Bharat Biotech announced the commencement of Phase III trials of COVAXIN on Monday.
The Phase III trials will involve 26,000 volunteers across India and will be 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. The trial has been registered at www.ctri.nic.in (CTRI/2020/11/028976) and approved by the Drugs Controller General of India.
Trial volunteers will receive two intramuscular injections about 28 days apart. Participants will be randomly assigned to receive COVAXIN(tm) 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 about 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be adults over 18 years of age.
COVAXIN(tm), India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) and the 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. COVAXIN(tm) 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.
Suchitra Ella, joint managing director of Bharat Biotech said, “The development and clinical evaluation of COVAXIN(tm) 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(tm) has garnered interest from several countries worldwide for supplies and introduction.”