The next phase of polio eradication and the vaccines used A training module for health workers on the switch from trivalent OPV to bivalent OPV Note: This training module may be updated in coming months and recirculated widely.

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 health workers in implementation of the switch Be able to respond to parental concerns regarding vaccine safety and effectiveness Duration 2 hours

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 health workers? 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?” 3 What are the key messages related to this change?

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

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 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

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 end of 2015 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

Why will we eventually stop use of OPV? OPV contains live but weakened virus, and in very rare cases, OPV can cause paralysis.: Vaccine - Associated Paralytic Poliomyelitis (VAPP): There are an estimated 250-500 VAPP cases globally per year. Circulating Vaccine Derived Poliovirus (cVDPV): Since 2005, there have been at least 671 cases of paralytic polio from type 2 cVDPV2s. 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 250-500 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: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek/Circulatingvaccinederivedpoliovirus.aspx 7

An important step in the effort to eradicate polio To fully eradicate polio, we need to eliminate VAPP and cVDPV by: Gradually phasing out OPV Starting with the removal of the type 2 component of tOPV The risks associated with the type 2 component of tOPV now outweigh the benefits: Type 2 component of tOPV causes around 40% of VAPP and over 90% of cVDPV cases Type 2 component of tOPV interferes with immune response to types 1 and types 3 Recall that the last type 2 wild poliovirus was detected in 1999. 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.” 8

Polio Eradication Endgame and Strategic Plan In 2013, the World Health Organization (WHO) developed the Polio Eradication Endgame and Strategic Plan 2013-2018. 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, mainly against type 2. To the facilitor: “In 2013, the World Health Organization (WHO) developed the Polio Eradication Endgame and Strategic Plan 2013-2018. 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” 9

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 + IPV protect against poliovirus types 1, 2 and 3. bOPV has a lower risk of cVDPVs and time limited. 10

OPV and IPV After April 2016 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. IPV is not a 'live' vaccine, therefore 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

The role of health workers in the switch from trivalent OPV to bivalent OPV 12

Your role in the switch Health workers will play a critical role in the switch: Ensuring bOPV is available at vaccination points Using only bOPV after the switch day in April 2016 Disposing of tOPV properly Answering any questions about 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” 13

National switch day The switch is a global event. It will take place in April 2016, in every health facility in every country that still uses tOPV Within a two-week predetermined 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.” 14

bOPV simply replaces tOPV: The importance of our National Switch Day: xx April Any place that continues to use tOPV after xx April is at risk of generating and exporting type 2 cVDPVs, potentially putting its neighbours at risk. bOPV simply replaces tOPV: bOPV follows the same immunization schedule as tOPV, has the same attributes for administration as tOPV Note: If a child begins his or her vaccination schedule with tOPV, there is no problem to complete the schedule with bOPV To the facilitator: (Note: please insert your country’s stop date in red on the slide) “All tOPV-using countries will switch to bOPV during the first 2 weeks of April 2016. It is extremely important that all countries switch from tOPV to bOPV during the first two weeks of April 2016. A district that continues to use tOPV after {insert stop date} could put neighbouring districts at risk.” 15

A globally synchronized event In April 2016, every health worker, in every health facility, in every country using OPV, will contribute to a major milestone on the road to polio eradication 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.” 16

On switch day, health workers will:* Stop using tOPV and instead use bOPV only Take all tOPV out of the cold chain (both opened and unopened vials) Place tOPV in a marked bag provided specifically for this vaccine Dispose of the tOPV vials as instructed by the vaccination programme   *Procedures may vary by country. To the facilitator: (content may need to be adapted to reflect your country’s procedures) “On switch day, health workers will: “Stop using tOPV and only use bOPV instead Take all tOPV out of the cold chain (opened and unopened) Place tOPV in the marked bag provided specifically for this vaccine Dispose as instructed at your health facility”  17

Switch monitoring People appointed as “Switch Monitors” will visit health facilities during the two weeks after the National Switch Day. Monitors will verify that no tOPV stocks remain at facilities and remove any remaining stocks of tOPV, if found. This is to make sure that tOPV with its type 2 component has been fully withdrawn To the facilitator: “Switch Monitors will visit health facilities during the two weeks after the National Switch Day. Monitors will verify the absence of tOPV stocks and remove any remaining stocks of tOPV. “ 18

Key messages for parents and caregivers about the switch from trivalent to bivalent OPV

Do health workers need to explain the switch to parents and caregivers? It will not be necessary for you to take the initiative to explain the switch from tOPV to bOPV to all caregivers because the: General public may not be aware that there are 3 types of polioviruses Change may not be noticeable to caregivers and the public Vaccine attributes, schedule, and potential side effects remain the same Given this level of general awareness, you may not receive any questions about the change. You can reassure caregivers that this combination of IPV and OPV will keep their children and their community safe from polio. To the facilitator: “Do health workers need to explain the switch to parents and caregivers? It may not be necessary to explain the switch from tOPV to bOPV to all parents or caregivers because the: Difference between tOPV and bOPV may not be fully understood by most caregivers General public may not be aware that there are 3 types of polioviruses Change in vaccine will not be noticeable to parents Given this level of general awareness, you may not receive any questions about this change. Health workers can reassure parents and caregivers that this combination of IPV and OPV will keep their children and their community safe.” 20

Reassuring parents and caregivers If asked, health workers can say to parents: “We are using a different type of oral vaccine together with the injectable vaccine to protect children from the few remaining cases of polio.” “These vaccines together will work to end polio in our community and the world. ” Facilitator: “Health workers can say to parents: “We are using a different version of the oral vaccine together with the injectable vaccine to keep children safe from the few remaining cases of polio. These vaccines together will work to end polio in our community and the world. ” 21

Frequently Asked Questions Will children have protection from wild poliovirus type 2 or from type 2 VDPVs after the switch from tOPV to bOPV? How will they be protected from type 2 polioviruses? IPV will help to protect children against poliovirus types 1, 2, and 3. After the switch from tOPV to bOPV, IPV will help to boost protection against paralytic polio caused by the type 2 poliovirus, and offer additional protection against types 1 and 3. To the facilitator: Read question, then the answer: “Will children have protection from wild poliovirus type 2 or from type 2 cVDPV polioviruses after the switch from tOPV to bOPV? How will they be protected from type 2 polioviruses? IPV protects children against polioviruses types 1, 2, and 3. After the switch from tOPV to bOPV, IPV use will help to protect against paralytic poliomyelitis from poliovirus type 2 and offer additional protection against types 1 and 3.” 22

Frequently Asked Questions What if a child received one type of OPV before and is getting the new type of OPV now? Is it ok to combine these vaccines?   Both types of OPV are extremely safe vaccines, and can be given to the same child at different visits. Thanks to the addition of the injectable polio vaccine in programmes, the infant will still be protected against paralytic polio from all 3 types of poliovirus 23

Frequently Asked Questions If countries have unused supplies or inventories of tOPV after the switch date, can they first use those supplies before making the switch to bOPV? No. All countries, and all health facilities, must stop using tOPV on the switch day and any remaining tOPV stock must be destroyed. Any area continuing to use tOPV after all others have switched to bOPV puts neighbouring communities at risk of a cVDPV2 outbreak. To the facilitator: Read question, then the answer: “If countries have unused supplies or inventories of tOPV after the switch date, can they first use those supplies before making the switch to bOPV? No. They must stop using tOPV on the switch date and any remaining inventories must be destroyed. Any area continuing to use tOPV after all others have switched to bOPV puts neighbouring communities at risk of a cVDPV2 outbreak.” 24

In summary OPV will be phased out gradually, beginning with the type 2 component of trivalent OPV. tOPV will be replaced with bOPV everywhere in the world at in April 2016. Health workers should not immunize children with tOPV on or after <insert date> in any circumstance. This will take us one step closer to polio eradication. Facilitator: (Note: please insert National Switch Date on the slide and in the narrative below). “In summary, OPV will be phased out gradually, beginning with the type 2 component of trivalent OPV. tOPV will be replaced with bOPV everywhere in the world at the same time in April 2016 This will take us one step closer to polio eradication. Health workers should not immunize children with tOPV on or after <insert date here> in any circumstance.” 25

End of module Thank you for your attention!