Developed by Bharat Biotech, India's first indigenous COVID-19 vaccine 'Covaxin' is all set to enter the human clinical trial phase. The vaccine has been developed in collaboration with the Indian Council Of Medical Research (ICMR) and the National Institute of Virology (NIV). It has got a nod from the Drug Controller General Of India (DCG) for conducting human clinical trials, the company announced on Monday.
Results from pre-clinical trials have been promising and show extensive safety and effective immune responses.
The Vaccine Showed Safety And Immune Response In Initial Phase Trials
The pre-clinical trials for the vaccine named Covaxin demonstrated safety and immune response, human clinical trials for which will start next month. The company has stated that collaboration with ICMR and NIV has been instrumental in developing the vaccine, The Print reported.
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
Apart from Bharat Biotech, around five other Indian companies are working towards developing a COVID-19 vaccine, in the country.
Human clinical trials are scheduled to start in July 2020, the company said. The vaccine was developed and manufactured in Bharat Biotech's facility at Genome Valley in Hyderabad, India.
Presently, India ranks fourth in the number of coronavirus cases across the world. In fact, on Monday itself, India reported around 20,000 fresh cases of coronavirus. Importantly, no vaccine in the world has been approved for commercial distribution yet. However, more than 100 vaccines have been approved for human clinical trials and awaiting results.
Chairman and Managing Director of the company Dr Krishna Ella said: "We are proud to announce COVAXIN, India's first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform."
The company had expedited the process of developing this vaccine in compliance with the national regulatory protocols, hence also completed the comprehensive pre-clinical trials. Results from these studies have been promising and show extensive safety and effective immune responses, the release added. Apart from Bharat Biotech, around five other Indian companies are working towards developing a COVID-19 vaccine, in the country.
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