“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 stated. “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 stated.
Currently, section 2 and 3 scientific trials of the Oxford vaccine candidate is happening within the United Kingdom, section 3 scientific trial in Brazil and section 1 and a couple of scientific trials in South Africa. The officers stated that the SII had submitted a revised proposal on Wednesday after the knowledgeable panel on Tuesday, following deliberation over its utility, had requested it to revise its protocol for the section 2 and 3 scientific trials in addition to in search of some extra data.
The panel has additionally advisable that the scientific trial websites which have been proposed for the examine be distributed throughout India.
According to the revised proposal, 1,600 individuals aged above 18 years will take part within the trials throughout 17 chosen websites, together with AIIMS Delhi, BJ 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.
“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults,” the official stated.
The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first utility to the DCGI on July 25 in search of permission for conducting the section 2 and 3 trials of the potential vaccine.