Bharat Biotech on Monday announced commencement of Phase III trials of COVAXIN™. 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.
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 immunogencity data. Volunteers who wish to participate in this trial should be adults over 18 years of age.
The trials are being conducted at 22 institutes in India including the All India Institute of Medical Sciences (AIIMS), the Guru Tegh Bahadur Hospital (both New Delhi), the Aligarh Muslim University, the Grant Government Medical College and Sir J.J. Group of Hospitals, Lokmanya Tilak Municipal General Hospital and Medical College (Sion Hospital) (all three Mumbai), the ICMR-National Institute of Cholera and Enteric Diseases, Kolkata, the Directorate of Public Health and Preventive Medicine, Chennai and King George Hospital, Vizag.
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 of Bharat Biotech.