The COVID-19 vaccine is the need to the hour and everyone is trying to come up real fast with it. Bharat Biotech, which had sought DCGI’s nod for conducting phase-3 clinical trials of its COVID-19 vaccine candidates, has been asked to submit complete safety and immunogenicity data of the ongoing phase-2 trial, besides providing some clarifications, before proceeding for the next stage.
The Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) is indigenously developing the vaccine candidate, Covaxin. According to the officials, the Hyderabad-based vaccine developer applied to the Drugs Controller General of India (DCGI) on 2nd October, seeking its permission to conduct the phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate.
The application submitted by the firm reads 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. According to some sources, the second phase trial of the Covaxin is still going on and the second dose is yet to be given to volunteers at some sites.
On 5th October, the subject expert committee (SEC) at the Central Drugs Standard Control Organisation (CDSCO) deliberated on the application. The panel said in its recommendations, “After detailed deliberation, the committee opined that the design of the phase-3 study is in principle satisfactory except for clarification on the definition of asymptomatic, etc. 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.”
As per a source, the SEC also mentioned out during the discussion that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported so far. The source also highlighted that the most common adverse event was pain at the injection site, which resolved transiently.
The indigenously developed vaccine candidate by Zydus Cadila Limited is also in its Phase-2 of the human clinical 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 of the candidates in India.