Bharat Biotech Launches Typhoid Conjugate Vaccine

Bharat Biotech has launched the world’s first typhoid vaccine that can be given to infants older than six months.

AsianScientist (Sep. 2, 2013) – Bharat Biotech has launched the world’s first typhoid vaccine that can be given to infants older than six months.

The Hyderabad, India-based company is already the world’s largest producer and supplier of Vi typhoid vaccine, having distributed over 50 million doses globally. But currently available typhoid vaccines fall short in two major characteristics, namely long term protection and protection for the critical group that requires it most: children below two years of age.

Typbar-TCV™, a fourth generation vaccine against typhoid disease, was evaluated in 1,200 healthy subjects at nine clinical sites, where it demonstrated long term protection to adults and infants six months and older.

In the pivotal Phase III clinical study, the conjugate vaccine presented 98 percent seroconversion in infants aged 6 months to 24 months, 99 percent in children between 2 to 15 years of age, and 92 percent in the 15 to 45 year age group, as measured by four-fold increase in serum IgG responses. It also proved superior to the Vi polysaccharide typhoid vaccines, and was safe and well tolerated in all tested age groups.

“We hope this vaccine will reach millions of people and help reduce the burden of this devastating disease in infants and children,” said Dr. Krishna M. Ella, Chairman and Managing Director of Bharat Biotech.

Typhoid fever is a life threatening illness caused by the bacterium Salmonella typhi, which is transmitted through food or drink contaminated by the feces or urine of infected people. Symptoms include high fever, malaise, headache, constipation, diarrhea, etc. A healthy carrier state may follow acute illness.

According to the World Health Organization, 90 percent of typhoid deaths occur in Asia and persists mainly in children under five years of age. In India, typhoid fever is observed throughout the year and a greater number of cases coincide with the rainy season. While typhoid fever can be cured by antibiotics, resistance to antimicrobials is widespread along with poor diagnostics, hence prevention of typhoid fever is better than the cure.

“Typhoid fever remains an important public health challenge in many countries of the world mainly because of poor diagnostics and increasing resistance to antibiotics. At present fundamental prevention strategies like improved sanitation, good hygienic practices and access to clean water are still out of reach for many impoverished communities. One of the most cost effective approaches to prevent infectious diseases, are vaccines which are available now and could help control the disease resulting in reduction of unnecessary suffering and adverse financial consequences.” Dr. Christian Loucq, M.D., Director-General of the International Vaccine Institute (IVI) said.

Bharat Biotech has commenced commercial production of Typbar-TCV™ in pre-filled syringes at its vaccine production facility in Genome Valley. The plant has the capacity to produce 10 million doses each year, and up to 50 million doses per year in the future. The vaccine will soon be supplied to global markets such as South East Asia, South America, Africa, Central Asia, and South Asia.

In May, the company released positive Phase III results for its novel rotavirus vaccine, which may soon be available for just US$1 per dose.

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Source: Bharat Biotech.
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