The Drugs Controller General of India (DCGI) has given approval to ‘Covaxin’ for phase 3 clinical trials with certain conditions. The indigenous Covid-19 vaccine has been developed by the Hyderabad-based firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
A subject expert committee on Covid-19 at the Central Drugs Standard Control Organisation (CDSCO) had recommended granting permission to the company for conducting phase 3 clinical trial of its vaccine ‘Covaxin’ after assessing the safety and immunogenicity data of the phase 1 and 2 trials. “The DCGI gave permission to Bharat Biotech to conduct phase 3 clinical trial of the ‘Covaxin’ on Friday,” an official told PTI.
The vaccine ‘Covaxin’ is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The vaccine maker had applied to the DCGI on October 2 seeking permission to conduct phase 3 randomised double-blind placebo-controlled multi centre trial of its Covid-19 vaccine.
It was asked to submit complete safety and immunogenicity data of the phase 2 trial besides providing some clarifications before proceeding to the next stage. The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow. The phase 3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, sources said.