Hyderabad-based Bharat Biotech has got clearance from authorities to conduct phase 3 trials in India for COVAXIN, one of the indigenous vaccine candidates being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, Pune. The third phase of the trials are expected to start from the first week of November. The recommendation was given by an expert panel at the Central Drugs Standard Control Organisation (CDSCO) after assessing the safety and immunogenicity data of phase 1 and 2 clinical trials, which were sent to the Drugs Controller General of India (DCGI) for final approval.
The Hyderabad-based vaccine maker had on October 2, sought the DCGI's permission to conduct phase three randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine. The firm, in its application, had said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites across 10 states including places like Delhi, Mumbai, Patna and Lucknow. The phase 3 clinical trial application has proposed a dose of 0.5 ml on day 0 and 28, sources said.
In continuation of an expert meeting held on October 5, the Hyderabad-based firm presented their data from phase 1 and 2 along with data from animal studies in two species including non-human primates. "After detailed deliberation and the available evidence, the committee recommended that permission to conduct phase 3 clinical trial be granted," the panel said.
In July, the DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.
Other vaccines being developed in India include Ahmedabad-based Zydus Cadila’s ZyCoV-D. The vaccine trials for this, are presently in phase 2 after showing favourable results in phase 1. Another promising vaccine globally, is the ChAdDOx1-S, which being developed by drugmaker AstraZeneca along with Oxford University. Clinical trials for the same in India are being run by the Serum Institute of India (SII), and have reached phase 3.
With PTI inputs