Bharat Biotech says typhoid vaccine shown to be safe, effective in human trials
Bharat Biotech Ltd, a Hyderabad-based vaccine maker, said its next-generation typhoid vaccine, Typbar-TCV, had demonstrated its safety and efficacy in a high-risk human challenge clinical study carried out at Oxford University.
The clinical studies showed 87% effectiveness as per the trial results published in Lancet, the company said in an official statement on Monday. The Lancet study demonstrated that immunization with Typbar-TCV is safe, well tolerated and will have significant impact on disease incidence in typhoid-endemic areas that introduce the vaccine. This study was conducted in 112 adult volunteers and used a “controlled human infection model”.
According the Lancet study, the vaccine is safe, 100% immunogenic and prevents 55% of typhoid infections in the challenge trial and up to 87% of infections, when using real-life definitions of typhoid fever.
“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,” the statement said.
“The results of this study and the 87% effectiveness success endorse more than 10 years of research and development efforts to develop this vaccine and various clinical trials that have been carried out over the past eight years. The company has built dedicated facilities for the manufacture of this vaccine,” said Krishna Ella, chairman and managing director of Bharat Biotech.
Multi-drug-resistant Salmonella typhi has become a major public health problem, as more people are prescribed antibiotics for even common fever in developing nations.
The trial led by Andrew Pollard, director, Oxford Vaccine Group, was designed based on human infection models where many of the participants, mostly university students, were to consume a drink containing bacteria.
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. Although typhoid as a disease is amenable to antibiotics treatment, increasing frequencies of multi-drug resistance is posing a serious threat and limiting the effectiveness of such treatments.
The Product Summary File has been submitted to the World Health Organization (WHO) for prequalification. WHO prequalification would allow for Unicef to procure this vaccine for low-income countries where the disease burden is very high, the statement said.
TypbarTCV is currently licensed in India, Nigeria and Nepal, with registrations underway in Malaysia, Turkey, Thailand, Uganda, Kenya, Bangladesh, Pakistan and Vietnam.
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