Bharat Biotech starts Phase 3 trial for its anti Covid vaccine in India

Bharat Biotech on Monday announced the start of phase-3 clinical trials of its anti-coronavirus disease (Covid-19) vaccine candidate, Covaxin, in India.

The trial will include 26,000 participants in 22 sites across the country and will be conducted in partnership with the Indian Council of Medical Research (ICMR).

“The Phase III trials will involve 26,000 volunteers across India, conducted in partnership with ICMR. It is the largest clinical trial conducted for a Covid-19 vaccine in India. This is India’s first phase 3 efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted in India,” said Bharat Biotech in a statement.

The trial has been registered with the clinical trials registry of India, and approved by the Drugs Controller General of India (DCGI).

“Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive Covaxin 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. Covaxin has been evaluated in 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data,” the company statement further read.

Volunteers for the trial are adults above 18 years of age.

Covaxin, India’s indigenous Covid-19 vaccine candidate by Bharat Biotech is being developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility.

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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 development and clinical evaluation of Covaxin marks a significant milestone for vaccinology in India for a novel vaccine. 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,” said Suchitra Ella, joint managing director, Bharat Biotech.

Participating volunteers, who undergo vaccination in the Phase 3 trials, will be monitored to detect occurrence of Covid-19 disease.

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