Bharat Biotech, one of India’s leading Bio-Technology companies, has got approval for human trials of their potential Covid-19 vaccine Covaxin from Drug Controller General of India on 29th June. DGCI, the drug regulator body, has permitted the company to conduct phase I and phase II clinical trials for the first indigenous Covid-19 vaccine that are expected to begin in July. Bharat Biotech has developed the potential vaccine in collaboration with the National Institute of Virology, and Indian Council of Medical Research (ICMR).
COVAXIN™, India’s 1st indigenous Covid-19 vaccine, developed by Bharat Biotech successfully enters human trials.— BharatBiotech (@BharatBiotech) June 29, 2020
@ICMRDELHI @DBTIndia @icmr_niv #BharatBiotech #COVAXIN #covid19 #Collaboration #Indiafightscorona #makeinindia #ICMR #coronavirusvaccine pic.twitter.com/MSehntuE8d
Promising pre-clinical studies led to trial approval
The company presented the results of pre-clinical studies of the potential vaccine that ensure safety and immunity response. The pre-clinical trials of the potential Covid-19 vaccine took two months to complete after getting approval from the regulatory body. Krishna Ella, Chairman and MD of Bharat Biotech, said, “The collaboration with NIV was instrumental in developing this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project.” The vaccine is being developed in a high containment facility in Hyderabad.
Ella added that their ongoing research and expertise in forecasting epidemics had enabled them to successfully manufacture a vaccine for the H1N1 pandemic. “Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling the future pandemics.”
Race to develop vaccine for Covid-19
There are around 86 teams working across the globe to develop vaccines for Covid-19. Some of them have already entered clinical trials. According to the World Health Organization, 13 vaccines are undergoing clinical trials. 129 vaccines are currently in the pre-clinical evaluation phase. In India, Zydus Cadila, Serum Institute of India and other Indian pharma companies are developing a vaccine for the infection.
Rising Covid-19 cases in India
As per the Ministry of Health, out of 5,49,946 cases in India, 3,34,821 patients have been cured while 16,893 have lost their lives due to complications related to Covid-19. 2,15,125 cases are still active in the country, with Maharashtra having maximum cases, followed by Tamil Nadu and Delhi.