Bharat Biotech begins phase III trial for COVAXIN
The Phase III trial of COVAXIN will involve 26,000 volunteers all over the country and will be the largest clinical trial conducted for the vaccine of Coronavirus in India.
Bharat Biotech on November 16, 2020, announced the start of the third phase of clinical trials for COVAXIN. The trials will be conducted in partnership with ICMR (Indian Council of Medical Research).
The Phase III trials of COVAXIN will involve 26,000 volunteers all over India and will be the largest clinical trial conducted for the vaccine of Coronavirus in India.
The trials will also be India’s first phase 3 efficacy study for the COVID-19 vaccine and the largest efficacy third phase trial ever conducted in the country. The phase 3 trial has been registered at www.ctri.nic.in and is also approved by the Drugs Controller General of India (DCGI).
Phase 3 clinical trial of COVAXIN™️ takes off as the largest efficacy trial ever conducted in India, with about 26,000 participants. pic.twitter.com/qyCkoOkUl9— BharatBiotech (@BharatBiotech) November 16, 2020
Phase III Trial of COVAXIN: Key Highlights:
• Volunteers participating in trials will be receiving two intramuscular injections about 28 days apart.
• Participants will be assigned randomly for receiving COVAXIN or placebo.
• The trial will be double-blinded, in such a way that the participants, investigators, and the company will not be aware of who has been assigned to which group.
• Volunteers who wish to participate in the phase 3 trial of COVAXIN must be adults or above 18 years of age.
Phase 1 and Phase II trial of COVAXIN:
In Phase 1 and Phase II clinical trials of COVAXIN, it has been evaluated in about 1000 subjects and has successfully shown promising immunogenicity and safety data. The trials were conducted by Bharat Biotech in collaboration with ICMR.
COVAXIN by Bharat Biotech:
India’s indigenous COVID-19 vaccine by Bharat Biotech, COVAXIN, has been developed in collaboration with the National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR).
The inactivated COVID-19 vaccine is developed and manufactured in the BSL-3 (Bio-Safety Level 3) biocontainment facility of Bharat Biotech. COVAXIN is a highly purified vaccine which is also inactivated. It is manufactured in a Vero cell manufacturing platform that has an excellent safety track record of more than 300 million doses supplied.
Significance of manufacturing COVAXIN in India:
According to the Joint Managing Director of Bharat Biotech, Suchitra Ella, the development, as well as the clinical evaluation of COVAXIN, marks an important milestone for vaccinology in India.
It is highly significant for the Indian companies to innovate as well as develop indigenous vaccines, especially during the COVID-19 pandemic. The indigenously developed vaccine has also garnered interest from several countries worldwide for the supply.
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