Hyderabad, Nov 16: Vaccine maker Bharat Biotech on Monday announced that it has commenced Phase-3 trials of Covaxin, India’s first indigenous vaccine for Covid-19.
The Phase-3 trials, which involve 26,000 volunteers across India, are being conducted in partnership with the Indian Council of Medical Research (ICMR).
This is India’s first Phase-3 efficacy study for a Covid-19 vaccine, and the largest Phase-3 efficacy trial ever conducted in India, the Hyderabad-based company said.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive Covaxin or a 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.
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.
Participating volunteers, who undergo vaccination in the Phase-3 trials, will be monitored to detect occurrence of Covid-19.
Covaxin has been evaluated in about 1,000 subjects in Phase-1 and Phase-2 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 by Bharat Biotech is developed in collaboration with the 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.
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.