India’s top drug regulator– Drugs Controller General of India (DCGI) has granted permission to Serum Institute of India (SII) to conduct 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 said.
As per the study design, each subject will be administered two doses 4 weeks apart (First dose on Day 1 and Second dose on Day 29) following which the safety and immunogenicity will be assessed at predefined intervals, the official 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 ANI had reported that the domestic pharma giant had made an application to DCGI for grant of permission to conduct phase 2, 3 clinical trials of coronavirus vaccine (ChAdOxlnCoV- 19) in India.
The vaccine was manufactured by Serum in India under technical collaboration with Oxford University/Astra Zeneca and is called as COVISHIELD (SII-ChAdOx1 nCoV-19).