Vaccine maker Bharat Biotech’s next generation typhoid vaccine, Typbar-TCV, has demonstrated its safety and efficacy in a clinical study carried out at the Oxford University.
“Published in The Lancet , the study is the first to demonstrate that immunisation with Typbar-TCV is safe, well tolerated and will have significant impact on disease incidence in typhoid endemic areas that introduce the vaccine,’’ the Hyderabad-based company said in a release issued here on Monday.
This is the first clinical trial which was conducted in 112 adult volunteers and used a “controlled human infection model”.
According to the study, the vaccine is safe, 100 per cent immunogenic, and prevents 55 per cent of typhoid infections in the challenge trial and up to 87 per cent of infections, when using real life definitions of typhoid fever.
“The results of this study and the 87 per cent effectiveness success endorse more than 10 years of R&D efforts to develop this vaccine and various clinical trials that have been carried out over the past eight years,” said Krishna Ella, Chairman & Managing Director.
The Product Summary File has been submitted to World Health Organisation (WHO) for pre-qualification. WHO pre-qualification will allow for UNICEF to procure this vaccine for low-income countries where the disease burden is very high.
TypbarTCV is currently licensed in India, Nigeria, and Nepal, with registrations under way in Malaysia, Turkey, Thailand, Uganda, Kenya, Bangladesh, Pakistan, Vietnam.