The switch from
trivalent to bivalent
oral polio vaccine
Planning and
Implementation
July 2015
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Contents
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Polio Endgame Objective 2
Rationale for switching from tOPV to bOPV
Dates and timelines around the Switch
Guidance for implementation:
– Plan
– Prepare
– Implement
– Validate
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Objectives of the Polio Eradication &
Endgame Strategic Plan 2013-2018
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• Detect and interrupt all poliovirus
transmission
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• Strengthen immunization systems,
introduce inactivated polio vaccine (IPV)
and withdraw oral polio vaccines (OPV)
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• Contain poliovirus and certify
interruption of transmission
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• Plan polio’s legacy
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Objective 2 of the plan addresses the
Endgame through three distinct stages
2019-2020
2016
Withdraw
Switch
Before end
2015
• bOPV & routine OPV use
• tOPV to bOPV
Introduce
• at least one dose of IPV into
routine immunization
Ongoing STRENGTHENING of routine immunization services
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tOPV
bOPV
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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
detected
• The 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
– Interferes with immune response to poliovirus types 1 and 3 in tOPV
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Type 2 component of tOPV is responsible for >97% of
all circulating vaccine derived poliovirus (cVDPV)
in recent years
200
180
160
140
120
cVDPV1
100
cVDPV2
cVDPV3
80
60
40
20
0
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
*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 switch
May 2015
World Health Assembly endorsement of the process
and tentative timelines
September 2015
National Switch Plans finalized
October 2015
Strategic 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 planning
All 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 Day
Countries will select one day during the 2-week switch window
as their National Switch Day.
On this day, countries will:
• Remove and dispose of tOPV
• Begin use of bOPV
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 day
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Proposed* Switch Window and Validation
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April 2016
Proposed Switch Window: April 17th – May 1st
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Countries select a National Switch Day within this 2-week period. All use of tOPV will stop on this date.
May 2016
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Two weeks after the National Switch Day, countries will schedule a National Validation Day.
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The collection
tOPVmust
frombe
the
cold chain
bedate.
validated by this date
AlloftOPV
disposed
of must
by this
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*Exact dates of the Switch Window will be confirmed by SAGE in October 2015
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Example of switch dates in a country
Stop use of tOPV and remove from cold chain.
Begin use of bOPV on the same day
Two week window for independent monitoring
All tOPV must be withdrawn from the cold chain and
validation completed by this date
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Components of a successful switch
Reducing
excess while
avoiding
stock-outs
tOPV
supply
- Stock
inventories
- Procurement
- Smaller
deliveries
Minimizing
time that
tOPV &
bOPV are in
cold chain
together
bOPV
supply
- Procurement
- Cold chain
plan
Safely
disposing of
all tOPV
Waste Mgmt
- Site selection
- Disposal
methods
Ensuring
tOPV is not
used after
the Switch
Training
&
Comms
- Timing
- Storage
- Collection of
tOPV
Making sure
milestones
are met
Ensuring
national
withdrawal
of tOPV
Monitoring
Validation
- Process
Monitoring
- Reporting
- Site Visits
- Monitoring
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Shared responsibilities  a successful switch
Global/Regional
Support
Supply
Motivation & discussion Ensuring global supply
Scientific guidance
Regulatory
Communications
Technical and financial support
Validation
Global tOPV withdrawal
Country Effort
Planning
Oversight committees
Budget
National Plan
Supply
Monitoring
Preparation
Supply management
bOPV licensing
Waste mgmt
Training
Communications
Validation
Recall from service
Disposal
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PLAN
PREPARE
IMPLEMENT
VALIDATE
(by end of September
2015)
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Establish management structure
Establish 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 2016
 Minimize 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
National Switch Plans should be finalized and approved by
the ICC by end September, 2015
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Management and Operational Oversight
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National and Regional Switch Committees
PRIOR TO SWITCH:
National and Regional Switch Management Committees
• Plan, manage, and oversee the implementation of the switch
activities
• Interagency 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 Monitors
PRIOR 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 Analysis
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•
•
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Licensing
OPV supply & distribution
Waste management
Communications and
training needs
• Experience with previous
recalls
• Resources
National Switch Plan
by end of Sept 2015
• Management and operational
oversight
• Budget
• Work plans and timelines
• Supply and distribution
• Logistics
• Monitoring
• Training and communication
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PLAN
PREPARE
(Q3
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


IMPLEMENT
VALIDATE
2015-Q1 2016)
Update tOPV procurement plan and inventory
Plan bOPV procurement and distribution
Establish support mechanisms
 Secure budget
 Set up switch support teams
 Finalize 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 distribution
To 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 switch
 Distribute bOPV to the periphery two weeks prior to the switch
 Remove all tOPV from the cold chain at all levels on switch day
Self-procuring countries may need to conduct additional
activities when developing their procurement plans,
tenders and contracts with suppliers.
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Waste management
National planners should develop and communicate a tOPV
collection and disposal plan for the country
•
Disposal 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.
Co-Incineration
Encapsulation
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.
For rural areas only
Preferred for both rural
and urban areas
Protected Sanitary
Landfill disposal
Accessible landfill sites
that are fenced off and
inaccessible to the public
and free of visible illegal
recycling activities
For rural areas only
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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 Preparations
A strategic communications and advocacy plan should address:
•
Identification of key audiences and stakeholders
•
Channels and timelines for information dissemination, e.g. orientation briefings
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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 needed
Proactive 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 Monitoring
National 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
Reporting
• Monthly until Feb 2016
 Waste management plan
 Vaccine delivered
 Training completed
• Weekly from March 2016
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PLAN
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
PREPARE
IMPLEMENT
(2 weeks before switch to
switch day)
VALIDATE
Train switch monitors
Train 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 Workers
Emphasize practical implications of the switch:
• Technical rationale for the switch
• When 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 together
• Strategies 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 unnecessary
– tOPV should be clearly marked and stored separately within the cold
storage to reduce confusion
• A direct exchange is preferable, in order to avoid presence of
tOPV in health facilities after the Switch Day
• Some 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
1 “Push” Exchange:
District delivers bOPV
to Facilities and picks
up tOPV
simultaneously
2 “Pull” Exchange:
Facilities collect bOPV
from district and
surrender tOPV
Benefits
•
•
•
•
3 Preposition: Deliver
•
bOPV to Health
Facilities just before
Switch day
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All HF receive their bOPV
uniformly on time,
tOPV is removed from all
facilities and disposed of at
District level (or higher)
Logistical implications
•
Requires additional funding and
logistical manpower at District
level at time of Switch
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Reminders for HF staff to come on
given day
Ability 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
tOPV is removed from HF as
they collect bOPV, disposed at
District level (or higher)
Less resource-intensive for
District than Push model
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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
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Reminders to ensure that HCW
remove tOPV from cold chain on
Switch day
Organize collection of tOPV from
HF in following 2 weeks
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tOPV recall and disposal
On Switch Day, countries will:
• Immediately remove all opened
and unopened tOPV vials from the
cold chain at all levels
• Place tOPV vials in a bag or
container and label it as waste
• Send to disposal facility, or set
aside for collection, as instructed
by the switch committee
Date withdrawn from cold chain:_______
Quantity in doses: ___________________
Countries should not keep recalled
tOPV in the cold chain.
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PLAN
PREPARE
IMPLEMENT
VALIDATE
(during 2 weeks post Switch
Day)
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Switch monitors to validate at selected sites
Report to National Switch Validation Committee
NSVC reviews data and validates the switch
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Validating the Switch
For 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
facilities
Reporting: to the National Switch Validation Committee (NSVC)
within 2 weeks of the Switch (i.e. by the National Validation
Day)
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Facilities down to District level
Independently monitor ALL
For HEALTHCARE facilities, sample a selected
number to independently monitor
Risk-based Purposive
Sampling
Select 10%
tOPV vial (opened or
unopened) in cold
chain
Prioritize facilities such as
• Highest population or tOPV doses
• receiving tOPV just before switch
• suspected non-compliance
• coverage<80%
No
Stop & report to
National
Validation
Committee
Yes
REPORT
validation
to WHO
Select additional 5%
of high risk facilities
in same district
Yes
Sweep* entire district
tOPV vial (opened
or unopened) in
cold chain
No
Stop & report to
National
Validation
Committee
Sweep denotes intensified monitoring of all other health facilities with involvement of staff from the regional level or higher
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National Validation
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.
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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
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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
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Additional monitoring needed more than two weeks following the national
switch day can be conducted by National Immunization Program
supervisors and other staff
For more information on the validation process and timelines,
please see the Independent Monitoring Guide
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Materials available to support planning
and implementation of the Switch
Planning:
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Switch Guidelines
National Switch Plan Template (and walk-through guide)
Chronogram with timeline of activities
Switch budget template
Logistics guide
Independent monitoring guide and job aid
Communications and training:
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Communications planning guide
Issues management and media kit
Stakeholder engagement guide
Training materials for health workers and logisticians
All materials available online:
who.int/immunization/diseases/poliomyelitis/endgame_objective2/en/
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