A single-dose injectable Typhoid Conjugate Vaccine of Biological E has been pre-qualified by the World Health Organisation, making the vaccine maker one of two pre-qualified suppliers of TCV to UN agencies. Manufactured at its GMP manufacturing facilities in Hyderabad, the vaccine was developed in collaboration with the GSK Vaccines Institute for Global Health, Italy.
GVGH had developed the vaccine strain and transferred the technology to BE in 2013. The company further developed the vaccine, including manufacturing process optimisation and scale up, pre-clinical studies and clinical trials for Phase I, II/III in India, a BE release said.
Terming the pre-qualification a remarkable accomplishment and a significant milestone for the company, BE Managing Director Mahima Datla said, “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.”
The pre-qualification allows BE to make a “significant contribution to unmet public health needs in developing countries by helping protect children against typhoid and helping to secure the supply of vaccines against typhoid,” the company said.
BE’s TCV can be administered to children from six months of age to adults up to the age of 45. It is formulated with Vi polysaccharide conjugated to a carrier protein (CRM197). The release said the Vi polysaccharide antigen is derived from C. freundii, a non-pathogenic source (BSL 1 organism), compared to virulent Salmonella Typhi used by other manufacturers. The carrier protein used for conjugation is a non-toxic CRM197 protein locally developed by BE through in-house research and development.
Clinical studies in India have shown 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. In March, it had received approval from India’s health regulators to authorise and market a new TCV (BE’s product TYPHIBEV) for infants, children and adults, the release said.
According to WHO website, prequalification ensures vaccines used in immunisation programmes are safe and effective. The pre-qualification provides Member States and procurement agencies such as Gavi, the Vaccine Alliance, the Global Fund and UN organisations like UNICEF, with the information required to purchase vaccines matching the specific needs of the programme.