Updated 2011 WHO Rubella Vaccine Position Paper and Implications for Regions and Countries

1. Updated 2011 WHO Rubella Vaccine Position Paper and Implications for Regions and Countries 10th Measles Initiative Meeting September 13-14, 2011, Washington DC Susan. E. Reef, CDC/GID/DEEB Peter M. Strebel, WHO/HQ/IVB/EPI

2. Outline • Global and regional status • CRS burden • Vaccine uptake and regional goals • 2011 WHO Rubella Vaccine Position paper • Vaccine Strategy Recommendations • Modeling Examples • GAVI update • Summary

3. Updated Estimates of the Burden of CRS, globally*† in 1996 and 2008 *unpublished, Adams E, Vynnycky E †All member states

4. Rubella Vaccine Use by WHO Region, 1996 vs. 2010

5. WHO Regions by Rubella/CRS Control Target (2011) EUR-Rubella Elimination 2015 WPR-Accelerated Rubella Control and CRS Prevention 2015 AMR- Rubella Elimination 2010 EMR-National CRS Prevention

6. 2011 WHO Rubella Vaccine Position Paper

7. Purpose and Approaches • The primary purpose is to prevent the occurrence of congenital rubella infection including CRS • Two general approaches to using rubella vaccine: • CRS reduction only through immunization of adolescent girls and/or women of childbearing age (WCBA) • Interruption of rubella virus transmission, thereby eliminating rubella as well as CRS. • Introduction of RCV in the routine childhood immunization schedule combined with vaccination of older age groups who are susceptible to rubella.

8. Countries planning to introduce RCV • Should review the epidemiology of rubella and assess the burden CRS • Establish rubella/CRS prevention as a public health priority • Depending on the burden of CRS and available resources, countries should determine their goal and time frame for achieving it • Introduction of RCV implies a long-term commitment to achieving and maintaining sufficient immunization coverage to ensure sustained reduction in CRS incidence. • Strong political commitmentto the elimination of rubella and CRS, and sustainable financingfor vaccination and surveillance activities must be in place before initiating rubella vaccination.

9. Field and laboratory surveillance • Should be fully integrated with measles in a single surveillance system • Need to document the impact of rubella vaccination: • laboratory-supported surveillance for rubella and CRS surveillance • molecular epidemiology • monitoring of vaccine coverage • monitoring population immunity using seroprevalence surveys where appropriate.

10. Rubella/CRS Elimination • SAGE recommends that countries should take the opportunity of the two dose measles vaccine strategy to use MR or MMR vaccine. • The preferred approach is to begin with MR vaccine or MMR vaccine in a wide-age range campaign followed immediately with introduction of MR, or MMR vaccine in the routine program. • The first dose of MR vaccine can be delivered at 9 months or 12 months of age depending on the level of measles virus transmission[1]. • Only one dose of RCV is needed to achieve rubella and CRS elimination • All subsequent follow-up campaigns should use MR vaccine or MMR vaccine. [1] See Wkly Epid Rec No. 35, 2009, pp. 349-360.

11. Paradoxical Effect • Sustained low rubella immunization coverage in infants and young children (for example, when rubella vaccine is used in the private sector alone) will result in an increase in susceptibility among WCBA that may increase the risk of CRS (i.e., a paradoxical effect). • However, if vaccination coverage is sufficiently high, rubella transmission will be markedly reduced or interrupted, thereby removing the risk of rubella exposure for pregnant women.

12. Minimum coverage required • SAGE recommends that countries introducing RCV should achieve and maintain immunization coverage of 80% or greater with RCV delivered through routine services and/or regular SIAs.

13. Predictions of the effect of combining 80% routine RCV coverage among 1 yr olds from 2010 in Ethiopia (Addis Ababa) with a starting mass campaign (1-15 yr olds) with + without subsequent SIAs (1-4 yr olds), with 80% coverage Mass campaign + routine Mass campaign + routine + 4 yearly SIAs Routine only CRS incidence/100,000 livebirths Years since the start of vaccination

14. CRS Reduction Alone • Vaccination of adolescent and adult females only • Through either routine services or SIAs • Provides direct protection to WCBA • Impact is limited by the coverage achieved and the age groups targeted • In the absence of vaccination of infants and young children, rubella continues to circulate resulting in ongoing exposure of pregnant women and the associated risk of CRS.

15. GAVI • Timeline for support • 2008 –Selected HPV, JE, typhoid and rubella vaccines to support but due to the financial crisis, did not make any financial commitment. • 2011 – GAVI Accelerated Vaccine Introduction (AVI) worked with subteams to develop Vaccine Introduction Strategy (VIS) for HPV, JE, typhoid and rubella vaccines • September - PPC Program and Policy Committee will review proposed strategies • November – GAVI board will the recommended strategies from the PPC

16. Summary • Burden of CRS greatest in regions that most of the countries are not using rubella vaccine and have no regional control goal • Risk of CRS is greater than the risk of a paradoxical effect • SAGE is recommending countries use the measles vaccine delivery strategy to introduce rubella vaccine • "every dose of single antigen measles vaccine is a missed opportunity for prevention of CRS" • Requirements are political and financial commitment to achieve and maintain coverage at >80% • GAVI is considering supporting rubella vaccine introduction

17. Thank You