Rotavirus vaccination: Issues & IAPCOI perspectives
Vipin M. Vashishtha, MD, FIAPConvener, IAPCOI 2011-13
August 24th & 25th 2012 Mid-term Meeting of IAPCOI,
The Hyatt Regency Hotel, Mumbai
Issues:
• Individual protection: for office practice setting
• Public use: Mass use of RV vaccines through introduction in to NIP
I. Individual Protection:
I. Individual Protection:
• Need to offer RV vaccine: Is there sufficient need?
• What hierarchy in relation to other routine pediatric vaccines?
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
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?
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?
Immunogenicity of RV1:
II. Public use
Issues to confront with:
• Is there sufficient disease burden to merit mass vaccination?
• Are the available vaccines ‘potent’ enough to meet the challenge?
Are the available vaccines ‘potent’ enough?
• Adequate efficacy & effectiveness against RV disease
• What level of evidence do we have? • Do we have ‘proper match’?
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?
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?
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?
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?
Indian Rotavirus vaccine (116E)
• What is the current status of phase 3 trial?• Any preliminary report on efficacy?
Cost-effectiveness of mass RV vaccination
• Is there any ongoing cost-effective analysis from India?
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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