This story is from October 02, 2017
Oxford study finds Bharat Biotech’s next gen typhoid vaccine efficacious
Hyderabad: City-based vaccine maker
“This data is highly significant since the currently available vi-ps typhoid vaccines cannot be administered to children below two years, and do not confer long term immunity. Typbar-TCV can be administered to children below two years of age and does confer long-term immunity. Protection over a longer term reduces the need for repeat vaccinations,” Bharat Biotech said in a press communique.
According to the company, the results of the study, which was conducted in 112 adult volunteers and used a “controlled human infection model”, clearly show that the new Typhoid Conjugate vaccine gives significantly superior performance as compared to the Typhoid Vi polysaccharide vaccine, the company said. Commenting on the study, Bharat Biotech chairman and managing director Dr Krishna Ella said: “The 87% effectiveness success endorses 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.” Pointing out that Bharat Biotech has already built dedicated facilities for the manufacture of this vaccine, Ella said that the study paves the way for an early realisation of an effective vaccine that can help reduce the typhoid fever disease burden faced by millions of families. “Multidrug-resistant salmonella typhi has become a major public health problem, as more people are being prescribed antibiotics for even common fever in developing nations,” he said. Bharat Biotech is working with the Typhoid Vaccine Acceleration Consortium in carrying out field trials in different countries to evaluate the efficacy of TypbarTCV. The Product Summary File has been submitted to World Health Organisation for prequalification, which would allow for UNICEF to procure this vaccine for low-income countries where the disease burden is very high. TypbarTCV is currently licenced in India, Nigeria, and Nepal, with registrations underway in Malaysia, Turkey, Thailand, Uganda, Kenya, Bangladesh, Pakistan and Vietnam, among 30 other countries. Typhoid is caused by the bacterium Salmonella Typhi, and is responsible for around 20 million new infections and 200,000 deaths each year, mainly in South and South East Asia and Africa.
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Bharat Biotech
on Monday said that its next generation typhoid vaccine, Typbar-TCV, has demonstrated its safety and efficacy in a high risk human challenge clinical study carried out at Oxford University. According to the study published in The Lancet, the vaccine is safe, 100% immunogenic, and prevents up to 87% of infections when using real life definitions of typhoid fever.According to the company, the results of the study, which was conducted in 112 adult volunteers and used a “controlled human infection model”, clearly show that the new Typhoid Conjugate vaccine gives significantly superior performance as compared to the Typhoid Vi polysaccharide vaccine, the company said. Commenting on the study, Bharat Biotech chairman and managing director Dr Krishna Ella said: “The 87% effectiveness success endorses 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.” Pointing out that Bharat Biotech has already built dedicated facilities for the manufacture of this vaccine, Ella said that the study paves the way for an early realisation of an effective vaccine that can help reduce the typhoid fever disease burden faced by millions of families. “Multidrug-resistant salmonella typhi has become a major public health problem, as more people are being prescribed antibiotics for even common fever in developing nations,” he said. Bharat Biotech is working with the Typhoid Vaccine Acceleration Consortium in carrying out field trials in different countries to evaluate the efficacy of TypbarTCV. The Product Summary File has been submitted to World Health Organisation for prequalification, which would allow for UNICEF to procure this vaccine for low-income countries where the disease burden is very high. TypbarTCV is currently licenced in India, Nigeria, and Nepal, with registrations underway in Malaysia, Turkey, Thailand, Uganda, Kenya, Bangladesh, Pakistan and Vietnam, among 30 other countries. Typhoid is caused by the bacterium Salmonella Typhi, and is responsible for around 20 million new infections and 200,000 deaths each year, mainly in South and South East Asia and Africa.
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