Hyderabad-based Bharat Biotech's Covaxin approved for emergency use

The Subject Expert Committee of Drugs Controller General of India (DCGI) has recommended Hyderabad based Bharat Biotech Coronavirus candidate vaccine Covaxin restricted emergency usage along with Serum Institute Covishield on January 2.

By Newsmeter Network  Published on  2 Jan 2021 1:27 PM GMT
Hyderabad-based Bharat Biotechs Covaxin approved for emergency use

Hyderabad: The Subject Expert Committee of the Drugs Controller General of India (DCGI) recommended Hyderabad-based Bharat Biotech's COVID-19 vaccine, Covaxin, for restricted emergency use on 2 January.

"Grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd., Hyderabad," said the Expert Committee.

Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The vaccine is indigenous, an inactivated vaccine developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility located in Genome Valley, Hyderabad.

On 1 January, the government-appointed Subject Expert Committee had approved Oxford-AstraZeneca COVID-19 vaccine manufactured by the Serum Institute of India (SII) for conditional emergency use. Covishield is developed by Oxford University and pharma major AstraZeneca. Both the vaccine recommendations will be sent for approval to the Drugs Controller General of India (DCGI).

"Grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to M/s Serum Institute of India, Pune," said the Expert Committee about the Covishield.

Phase I and II of clinical trials of Covaxin has shown that the vaccine is safe and generates a desired immune response. The vaccine did not show any major adverse reaction among the volunteers. It was well tolerated in all dose groups with no vaccine-related serious adverse events. Robust humoral and cell-mediated responses were observed in the Algel-IMDG recipients.

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