WHO pre-qualifies Biological E’s typhoid conjugate vaccine

New Delhi: Hyderabad-based Biological E. Limited (BE) on Friday announced that its Typhoid Conjugate Vaccine (TCV) has been pre-qualified by the World Health Organisation (WHO). With this pre-qualification, BE became one of two pre-qualified suppliers of TCV to the UN agencies.

BE’s TCV is a single-dose injectable vaccine, which can be administered to children from 6 months of age to adults up to the age of 45 and it is formulated with Vi polysaccharide conjugated to a carrier protein (CRM₁₉₇). The Vi polysaccharide antigen used in BE’s TCV is derived from C. freundii, which is a non-pathogenic source (BSL 1 organism), compared to virulent Salmonella Typhi used by other manufacturers, and the carrier protein used for conjugation is a non-toxic CRM₁₉₇ protein locally developed by BE through in-house R&D effort. 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, which first developed the vaccine strain and transferred the technology to BE in 2013. BE has 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. Today, this vaccine is being manufactured in BE’s GMP manufacturing facilities in Hyderabad, India.

“This is a remarkable accomplishment and a significant milestone in the journey of our vaccines. I am delighted that we have been able to produce a new WHO pre-qualified vaccine. We believe that every year this vaccine would save about 1.5 Lakh people worldwide,” said Mahima Datla, Managing Director, Biological E. Limited.

“GSK, through its R&D efforts at GVGH, is proud to have played an essential role in providing technologies to Biological E for their Typhoid Conjugate Vaccine (TCV),” said Francesco Berlanda-Scorza, GVGH Director. For more than a decade, GVGH has been advancing vaccines for under-recognised diseases, and as a result of an innovative partnership with Biological E to develop this vaccine, and TCV prequalification by WHO, many more children will have access to a much-needed intervention for the prevention of typhoid fever.”

In March 2020, BE received approval from India's health regulators to authorise and market a new TCV (BE’s product TYPHIBEV) for infants, children and adults from 6 months.

This pre-qualification from WHO allows BE to make a significant contribution to unmet public health needs in developing countries by helping to protect children against typhoid and helping to secure the supply of vaccines against typhoid.