New Delhi: The Drugs Controller General of India (DCGI) has given green signal to Pune-based Serum Institute of India (SII) to conduct the phase 2 and 3 of clinical human trials of the University of Oxford-developed COVID-19 vaccine in India.
News agency PTI, while quoting sources from the government, said that DCGI chief Dr VG Somani has given ‘go-ahead’ to the SII for the phase 2 and 3 trials of the Oxford vaccine candidate late on Sunday night. This was done following the recommendations from the Subject Expert Committee on COVID-19.
Central Drugs Standard Control Organisation (CDSCO) expert panel, as a rapid regulatory response on Friday, granted permission to the Oxford vaccine candidate ‘Covishield’ for human trials in phase 1 and 2.
“The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials,” a senior official said.
“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said.
