New Delhi (NVI): Serum Institute of India (SII), Pune, has got approval from Drugs Controller General of India (DCGI) to conduct Phase 2 and 3 clinical trials of COVID-19 vaccine candidate, “Covishield” developed by the Oxford University.
The approval was granted to SII after an evaluation based on the recommendations of the Subject Expert Committee (SEC) on COVID-19.
The Institute has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials.
According to the design, each subject will be administered two doses four weeks apart following which the safety and immunogenicity will be assessed at predefined intervals.
On July 25, the Serum Institute, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate submitted its first application to the DCGI, seeking permission for conducting the phase 2 and 3 trials of the potential vaccine besides seeking some additional information.
The panel has also recommended that the clinical trial sites which have been proposed for the study be distributed across India.
The SEC on last Friday, accepted the revised protocol submitted by the company. As per the revised proposal, 1,600 people aged above 18 years will participate in the trials across 17 selected sites.
As per the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults.
Serum Institute CEO Adar Poonawalla said that Oxford-AstraZeneca coronavirus vaccine will be branded as Covishield and they hope to launch it by the end of 2020 and by first quarter Covishield will start reaching masses.
Apart from this, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.