Serum Institute of India gets nod for phase 2 & 3 trials of Oxford vaccine
   Date :04-Aug-2020

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By Payal Banerjee ;
 
NEW DELHI,
 
THE Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India for conducting phase 2 and 3 human clinical trials of the Oxford University’s COVID-19 vaccine candidate in the country, according to the Health Ministry. Government officials told PTI that DCGI Dr V G Somani granted the approval late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on COVID-19.
 
“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, referring to the Central Drugs Standard Control Organisation (CDSCO). “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 pre-defined intervals,” the official said.
 
The DCGI has given approval to SII, Pune, to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine (COVISHIELD) in India and this will hasten the development of the COVID-19 vaccine, the Health Ministry said in a statement.