1. Rotavirus vaccination: Issues & IAPCOI perspectives Vipin M. Vashishtha, MD, FIAP Convener, IAPCOI 2011-13 vipinipsita@gmail.com August 24 th & 25 th 2012 Mid-term Meeting of IAPCOI, The Hyatt Regency Hotel, Mumbai

2. Issues: Individual protection: for office practice setting Public use: Mass use of RV vaccines through introduction in to NIP

3. I. Individual Protection:

4. Need to offer RV vaccine: Is there sufficient need? What hierarchy in relation to other routine pediatric vaccines?

5. Status of RV vaccine: What ought to be the relative status of RV vaccine in individual child’s immunization record? Vs Hib Vs IPV Vs PCV Vs acellular pertussis

6. How best to optimize performance of available RV vaccines in office setting? Issues to confront with: Type of vaccine? Number of doses? Schedule? Age restriction? Co-administration with OPV? Role of breast feeding? Recommendation on spitting/regurgitation?

7. Issues with RV1: Do we have ANY data on even immunogenicity of RV1 at 6, 10 weeks schedule in India? Are we justified in recommending TWO dose 6 & 10 weeks schedule even in suboptimal sero- conversion rates?

9. Immunogenicity of RV1:

10. II. Public use

11. Issues to confront with: Is there sufficient disease burden to merit mass vaccination? Are the available vaccines ‘potent’ enough to meet the challenge?

12. Are the available vaccines ‘potent’ enough? Adequate efficacy & effectiveness against RV disease What level of evidence do we have? Do we have ‘proper match’?

13. How to address the issue of poor efficacy of oral vaccines in India? Using higher potency ? Using more doses ? Use different schedule: late administration? Increasing interval between doses? Co-administration with other vaccines: ‘Separate’ with other oral vaccines? Use buffers? Issuing precaution regarding breastfeeding?

14. Are the available RV vaccines safe? Do we have background rates for IS? Do we have adequate PMS data on IS associated with RV vaccine use in India?

15. Issues with RV1 in India Do we have adequate data on efficacy of RV1 on 6, 10 week schedule? Need a demonstrative project on 2 Vs 3 doses of RV1 in India? Need to assess the potential benefits of a 3 rd dose of RV1 in India?

19. RV Vaccines: administration schedule Should all RV vaccine be used in a three or more-dose schedule? Should age-restriction on RV vaccines be removed?

21. Indian Rotavirus vaccine (116E) What is the current status of phase 3 trial? Any preliminary report on efficacy?

22. Cost-effectiveness of mass RV vaccination Is there any ongoing cost-effective analysis from India?

23. RV Vaccines: futuristic issues What is the pipeline for new RV vaccines? Role of a neonatal RV vaccine? Status of parenteral RV vaccine? Inactivated RV vaccines?