1 Polio Eradication & Post Eradication Vaccination Policy March 2007

2 A bit of background….

3 Egyptian stele with polio- afflicted priest circa 3000 B.C. Polio Eradication

4 Two Excellent Vaccines Dr Jonas Salk IPV, 12 April 1955 Dr Albert Sabin OPV, 1961 & 1962

5

6 Polio – the world in : World Health Assembly Voted to Eradicate Polio >350,000 cases >125 polio-endemic countries

7 Polio Eradication Strategies 1. Routine Immunization 2. National Immunization Days (NIDs/SNIDs) 3. Surveillance 4. Mop-ups

8 Americas Last Polio Case Peru 1991 Successful Proof of Principle Polio Eradication

9 A Brief History of Eradication Polio Eradication

10 A glimpse at recent history….

11 Polio - the world in 2003 >99% reduction in disease 784 cases 6 polio-endemic countries

12 Challenge 1: Persistent Polio Despite Very High Coverage

13 Challenge 2: International Spread of Poliovirus, countries, 71 events Indian origin: 13 (18%) Nigerian origin: 58 (82%) Case or outbreak following importation (last 6 months) Endemic countries Wild virus type 1 Wild virus type 3

14 Challenge 3: Campaigns in key areas were still missing too many children Very young children & minorities Insecure areas & mobile populations OPV rumours & very poor quality NIDs

15 A new, 2-pronged approach…

16 1. New tools were developed to stop polio in infected areas & limit international spread.

17 New Polio Vaccines monovalent OPV types 1 & 3 (mOPV1 & mOPV3) New Trial Data, Egypt 'monovalent' OPV protects 2 x greater

18 Per Dose Efficacy of mOPV1 vs. tOPV India * AssumptionVaccineLocationVaccine efficacy (%) (95% CI) trivalentROI21 ( ) Bihar14 (4 - 24) UP10 (6 - 13) No routine tOPVmonovalentROINA Bihar41 (0 - 71) UP28 ( )** First three doses routine tOPV monovalentROINA Bihar50 (0 - 81) UP31 ( )** ** significantly better than trivalent vaccine in UP to end of September *

19 New Laboratory Diagnostics New lab methods confirm polio 2 x faster. New Diagnostic Algorithm By Nov 2006, the new methods were already being introduced into AFRO & EMRO laboratories.

20 New approaches to engage all societies Community Dialogues Northern Nigeria Muslim Leader Conclave Northern India

21 New international standards for polio outbreak response FAST: start within 4 weeks. VERY LARGE: 2-5 million children. HIGH QUALITY:house-to-house. SUSTAINED:minimum 3 rounds. OPTIMAL VACCINE:mOPV. Adopted by the World Health Assembly, May 2006

22 New Recommendations to Reduce International Spread World Health Assembly EB 22 January 2007 ' Establish 'standing recommendation' under International Health Regulations, requiring full OPV immunization of all travellers from all infected areas' Saudi Arabia now requires proof of OPV for entry visas.

23 Polio – the world at end ,968 cases 4 endemic countries district with type 1 polio district with type 3 polio endemic areas

24 Cases in polio-free areas plummeted with enhanced outbreak responses

25 2. New strategies were developed to address the unique challenges in the last 4 endemic areas.

26 Northern Nigeria

27 Fixed Sites: 5 days mOPV1, measles, DPT deworming medicine, bednets, etc Mobile Teams (house-to-house): 5 days mOPV1, social mobilization. New 'Immunization Plus Days' (IPDs)

28 Impact of New 'IPD' Strategy on Zero-Dose Children, rd Quarter 1 st Quarter 2 nd Quarter > 20% 10-19% < 10 % 'Missed' Children Zero-dose children in north Nigeria fell from 50% to 20%

29 tOPVmOPV Impact of IPDs & mOPV1, Nigeria 2006

30 Northern India

31 * data as on 9 th December 2006 Polio is now a disease of very young children (P1 cases by age, Uttar Pradesh, 2006) >85% of cases are aged <3 years

32 Age range IMMUNE SUSCEPTIBLE New plan to close immunity gap in young children mOPV1 rounds every 4 weeks & mOPV1 at birth

33 Pakistan & Afghanistan Shared border areas & populations

34 Special emphasis on reaching shared, difficult-access populations. 6 campaigns in infected areas (Jan-Jun) Full use of monovalent OPVs Intensified Strategy, AFG & PAK 2007 Polio Low Season

35 New Strategies, AFG & PAK AFG & PAK Ministers Announce Synchronized, Cross-Border 'Final Push', Nov 2006 President Karzai Announces Polio Action Group to Coordinate all Ministries

36 In we have a 2 nd, and best, chance to eradicate polio using new tools & strategies that are 2x times better than before.

37 The optimum vaccination strategy in a polio-free world…

38 …depends on the overall plan for managing longterm polio risks

39 Risks of Polio After 'Eradication' VAPP 2-4/m birth cohort stable iVDPV28 identified <1 decreases (since 1963) cVDPV1* per year 10increases IPV sites1 accident (1990s) <1decreases Lab accident 1 investigation NKdecreases Deliberate0 NKunknown FrequencyAnnualEvolution Risk to dateburden over time *based on current understanding

40 Philippines cases Hispaniola cases Madagascar 2002 & cases China cases Indonesia cases cVDPV Outbreaks (Circulating Vaccine-derived Polioviruses, )

41 Advisory Committee on Polio Eradication (ACPE), 2004 Policy Directive: after interruption of wild type poliovirus, continued OPV use would be incompatible with eradication. Timing: cessation of routine OPV must occur while population immunity & surveillance sensitivity are high.

42 Polio Risks & OPV Cessation (by income bracket* & immunization policy) Timeline: years after cessation 0124 Principle risks during OPV cessation phase Principle risks in the 'post-OPV' era 35 Low income OPV-using countries High income IPV-using countries circulating VDPVs mishandled OPV stocks iVDPVs (short term excretors) negligible risks (contingent on high income countries) laboratory accident IPV production accident iVDPVs (chronic excretors) intentional use * in upper-middle income countries, risks & policies may reflect high income; low-middle income countries may reflect low income countries.

43 Options for Longterm Polio Immunization Policy Stop all polio immunization. Stop all OPV; limited IPV use. Replace all OPV with IPV. Introduce new polio vaccines. Not possible or realistic from regulatory, manufacturer & other perspectives Could inadvertantly increase longterm risks (due to lack of vaccines, bioterrorism, etc)

44 Global Risk of cVDPV Emergence after Synchronous OPV Cessation * from Duintjer-Tebbens RJ et al. Risks of Paralytic Disease due to Wild or Vaccine-derived Poliovirus after Eradication. Risk Analysis 2006;26(6):

45 Potential Options in the 'Post-OPV' Era Countries with 'biohazards' routine IPV (handling/storing poliovirus)very high coverage 4-5 dose schedule Countries perceiving high risk routine IPV (e.g. bioterrorism, biohazards)2 dose schedule (?) fractional dosing (?) Other countries Int'l stockpile of mOPV

46 1. Reduce risk of virus release from IPV production sites 2. Maintain access to OPV after commercial production ends. Advisory Committee on Polio Eradication "…urges acceleration of studies to demonstrate safety and efficacy of an IPV using Sabin strains." A 'Sabin-IPV'?

47 In battle, no plan survives contact with the enemy. von Moltke, the elder.

48 Conclusions

49 Immediate Priorities - Polio Eradication Reaching the missed kids in 4 areas, Managing outbreaks, Closing the financing gap, Opening & sustaining a dialogue with the heads of governments.

50 Closing the Funding Gap Risk Financing, (at 1 Jan 2007) Funding Gap US$ 575 million Singapore, ‘Other’ includes: the Governments of Austria, Australia, Belgium, Czech Republic, Finland, Hungary, Iceland, Ireland, Italy, Luxembourg, Malaysia, Monaco, New Zealand, Oman, Pakistan, Portugal, Qatar, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Turkey, the United Arab Emirates; African Development Bank; AG Fund; American Red Cross; De Beers, Inter-American Development Bank, Central Emergency Response Fund (CERF), International Federation of Red Cross and Red Crescent Societies, Oil for Food Programme, OPEC Fund, Sanofi Pasteur; Saudi Arabian Red Crescent Society, Smith Kline Biologicals, UNICEF National Committees, UNICEF Regular and Other Resources, United Arab Emirates Red Crescent Society, WHO Regular Budget and Wyeth. G8 51% Non-G8 OECD/ Other 12% Multilateral Sector 16% Private Sector 21% Other

51 'We will finish polio eradication' Dr Margaret Chan WHO Director-General Elect WHA acceptance speech 9 Nov 2006