The Hyderabad-based company claims that Typbar TCV is the world's first clinically proven TCV.
The WHO pre-qualification enables the procurement and supplies of this life saving vaccine to Unicef, the Pan-American Health Organization (PAHO) and GAVI (a vaccine alliance) supported countries.
Typbar TCV has been evaluated in Human Challenge Studies at Oxford University and typhoid conjugate vaccines have been recommended by WHO's Strategic Advisory Group of Experts on Immunization (WHO-SAGE).
Typbar TCV is the first typhoid vaccine, clinically proven to be administered to children from 6 months of age to adults and confers long term protection against typhoid fever, said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech.
International Health Metrics and Evaluation (IHME) estimates that in 2016, there were approximately 12 million cases of typhoid fever resulting in around 130,000 deaths.
Typhoid fever is caused by the bacterium Salmonella Typhi (S. Typhi), which infects humans due to contaminated food and beverages from sewage and other infected humans.
Currently a third of the global population is at risk of typhoid fever, which results in reduced school attendance, loss of work and wages, lowered pregnancy outcomes and impaired physical and cognitive development of children.
Typbar TCV is a result of dedicated product development at Bharat Biotech since 2001, where all aspects of the product profile were studied and evaluated in human clinical trials.
WHO-SAGE recommended the use of typhoid conjugate vaccines for use in infants between 6 and 23 months of age and catch up vaccinations for children between 2 and 15 years of age. This recommendation paves the way for countries to introduce the vaccine into their immunization programs.
"With the recent Gavi Board approval of a $85 million funding window to make the typhoid conjugate vaccine available in Gavi-supported countries, we now expect the first introductions to take place as soon as the first half of 2019," said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance.
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