The phase-three human clinical trial of Hyderabad-based Bharat Biotech’s indigenously developed anti-coronavirus vaccine candidate Covaxin began at the AIIMS here on Thursday. Dr MV Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers received the first dose.
The vaccine would be given to around 15,000 volunteers at the AIIMS over the next few days. The first dose of 0.5 ml intramuscular injection was given to four volunteers. They were under observation for two hours and will be monitored for the next few days, said an official at the AIIMS.
As part of the trial application, a dose of 0.5 ml would be given on day 0 and on day 28. The phase-three randomised double-blind placebo-controlled multi-centre trial would cover 28,500 subjects aged 18 years and above.
It would be conducted in around 25 sites across 10 States. The trial has already started at a few sites like Gujarat.
The Bharat Biotech has been given the permission for conducting phase-3 human clinical trials of the Covaxin from the Drugs Controller General of India (DCGI).
The safety and immunogenicity data of the phase one and two trials were submitted to the Central drug regulator. The pharma firm, while applying for phase-three trial, stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported.
The most common adverse event was pain at the injection site, which resolved transiently, the drug maker had said.
Bharat Biotech said that the World Health Organisation (WHO), United States Food and Drug Administration (USFDA), and India’s Central Drugs Standard Control Organisation (CDSCO) approves respiratory disease vaccine if it was at least 50 per cent effective. Now, the company is aiming only a little higher, announcing that the trial data shows the vaccine is at least 60 per cent effective.