Bharat planning Indian submission for rotavirus vaccine

Bharat Biotech International Ltd. (Hyderabad, India) said oral Rotavac significantly reduced severe rotavirus diarrhea by 56% during the first year of life vs. placebo in an Indian Phase III trial to prevent rotavirus gastroenteritis. Bharat said protection from severe rotavirus diarrhea continued into the second year of life, but could not be reached for details. The double-blind trial enrolled 6,799 infants aged 6-7 weeks at the time of enrollment to receive three doses of Rotavac or placebo at 6, 10 and 14 weeks of age co-administered with childhood vaccines against diphtheria, pertussis, tetanus, influenza B, HBV and polio. Data were presented at the International Symposium on Rotavirus Vaccines for India in New Delhi.

Rotavac -- a live attenuated 116E rotavirus monovalent vaccine -- was developed in collaboration with the India's Department of Biotechnology, NIH's National Institute of Allergy and Infectious Diseases (NIAID), the U.S. Centers for Disease Control and Prevention, Stanford University School of Medicine, the Bill & Melinda Gates Foundation and Program for Appropriate Technology in Health (PATH). ...