Diarrhea is a leading cause of death and morbidity in children worldwide. Prior to the 1970’s the main infectious cause was unknown and Gastroenteritis Wards were common in Children’s Hospitals in Australia. As a result of a collaboration between Clinicians and Scientists at the Melbourne Royal Children’s Hospital and the University of Melbourne, using a novel approach, rotavirus was identified in the small bowel biopsies of children with acute severe gastroenteritis. Following on from this landmark discovery rotavirus was subsequently identified in the stool of children with acute severe dehydrating gastroenteritis globally, providing the target for the development of vaccines for prevention of severe rotavirus disease. Today over 114 countries have introduced a rotavirus vaccine into their national or regional immunisation program.
The RV3-BB vaccine is a novel human neonatal vaccine developed at MCRI to target prevention from severe rotavirus disease from birth. Clinical trials of RV3-BB vaccine have been conducted in Australia, New Zealand, Indonesia and Malawi. RV3-BB vaccine has been shown to be safe, immunogenic and efficacious when administered in a neonatal or infant administration schedule. In Indonesian babies, RV3-BB was associated with a protective efficacy of 94% at 12 months of age and 75% at 18 months of age when administered in the neonatal schedule. RV3-BB vaccine has now been licensed to emerging country vaccine manufacturers with the aim to provide an affordable vaccine. Indonesian manufactured (PT BioFarma) RV3 vaccine is planned for introduction into the national immunisation program in Indonesia in 2023.