- Bharat Biotech’s coronavirus vaccine Covaxin is the first COVID-19 vaccine to get DGCI’s (Drug Controller General of India) nod.
- The drug regulatory body allowed the pharma company to conduct phase I and phase-II clinical trials.
- The vaccine was developed in collaboration with the National Institute of Virology, IndianCouncil of Medical Research (ICMR).
- The human trials of Covaxin are likely to begin in July.
- According to the World Health Organisation (WHO), there are 13 vaccines undergoing clinical trials as of now. While 129 are in the pre-clinical evaluation phase.
India, on Monday (June 29) got the approval for conducting human trials of a potential coronavirus vaccine.
Covaxin — developed by the Indian vaccine and bio-therapeutics manufacturer Bharat Biotech — is the first COVID-19 vaccine to get DGCI’s (Drug Controller General of India) nod. The drug regulatory body allowed the pharma company to conduct phase I and phase II clinical trials.
COVAXIN™, India’s 1st indigenous Covid-19 vaccine, developed by Bharat Biotech successfully enters human trials.… https://t.co/Q6X8uJVrHK— BharatBiotech (@BharatBiotech) 1593453110000
The human trials of the vaccine — which was developed in collaboration with the National Institute of Virology, IndianCouncil of Medical Research (ICMR) — are likely to begin in July.
The development comes after Bharat Biotech showed the results of pre-clinical studies of the potential vaccine, ensuring safety and immunity response. The company says that they completed pre-clinical studies in two months — after the regulatory approval.
“The collaboration with and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project,” Krishna Ella, Chairman and MD of Bharat Biotech
told the Indian Express.
The drug manufacturer said that the vaccine has been developed in a high containment facility in Hyderabad.
“Our ongoing research and expertise in forecasting epidemics has enabled us 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,” Ella
Scientists across the globe are now working towards a vaccine faster than ever. As many as 86 teams are presently working to come up with a Covid-19 vaccine including those undergoing clinical trials.
According to the World Health Organisation (WHO), there are 13 vaccines undergoing clinical trials as of now. While 129 are in the pre-clinical evaluation phase.
Coronavirus infection has already cost over 16,475 lives in India and the world is now waiting with bated breath for a vaccine. Zydus Cadila, Serum Institute of India and other Indian pharma giants are also working to develop COVID-19 vaccines.
According to the Ministry of Health and Family Welfare, the total COVID infections spiked to 548,318, as on June 30.
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