1. 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

2. 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

3. 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
To the facilitator:
Explain to the participants the questions that will be answered in this module.
“In this module you will learn more about the next stage of polio eradication which involves a change in the oral polio vaccine.
We will provide you with answers to the following questions:
Why does the world need to switch from trivalent to bivalent OPV?
What is the role of health workers?
What are the key messages related to this change?”
What are the key activities that will need to be carried out?

4. Polio eradication and the switch from trivalent OPV to bivalent OPV4

5. 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: , 2, and 3. The last type 2 wild poliovirus was detected in 1999
Together, we can finish the job of eradicating polio.
To the facilitator:
“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.
Together, we can eradicate polio.” 5

6. 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 types 1, 2, and 3
Should be used in all routine immunization schedules worldwide by the time of the OPV switch
Bivalent OPV (bOPV) protects against types 1 and 3
IPV protects against types 1, 2, and 3
To the facilitator:
Emphasize: “Both OPV and IPV are needed during this stage of polio eradication”
And review the differences between OPV and IPV. 6

7. Polio Eradication Endgame and Strategic Plan
In 2013, the Polio Eradication and Endgame Strategic Plan 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
To the facilitor:
“In 2013, the Polio Eradication and Endgame Strategic Plan was endorsed by the World Health Assembly. This global plan recommends the:
Gradual withdrawal of all OPV worldwide, beginning with the type 2 component of OPV (the switch from trivalent to bivalent OPV)
Introduction of IPV into routine immunization before the switch from trivalent to bivalent OPV” 7

8. 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
To the facilitor:
“The transition from trivalent OPV to bivalent OPV is an important step in the effort to eradicate polio.
Because OPV contains live virus, in very rare cases, OPV can cause paralysis.
There are two forms of vaccine-derived polioviruses:
Vaccine Associated Paralytic Paralysis (VAPP): There are an estimated VAPP cases globally per year. Of these, about 40% are caused by the type 2 component of tOPV.
Circulating Vaccine Derived Poliovirus (cVDPV): Almost all cVDPV outbreaks in recent years have been caused by the type 2 component of tOPV.
Reference for # cases of cVDPVs: 8

9. Type 2 wild poliovirus has already been eradicated!
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
To the facilitor:
“Even though these occur very rarely, we must eliminate VAPP and cVDPV to fully eradicate polio. We can do this by gradually phasing out OPV, beginning with the type 2 component of tOPV.
The type 2 component of tOPV:
Causes ~30% of VAPP cases and over 90% of cVDPV cases
Interferes with immune response to types 1 and types 3
Since 1999, naturally occurring type 2 wild poliovirus has not been detected. Because of this, the risks associated with the type 2 component of tOPV now outweigh the benefits.” 9

10. The switch from tOPV to bOPV
In April 2016, withdraw type 2
tOPV and IPV protect against poliovirus types 1, 2 and 3.
The type 2 component of tOPV causes the majority of cVDPV cases.
To the facilitor:
“The Switch from tOPV to bOPV”.
Please point out to participants that the tOPV droplet has the numbers “1, 2 and 3” inside of it. And the bOPV droplet only has the numbers “1 and 3”. And say: “By switching from tOPV to bOPV, we are removing the type 2 component of the oral polio vaccine.” Next, show how IPV contains a “1, 2 and 3” and emphasize that IPV protects against all three types of poliovirus.
“We are removing the type 2 component of OPV because it causes the majority of cVDPVs. By using bOPV along with IPV, children are protected against all three types of the poliovirus and have a lower risk of paralysis caused by vaccines.”
bOPV and IPV protect against poliovirus types 1, 2 and 3.
bOPV has a lower risk of cVDPVs. 10

11. 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
To the facilitator:
Read:
“IPV will provide protection against polio type 2 after the type 2 component of OPV is removed.
IPV also provides additional protection against types 1 and 3.
Used together, OPV and IPV will provide strong protection against polio during the final phases of polio eradication.”
Used together, OPV and IPV provide the best form of protection in the final stages of polio eradication. 11

12. 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
To the facilitator: Please insert the date of the National Switch Day for your country in the areas highlighted in red. Please emphasize that tOPV cannot be used after this date.
“The switch is a global event. It will take place in every health facility in countries still using tOPV in April 2016.
In our country the switch will take place on {date to be filled out}. Beginning on that date, no more tOPV will be used anywhere and for any programme, private nor public, in the country.
tOPV cannot be used on or after <insert date>
bOPV will follow the same immunisation schedule as tOPV.” 12

13. The role of logisticians and vaccine officers in the switch from trivalent OPV to bivalent OPV13

14. Your role in the switch
The Switch is largely a logistical exercise, therefore you will play a critical role in ensuring:
Sufficient stocks of tOPV are available for vaccination until the Switch
Excess stocks of tOPV for disposal after the Switch are minimized
bOPV is available in all health facilities on Switch day
All tOPV is collected and disposed of quickly after the Switch
Facilitator:
“Health workers have a key role in the switch from tOPV to bOPV.
It is very important that health workers:
Ensure that bOPV is not used after the switch to tOPV
Dispose of tOPV properly
Answer any questions about the switch” 14

15. The stock management challenge:

16. to implement the switch from trivalent to bivalent OPV
Key activities needed
to implement the switch from
trivalent to bivalent OPV

17. Plan Prepare Implement National Switch Day Validate By June 2015
- Draft national switch plan (budgeted and finalized by Sept 2015)
Prepare
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
Implement
Two to four weeks prior to the switch
- Distribute bOPV to periphery and service points
National Switch Day
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
Validate
Within two weeks after the switch day
- Removal of tOPV from cold chain will be validated within two weeks after switch day

18. Key logistics activities
tOPV stock inventories
Review and adjustment of procurement plans
Final shipments of tOPV
Distribution of bOPV
Collect/dispose tOPV

19. 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.
First Inventory: in order to revise the quantity and timing of subsequent shipments to the country and avoid overstocking
Second Inventory: in order to fine tune the final shipment quantity and redistribute supply in-country if necessary
Aggregate all the data at the CVS level for analysis (see below). The inventory tool developed by UNICEF  may be used to summarize the stock information collected

20. 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
In order to minimize both the risk of tOPV stockouts prior to the Switch, and the risk of excess stocks of tOPV that will need to be disposed of after the Switch
contingency stock to be able to respond to the risk of localised stockouts : One week of contingency stock should sit at the CVS level, while one week should sit at either the Regional or District level (depending on cold chain capacity)

21. 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

22. 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

23. 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

24. The Switch at the last mile: 3 scenarios
** FOR ADAPTATION BY COUNTRY
The Switch at the last mile: 3 scenarios
Benefits
Logistical implications
“Push” Exchange:
District delivers bOPV to Facilities and picks up tOPV simultaneously 1
All HF receive their bOPV uniformly on time,
tOPV is removed from all facilities and disposed of at District level (or higher)
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
“Pull” Exchange: Facilities collect bOPV from district and surrender tOPV
tOPV is removed from HF as they collect bOPV, disposed at District level (or higher)
Less resource-intensive for District than Push model 2
NOTE: Countries should adapt this slide to include specific instructions for the Switch mechanism they have chosen
Preposition: Deliver bOPV to Health Facilities just before Switch day 3
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

25. Collection and Disposal of tOPV
** FOR ADAPTATION BY COUNTRY
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
NOTE: Countries should modify this slide to include details and instructions of their actual collection/disposal plan for each level

26. Collection and Disposal of tOPV
Date withdrawn from cold chain:_______
Quantity in doses: ___________________
On Switch Day:
Remove any remaining tOPV from the cold chain at all levels
Note the amount of tOPV removed in stock registries
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
The national planning team should develop a tOPV collection and disposal plan, and communicate to lower levels

27. 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. 27

28. End of module
Thank you
for your attention!