In a huge move for India, the country’s drug regulator, Central Drugs Standard Control Organisation has given approval to Bharat Biotech to conduct clinical trials for the first indigenous COVID vaccine candidate- Covaxin.
On Monday, 29 June, the company announced that they received DCGI approval for Phase I & II Human Clinical Trials, and are scheduled to start across India in July 2020.
In a press release, Dr Krishna Ella, Chairman and Managing Director wrote,
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech, and then the inactivated vaccine developed and manufactured in their High Containment facility in Hyderabad.
What is an Inactivated Vaccine?
An inactivated vaccine or a killed vaccine uses the killed version of the pathogen that causes the disease. They are made from viruses or bacteria that have been killed clinically and therefore they cannot cause diseases anymore, according to WHO.
Inactivated whole-cell vaccines often cannot produce an immune response or if they do, the response will be short-lived. You may need many doses of the inactivated vaccine to provoke a sufficient response. Comparatively, vaccines made from live viruses are often more powerful at provoking immunity.
On the plus side, since they are inactive, they pose no danger of disease and are safe and stable.
The release added that the CDSCO, the Drug Controller General of India and the Ministry of Health & Family Welfare granted permission to initiate clinical trials after Bharat Biotech submitted their results from preclinical studies to demonstrate safety and an immune response.
Other Indian firms in the pre-clinical stages of developing a COVID-19 vaccine are Zydus Cadila, Serum Institute of India and Panacea Biotec, reported The Indian Express.