WHO pre-qualifies Biological E’s typhoid vaccine
Hyderabad: Biological E has said that its Typhoid Conjugate Vaccine (TCV) has been pre-qualified by the World Health Organization (WHO), making the company one of two pre-qualified suppliers of TCV to the UN agencies.
BE’s TCV is a single-dose injectable vaccine that can be administered to children from six months of age to adults up to the age of 45, and it is formulated with Vi polysaccharide conjugated to a carrier protein (CRM197).
Clinical studies conducted in India have shown that the safety and immunogenicity profiles of this vaccine are comparable with those of the other WHO pre-qualified TCV. BE offers this vaccine as single-dose and multi-dose vials for ease of administration.
The vaccine was developed in collaboration with the GSK Vaccines Institute for Global Health (GVGH) based in Siena, Italy. The institute first developed the vaccine strain and transferred the technology to BE in 2013. BE further developed the vaccine, including manufacturing process optimisation and scale-up, pre-clinical studies and comprehensive phase I, II and III clinical trials in India. Currently, this vaccine is being manufactured in BE’s GMP manufacturing facilities in Hyderabad.
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