Covaxin Phase-3 Clinical Trials Begin in AIIMS

India-made COVID-19 vaccine Covaxin began its phase-3 human clinical trial at AIIMS in New Delhi on Thursday with Dr. M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers getting the first dose.

Approximately 15,000 volunteers at AIIMS will be given the Covaxin shot as part of the clinical trials.

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‘Covaxin, India's indigenous coronavirus vaccine by Bharat Biotech, is developed in collaboration with the ICMR - National Institute of Virology (NIV). ’

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Bharat Biotech announced the commencement of Phase-3 trials of Covaxin on November 16. The Phase-3 trials will involve 26,000 participants across India, conducted in partnership with ICMR.

It is the biggest clinical trial conducted for a coronavirus vaccine in India.

Trial volunteers will take two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to get Covaxin or placebo. The trial is double-blinded, where the investigators, the participants, and the company will not be aware of who is assigned to which group.

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Covaxin has been evaluated in 1,000 subjects in Phase-1 and Phase-2 clinical trials, promising safety and immunogenicity data. Volunteers who wish to join in this trial should be adults over 18 years of age.

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Source-Medindia

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