Bharat Biotech's COVID-19 vaccine first in India to receive nod for human trials

Bharat Biotech India Ltd’s COVID-19 vaccine ‘Covaxin’ has become the first candidate developed in India to receive the Drug Controller General of India’s (DGCI) approval to enter human trials.

Company got approval from DGCI to conduct a phase I and II clinical trial of its vaccine candidate ‘Covaxin’, which it developed in in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV), said the company’s statement.

It added that the indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s facility located in Genome Valley in Hyderabad and human clinical trials are scheduled to start across India in July.

“We are proud to announce ‘Covaxin’, India’s first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project," Bharat Biotech chairman and managing director Mr Krishna Ella said.

There are multiple vaccine trials ongoing in India, including those of candidates by Zydus Cadila, Serum Institute of India and Panacea Biotec, but all of them are in pre-clinical stage as of now.

To be sure, apart from developing its own vaccine, Serum Institute is also in pact to manufacture the candidate jointly being developed by University of Oxford and Astrazeneca plc.

Bharat Biotech also has another vaccine candidate, ‘CoroFlu’, that it is developing in collaboration with University of Wisconsin–Madison and vaccine manufacturer FluGen.

Around 150 vaccine candidates are present globally that under development currently, of which 17 are undergoing human trials. Only University of Oxford’s vaccine is the furthest in the trial, currently in the third phase, while there are various candidates in the second phase.

According to the experts, there need to be at least half a dozen successful vaccines against COVID-19 to successfully meet the global demand.

 

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.