Bharat Biotech International, a leading Indian biotechnology company, has reportedly announced that its potential coronavirus vaccine, Covaxin, has received Drug Controller General of India (DCGI) approval to start human trials.

The Indian drug regulatory body has granted the company permission to initiate both phase I as well as phase II clinical human trials for, what is likely to be the country’s first indigenous coronavirus vaccine. The human trials for the drug candidate, which the company developed in a collaborative effort with the Indian Council of Medical Research, and National Institute of Virology, are expected to start in July.

The approval comes after the company showcased positive results from the pre-clinical studies conducted on the vaccine, which ensured safety as well as immunity response. The biotech company claims that it completed the pre-clinical trials within a period of two months.

Bharat Biotech Chairman and MD, Krishna Ella, stated that the company’s collaboration with National Institute of Virology played an integral role in the development of the vaccine candidate. Additionally, the proactive guidance and support the company received from CDSCO allowed the project to obtain the regulatory approvals.

Ella further added that company’s ongoing research as well as expertise in projecting epidemics has allowed it to create a vaccine for H1N1 pandemic successfully. Bharat Biotech, continuing its focus on developing the sole BSL-3 facilities for testing and manufacturing in the country, is committed to work on its vaccine development efforts as a high priority goal of national importance to showcase India’s prowess in handling future pandemics.

Across the globe, scientist are diligently working towards the discovery of a viable vaccine, with as much as 86 teams currently working to develop an effective coronavirus vaccine. The WHO cites that presently there are 13 vaccines that are undergoing clinical trials with as many as 129 potential vaccines in pre-clinical evaluation phase.

Source credit: https://www.businessinsider.in/india/news/an-indian-covid-19-vaccine-made-by-bharat-biotech-is-set-to-enter-human-trials/articleshow/76702286.cms