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India’s first COVID-19 vaccine, COVAXIN, cleared for human trials

The clinical trials of the experimental COVID-19 vaccine in humans are scheduled to end by 31 July 2020.

India’s first vaccine candidate against the novel coronavirus, COVAXIN, has received a nod from the Drug  Controller General of India (DCGI) for further clinical trials Phase I and 2 in infected people. The vaccine is under development by Hyderbad-based biotechnology firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

The clinical trials of the experimental COVID-19 vaccine in humans are scheduled to begin in July 2020, Bharat Biotech said in a note. COVAXIN has been expedited through national regulatory protocols, and subjected to “comprehensive pre-clinical studies” according to the company, which reports that the results are “promising” and “show extensive safety and effective immune responses”.

Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled approvals to this project. We worked tirelessly to deploy our proprietary technologies towards this platform.”

“The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad,” the company added.

The company hasn’t yet released details on how long the next steps are likely to take, when the vaccine might be launched in the market or its price.

In May 2020, Bharat Biotech went into a partnership with Thomas Jefferson University, Philadelphia, for an exclusive deal to develop a new vaccine candidate for COVID-19 that was invented at Jefferson. The vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins, according to a Business Line report.

Dr Matthias Schnell, an infectious diseases expert, and his lab at Thomas Jefferson reportedly developed the vaccine in January, after which they completed preliminary tests in animal models that showed a “strong antibody response in mice receiving it,” the report adds.

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