Biological E unveils its Typhoid Conjugate Vaccine, manufacturing plant at Genome Valley

Hyderabad:  The leading biopharmaceutical company, Biological E. Limited has unveiled its new Typhoid Conjugate Vaccine (TCV) on the sidelines of ‘BioAsia 2020’ at Hyderabad on 17th February. It was followed by the inauguration of its manufacturing plant in the Special Economic Zone at Genome Valley in Kolthur Village on the outskirts of the city.

Mr K T Rama Rao, the Minister for Information Technology, Industries & Commerce, Government of Telangana who inaugurated the plant appreciated expansion initiatives of Biological E. Addressing the gathering, Mr Rama Rao said, “We are committed to making the State of Telangana number one State in terms of industrial growth and employment generation with a special focus on life sciences. In fact, these growth engines will not only boost the economy of the State but also improve the livelihood of people, who depend directly or indirectly on these industries. We are happy to see that this massive state-of-the-art plant, the foundation stone for which was laid during BioAsia 2017, is getting inaugurated during this 17th edition of BioAsia today.’’

Welcoming the gathering, Ms. Mahima Datla, Managing Director, Biological E. Limited, while thanking the Minister for inaugurating the plant and unveiling the vaccine, mentioned, “BE has invested around Rs.300 crore for building this plant, which is now ready for commercial production, on about 29 acres of land. This Plant would generate employment opportunities for around 1000 people. This new facility will help our existing Vaccines Plant enhance the production and manufacturing of new products, which are in the pipeline.”

Recently, BE received the authorization from the health regulatory authorities of India to license and market a new Typhoid Conjugate Vaccine. The approval from the Central Drugs Standard Control Organisation (CDSCO) is based on a thorough assessment of the vaccine’s efficacy and safety profile.. TCV is an injectable single-dose vaccine to be administered to children from 6 months old as well as adults and 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 this vaccine are comparable to the other licensed and WHO Pre-qualified Typhoid conjugate vaccine.

This 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 optimization and scale up, pre-clinical studies and full clinical trials in India. This vaccine will be manufactured in BE’s GMP manufacturing facilities in Hyderabad, India and could be commercially available within 3 months.

With this authorization from CDSCO the vaccine is now approved to be marketed in India, and it also allows BE to submit the vaccine for WHO pre-qualification (PQ) and registration in several other countries. This will help to expand its current portfolio of seven WHO PQ vaccines.

“We are happy that our joint efforts have successfully produced a promising Typhoid vaccine. This is a remarkable milestone in our collaborative journey with the GSK Vaccine Institute for Global Health to save the maximum number of people, particularly children, around the world from Typhoid, which is deadly, yet vaccine preventable disease,” said Ms. Mahima Datla while commenting further on the development.

Dr Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented: “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 based on GSK latest science to help protect people in developing countries against major health threats. We are very pleased with the excellent and close collaboration with BE.”

Upon pre-qualification by WHO, which is anticipated in 2020, this new vaccine is anticipated to significantly contribute to the unmet public health need in developing countries by helping protect children against typhoid fever and by contributing to securing the supply typhoid vaccines.

It is estimated that in 2017, typhoid fever caused more than 116,000 deaths worldwide – more than a billion people are at risk globally with the highest morbidity and mortality in Asia (nearly 9 million cases and over 90,000 deaths). It is estimated that vaccination against Salmonella enterica serovar Typhi (S. Typhi) could help save thousands of lives.