Bharat Biotech’s Covid vaccine gets DCGI nod for clinical trials

Bharat Biotech’s Covid vaccine gets DCGI nod for clinical trials

Developed by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research (ICMR), the COVAXIN candidate uses an inactivated strain of the novel coronavirus to prime the body to generate an immune response and fight off the actual virus attack. The collaboration with ICMR and NIV was instrumental.

Chairman and Managing Director of the company Dr. Krishna Ella said: We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19.

China's military received the approval to use a COVID-19 vaccine candidate developed by its research unit and CanSino Biologics after clinical trials proved it was safe and showed some efficacy, the company said on Monday.

The DGCI, CDSCO (Central Drugs Standard Control Organisation), and Ministry of Health and Family Welfare granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. "The proactive support and guidance from CDSCO have enabled approvals.[and] Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform (sic)".

The project started enrolling volunteers on June 23, and plans to recruit 168 healthy individuals, half of them aged 18 to 59 years old and the other half aged at least 60 years, to evaluate the safety and tolerance of the new coronavirus (SARS-CoV-2) mRNA vaccine.

But vaccines against viruses are extremely hard to develop, and a "gold standard" preventor - one that lasts six months, is at least 50 per cent effective and can successfully prevent transmission of the virus - will no doubt take time.

Vaccine testing typically begins with animal and lab testing before going on to different stages of human testing.

A vaccine candidate against COVID-19 (the SARS-CoV-2 virus), provided by Imperial College London.

In the past, vaccine maker Bharat Biotech has manufactured the H1N1 vaccine during the swine flu outbreak, and has over 140 global patents and 16 vaccines in its portfolio. Their candidate is now in pre-clinical studies. Pune biotech firm Serum Institute and Panacea Biotec in Delhi, are also among the leading candidates from India to develop a COVID-19 vaccine. Since January, J&J has been working directly with governments and health authorities to help end this fast-moving COVID-19 pandemic.

India, which lags only the United States, Brazil and Russian Federation in total cases, reported close to 20,000 new infections on Monday, according to data from the country's federal Health Ministry.

The Ministry of Home Affairs has released guidelines for Unlock 2.0, which is expected to come into force till 31 July.



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