This is the first Phase 3 efficacy study in India for a COVID-19 vaccine.
Hyderabad:
Bharat Biotech announced the start of phase III trials of COVAXIN on Monday.
The phase III trials will involve 26,000 volunteers across India and will be carried out in partnership with the ICMR. This is the largest clinical trial conducted for a COVID-19 vaccine in India.
This is the first phase 3 efficacy study in India for a COVID-19 vaccine and the largest phase III efficacy trial ever conducted in India. The trial was 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 approximately 28 days apart. Participants will be randomized to receive COVAXIN ™ or a placebo. The trial is double-blind, so investigators, participants and the company will not know who is assigned to which group.
COVAXIN has been evaluated in approximately 1,000 subjects in phase I and phase II clinical trials, with promising data on safety and immunogenicity. Volunteers who wish to participate in this trial must be adults over 18 years of age.
COVAXIN ™, India’s native COVID-19 vaccine by Bharat Biotech is being developed in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV). This native inactivated vaccine is developed and manufactured in the BSL-3 (Bio-Safety Level 3) biological containment facility of Bharat Biotech. COVAXIN ™ is a highly purified and inactivated vaccine made in a vero cell manufacturing platform with an excellent safety record of over 300 million doses delivered.
Suchitra Ella, Deputy Managing Director of Bharat Biotech, said: “The development and clinical evaluation of COVAXIN ™ marks an important milestone for vaccinology in India. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic. COVAXIN ™ has aroused the interest of several countries around the world for the supplies and introduction. ”
