The Promise of Introducing Rubella Containing Vaccines on the Impact of Rubella and Measles Control

Transcription

1 The Promise of Introducing Rubella Containing Vaccines on the Impact of Rubella and Measles Control GAVI Partners Forum 4 6 December 2012, Dar es Salaam, Tanzania Maya van den Ent, MPH, UNICEF Peter Strebel, MD, MPH, WHO Steve Cochi, MD, CDC Susan Reef, MD, CDC Robert Kezaala, MD, UNICEF UNICEF/MLWB /Noorani;

2 Outline The clinical manifestations of Congenital Rubella Syndrome (CRS) Burden and cost of CRS Rubella vaccine use Rubella Position Paper New Strategic Plan Timelines and budget implications Opportunity combining measles and rubella

3 The clinical manifestations of Congenital Rubella Syndrome (CRS) Burden and Cost of CRS Rubella vaccine use Rubella Position Paper New Strategic Plan Timelines and budget implications Opportunity combining measles and rubella

4 Congenital Rubella Syndrome Infection early in pregnancy most dangerous (<12 weeks gestation) Weeks % CRS* Weeks % Weeks % Weeks % Weeks > 17 0% May lead to fetal death or premature delivery Organ specificity generally related to stage of gestational infection *Miller E. Lancet 1982;2:781-4.

5 Congenital Rubella Syndrome Hearing Impairment Cataracts Heart defects Microcephaly Developmental Delay Bone alterations Liver and spleen damage

6 Congenital Rubella Syndrome Ages 1 40 years Courtesy: Dr Louis Z Cooper

7 Among the most tragic infectious diseases of humans are those that pass from the pregnant woman to her unborn child.

8 The clinical manifestations of Congenital Rubella Syndrome (CRS) Burden and Cost of CRS Rubella vaccine use Rubella Position Paper New Strategic Plan Timelines and budget implications Opportunity combining measles and rubella

9 Average incidence of CRS per 100,000 live births, 2008 Average CRS incidence per 100,000 live births <50 50-< <150 >150 No data Source: Vynnycky, Adams, HPA,et al (in preparation)

10 CRS burden estimates, globally * and by region, 1996 and 2008 Regions Est. CRS Cases Range Est. CRS Cases Range GLOBAL 120,342 25, , ,888 16, , , ,000 50,000 0 AFR AMR EMR EUR SEAR WPR *unpublished, Adams E, Vynnycky E Est. CRS Cases 1996 Est. CRS Cases 2008 All member states

11 Cost of CRS (2) Between 1980 and 2010, 26 economic analyses were published 20 studies high-income countries 5 studies middle-income countries 1 study lower middle-income country No studies conducted in low-income countries Findings CRS is costly Lifetime costs $ 50,000 (Barbados) $ 98,734 (Oman) - $ 514,853 (Canada) Rubella vaccination programs are economically justifiable and demonstrated cost-effectiveness or cost-benefit ratios in high-income and middle-income countries

12 The clinical manifestations of Congenital Rubella Syndrome Burden and Cost of CRS Rubella vaccine use Rubella Position Paper New Strategic Plan Timelines and budget implications Opportunity combining measles and rubella

13 Countries using rubella vaccine in their national immunization system countries 12% of birth cohort countries 41% of birth cohort RCV Users: GNI per capita $6, '800 3'600 Kilometers Source: WHO/IVB database and the "World Population Prospects: the 2010 Revision", New York, UN 194 WHO Member States. Date of slide: 1 October RCV non-users: GNI per capita $635 The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO All rights reserved 13

14 The clinical manifestations of Congenital Rubella Syndrome Burden and Cost of CRS Burden of rubella and CRS Rubella Position Paper New Strategic Plan Timelines and budget implications Opportunity combining measles UNICEF 2010/Habibul and rubella Haque/Drik

15 2011 WHO rubella position paper Burden of CRS greatest in regions where most of the countries are not using rubella vaccine and that have no regional control goal Risk of CRS is greater than the risk of a paradoxical effect WHO recommends countries use the opportunity offered by accelerated measles control and elimination activities to introduce RCVs

16 Moving towards Rubella and CRS Elimination Primary goal is prevention of congenital rubella infection including CRS General approaches: Reduce CRS only by immunizing adolescent girls or women of childbearing age Interrupt rubella virus transmission and eliminate rubella + CRS Preferred approach: interruption of rubella virus transmission leading to elimination of rubella and CRS Start with a wide age-range SIA giving MR or MMR Immediately introduce MR or MMR in routine Follow-up SIAs should give MR Wkly Epid Rec, 15 July 2011; 86(29):

17 Optimal Age for RCV1 Only 1 dose of RCV is needed Excellent immunogenicity (>95% at 9 months) Transmissibility of rubella << measles Give it with MCV1 Higher coverage (avoid drop out between MCV1 MCV2) Ensure protection before exposure Either M, MR or MMR can be used for routine MCV2 Logistic advantages using same vaccine

18 WHO preferred approach Additional recommended vaccination strategies: Target adolescent girls and/or women of child-bearing age Vaccination of health care workers, male and female To avoid potential increase in CRS incidence, countries need to achieve and maintain coverage 80% through routine or SIAs Integrate field and laboratory surveillance for rubella with measles

19 The case of Congenital Rubella Syndrome Burden of rubella and CRS Rubella vaccine use Rubella Position Paper New Strategic Plan Timelines and cost implications Opportunity combining measles and rubella

20 By end 2015: Goals Reduce global measles mortality by at least 95% compared with 2000 estimates Achieve regional measles and rubella/crs elimination goals Measles: The American, European, W. Pacific, and E. Mediterranean Rubella: The American and European By end 2020: Achieve measles and rubella elimination in at least five WHO regions 20

21 Measles and Rubella Elimination Goals by WHO Region, February 2012 Americas, Europe, E. Mediterranean, W. Pacific, Africa have measles elimination goals Americas and Europe have rubella elimination goals *) *) WPR: Rubella / CRS Reduction by 2015 SEAR: 95% Measles Mortality Reduction by 2015

22 Priorities Reach the 2015 measles mortality reduction goal and regional elimination targets Strengthen immunization systems 68 priority countries Low and lower-middle income countries High measles burden (low MCV1 coverage) High rubella/crs burden (not using RCV) 22

23 UNICEF 2010/Habibul Haque/Drik The case of Congenital Rubella Syndrome Burden of rubella and CRS Rubella vaccine use Rubella Position Paper New Strategic Plan Timelines and budget implications Opportunity combining measles and rubella

24 Time Line Rubella vaccine introduction Timeline before introduction Issue 2 years before Burden assessment & Advocacy 1.5 year before GAVI Application 9 month before SIA planning Introduction Catch up SIA implementation Introduction in Routine Immunization

25 Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov No. of Cases Decision making Rubella vaccine introduction : Example from Nepal Information examined Rubella epidemiology > 95% of rubella cases were less than 15 years of age; Sero - prevalence study conducted 91% of women years of age have acquired rubella immunity Estimated CRS burden Using sero prevalence study and modeling, approximately 1,400 infants born with CRS or 192/100,000 live births in 2008; Documented the presence of CRS among students attending a school for the deaf Decision Introduce MR through wide age campaign targeting persons aged 9 months -14 years followed by MR in routine at 9 months Confirmed Measles and Rubella Cases, Nepal, Note: Rubella IgM test started from Jan 2004 Catch-up Measles Campaign Months and Year Measles Cases * Includes labconfirmed and epilinked cases Follow-up Measles Campaign Rubella Cases Data source: WHO-IPD, as of 28 Dec 2010

26 Budget Implications (1) Vaccine cost (UNICEF) Measles: $0.27 per dose MR: $0.52 per dose Routine Immunization At least one dose Rubella containing vaccine Follow-up campaigns with Rubella containing vaccine (MR or MMR) Surveillance

27 Budget Implications (2) GAVI support : Bundled MR vaccine for catch-up campaign Operational costs ($0.65 per child) Vaccine introduction grant $100,000 or 0.80 per child targeted for routine 1 st dose what ever is highest Countries responsible for: Remainder of operational costs for catch-up campaign Sustainable financing of MR vaccine for routine 1 st dose, Subsequent follow-up campaigns (MRI supported) Vaccination of women of child-bearing age

28 2013 Bangladesh Cambodia Cape Verde Ghana Kiribati Rwanda Nepal Senegal Samoa Solomon Islands Vanuatu Vietnam Projected Rubella introductions, GAVI and non-gavi, Benin Botswana Djibouti Gambia Lesotho Mali Pakistan Papua New Guinea South Africa Sudan Tanzania 2015 Afghanistan Burundi Cameroon Korea, DPR? Eritrea Kenya Myanmar Namibia Philippines Sao Tome e Principe Somalia South Sudan Uganda Yemen Zimbabwe 2016 Burkina Faso Central African Republic Comoros Congo, DR Congo, Rep Ethiopia Madagascar Malawi Mozambique Niger Swaziland Timor Leste Togo Zambia 2017 Angola Cote d'ivoire Gabon Liberia Mauritania Nigeria 2018 Chad Equatorial Guinea Guinea Guinea-Bissau Sierra Leone (total includes India and Indonesia) Total by Based on projections from WHO, UNICEF, and GAVI Strategic Demand Forecast, September 2012 (subject to change); India and Indonesia plans are uncertain

29 The case of Congenital Rubella Syndrome Burden of rubella and CRS Rubella vaccine use Rubella Position Paper New Strategic Plan Timelines and budget implications UNICEF 2010/Habibul Haque/Drik Opportunity combining measles and rubella

30 confirmed measles cases MCV1 coverage Measles cases and routine MCV1 coverage, Zambia, ,000 30,000 Under 15 campaign Under 5 campaign 100% Under 15 campaign (sub national) 20,000 Under 5 campaign 50% 10,000-0% confirmed measles cases MCV1 coverage

31 Confirmed Measles Cases 0-8 months 9-11 months 1-4 years 5-9 years years years years years >25 years Measles cases by age, Zambia Under Five Follow up campaign Catch -up campaign Age

32 Measles & Rubella Raising age of children affected by measles In 2012, 7 out of the 27 countries funded by MR Initiative, targeted children older than five years during the campaigns MR campaigns for 9 months 14 years: opportunity to control measles in older agegroups

33 Rubella coverage in infants & Measles and Rubella cases in the Americas, Measles Catch-up campaigns MR Speed-up campaigns Follow-up campaigns 33

34 Summary High Cost of CRS CRS burden highest in regions and countries not using rubella vaccine Case for rubella introduction: More Rubella and CRS cases detected, as surveillance improves New position paper on rubella New Strategic Plan integrating rubella with measles New GAVI funding for rubella Cheap, safe, effective vaccine available Use MR catch-up campaigns to boost measles control

35 35 Thank you.

36 Measles Rubella Resources WHO Position Papers Measles: Rubella: Measles mortality estimation, Measles global progress supplement, J Infect Dis 2011; 204(suppl1) Rubella elimination in the Americas supplement, J Infect Dis 2011; 204(suppl2) Immunologic Basis for Immunization Measles (module 7): Rubella (module 11): Outbreak response guidelines: Global Measles and Rubella Strategic Plan

37 Extra slides

38 Proportion of countries offering rubella vaccine in routine by WHO region, % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% * Apparent decrease in 2011 because South Sudan joined EMRO but does not offer rubella vaccine in routine AFR AMR EMR* EUR SEAR WPR Global 60 countries yet to introduce rubella vaccine 38

39 Distribution of reported rubella genotypes, Data as of 3 August 2012 West Europe countries reporting laboratory confirmed rubella 12 countries reporting genotype information Legend 1a 1E 1j 2B Pie slice size proportional to the number of years each genotype was reported '500 5'000 Kilometers Acknowledgement: WHO LabNet. 39 The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO All rights reserved.

40 WHO Region Reported Cases of Rubella and Congenital Rubella Syndrome, by WHO Region, 2011 No. of member states in region Member states reporting rubella No. % No. of rubella cases Rubella incidence per million population Member states reporting CRS No. % No. of CRS cases AFR % 16, % 0 AMR % % 2 EMR % 2, % 2 EUR % 7, % 6 SEAR % 9, % 3 WPR % 76, % 201 Global % 112, % 214 Data received at WHO as of 14/07/2012

41 Updated estimates of the burden of CRS globally * in 1996 and 2008 Regions Est. CRS Cases Range Est. CRS Cases Range AFR 31, ,017 42, ,228 AMR 9, , EMR 9, ,287 5, ,384 EUR 9, , SEAR 50, ,432 52, ,274 WPR 10, ,839 10, ,618 GLOBAL 120,342 25, , ,888 16, ,754 *unpublished, Adams E, Vynnycky E All member states

42 Updated estimates of the burden of CRS globally * in 1996 and Regions Est. CRS Cases Range Est. CRS Cases Range GLOBAL 120,342 25, , ,888 16, ,754 *unpublished, Adams E, Vynnycky E All member states

43 Cost of CRS (1) The Rubella Project 1000 Patients from metropolitan New York Impact in USA > 1% of pregnancies Financial Costs for those in congregate supported housing: ~$175,000 /person/ year Human costs: immeasurable Courtesy: Dr Louis Z Cooper

44 Benefit Cost Ratios selected vaccines Vaccine Country Benefit Cost Ratios MMR Barbados 4.7 Guyana 38.8 Caribbean 13.3 Hepatitis B China Israel 2.8 Hib Chile 1.7 Israel 1.5 South Africa Source: Hinman et al 2002

45 Annual # of Doses Given (millions) Cumulative # since 2012 (millions) Projected annual and cumulative number of MR vaccine doses, Catch-up campaigns Sudan Pakistan Bangladesh Kenya Indonesia India India India Ethiopia DR Congo Nigeria Based on GAVI Strategic Demand Forecast, September 2012 (subject to change); No vaccines for follow-up campaigns nor routine immunization included in the forecast India and Indonesia plans are uncertain