The Serum Institute of India (SII) has received approval from Drug Controller General of India (DCGI) to move ahead for phase 2 and 3 human clinical trials in India on the potential covid-19 vaccine, a senior government official said.
“After a thorough evaluation, the DCGI has given approval to SII to perform phase-II, III clinical trial based on the recommendations of the Subject Expert Committee (SEC),” the official source told ANI.
“As a rapid regulatory response, the proposal was deliberated in the SEC through a virtual meeting earlier this week. And after considering the data generated on the vaccine in phase-1, 2 of the Oxford University trial, the committee recommended granting permission to conduct phase 2, 3 clinical trials of COVISHIELD (SII-ChAdOx1 nCoV-19) healthy adult subjects at risk in the country,” the official further said.
According to the official, the pharma firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the Central Drugs Standard Control Organization (CDSCO) before it can proceed to phase-3 of the clinical trial.
Last week, SII, the domestic pharma giant had sought DCGI’s nod to conduct phase 2, 3 clinical trials of coronavirus vaccine (ChAdOxlnCoV- 19) in India. The vaccine called COVISHIELD has been manufactured by Serum in India under technical collaboration with Oxford University/Astra Zeneca.
Currently, phase 2, 3 clinical trials of the Oxford sponsor vaccine is ongoing in United Kingdom, phase 3 clinical trial in Brazil and phase 1, 2 clinical trials in South Africa, as per the ANI report.