Vaccine candidate, “Covaxin” being developed by the Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) is currently under phase 2 clinical trials and is at the verge of completion. Before proceeding to the phase 3 clinical trials Bharat Biotech has been asked to submit complete safety data of ongoing trials of ‘Covaxin.’
On the 2nd of October, Bharat Biotech had applied to the Drugs Controller General of India (DCGI), to seek permission to conduct the phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate ‘Covaxin.’ The study will be of 28,500 subjects covering aged 18 years and above which will be conducted in 19 sites, including Delhi, Mumbai, Patna and Lucknow, across 10 states.
The subject expert committee (SEC) at the Central Drugs Standard Control Organisation(CDSCO) after a detailed deliberation of the application opined “that the design of the phase-3 study is in principle satisfactory except for clarification on the definition of asymptomatic.”
“However, the study should be initiated with an appropriate dose identification from the phase-2, safety and immunogenicity data and the firm should submit safety.
According to sources, the phase-2 trial of the Covaxin is going on and is left to give the second dose to volunteers at some sites.
On September 23, Hyderabad-headquartered Bharat Biotech also announced its partnership with the Washington University School of Medicine in St Louis, Missouri and that they are working on manufacturing a billion doses of an intranasal COVID-19 vaccine.
