Transcript English pptx, 753kb

The next phase of polio eradication
and the vaccines used
A training module for logisticians on
the switch from trivalent OPV to bivalent OPV
August 2015
For adaptation and use by regions and countries
Learning objectives
 At the end of the module, the participant will:
– Know the benefits of switching from trivalent to
bivalent OPV
– Understand the role of logisticians and vaccine
officers in implementation of the switch
 Duration
– 2 hours
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This training module will answer
the following questions:
1
Why does the world need to
switch from trivalent OPV to
bivalent OPV?
2
What is the role of logisticians?
3
What are the key activities that
will need to be carried out?
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Polio eradication and the
switch from trivalent OPV
to bivalent OPV
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We are close to the eradication of polio
• Immunization efforts have reduced the number of polio
cases globally by more than 99% over the last two decades.
• The transition from trivalent OPV to
bivalent OPV is part of the polio
eradication strategy.
• There are three types of polio viruses:
1, 2, and 3. The last type 2 wild poliovirus
was detected in 1999
Together, we can finish the job of eradicating polio.
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Both OPV and IPV are needed
at this stage of polio eradication
Oral Polio Vaccine (OPV)
Inactivated Polio Vaccine (IPV)
Administered by drops
Administered by injection
Contains live, weakened virus
Contains killed virus
Provides immunity through the gut
and associated herd immunity
Provides immunity through the blood
Trivalent OPV (tOPV) protects against Should be used in all routine immunization
types 1, 2, and 3
schedules worldwide by the time of the
OPV switch
Bivalent OPV (bOPV) protects against IPV protects against types 1, 2, and 3
types 1 and 3
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Polio Eradication
Endgame and Strategic Plan
In 2013, the Polio Eradication and Endgame Strategic Plan
2013-2018 was endorsed by the World Health Assembly.
This global plan recommends the:
• Withdrawal of all OPV worldwide, beginning with the type 2
component in April 2016 (“the switch” from tOPV to bOPV)
• Introduction of IPV into routine immunization before the
switch from tOPV to bOPV to maintain protection against all
3 types of poliovirus
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Why will we eventually stop use of OPV?
OPV contains live but weakened virus, and in very rare
cases, the weakened virus can regain the ability to cause
paralysis.
Continued use of OPV carries two very rare risks:
• Vaccine Associated Paralytic Paralysis (VAPP)
• Vaccine Derived Poliovirus (VDPV)
To fully eradicate polio, we need to eliminate VAPP and
VDPV by gradually phasing out OPV… starting with the
removal of the type 2 component of tOPV
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Why remove type 2?
Type 2 wild poliovirus has already been eradicated!
There has not been a case of type 2 wild
poliovirus detected since 1999.
Therefore, the risks associated with the type 2 component of
tOPV now outweigh the benefits:
• Type 2 component of tOPV causes around 30% of VAPP and
over 90% of VDPV cases
• Type 2 component of tOPV interferes with immune response to
types 1 and types 3
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The switch from tOPV to bOPV
In April 2016,
withdraw type 2
• tOPV and IPV protect against
poliovirus types 1, 2 and 3.
• bOPV and IPV protect against
poliovirus types 1, 2 and 3.
• The type 2 component of tOPV
causes the majority of cVDPV cases.
• bOPV has a lower risk of cVDPVs.
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OPV and IPV
After April 2016
• IPV will provide protection against type
2 polioviruses after the type 2
component of OPV is removed.
• IPV also provides additional protection
against types 1 and 3 polioviruses.
• IPV is not a 'live' vaccine, therefore it
carries no risk of VAPP or cVDPV
Used together, OPV and IPV provide the best form of
protection in the final stages of polio eradication.
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National Switch Day
• The switch is a global event. It will take place in April 2016, in
every cold chain store and health facility in every country that
still uses tOPV
• Within this two-week period, it is essential for each country to
switch from tOPV to bOPV on one selected day: the National
Switch Day
• In <insert country>, our National Switch Day will be xx April.
From this date, tOPV will no longer be used anywhere in the
country, and not for any programme, private nor public
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The role of logisticians
and vaccine officers
in the switch from
trivalent OPV to bivalent OPV
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Your role in the switch
The Switch is largely a logistical exercise, therefore you
will play a critical role in ensuring:
1. Sufficient stocks of tOPV are available
for vaccination until the Switch
2. Excess stocks of tOPV for disposal after
the Switch are minimized
3. bOPV is available in all health facilities on Switch day
4. All tOPV is collected and disposed of quickly after the
Switch
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The stock management challenge:
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Key activities needed
to implement
the switch from
trivalent to bivalent OPV
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Plan
Prepare
Implement
National
Switch Day
Validate
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By June 2015
- Draft national switch plan (budgeted and finalized by Sept 2015)
May to September 2015
- Complete first detailed tOPV inventory; adjust tOPV delivery
October to November 2015
- Complete second tOPV inventory; adjust tOPV orders and/or delivery. Order bOPV
- Develop waste management protocol (collection plan and disposal method)
December 2015 to January 2016
- Receive last tOPV delivery to country; (may vary based on country ordering cycle)
- Redistribute remaining tOPV stock within country as required
- Begin bOPV deliveries to country (may extend into Feb-Mar 2016 for some countries)
February to March 2016
- Deliver last 1-2 months of tOPV to periphery; redistribute as needed
Two to four weeks prior to the switch
- Distribute bOPV to periphery and service points
A day chosen during the two week switch window in April 2016
- Stop use of tOPV and remove tOPV from cold chain
- Begin use of bOPV
Within two weeks after the switch day
- Removal of tOPV from cold chain will be validated within two weeks after switch day
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Key logistics activities
 tOPV stock inventories
 Review and adjustment of procurement plans
 Final shipments of tOPV
 Distribution of bOPV
 Collect/dispose tOPV
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Two national tOPV inventories
• Important in order to minimize shortage and wastage.
• First Inventory: As soon as possible (prior to September 2015)
• Second Inventory: Conduct approximately 6 months before
the Switch (~Oct/Nov 2015 or prior to the final shipment of
tOPV).
• Direct physical count (include SIAs & RI stocks) with expiration
date, packaging and location of stocks at all levels.
• Update all stock management systems accordingly.
Include all types of facilities and vaccine storage points,
including private sector, pharmacies, etc.
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Review and adjust procurement plans
• Based on tOPV inventories, data should be analyzed prior
to placing final tOPV orders
• Calculate tOPV requirements so that the majority of the
buffer stock in the system is consumed by April 2016
• Account for up to two weeks extra buffer supply as
contingency stock
• One week of contingency stock should sit at Central level
• One week of contingency stock should sit at Regional
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Final shipments of tOPV
• Calculate quantity and distribute final orders of tOPV to
lower levels
• Where possible, supplies should be calculated using
based on previous consumption:
tOPV used over a given period =
stock at beginning of period + received stock – current stock
• If any polio SIAs are planned, include the quantity
required in the allocation
• If any contingency stock is to be held at that level, include
this amount in allocation
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Final shipments of tOPV
• If consumption-based method not possible, and target
population size is reliable, can use target beneficiaries:
Amount of tOPV to distribute to the next level down =
((Annual target population × number of doses needed per person
× Wastage factor) × (number of days of stock to be delivered/365))
– (tOPV stock remaining as reflected in the second inventory)
• If results of inventories revealed significant overstock,
adjust second-to-last shipment, and/or consider
redistribution of tOPV
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Distribute bOPV
• The bOPV should be distributed early enough to arrive
at the District level two weeks before the Switch.
• Ensure that bOPV is stored separately from tOPV in
order to avoid any risk of being mixed with tOPV
deliveries and administered to patients prior to the
Switch.
 Store on different shelves or opposite sides of the fridge
 Clearly label tOPV: Use special tOPV stickers on tOPV
secondary packaging, if available
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** FOR ADAPTATION BY COUNTRY
The Switch at the last mile: 3 scenarios
Benefits
1 “Push” Exchange:
District delivers
bOPV to Facilities
and picks up tOPV
simultaneously
2 “Pull” Exchange:
Facilities collect
bOPV from district
and surrender tOPV
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)
tOPV is removed from HF as
they collect bOPV, disposed
at District level (or higher)
Less resource-intensive for
District than Push model
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
The switch from trivalent OPV to bivalent OPV| 24 July 2016
Logistical implications
•
Requires additional funding
and logistical manpower at
District level at time of Switch
•
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
•
•
•
•
•
Reminders to ensure that
HCW remove tOPV from cold
chain on Switch day
Organize collection of tOPV
from HF in following 2 weeks
** FOR ADAPTATION BY COUNTRY
Collection and Disposal of tOPV
• The national planning team will develop a tOPV collection and
disposal plan, and communicate to lower levels
• This should include an assessment of available disposal equipment
• Ensure all selected disposal sites are informed about their task
and implement all necessary preparations
• Ensure all sites (including private) with tOPV stocks receive a
copy of the collection and disposal plan
• It is recommended that designated collection bags and tOPV
stickers are procured and distributed to all facilities along with
the final shipment of tOPV
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Collection and Disposal of tOPV
On Switch Day:
 Remove any remaining tOPV
from the cold chain at all levels
 Note the amount of tOPV
removed in stock registries
Date withdrawn from cold chain:_______
Quantity in doses: ___________________
 Place in designated bags or
containers marked with the “tOPV for disposal” sticker
 Transport it to the designated location to be disposed
of as per the tOPV collection and disposal plan
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In summary
• tOPV will be replaced with bOPV everywhere in the world at
the same time in April 2016.
• Careful monitoring of tOPV inventories leading up to the
Switch will help minimizing wastage and also prevent the
risk of stock outs
• Ensuring complete collection and disposal of tOPV following
the Switch will eliminate the risk of a cVDPV outbreak
• This will take us one step closer to polio eradication.
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End of module
Thank you
for your attention!
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