Bharat Biotech’s Typbar TCV, the world’s first clinically proven typhoid conjugate vaccine, has received pre-qualification from the World Health Organisation (WHO). The WHO pre-qualification enables procurement and supplies of this life-saving vaccine to UNICEF, Pan-American Health Organization (PAHO) and Global Alliance for Vaccines and Immunisation (GAVI)-supported countries. With this, Typbar TCV becomes one of the top 10 brands in the pharmaceutical sector and the company has an addressable traveller market opportunity of $2 billion globally. Typbar TCV has been evaluated in human challenge studies at Oxford University and typhoid conjugate vaccines have been recommended by WHO’s strategic advisory group of experts on immunisation (WHO-SAGE). It is the fourth generation vaccine against typhoid, proven to provide long-term protection to adults and infants – six months and older. Currently available typhoid vaccines fall short in two major characteristics, namely long-term protection and protection for children below two years of age, the population that needs it the most.
Highlighting the importance of WHO pre-qualification, Krishna Ella, CMD of Bharat Biotech, said: “Typbar TCV is the first typhoid conjugate vaccine, clinically proven to be administered to children from six months of age to adults and confers long-term protection against typhoid fever. When we started this project, typhoid fever was a neglected tropical disease.” The company has so far invested Rs 150 crore in the last 12 years on development of the vaccine and has a dedicated manufacturing facility for it. There is also a committed investment from the University of Maryland and Bill and Melinda Gates Foundation for about $36.9 million to undertake further research. Ella said the board of GAVI has an approved funding of $85 million for 2018-2019 and is willing to fund $200 million by 2020 for procurement programmes in developing countries, as the disease incidence rate is about 17.8 million people globally.
To be priced at Rs 1,500 per dose, Typbar TCV has been evaluated in several clinical trials, in several thousand healthy adults and children across 21 sites in India and the UK. Active post-marketing surveillance is going on and has been completed in more than 7,000 subjects since the launch of the vaccine in 2013. The company holds a portfolio of 60 patents and has delivered more than three billion doses of vaccines to over 65 countries. With five years of follow up data for seroconversion, Typbar TCV at 25µg/dose has proven to be long-term protection for children and adults.
“With the recent GAVI board approval of an $85-million funding window to make the typhoid conjugate vaccine available in GAVI-supported countries, we now expect first introductions to take place as soon as the the first half of 2019,” Seth Berkley, CEO of Gavi said. “For Typbar TCV to reach vulnerable populations, the price is $1.50 per dose for procurement for GAVI-supported countries. Also, recognising the importance of sustained vaccine procurement for low income and low-middle income countries, and in the interest of global public health, we announce a further price reduction to around $1 or below per dose, post procurement of 100 million doses for LICs and LMICs (low and middle income countries),” Ella said
Meanwhile, in its efforts to become a comprehensive healthcare solutions provider for vaccine-preventable infectious diseases, Bharat Biotech has partnered with the University of Maryland and the Wellcome Trust to develop and evaluate vaccines for non-typhoidal salmonella (NTS) against serovars typhimurium and enteritidis. To provide global access to typhoid conjugate vaccines, the company is collaborating with the Clinton Health Access Initiative. Bharat Biotech will supply up to 50 million doses per year and is working on expanding its manufacturing capacity to reach about 200 million doses. Registrations for Typbar TCV are in process in more than 30 countries. Tt is already registered in India, Nigeria, Cambodia and Nepal.