OVERVIEW OF THE POLIO ERADICATION AND ENDGAME STRATEGIC PLAN AND THE topv TO bopv SWITCH Dr. Karen Lewis-Bell Advisor, Immunization Switch Monitoring Training Jamaica, December 9, 2015
Presentation Outline Global and Regional situation of Poliomyelitis Polio Endgame Strategic Plan and Timeline Why the Switch Global and Regional use of OPV Switch milestones
Advances in Polio Eradication 350,000 cases 1988 125 endemic countries World Health Assembly resolved to eradicate polio 2013-2014 416 cases reported in 2013 359 cases reported in 2014 3 endemic countries 2013-2014: 7 countries with re-established transmission 2
3 Global Transmission of Polio
Global Transmission of Polio Total cases Year-to-date 2015 Year-to-date 2014 Total in 2014 WPV cvdpv WPV cvdpv WPV cvdpv Globally 60 21 315 50 359 56 - in endemic countries 60 2 296 46 340 52 - in nonendemic countries 0 19 19 4 19 4 http://www.polioeradication.org/dataandmonitoring/poliothisweek.aspx Data as at 2 December, 2015 4
Country Distribution of WPV and cvdpv 2014-2015 Countries Year-to-date 2015 Year-to-date 2014 Total in 2014 Onset of paralysis of most recent case WPV cvdpv WPV cvdpv WPV cvdpv WPV cvdpv Afghanistan 17 0 23 0 28 0 03-Nov15 NA Pakistan 43 2 267 20 306 22 2-Nov-15 9-Feb-15 Cameroon 0 0 5 0 5 0 09-Jul-14 NA Equatorial Guinea 0 0 5 0 5 0 03-May-14 NA Ethiopia 0 0 1 0 1 0 05-Jan-14 NA Guinea 0 1 0 1 0 1 NA 20-Jul-15 Iraq 0 0 2 0 2 0 07-Apr-14 NA Lao PDR 0 5 0 0 0 0 NA 28-Oct-2015 Madagascar 0 10 0 1 0 1 NA 22-Aug-15 Nigeria 0 1 6 26 6 30 24-Jul-14 16-May-15 Somalia 0 0 5 0 5 0 11-Aug-14 NA South Sudan 0 0 0 2 0 2 NA 12-Sep-14 Syrian Arab Republic 0 0 1 0 1 0 21-Jan-14 NA Ukraine 0 2 0 0 0 0 NA 07-Jul-15 http://www.polioeradication.org/dataandmonitoring/polio thisweek.aspx 5 Data as at 2 December, 2015
Polio eradication plan In May 2012 the World Health Assembly declared poliovirus eradication to be a global public health emergency In January 2013 the Polio Eradication and Endgame Strategic Plan 2013-2018 approved
Objectives of the Polio Eradication & Endgame Strategic Plan 2013-2018 1 Detect and interrupt all poliovirus transmission 2 3 Strengthen immunization systems, introduce inactivated polio vaccine (IPV) and withdraw oral polio vaccines (OPV) Contain poliovirus and certify interruption of transmission 4 Plan polio s legacy 7
What is the new endgame approach to polio immunization policy? Sequential cessation of oral Sabin vaccine strains, starting with Sabin type 2 Replacing trivalent OPV(tOPV) with bivalent OPV (bopv) in a synchronized manner globally as the first step in OPV cessation Mitigating risk by including at least one dose of IPV in the routine immunization programme in addition to bopv (starting >6 months before switching from topv to bopv)
Objective 2 of the plan addresses the Endgame through three distinct stages 2019-2020 Before end 2015 2016 Introduce Switch topv to bopv at least one dose of IPV into routine immunization Withdraw bopv & routine OPV use Ongoing STRENGTHENING of routine immunization services 9
topv bopv 10
Both OPV and IPV are needed at this stage of polio eradication Oral Polio Vaccine (OPV) Administered by drops Contains live, weakened virus Provides immunity through the gut and associated herd immunity Trivalent OPV (topv) protects against types 1, 2, and 3 Bivalent OPV (bopv) protects against types 1 and 3 Inactivated Polio Vaccine (IPV) Administered by injection Contains killed virus Provides immunity through the blood Should be used in all routine immunization schedules worldwide by the end of 2015 IPV protects against types 1, 2, and 3
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: o Causes more than 90% of vaccine-derived polio viruses (VDPVs) o Causes up to approx. 30% of vaccine-associated paralytic polio (VAPP) cases o Interferes with immune response to poliovirus types 1 and 3 in topv Hence the plan to eventually stop the use of OPV 12
Type 2 component of topv is responsible for >97% of all circulating vaccine derived poliovirus (cvdpv) in recent years 200 180 160 140 120 100 80 cvdpv1 cvdpv2 cvdpv3 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 ) 13
Rationale for introducing routine doses of IPV prior to OPV2 cessation To prevent VAPP and cvdpv to maintain immunity against polio type 2 To mitigate the risks of outbreak if cvdpv2 or WPV2 is re-introduced after OPV2 is stopped a) reduce transmission b) prevent individual cases of polio c) provide priming to rapidly improve response to monovalent OPV2 in an outbreak To boost immunity to WPV1 and WPV 3
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 Used together, OPV and IPV provide the best form of protection in the final stages of polio eradication.
Key dates around the switch May 2015 September 2015 October 2015 December 2015* April 2016 May 2016 World Health Assembly endorsement of the process and tentative timelines National Switch Plans finalized Strategic Advisory Group of Experts (SAGE) assessed the epidemiology of persistent type 2 cvdpvs and confirmed the switch date At least 1 dose of IPV introduced into routine immunization programmes in all countries The Switch: replace topv with bopv globally. topv should no longer be used anywhere in the world in routine immunization or SIAs. 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. 16
topv in routine vaccine schedules 1. Anguilla 2.Antigua and Barbuda 3.Argentina 4.Bahamas, The 5.Barbados 6.Belize 7.Bolivia 8.Brazil 9.Chile 10.Colombia 11.Cuba 12.Curaçao 13.Dominica 14.Dominican Republic 15.Ecuador 16.El Salvador 17.Grenada 18.Guatemala 19.Guyana 20.Haiti 21.Honduras 22.Jamaica 23.Montserrat 24.Nicaragua 25.Paraguay 26.Peru 27.Saint Kitts & Nevis 28.Saint Lucia 29.Saint Vincent and the Grenadines 30.Suriname 31.Trinidad and Tobago 32.Turks and Caicos Islands 33.Venezuela 34.Virgin Islands (UK) topv: booster and/or campaigns 1.Mexico 2.Panama Not using topv 1. Aruba 2. Bermuda 3. Canada 4. Cayman Islands 5. Costa Rica 6. Puerto Rico 7. Saint Maarten 8. United States of America 9. Uruguay 10. Bonaire 11. Saba 12. St. Eustatius 13. French Guyana 14. Guadalupe 15. Martinique Use of topv in the Region
IPV/OPV Use in Countries 125 'OPV-only' countries IPV ONLY (47 countries) IPV/OPV (18 countries) OPV ONLY (125 countries)
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 or outbreaks from the use of topv Countries should not switch before the global switch window! 19
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
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 21
National Switch Day In the Caribbean including JAMAICA, the National Switch Day will be 26 April 2016. From this date, topv will no longer be used anywhere in the countries, neither in the private nor public sector
The importance of the National Switch Day: 26 April Any place that continues to use topv after 26 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
Role of the Health Care Worker in the switch Health workers will play a critical role in the switch: 1. Ensuring optimal topv use prior to the switch to minimize wastage 2. Ensuring bopv is available at vaccination points in time for the switch 3. Using only bopv after the switch day in April 2016 4. Disposing of unused topv properly 5. Answering any questions about the switch
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 The change will not be noticeable to caregivers and the public because the bopv is an oral vaccine just like topv The vaccine attributes, schedule, and potential side effects remain the same Given this level of general unawareness, you may not receive any questions about the change. If asked, you can reassure caregivers that this combination of IPV and OPV is best to keep their children and their community safe from polio.
Caribbean Sub-Regional Certification Committee A Caribbean Sub-Regional Certification Committee (SCC) was established in October, 2015 to oversee the requirements of the PEESP including the process & documentation of: The detection and interruption of all wild poliovirus transmission and the quality of the AFP surveillance system. Implementation of poliovirus safe handling and containment measures. Certification of the eradication of all poliovirus, commencing with wild poliovirus type 2 (WPV2). Withdrawal of all oral poliovirus vaccines (OPV), commencing with the type 2 component with the Switch in April 2016. 26
Caribbean Sub-Regional Certification Committee The SCC will be responsible to submit formal declaration of topv withdrawal and disposal to the Regional Certification Committee following the Switch. Periodically from now through April 2016: The RCC and SCC will review country progress on the Switch and Endgame goals through a regional dashboard May 2016: The SCC will review country reports on the switch and submit a consolidated Caribbean topv withdrawal and disposal report to the RCC. 27
Proper planning for the switch will help ensure: Successful recall of topv & introduction of bopv on April 26, 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 We all have a role to play in ending Polio Globally- Let s do it! 28
Acknowledgement Some slides used were from the presentations below: Polio Vaccination Policy a presentation done at TAG (July 2013) by Dr. Maher Various presentations on Poliomyelitis and the PEESP done by Dr. Cuauthémoc Ruiz Matus PAHO EPI Unit Chief Prof. J. Peter Figueroa SAGE and TAG member Dr. Cristina Pedreira- PAHO Advisor on Polio Polio eradication: Progress and Risks SAGE Working Group on Polio, 7 October, 2013 The switch from trivalent to bivalent oral polio vaccine Planning and Implementation- Alejandro Ramirez Gonzalez WHO, Polio Meeting, Colombia August 2015