Bharat Biotech’s typhoid vaccine gets WHO prequalification tag

Krishna Ella, chairman and managing director of Bharat Biotech, holds a package of the typhoid vaccine Typbar-TCV during a press conference in Hyderabad.
Bharat Biotechs typhoid vaccine gets WHO prequalification tag
Krishna Ella, chairman and managing director of Bharat Biotech, holds a package of the typhoid vaccine Typbar-TCV during a press conference in Hyderabad.

NEW DELHI: The World Health Organization (WHO) has given its nod to Bharat Biotech’s typhoid vaccine Typbar TCV, which has longer-lasting immunity than existing vaccines, requires fewer doses and can be used on recipients over six months of age.
The WHO prequalification paves the way for health and humanitarian organizations such as UNICEF, GAVI and Pan- American Health Organization to procure it for public health vaccination programs across the world.
“The fact that the vaccine has been prequalified by the WHO means that it meets acceptable standards of quality, safety and efficacy.
“This makes the vaccine eligible for procurement by UN agencies such as UNICEF, and Gavi, the Vaccine Alliance,” the WHO said in a statement.
In October 2017, the Strategic Advisory Group of Experts (SAGE) on immunization, which advises the WHO, recommended TCV for routine use in children over 6 months of age in typhoid endemic countries.

SAGE also called for the introduction of TCV to be prioritized for countries with the highest burden of typhoid disease or of antibiotic resistance to Salmonella Typhi, the bacterium that causes the disease.
“Use of the vaccine should also help to curb the frequent use of antibiotics for treatment of presumed typhoid fever, and thereby help to slow the alarming increase in antibiotic resistance in Salmonella Typhi,” the statement said.
Typhoid is a serious and sometimes fatal disease spread through contaminated food and water. Symptoms include fever, fatigue, headache, abdominal pain, and diarrhea or constipation.
For millions of people living in low and middle-income countries, typhoid is an ever present reality. Global estimates of the typhoid burden range between 11 and 20 million cases and between about 1,28,000 and 1,61,000 typhoid deaths annually. Poor communities and vulnerable groups such as children are often the most susceptible.

Typbar TCV is the world’s first typhoid vaccine clinically proven for use on recipients who can be as young as six months. A single dose offers 87% protective efficacy against typhoid, which sickened 12 million people and killed 130,000 worldwide in 2016.
Though the vaccine is approved for use in India, it is not yet a part of India’s Universal Immunization Program. It’s retail price in India is Rs 1,500.
Typhoid fever is caused by food and water contaminated by Salmonella Typhi (S. Typhi) bacteria; the cost of treating it ranges from $50 to $ 5,000 for outpatient and inpatient treatments in developing nations.
WHO recommends the use of typhoid conjugate vaccines for use on children between the ages of 6 months and 23 months, and catch-up vaccinations for children between the ages of 2 years and 15 years. “This vaccine will be a game changer because the unavailability of an effective vaccine for young children has been one of the major barriers to controlling typhoid. With GAVI’s approval of US$ 85 million funding, the first introductions of the vaccine in GAVI-supported countries are expected as early as the first half of 2019,” said Dr Seth Berkley, CEO, GAVI, the Vaccine Alliance.
Drug-resistant “superbug” strains of S. Typhi have been reported from several countries in Africa and South Asia, including India, China, Pakistan, Bangladesh and Nepal.

“Typhoid is hugely underdiagnosed and most people are not given appropriate treatment, leading to antimicrobial resistance (AMR).
“Since preventing typhoid will reduce disease and with it AMR, I think it’s an important vaccine in South Asia, where the burden of typhoid, and the AMR burden, are growing,” said Ramanan Laxminarayan, senior research scholar and lecturer at Princeton Environmental Institute.
Bharat Biotech has offered the vaccine at US $1.50 per dose for procurement for GAVI-supported countries.
“Recognizing the importance of sustained vaccine procurement for low-income and low-middle income countries, we have offered a further price reduction to around $ 1.0 or below/dose, post procurement of 100 million doses for lower and lower-middle income countries ,” said Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech.
Bharat Biotech has partnered with the Navi Mumbai Municipal Corporation and the US Centers for Disease Control to evaluate the effectiveness of Typbar TCV in Navi Mumbai using 100,000 doses, with an additional 300,000 doses at subsidized rates.-Agencies

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