Biological E completes Phase III trials of JE vaccine

City-based drug maker Biological E Limited (BE) has successfully completed Phase II and III study of inactivated Japanese Encephalitis (JE) vaccine on healthy infants of 1 to 3 years old across eight sites in India.

“This is an important milestone in the clinical development of this vero cell based inactivated JE vaccine manufactured in India based on the technology transfer agreement with Intercell,” the company said in a release on Friday. 

Intercell AG is a Vienna-based biotechnology company engaged in the development of vaccines for prevention of infectious diseases. The results of the study would be submitted to the Indian regulatory authority for licensure.

BE said its inactivated JE vaccine (JEEV) was not produced in mouse brains, but in vitro using cell culture. Hence, there was reduced risk of rare autoimmune neurological complications.  

“We are excited about the successful completion of our Phase-II/III clinical study, which enables us to offer this novel and safe vaccine to combat Japanese Encephalitis not only in India but also across Asia,” BE chairman and managing director, Vijay Kumar Datla, said.

JE is stated to be the leading cause of viral encephalitis in Asia, with 30,000–50,000 cases reported annually. Case-fatality rates range from 0.3 per cent to 60 per cent and depends on the population and on age. There is no specific treatment for JE and therapeutic management is only supportive.