New Delhi: 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 approval to enter human trials.
The DGCI has approved the company’s application 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), the company said in a release on Monday.
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, the company said.
“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 has enabled approvals to this project," Bharat Biotech chairman and managing director Krishna Ella said.
While there are multiple vaccine trials ongoing in India, including those of candidates by Zydus Cadila, Serum Institute of India and Panacea Biotec, 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.
Globally, there are nearly 150 vaccine candidates under development currently, of which 17 are undergoing human trials. 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.
Experts have said that there need to be at least half a dozen successful vaccines against covid-19 to successfully meet the global demand.