Hyderabad: Human Phase 3 trials of Covaxin, the anti-Covid-19 vaccine being developed by Bharat Biotech and the National Institute of Virology, commenced at the Nizam’s Institute of Medical Sciences here on Monday.
The test vaccine will be tested on 26,000 volunteers across 25 centres in India. This is the first and largest efficacy study in the country for Covaxin. NIMS is the first centre in India where the Covaxin Phase 3 trials are being carried out.
The volunteers will be randomly attached to either of the two groups: One will be given a placebo, where no vaccine is administered, and the other will receive the vaccine dose. The volunteers will not be aware who got what, that data will be known only to the researchers and the company.
Volunteers will be given two intramuscular injections approximately 28 days apart. Both the groups will be tracked for the next year.
The placebo group will be given injections without Covaxin; those who get the vaccine will be administered 6 microgram of Covaxin.
The trials will be carried out in two sites each in New Delhi and Mumbai and one site in all other states. The outcome of Phase 1 and Phase 2 clinical trials and evaluation for safety and immunogenicity data on 1,000 subjects was said to be promising following which Bharat Biotech was allowed to proceed with largescale human trials.
The vaccine if approved will be manufactured at Bharat Biotech’s Bio-Safety Level 3 high containment facility. It will be 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.