Bharat Biotech has announced its next generation typhoid vaccine, Typbar-TCV, has demonstrated its safety and efficacy in a high risk human challenge clinical study carried out at Oxford University. The clinical studies produced 87% effectiveness as per the trial results published in Lancet.
The study was conducted in 112 adult volunteers and used a controlled human infection model. According the study published in Lancet vaccine is safe, 100% immunogenic, and prevents up to 87% of infections, when using real life definitions of typhoid fever. Efficacy data from this trial will help to fill a long existing knowledge gap regarding Vi-conjugate vaccines.
This data is highly significant since the currently available vi-ps typhoid vaccines cannot be administered to children below 2 years, and do not confer long term immunity. Typbar-TCV can be administered to children below 2 years of age and does confer long term immunity. Protection over a longer term reduces the need for repeat vaccinations.
According to Dr. Krishna Ella chairman & managing director, Bharat Biotech the vaccine’s effectiveness endorses more than 10 years of R&D efforts and various clinical trials that have been carried out over the past 8 years. The company has built dedicated facilities for the manufacture of this vaccine. Typbar TCV conjugated to tetanus toxoid vaccine human challenge study holds great promise particularly in of south Asia and sub-Saharan Africa. The company is working with the Consortium in carrying out field trials in different countries to evaluate its efficacy.
“Multidrug-resistant Salmonella typhi has become a major public health problem, as antibiotics are prescribed antibiotics for even common fever in developing nations. Citing example of drug resistance against typhoid fever found in Hyderabad city in Pakistan, he said this paves way for an early realisation of an effective vaccine to reduce typhoid burden.
“We are proud being world-first to pursue a high risk human challenge study and be successful. The trial led by Prof. Andrew Pollard, Director, Oxford Vaccine Group, was designed based on human infection models where many of the participants, mostly University students, were to consume a drink containing bacteria. The trial results clearly show that the new Typhoid Conjugate vaccine gives significantly superior performance compared to the Typhoid Vi polysaccharide vaccine,” he added.
“Typhoid is preventable and its control should be a global health priority. We are pleased to support the Typhoid Vaccine Acceleration Consortium as part of our overall strategy to combat typhoid through an integrated approach including access to clean water, improved sanitation, and immunization, ” said Anita Zaidi, director, Enteric and Diarrheal Diseases team, Bill & Melinda Gates Foundation.
The Product Summary File is to World Health Organisation for prequalification which would allow for UNICEF to procure the vaccine for low-income countries where the disease burden is high. TypbarTCV is currently licensed in India, Nigeria, and Nepal, with registrations underway in Malaysia, Turkey, Thailand, Uganda, Kenya, Bangladesh, Pakistan, Vietnam, among 30 other countries.