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Coronavirus: Bharat Biotech gets approval to conduct human trials for vaccine

Bharat Biotech, a leading vaccine and bio-therapeutics manufacturers is all geared up to conduct human clinical trials with Covaxin.

Coronavirus: Bharat Biotech gets approval to conduct human trials for vaccine
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Bharat Biotech, a leading vaccine and bio-therapeutics manufacturers is all geared up to conduct human clinical trials in July with Covaxin to battle the coronavirus. Covaxin had earlier been developed in Hyderabad at the Genome Valley plant, in collaboration with the Indian Council of Medical Research (ICMR).

Krishna Ella, Chairperson and Managing Director of Bharat Biotech had made the announcement stating that the collaboration with ICMR and NIV has been instrumental in developing Covaxin. Furthermore, the support and the guidance from CDSCO had enabled approvals to the project, Ella stated.

On Monday, June 29, the Hyderabad-based firm announced that the Drug Controller General of India (DGI) gave the green light for phase-1 and phase-2 human clinical trials of the indigenously developed drug. The company had earlier submitted results generated from pre-clinical (animal) studies to get approval to conduct human clinical trials. These trials are meant to demonstrate safety and immune responses.

The SARS-CoV-2 strain was isolated at National Institute of Virology (Pune), an institute under the ICMR, and was transferred to Bharat Biotech. The company has a biosafety level-3 plant in the city of Hyderabad. These type of plants are conducive for work involving microbes, which could cause serious and potentially lethal diseases, through the inhalation route.

In the wake of the coronavirus, in what seems to be a major breakthrough in finding a successful treatment for the disease, scientists at Oxford University had earlier reached a consensus that the low-dose usage of ‘dexamethasone’, can be used to reduce death rates in severely affected patients suffering from coronavirus. The drug is said to cut the risk of death by a third for patients on ventilators. For those on oxygen, it cut deaths by a fifth.

While the country is witnessing a surge in the number of coronavirus cases every day, newer and more efficient drugs have been proving to be useful for treating COVID-19.

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