Bharat Biotech begins phase 3 trials for its COVID-19 vaccine with 26,000 participants

Bharat Biotech on Monday, November 16 said it has started phase III trials for 'Covaxin', its COVID-19 vaccine candidate being developed in collaboration with the Indian Council of Medical Research (ICMR). The Phase III trials for the indigenous vaccine will involve 26,000 volunteers across India and it will be the largest clinical trial conducted for a COVID-19 vaccine in the country.

The volunteers will receive two intramuscular injections approximately 28 days apart. The participants will be randomly assigned to receive a vaccine or placebo. The trial is double-blinded, such that the investigators, the participants, and the company will not be aware of who is assigned to which group. The vaccine candidate has been assessed in around 1,000 subjects in Phase I and Phase II clinical trials, with promising safety. Volunteers who wish to participate in this trial should be adults over 18 years of age, the company said in its release.

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"The development and clinical evaluation of COVAXIN marks a significant milestone for vaccinology in India. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic. COVAXIN has garnered interest from several countries worldwide for supplies and introduction", Suchitra Ella, joint managing director of Bharat Biotech said.

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India's first and largest study for COVID-19 vaccine

The phase III trials of the vaccine candidate will be India's first and largest study and trial for the COVID-19 vaccine ever conducted, the company said while adding the trial has been registered at www.ctri.nic.in (CTRI/2020/11/028976) and approved by the Drugs Controller General of India.

India's indigenous COVAXIN vaccine by Bharat Biotech is developed in collaboration with the ICMR and the National Institute of Virology (NIV). This inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) biocontainment facility. COVAXIN is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied, the company said.

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(With ANI inputs)