Bharat Biotech on Monday announced the commencement of phase III trials of the COVID-19 vaccine, Covaxin. It is the largest clinical trial conducted for a COVID-19 vaccine in India.
The phase III trials will involve 26,000 volunteers across 25 centres in India, being conducted in partnership with ICMR. 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 with ICMR and approved by the Drugs Controller General of India.
The third trial may be completed by early 2021. The most important thing is that India works on an affordable biotech vaccine, so it is expected that the Covaxin may be the cheapest vaccine in the world.
Participating volunteers who undergo vaccination in the Phase III trials, will be monitored over the next year to detect the occurrence of COVID-19 disease. Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 6 microgram (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 has been evaluated in 1000 subjects in phase I and II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial have to be adults over 18 years of age and it is still an investigational product.
Covaxin is 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.
It 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.