The Drugs Controller General of India (DCGI) has requested the Indian biotechnology company Bharat Biotech to submit the complete safety and immunogenicity data of the ongoing phase-2 clinical trial of its novel coronavirus vaccine candidate ‘Covaxin’ before proceeding to the next phase.
The vaccine is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). According to sources, the phase-2 trial of the Covaxin is going on and the second dose is yet to be given to volunteers at some sites.
According to officials, the drug firm had sought DCGI’s nod for conducting a randomised double-blind placebo-controlled multicentre phase-3 study of its COVID-19 vaccine candidate on October 2.
The firm in its application said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites — including Delhi, Mumbai, Patna and Lucknow — across 10 states.
The company had presented phase-3 clinical trial protocol along with interim data of phase 1 and 2 clinical trials, according to a Bharath Bio official.
The subject expert committee (SEC) at the Central Drugs Standard Control Organisation (CDSCO) deliberated on the application on October 5. After detailed discussions, the committee opined that the design of the phase-3 study is in principle satisfactory except for some clarifications. The phase-3 clinical trial application proposed a dose of 0.5 ml of the vaccine on day 0 and 28.
“However, the study should be initiated with an appropriate dose identified from the phase-2 safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from the phase-2 trial for consideration,” the panel said in its recommendations.
Besides Bharat Biotech, another indigenously developed vaccine candidate by Zydus Cadila Ltd is in phase 2 trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials in India.