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Rotavirus vaccination : Issues & IAPCOI perspectives

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

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Rotavirus vaccination : Issues & IAPCOI perspectives

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

  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. I. Individual Protection: • 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 acellularpertussis

  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?

  8. Immunogenicity of RV1:

  9. II. Public use

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

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

  12. 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?

  13. 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?

  14. 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 3rd dose of RV1 in India?

  15. 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?

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

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

  18. 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?

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