India's first coronavirus vaccine COVAXIN developed by Hyderabad-based Bharat Biotech gets approval from DCGI to begin human clinical trials.
India's first coronavirus vaccine COVAXIN developed by Hyderabad-based Bharat Biotech has got approval from the Drug Controller General of India (DCGI) to start with human clinical trials. The company on its website said it is pleased to announce its 3 COVID-19 vaccines in collaboration with the University of WISCONSIN, ICMR and Thomas Jefferson University.
Made in India
Coronavirus vaccine --COVAXIN-- is India's first indigenous inactivated vaccine for highly infectious and deadly disease COVID-19.
Who is making Covaxin?
Bharat Biotech's COVAXIN has got the approval from the Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare to being with Phase I and II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
The indigenous and inactivated vaccine has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley, Hyderabad.
The Drug Controller General of India (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after Bharat Biotech submitted results generated from pre-clinical studies, demonstrating safety and immune response.
The SARSCoV2 strain was isolated in NIV, Pune & transferred to BharatBiotech.
When will COVAXIN human clinical trials begin?
COVAXIN human clinical trials are scheduled to begin in next month July 2020 across the country.
When will coronavirus vaccine -- COVAXIN -- be available in the market?
According to a release, human clinical trials Phase 1 and Phase 2 of the COVAXIN will commence from July, therefore, at present no confirm information is available as to when the vaccine will be available in the market for human use.
A press release by the company, Bharat Biotech, it said results from these studies have been promising and show extensive safety and effective immune responses.
PM Modi on status of coronavirus vaccine development in India
Speaking on the status of coronavirus vaccine development, PM Modi took to his Mann Ki Baat Twitter handle and said, "Work being done in our labs on Corona vaccine is being keenly observed by the world and we are hopeful too."
What Bharat Biotech Chairman, Managing Director has to say on COVAXIN
Bharat Biotech's Chairman and Managing Director, Dr Krishna Ella says "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.
He added, "Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," he said. Expedited through the national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies.
Several other Indian companies working on COVID-19 vaccine
Apart from Bharat Biotech, 5 other Indian firms are also working to make a vaccine that has had a disastrous impact across the world affecting health and wealth of millions of people. Not only India, but pharma companies, researchers, scientists are working day-night across nations to find a vaccine for coronavirus as present medications available in the world have not been effective to contain the disease.
(With inputs from PTI)
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