Bharat Biotech on Friday announced the start of Phase 1 human clinical trial of Covaxin, India’s first indigenous COVID-19 vaccine. The trial began on July 15.


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Taking to micro-blogging site Twitter, Bharat Biotech said, "India's First Indigenous COVID 19 Vaccine, COVAXIN, initiated Phase-1 clinical trials across the country on 15th July 2020."


"We are proud to announce the start of Phase 1 human clinical trial of Covaxin on July 15th, 2020. This is a randomised, double-blind, placebo-controlled clinical trial in 375 volunteers in India," it tweeted a post.



As far as clinical trials are concerned, "double-blind" means neither patient nor researcher knows who is getting a placebo and who is getting the treatment.


Covaxin got the nod for human trials by the Drug Controller General of India on June 29. "The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response," Bharat Biotech had said earlier.


The COVAXIN has been developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. 


The Drugs Controller General of India (DCGI) had permitted two vaccines -- one developed by the Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research and another one by ZydusCadila Healthcare Ltd to go in for the first and second phase of human clinical trials.


There are two Indian vaccine candidates that have undergone successful toxicity studies in rats, mice and rabbits and this data was submitted to the DCGI, following which both got clearance to start an early phase human trials earlier this month, ICMR Director-General Dr Balram Bhargava had said.