OdishaPlus Bureau
The Drugs Controller General of India (DCGI) has given its consent to the Serum Institute of India (SII) for conducting phase II and III human clinical trials of the Oxford University developed COVID-19 vaccine in India. The approval for conducting phase II and III clinical trials was granted by DGCI Dr V G Somani after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on COVID-19.
A senior official said, “The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase III clinical trials”. Each subject will be administered two doses four weeks apart following which the safety and immunogenicity will be assessed at predefined intervals.
SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the phase II and III clinical trials besides seeking some additional information. The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.
1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.
At present, phase II and III clinical trials of the Oxford vaccine candidate is being conducted in the United Kingdom, phase III clinical trial in Brazil and phase I and II clinical trials in South Africa.