India’s drug regulator has granted approval for clinical trials of the first indigenously developed vaccine candidate against Covid-19.
The vaccine candidate Covaxin is developed by Bharat Biotech using the Covid-19 genome isolated by the National Institute of Virology, a Pune-based research facility under the aegis of Indian Council of Medical Research.
“We are proud to announce COVAXIN, India’s first indigenous vaccine against Covid-19,” Krishna Ella, Chairman and Managing Director of Bharat Biotech said in a statement.
It said the Drug Controller General of India has granted permission to initiate Phase I & II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
Human clinical trials are scheduled to start across India in July 2020, the statement added.
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies, Ella said adding that the results from these studies have been promising and show extensive safety and effective immune responses.
A number of drug manufacturers across the globe are working to find a cure for Covid-19, but no pharmaceutical firm has succeeded yet.
According to the World Health Organisation (WHO), of the 140 vaccines at different stages of development worldover, 16 are currently in late-stage clinical trials.
Of these 16 vaccine candidates, five are being researched in China, three in the US, two in the UK, and one each in Australia, Germany, and Russia.
