Hyderabad: Bharat Biotech on Wednesday said its Typbar TCV or the typhoid conjugate vaccine against typhoid fever, has received pre-qualification from the World Health Organisation (WHO).
This enables the procurement and supplies of this vaccine to UNICEF, Pan-American Health Organisation (PAHO) and GAVI-supported countries, the Hyderabad-based company said in a statement. 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 immunisation (WHO-SAGE), it said.
“Typbar TCV is the first typhoid vaccine, clinically proven to be administered to children from six months of age to adults and confers long term protection against typhoid fever," the company said. 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. 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, according to the company.
With five years of follow up data for seroconversion, Typbar TCV at 25µg / dose has proven long term protection for children and adults alike, and can be administered to children from six months of age, the statement said. Dr Krishna Ella, chairman and managing director of Bharat Biotech, said, “Typbar TCV is the first typhoid conjugate vaccine, clinically proven to be administered to children from six months of age to adults and confers long term protection against typhoid fever."
According to Oxford University professor Andrew Pollard, “the WHO prequalification of Typbar TCV marks an important milestone in the global effort to rid the world of typhoid fever and improve health for some of the most vulnerable populations in the world".
With the aim to accelerate the introduction of new typhoid conjugate vaccines as part of an integrated approach to reduce the burden of typhoid disease, Bharat Biotech has partnered with the Typhoid Vaccine Acceleration Consortium (TyVAC), a union between the Centre for Vaccine Development at the University of Maryland, the Oxford Vaccine Group at Oxford University, and PATH.
The consortium is conducting effectiveness studies for typhoid conjugate vaccines in Nepal, Malawi, and Bangladesh. Bharat Biotech has donated 50,000 doses of Typbar TCV, towards the conduct of these studies, it was stated.