall national communications planning guide

Issues management and media kit

Stakeholder engagement

Training materials for health workers and logisticians

FAQs and messaging documents

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Communications PreparationsA strategic communications and advocacy plan should address:Identification of key audiences and stakeholders Channels and timelines

for information dissemination, e.g. orientation briefings Development of materials from existing global and regional tools (FAQs, fact sheets, training materials, etc.)

Technical briefings, to take place with health staff, partners, private sector and other groups involved or affected by the switch An issues

management plan should be developed and on stand by if neededProactive communication to caregivers/communities may not be

recommended depending on local considerations.

As the

OPV switch is a key technical component of the larger Polio Endgame

Plan, there is an opportunity to frame communications

within the broader context of polio eradication and strengthening routine immunization, rather than a standalone activity.

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Process MonitoringNational Switch Management Committees (or ICC) will monitor switch planning and implementation and report to the WHO and UNICEF country offices on selected, agreed upon indicators and milestones:

Potential Indicators/Key milestones

National plan completed

Budget

determined

OPV procurement

plan completed

tOPV inventories completed

Waste management plan

Vaccine delivered

Training completed

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Reporting

Monthly until Feb 2016

Weekly from March 2016 Slide28

Train switch monitorsTrain health workers and logisticians

Organize communications and media events

Distribute bOPV to all peripheral levels

Collect and dispose

of

tOPV

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Training of Health WorkersEmphasize practical implications of the switch:Technical rationale for the switchWhen to start using bOPV and stop using tOPV (National Switch Day)

How to make best use of storage capacity in the weeks prior to the switch when both

tOPV and bOPV will be in the cold chain togetherStrategies to ensure bOPV

is not used prior to the switch and tOPV is not used after the switch

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bOPV – tOPV exchange To avoid stockouts around the switch, for a two-week period prior to National Switch Day, both bOPV and tOPV will be stored together at the district level cold stores

Short-term in nature, thus expansion of equipment likely unnecessarytOPV

should be clearly marked and stored separately within the cold storage to reduce confusionA direct exchange is preferable, in order to avoid presence of tOPV in health facilities after the Switch DaySome countries

may consider “prepositioning” bOPV at health facilities through routine deliveries prior to the Switch (e.g. for remote facilities with difficult access)

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The Switch at the last mile: 3 scenarios 31

“Push” Exchange: District delivers bOPV to Facilities

and picks up tOPV simultaneously

“Pull” Exchange: Facilities collect bOPV from district and surrender tOPV

Preposition

: Deliver bOPV to Health

Facilities

just before Switch day

Requires additional funding and logistical manpower at District level at time of Switch

All HF receive

their

bOPV

uniformly on

time,

tOPV

is removed from

all facilities and disposed of at District level (or higher)

tOPV is removed from HF as they collect bOPV, disposed at

D

istrict level (or higher)

Less resource-intensive for District than Push model

Reminders for HF staff to come on given day

A

bility to reimburse HF for transportation costs

Relies on HF transport and time to do exchange

May

require additional funds for “mop up” activities

by District

Can work for remote HF that would unlikely be able to be accessed on Switch day

Usual model used for new vaccine intros; more familiar

Reminders to ensure that HCW remove tOPV from cold chain on Switch day

Organize collection of tOPV from HF in following 2 weeks

1

2

3

Benefits

Logistical implicationsSlide32

tOPV recall and disposalOn Switch Day, countries will:Immediately remove all opened and unopened tOPV vials from the cold chain at all levelsPlace

tOPV vials in a bag or container and label it as

wasteSend to disposal facility, or set aside for collection, as instructed by the switch committee

Countries should not keep recalled tOPV in the cold chain.

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Date withdrawn from cold chain:_______

Quantity in doses: ___________________Slide33

Switch monitors to validate at selected sitesReport to National Switch Validation Committee

NSVC reviews data and

validates the s

witch

PLAN

PREPARE

IMPLEMENT

VALIDATE

(during 2 weeks post

Switch Day)

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Validating the SwitchFor 2 weeks after the Switch Day, independent Switch Monitors will visit a sample of service points and storage facilities within the country to confirm facilities are free of tOPV.

Selection strategy:

Criteria depends on risk status of country as determined by GPEI

Indicator: Absence of tOPV in selected storage and service facilitiesReporting:

to the National Switch Validation Committee (NSVC) within

2 weeks of the

Switch (i.e. by the National Validation Day)

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Risk-based Purposive Sampling

Sweep denotes intensified monitoring of all other health facilities with involvement of staff from the regional level or higher

Select

10

%

Prioritize facilities such as

Highest population or tOPV doses

receiving

tOPV just before

switch

suspected non-compliance

coverage<80%

Stop & report to National Validation Committee

For

HEALTHCARE facilities

, sample a selected number to independently monitor

tOPV vial (opened

or unopened)

in

cold chain

Select

additional

5% of high risk facilities in same district

Sweep*

entire district

tOPV vial

(opened or unopened)

in

cold chain

No

Yes

No

Yes

REPORT validation to WHO

Stop & report to National Validation Committee

Facilities

down to

District level

Independently monitor ALL

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National Validation36For more information on the validation process and timelines, please

see the Independent Monitoring Guide

During the two weeks after the National Switch Day, the

National Switch Validation Committee (NSVC) must collate and analyze the validation data collected by the Switch Monitors.

The National Switch Management Committee should be notified as soon as possible of any failures to withdraw

tOPV

found by switch monitors so corrective action can be taken

Once the NSVC concludes that

tOPV

has been successfully withdrawn from the country, it should report the switch’s validation to the country’s government

Additional monitoring needed more than two weeks following the national switch day can be conducted by National Immunization Program supervisors and other staffSlide37

Planning:Switch Guidelines National Switch Plan Template (and walk-through guide)Chronogram with timeline of activitiesSwitch budget templateLogistics guideIndependent monitoring guide and job aid Communications and training:

Communications planning guide

Issues management and media kitStakeholder engagement guide

Training materials for health workers and logisticians

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Materials available to support planning and implementation of the Switch

All materials available online:

who.int/immunization/diseases/poliomyelitis/endgame_objective2/en

/