116E Rotavirus Vaccine Efficacy Against Death is 10% of Projected Figures. Comment on: Team science and the creation of a novel rotavirus vaccine in India: a new framework for vaccine development.


J Puliyel

The time lines described by Professor Bhan <PMID: 24629993> suggest that the private manufacturer to set up the plant for manufacture of this vaccine was funded by PATH, B&MG and the Government of India (DBT) in 2000, where as the Phase 3 trial only started in 2008. It is clear that regardless of efficacy in the phase 3 trial (or any objections by NTAGI members,) the vaccine had to be rolled out, if there was to be any returns on the investment.

I am less concerned about this waste of scarce resources - I am more concerned about safety <http://www.ncbi.nlm.nih.gov/pubmed/25091662#cm25091662_5770>. Dr Bhan has promised complete transparency with the data. I have written to him asking for the safety data in each of the three centers (which has not been published except in an aggregated form). This will help us understand the situation with regard safety issues better. I await his reply which he could share with this group in the interest of transparency.”