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Bharat Biotech begins clinical trials of TB vaccine on adults

This is the first vaccine against Tuberculosis derived from a human source by the Spanish biopharmaceutical company, Biofabri.

ByPTI

Published Mar 24, 2024 | 2:34 PM ⚊UpdatedMar 24, 2024 | 2:34 PM

Vaccine. Representational Image. (iStock)

Hyderabad-based Bharat Biotech International Ltd on Sunday, 24 March, said it started clinical trials of the Tuberculosis (TB) vaccine Mtbvac on adults in India.

This is the first vaccine against TB derived from a human source by the Spanish biopharmaceutical company, Biofabri, a press release from Bharat Biotech said.

The release said that Mtbvac is being developed for two purposes; first, as a more effective and potentially longer-lasting vaccine than BCG (Bacillus Calmette Guérin) for newborns and second, for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine.

The trials are carried out by Bharat Biotech in close collaboration with Biofabri.

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The trials

Trials to evaluate the safety and immunogenicity of Mtbvac started with a pivotal safety, immunogenicity and efficacy trial which has been planned to start in 2025, the release said.

It is a giant step to test in adults and adolescents in the country where 28 percent of the world’s TB cases accumulate. TB remains one of the world’s leading infectious causes of death, especially in India, Esteban Rodriguez, CEO of Biofabri said.

Krishna Ella, Executive Chairman Bharat Biotech said “Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today.”

The Mtbvac vaccine has passed several milestones before entering clinical trials in India. After the recent completion of a Phase-2 dose finding trial, a double-blind controlled Phase-3 clinical trial in newborns has been started in 2023 to compare the vaccine with the current BCG vaccine.

As many as 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 babies have been vaccinated, the release added.

(Disclaimer: The headline, subheads, and intro of this report along with the photos may have been reworked by South First. The rest of the content is from a syndicated feed, and has been edited for style.)