Biological E. unveils typhoid conjugate vaccine, commissions ₹300-cr plant near Hyderabad

Our Bureau Hyderabad | Updated on February 17, 2020

Representational image   -  scyther5

Biological E. Ltd on Monday commissioned its manufacturing plant at the Genome Valley Special Economic Zone near here and unveiled its new Typhoid Conjugate Vaccine (TCV).

TCV is an injectable single-dose vaccine to be administered to children, as old as six months, as well as adults. It contains Vi Polysaccharide derived from C. Freundii conjugated to CRM197 protein. The clinical studies conducted in India demonstrated that the safety and immunogenicity profiles of the vaccine are comparable to the other licensed and the WHO pre-qualified typhoid conjugate vaccine.

After inaugurating the new facility, Telangana IT and Industries Minister KT Rama Rao said: “We are committed to making Telangana the number one State in terms of industrial growth and employment generation with a special focus on life sciences. The foundation stone for the plant was laid during BioAsia 2017 and it is being inaugurated during the 17th edition of BioAsia today.”

Mahima Datla, Managing Director, Biological E. Ltd, said: “BE has invested around ₹300 crore for building this plant on a 29-acre land. The plant would generate employment for around 1,000 people and help our existing vaccine plant enhance the production and manufacture of new products in the pipeline.’’

Partnership with GSK Vaccines

Recently, BE received authorisation from the health regulatory authorities to license and market a new Typhoid Conjugate Vaccine. The approval from the Central Drugs Standard Control Organisation is based on a thorough assessment of the vaccine’s efficacy and safety profile.

The vaccine was developed in partnership with the GSK Vaccines Institute for Global Health, based in Siena (Italy), which first developed the asset and transferred it to BE in 2013. Subsequent developmental work on the vaccine was done by BE, including manufacturing process optimisation and scale up, pre-clinical studies and full clinical trials in India. The vaccine will be manufactured in BE’s GMP manufacturing facility in Hyderabad and could be commercially available within three months.

Thomas Breuer, Chief Medical Officer of GSK Vaccines, said : “Having this new vaccine approved is an important milestone for global health. It shows that GSK’s innovative and sustainable partnership model works to deliver vaccines to help protect people in developing countries against major health threats.”

Upon pre-qualification by WHO, which is expected this year, the new vaccine is anticipated to significantly contribute to the unmet public health need in developing countries by helping protect children against typhoid and by contributing to secure the supply of typhoid vaccines.

Published on February 17, 2020

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