Covaxin trial: Bharat Biotech on Saturday announced successful recruitment of 23,000 volunteers for Phase-3 clinical trial of its COVID-19 vaccine candidate
Hyderabad-based Bharat Biotech on Saturday announced successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of its COVID-19 vaccine candidate Covaxin across multiple sites in India.
In a statement, Bharat Biotech said that the Phase III human clinical trials of Covaxin began mid-November. It has been targeted to be done in 26,000 volunteers across India as the country’s first and only Phase III efficacy study for a COVID-19 vaccine. It is also the largest phase III efficacy trial ever conducted for any vaccine in India, according to the statement.
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The company said that Covaxin was evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results and acceptance in international peer-reviewed scientific journals.
Covaxin is India’s indigenous COVID-19 vaccine by Bharat Biotech developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The indigenous vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility.
Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with a track record of more than 300 million doses.
Commenting on the progress of trials, Suchitra Ella, Joint Managing Director of Bharat Biotech said, “We thank every volunteer who has taken the time to participate in this trial. Their volunteering spirit is a great morale boost for India and the world. We thank all the Principle Investigators, Doctors, medical staff and the hospitals for their cooperation and support in taking the phase III trials forward in 26,000 volunteers in India. We continue our progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of COVAXIN.”
Meanwhile, on Saturday, the subject expert committee (SEC) of the Central Drugs Standard Control Organisation(CDSCO) gave its nod to Bharat Biotech’s Covaxin for emergency use.