Hyderabad: After successful completion of Phase 1&2 clinical trials of COVAXIN, Bharat Biotech initiates Phase 3 trials in more than 25000 participants in over 25 centres across India.
An expert panel at the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission for conducting phase 3 clinical trials of its indigenously developed COVID-19 vaccine with certain conditions.
The recommendation was given after assessing the safety and immunogenicity data of phase 1 and 2 clinical trials and have been sent to the Drugs Controller General of India (DCGI) for final approval, official sources said.
The vaccine -- 'Covaxin' -- is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based vaccine maker had on October 2 sought the DCGI's permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine.
But it was asked to submit the complete safety and immunogenicity data of the phase 2 trial besides providing some clarifications before proceeding to the next stage.
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The firm in its application has 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 the subject expert meeting held on October 5, the Hyderabad based firm presented their data from phase 1 and 2 along with animal challenge data in two species including non-human primates (NHP) on the inactivated coronavirus vaccine (BBV152) along with the proposal to conduct event driven phase 3 clinical trial to assess the efficacy of the vaccine, the recommendations stated.
"After detailed deliberation and the available evidences, the committee recommended that permission to conduct phase 3 clinical trial be granted subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended as below...," the panel said.
Once a suspect case is confirmed, the principal investigator will evaluate the clinical information to classify it as a symptomatic case.
In July, the DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.
(PTI Report)
