Rotavirus vaccination: Issues & IAPCOI perspectives

Vipin M. Vashishtha, MD, FIAPConvener, IAPCOI 2011-13

vipinipsita@gmail.com

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?