HYDERABAD: Biopharma player Biological E Ltd on Friday said its Typhoid Conjugate vaccine (TCV) TYPHIBEV has received World Health Organisation (WHO) prequalification, making BE one of the only two prequalified suppliers of TCV to UN agencies. BE’s TCV is available as single and multi-dose vials.
Biological E said its TCV, which can be administered to children from 6 months of age to adults up to the age of 45, is a single-dose injectable vaccine that is formulated with Vi polysaccharide conjugated to a carrier protein (CRM197).
The Hyderabad-based company said that the Vi polysaccharide antigen used in the vaccine is derived from C freundii, which is a non-pathogenic source (BSL 1 organism) as compared to the virulent Salmonella Typhi used by other manufacturers. The carrier protein used for conjugation is a non-toxic CRM197 protein locally developed by the company through in-house R&D efforts, it added.
The vaccine was developed in collaboration with the Italy-based GSK Vaccines Institute for Global Health (GVGH), which first developed the vaccine strain and transferred the technology in 2013 to BE, which further developed the vaccine, including manufacturing process optimization and scale-up, pre-clinical studies, and comprehensive clinical trials for Phase I, II/III in India. The company is manufacturing the vaccine at its GMP manufacturing facilities in Hyderabad.
Terming the WHO prequalification as a significant milestone in the company’s journey, Biological E MD Mahima Datla said the company expects the vaccine to save about 1.5 lakh people worldwide.
