Coronavirus Vaccine in India: Experimental Covid-19 vaccine candidate Covaxin has been granted approval for Phase 3 Human Trial in India. Bharat Biotech’s Coronavirus Vaccine ‘Covaxin’ has been ‘cleared’ for Phase 3 clinical trials, tweeted Kiran Mazumdar-Shaw, Executive Chairperson of Biocon Limited. Covaxin is India’s indigenous vaccine. It is being developed by Bharat Biotech in collaboration with the National Institute of Virology (NIV), Pune, and the Indian Council of Medical Research (ICMR).
What has happened?
Central Drugs Standard Control Organisation (CDSCO) expert panel on Thursday night (October 22) recommended that permission must be granted to Covaxin makers to hold Phase 3 human trials. The approval came after the expert panel monitored the immunogenicity and safety data collected during Phase 1 and Phase 2 clinical trials of Covaxin. The recommendations have been sent to the Drugs Controller General of India (DCGI) for the final nod, as per PTI report.
Earlier on October 2, Hyderabad-based vaccine Bharath Biotech sought the DCGI’s nod to conduct a phase 3 human trial. Bharat Biotech called the Phase 3 human trial as “randomized double-blind placebo-controlled multicentre trial of its COVID-19 vaccine”. However, Bharat Biotech was told to submit two pivotal details. One is comprehensive data regarding the safety and immunogenicity of the Phase 2 clinical trial. Secondly, Bharat Biotech was asked to submit “some clarifications” in order to get into Phase 3 human trials.
In its application, Bharat Biotech revealed that the Phase 3 Human Trial would have 28,500 subjects or volunteers aged 18 years and above. The phase 3 human trials of Covaxin would be held in 19 sites across 10 states. These will include Mumbai, Delhi, Lucknow, and Patna. Bharat Biotech stated that during the Phase 3 human trials, a dose of 0.5 ml on day 0 and 28 will be administered, as per a PTI report.
Back In July, Bharat Biotech received a nod from the DCGI to conduct phase 1 and 2 clinical trials of Covaxin.