Completing The Endgame

Global Polio Eradication

ECCMID, April 27, 2015

ESCMID Online Lecture Library @ by author Outline

• Progress toward wild poliovirus eradication • Withdrawal of type 2 Oral Polio Vaccine • Managing the long-term risks • Global program priorities in 2015

ESCMID Online Lecture Library @ by author Wild Poliovirus Eradication, 1988-2012

125 Polio Endemic countries 125 Polioto Endemic 3 endemiccountries countries 400

300

19882012 200

Polio cases (thousands) 100 Last type 2 polio in Last Polio Case in the world India

0 ESCMID Online Lecture Library 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 @ by author Beginning of the Endgame

Success in India established strategic & scientific feasibility of poliovirus eradication

Poliovirus Type 2 eradication raised concerns about continued use of tOPV ESCMID Online Lecture Library @ by author Endgame Plan Objectives , 2013-18

1. Poliovirus detection & interruption

2. OPV2 withdrawal, IPV introduction, immunization system strengthening

3. Facility Containment & Global Certification ESCMID Online Lecture Library 4. Legacy Planning @ by author Vaccine-derived polio outbreaks (cVDPVs) 2000-2014

>90% VDPV cases are type 2 (40% of Vaccine-associated polio is also type 2)

Type 1 ESCMID Online LectureType 2Library Type 3 @ by author Justification for new endgame

Polio eradication not feasible without removal of all poliovirus strains from populations

ESCMID Online Lecture Library @ by author Interrupting Poliovirus Transmission

ESCMID Online Lecture Library @ by author Not detected since Nov 2012

ESCMID Online Lecture Library @ by author Wild Poliovirus type 1 (WPV1) Cases, 2013

Country 2013 2014

Pakistan 93 174

Afghanistan 14 10

Nigeria 53 6

Somalia 194 5

Cameroon 4 5

Equatorial Guinea 0 5

Iraq 0 2

Syria 35 1 Endemic countries Infected countries Ethiopia 9 1

Kenya 14 0 ESCMID Online Lecture TotalLibrary 416 209 Israel = Env. positive isolates (2013 , N=136 ) Gaza = Env. positve isolates (2013 , N= 7) @ by author Wild Poliovirus type 1 Cases, 2014

306

Endemic countries Infected countries 359

ESCMID OnlineIsrael = Env. positive Lecture isolates (2013 , N=136 Library; 2014, N=14 , last 30 Mar 2014) Gaza = Env. positve isolates (2013, N= 7 ; 2014, N=1, Jan )

*Data as of 23 April@ 2015 by author Wild Poliovirus Cases, Last 6 months

Last Case Iraq, 7 April, 2014 Syria: 21 Jan Israel (Env.): 30 March

Last Case , 24 Jul

Last Case Cameroon, 9 Jul Last Case Somalia, 11 Aug Equatorial Guinea: 3 May Ethiopia: 5 Jan

ESCMID Online Lecture Library No WPV Reported in Africa or Middle East @ by author Progress in Endemic Countries

ESCMID Online Lecture Library @ by author WPV1 Cases, 2012-14* 350 306 300

250

200

Cases 150 103 100 93 53 55 37 50 28 14 6 0 Afghanistan Nigeria Pakistan ESCMID Online2012 2013 Lecture2014 Library *Data as of 7 April@ 2015 (including by advance author notifications as of this date) Trends in LQAS results -

NIGERIA

2014:2013: 515 cases; cases; lots lots in in 41 7 LGAs atat ≥90%≥90%

Makoda Kunchi Dawakin-Tofa Tofa Gazewa Rimin- Gado Kabo MadobiKura Dawakin - Kudu Gaya 2014 Garum- Kiru Mallam Garko 6 cases Tudun- Wada ESCMID Online LectureLast Case in Library Nigeria: 24 July LQAS coverage <60% 60-80% 80-90% ≥90% @ by author Doguwa Risks in Nigeria

• Insecurity and conflict in the northeast • Elections & leadership transition • Loss of political commitment • Complacency

ESCMID Online Lecture Library @ by author WPV1 Cases, Afghanistan and Pakistan,

70 1 Jan-23 Apr, 2014 & 2015*

60 58

50

40

Cases 30 22 20

10 4 1 0 Afghanistan Pakistan ESCMID Online2014 Lecture2015 Library *Data as of 23 April@ 2015 (including by advanceauthor notifications as of this date) WPV1 Cases Afghanistan, 2014 N=28

Most Cases importation related , but endemic strain persists in Southern Region ESCMID Online Lecture Library @ by author Ensuring Progress in Afghanistan

• Accelerate Engagement with new leadership • Maintain dialogue with non-state actors • Ensure program neutrality ESCMID Online Lecture Library • Reduce missed children in South & East @ by author Public Health Emergency of International Concern

ESCMID Online Lecture Library @ by author International exportation of poliovirus in 2014

February

January April June August September October March

ESCMIDMarch Online Lecture Library @ by author Preventing International spread

•Public Health Emergency of International Concern (PHEIC) declared by DG, WHO, on 5 May 2014; extended 31 July, 13 November & 3 March 2015

•New emphasis on regional cooperation and cross-border coordination As of July 31

Countries with circulating Countries currently wild poliovirus, but NOT exporting wild ESCMID Online Lecturecurrently exporting Librarypoliovirus @ by author Withdrawal of type 2 OPV by April 2016

ESCMID Online Lecture Library @ by author OPV type 2 withdrawal Complete replacement of tOPV by bOPV

ESCMID156 tOPV Online using countries Lecture and territories (tOPV Library only and sequential schedules) @ by author 24 Preparedness Criteria for OPV2 withdrawal (November 2013 SAGE) 1) IPV introduction into OPV only-using countries; 2) Access to bOPV licensed for routine immunization; 3) Surveillance & response protocols for type 2 virus; 4) Phase 1 containment, with appropriate handling of type 2 materials; 5) Verification of wild poliovirus type 2 eradication.

ESCMID Absence of ‘persistent’Online Lecture cVDPV2s globally Library 25 @ by author 25 Rationale for Use of IPV • A single dose of IPV induces immunologic priming in >95% infants • A single dose of IPV among OPV- primed children is more effective in boosting humoral & mucosal immunity than another dose of OPV

Major implications for speeding eradication ESCMID& Online managing long Lecture-term risks Library @ by author Single-dose IPV Immunogenicity at 4 (and 8) mos Cuba, NVI P1 P2 P3 100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0% ID IM ID IM ID IM ESCMID Online Lecture Library 1st dose Priming 2nd dose Not immune ID: Intra-dermal.@ IM: Intra by-muscular author Sutter et al N Eng J Med 2013;368:416-24. Poliovirus type 1 excretion after bOPV Challenge: prevalence, titer, duration Control bOPV IPV

925 - 2014:345;922

Science Jafari et al Jafari

ESCMID Online Lecture Library @ by author IPV Introduction status - March 2015

16 introductions 108 commitments/intents to introduce in 2015

Introduced to date (84 countries or 43%) Formal commitment to introduce in (104 countries or 54%) 2015 Intend to introduce in 2015 (4 countries or 2%) (Cook Islands, Fiji, Mauritius, Turkmenistan) Intend to introduce in 2016 (Thailand) (2 countries or 1%) Formal commitment to introduce in 2016 (Saint Lucia)

Data source: WHO/IVB Database, as of 02 April 2015 Not AvailableESCMID Online Lecture Library Map production Immunization Vaccines and Biologicals (IVB), Not applicable World Health Organization 29 Date of slide: 2 April 2015 @ by author Progress Toward Elimination of Persistent cVDPV2

ESCMID Online Lecture Library

3 @ by author 0 Persistent* Circulating Vaccine-Derived Poliovirus type 2 (cVDPV2) Cases - Last 12 months

*Persistent cVDPV2 Strain: ESCMID Online LectureEvidence of circulation Library for >6 months @ by author Persistent cVDPV2 in Nigeria

• AFP case tOPV campaigns completed tOPV campaigns planned x ES tOPV+IPV campaigns completed

Nigeria: persistent cVDPV2 outbreaks by state, month and lineage As of 9 April 2015 Year / Month 2014 2015 2016

Viral grouping Source State Jul Jul Jan Jan Jan Jun Jun Oct Oct Apr Apr Apr Feb Sep Feb Sep Feb Dec Dec Aug Aug Nov Nov Mar Mar Mar May May Borno • Katsina • AFP Kano • • • • Jigawa • Nigeria-Old Jigawa x Kano x x x x x x x ENV Kaduna x x x x x Katsina x x Sokoto x x x x x x Borno • • • • • •

Kano • • AFP Jigawa • Nigeria-Chad Yobe • • Borno x x x x x x ENV Kano x

TheESCMID “Nigeria-Chad” lineage hasOnline not been isolated Lecture since November 2014. Library The “Nigeria-Old” lineage was isolated from ES in March 2015 (last case in October). @ by author Persistent cVDPV2 in Pakistan

• AFP case tOPV campaigns completed tOPV campaigns planned x ES tOPV+IPV campaigns completed

Pakistan: persistent cVDPV2 outbreaks by province, month and lineage

As of 9 April 2015 Year / Month

2014 2015 2016

Viral grouping Source Province Jul Jul Jan Jan Jan Jun Jun Oct Oct Apr Apr Apr Feb Sep Feb Sep Feb Dec Dec Aug Aug Nov Nov Mar Mar Mar May May • • • • • FATA Pakistan: 2 'old' • • • AFP only groupings • KP • AFP Sindh • Pakistan-New ENV Sindh x x x x x x x

• The “old” lineages not detected since June 2014 ESCMID• A new persistent Online lineage emerged inLecture Karachi in July 2014 Library @ by author April 2015 SAGE Conclusions & Recommendations

• Elimination of persistent cVDPV2 on track

• Plan firmly for April 2016 for OPV2 withdrawal

• Monitor progress towards cVDPV2 elimination, ensure remaining challenges are addressed

• SAGE to confirm April 2016 as the definite date forESCMID OPV2 withdrawal Online in OctoberLecture 2015 Library @ by author SAGE Conclusions & Recommendations - 2

• Endorsed approach to verification of poliovirus containment in essential facilities: –Facilities implement GAPIII –National Regulatory Authorities for containment (NRAc) certify essential facilities –RCCs may request WHO to verify containment per GAPIII –Countries or facilities may also request verification • Consider mechanisms to address risks associated with researchESCMID and therapeutic Online usesLecture of live polioviruses Library @ by author Program Priorities in 2015

• Get Pakistan/Afghanistan back on track • Intensify surveillance for poliovirus • Ensure preparedness for OPV2 withdrawal • Reduce risk of international spread, especially in Africa & Middle East • BuildESCMID stronger Online outbreak Lecture response Library capacity @ by author Summary – 2015 a defining year

• Unprecedented progress in Africa, risks remain • Pakistan: getting back on track, still an international risk • Strategic Priorities: Surveillance, risk reduction, response capacity • Rapid progress on preparedness for OPV2 withdrawal • Financial & political support essential for the Endgame ESCMID Online Lecture Library @ by author >10 million Cases Prevented, ESCMID Online LectureThank Library You @ by author ESCMID Online Lecture Library @ by author Endgame Contingency Plans

• Bio-security of vaccine production: Sabin IPV, new generation vaccines, non-infectious processes

• Affordable IPV: S-IPV, production in low cost settings, adjuvants, dose sparing delivery, combination products

• Maintaining mucosal immunity: more genetically stable oral vaccine strains, new adjuvanted IPV

• Enhanced virus detection sensitivity: Environmental surveillance, new diagnostics

• ESCMIDChronic excretors Online: Anti-virals Lecture, monoclonal AbsLibrary @ by author