The next phase of polio eradication and the

The next phase of polio eradication and the vaccines used A training module for logisticians on the switch from trivalent OPV to bivalent OPV July 2015 For adaptation and use by regions and countries

Learning objectives l 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 l Duration – 2 hours 2| The switch from trivalent OPV to bivalent OPV| December 2021

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? 3| The switch from trivalent OPV to bivalent OPV| December 2021

Polio eradication and the switch from trivalent OPV to bivalent OPV 4| The switch from trivalent OPV to bivalent OPV| December 2021

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. 5| The switch from trivalent OPV to bivalent OPV| December 2021

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 (t. OPV) 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 (b. OPV) protects against IPV protects against types 1, 2, and 3 types 1 and 3 6| The switch from trivalent OPV to bivalent OPV| December 2021

Polio Eradication Endgame and Strategic Plan In 2013, the Polio Eradication Endgame and 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 t. OPV to b. OPV) • Introduction of IPV into routine immunization before the switch from t. OPV to b. OPV to maintain protection against all 3 types of poliovirus 7| The switch from trivalent OPV to bivalent OPV| December 2021

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 t. OPV 8| The switch from trivalent OPV to bivalent OPV| December 2021

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 t. OPV now outweigh the benefits: • Type 2 component of t. OPV causes around 30% of VAPP and over 90% of VDPV cases • Type 2 component of t. OPV interferes with immune response to types 1 and types 3 9| The switch from trivalent OPV to bivalent OPV| December 2021

The switch from t. OPV to b. OPV In April 2016, withdraw type 2 • t. OPV and IPV protect against poliovirus types 1, 2 and 3. • The type 2 component of t. OPV causes the majority of c. VDPV cases. 10 | The switch from trivalent OPV to bivalent OPV| December 2021 • b. OPV and IPV protect against poliovirus types 1, 2 and 3. • b. OPV has a lower risk of c. VDPVs.

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 c. VDPV Used together, OPV and IPV provide the best form of protection in the final stages of polio eradication. 11 | The switch from trivalent OPV to bivalent OPV| December 2021

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 t. OPV • Within this two-week period, it is essential for each country to switch from t. OPV to b. OPV on one selected day: the National Switch Day • In <insert country>, our National Switch Day will be xx April. From this date, t. OPV will no longer be used anywhere in the country, and not for any programme, private nor public 12 | The switch from trivalent OPV to bivalent OPV| December 2021

The role of logisticians and vaccine officers in the switch from trivalent OPV to bivalent OPV 13 | The switch from trivalent OPV to bivalent OPV| December 2021

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 t. OPV are available for vaccination until the Switch 2. Excess stocks of t. OPV for disposal after the Switch are minimized 3. b. OPV is available in all health facilities on Switch day 4. All t. OPV is collected and disposed of quickly after the Switch 14 | The switch from trivalent OPV to bivalent OPV| December 2021

The stock management challenge: 15 | The switch from trivalent OPV to bivalent OPV| December 2021

Key activities needed to implement the switch from trivalent to bivalent OPV 16 | The switch from trivalent OPV to bivalent OPV| December 2021

Plan Prepare Implement National Switch Day Validate 17 | By June 2015 - Draft national switch plan (budgeted and finalized by Sept 2015) May to September 2015 - Complete first detailed t. OPV inventory; adjust t. OPV delivery October to November 2015 - Complete second t. OPV inventory; adjust t. OPV orders and/or delivery. Order b. OPV - Develop waste management protocol (collection plan and disposal method) December 2015 to January 2016 - Receive last t. OPV delivery to country; (may vary based on country ordering cycle) - Redistribute remaining t. OPV stock within country as required - Begin b. OPV deliveries to country (may extend into Feb-Mar 2016 for some countries) February to March 2016 - Deliver last 1 -2 months of t. OPV to periphery; redistribute as needed Two to four weeks prior to the switch - Distribute b. OPV to periphery and service points A day chosen during the two week switch window in April 2016 - Stop use of t. OPV and remove t. OPV from cold chain - Begin use of b. OPV Within two weeks after the switch day - Removal of t. OPV from cold chain will be validated within two weeks after switch day The switch from trivalent OPV to bivalent OPV| December 2021

Key logistics activities þ t. OPV stock inventories þ Review and adjustment of procurement plans þ Final shipments of t. OPV þ Distribution of b. OPV þ Collect/dispose t. OPV 18 | The switch from trivalent OPV to bivalent OPV| December 2021

Two national t. OPV 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 t. OPV). • 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. 19 | The switch from trivalent OPV to bivalent OPV| December 2021

Review and adjust procurement plans • Based on t. OPV inventories, data should be analyzed prior to placing final t. OPV orders • Calculate t. OPV 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 20 | The switch from trivalent OPV to bivalent OPV| December 2021

Final shipments of t. OPV • Calculate quantity and distribute final orders of t. OPV to lower levels • Where possible, supplies should be calculated using based on previous consumption: t. OPV 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 21 | The switch from trivalent OPV to bivalent OPV| December 2021

Final shipments of t. OPV • If consumption-based method not possible, and target population size is reliable, can use target beneficiaries: Amount of t. OPV to distribute to the next level down = ((Annual target population × number of doses needed person × Wastage factor) × (number of days of stock to be delivered/365)) – (t. OPV 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 t. OPV 22 | The switch from trivalent OPV to bivalent OPV| December 2021

Distribute b. OPV • The b. OPV should be distributed early enough to arrive at the District level two weeks before the Switch. • Ensure that b. OPV is stored separately from t. OPV in order to avoid any risk of being mixed with t. OPV deliveries and administered to patients prior to the Switch. ü Store on different shelves or opposite sides of the fridge ü Clearly label t. OPV: Use special t. OPV stickers on t. OPV secondary packaging, if available 23 | The switch from trivalent OPV to bivalent OPV| December 2021

** FOR ADAPTATION BY COUNTRY The Switch at the last mile: 3 scenarios Benefits 1 “Push” Exchange: District delivers b. OPV to Facilities and picks up t. OPV simultaneously 2 “Pull” Exchange: Facilities collect b. OPV from district and surrender t. OPV 3 Preposition: Deliver b. OPV to Health Facilities just before Switch day 24 | • • • All HF receive their b. OPV uniformly on time, t. OPV is removed from all facilities and disposed of at District level (or higher) t. OPV is removed from HF as they collect b. OPV, 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| December 2021 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 t. OPV from cold chain on Switch day Organize collection of t. OPV from HF in following 2 weeks

** FOR ADAPTATION BY COUNTRY Collection and Disposal of t. OPV • The national planning team will develop a t. OPV 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 t. OPV stocks receive a copy of the collection and disposal plan • It is recommended that designated collection bags and t. OPV stickers are procured and distributed to all facilities along with the final shipment of t. OPV 25 | The switch from trivalent OPV to bivalent OPV| December 2021

Collection and Disposal of t. OPV On Switch Day: þ Remove any remaining t. OPV from the cold chain at all levels þ Note the amount of t. OPV removed in stock registries Date withdrawn from cold chain: _______ Quantity in doses: __________ þ Place in designated bags or containers marked with the “t. OPV for disposal” sticker þ Transport it to the designated location to be disposed of as per the t. OPV collection and disposal plan 26 | The switch from trivalent OPV to bivalent OPV| December 2021

In summary • t. OPV will be replaced with b. OPV everywhere in the world at the same time in April 2016. • Careful monitoring of t. OPV inventories leading up to the Switch will help minimizing wastage and also prevent the risk of stock outs • Ensuring complete collection and disposal of t. OPV following the Switch will eliminate the risk of a c. VDPV outbreak • This will take us one step closer to polio eradication. 27 | The switch from trivalent OPV to bivalent OPV| December 2021

End of module Thank you for your attention! 28 | The switch from trivalent OPV to bivalent OPV| December 2021