Hyderabad: Bharat Biotech announced the commencement of phase III trials of COVAXIN on 16 November. The trials will involve 26,000 volunteers across 25 centres in India and is being conducted in partnership with ICMR.
This is India's first phase III efficacy study for a COVID-19 vaccine and the largest one ever conducted in India. The trial has been registered at http://ctri.icmr.org.in/ and approved by the Drugs Controller General of India.
Participating volunteers who undergo vaccination in the phase III trials will be monitored over the next year to detect the occurrence of COVID-19. Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 6 micrograms (mcg) injections of COVAXIN or two shots of 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.
COVAXIN was tested on around 1,000 subjects in phase I and 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, India's indigenous COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The indigenous inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high 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.
Meanwhile, US biotech company Moderna, on Monday, said its COVID-19 vaccine is 94.5 per cent effective after phase III. Earlier, Pfizer had claimed that its vaccine is 90 per cent effective after phase III trials.