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New Delhi:
The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting section 2 and 3 human medical trials of a COVID-19 vaccine candidate, developed by the University of Oxford, within the nation.
Government officers informed PTI that the approval for conducting section 2 and 3 medical trials by the SII was granted by DCGI Dr V G Somani late Sunday night time after an intensive analysis primarily based on the suggestions of the Subject Expert Committee on COVID-19.
As a speedy regulatory response, the knowledgeable panel on the Central Drugs Standard Control Organisation (CDSCO) on Friday, after an in depth deliberation and contemplating the information generated on the vaccine candidate in section 1 and a couple of of the Oxford University trial, had advisable granting permission for section 2 and 3 medical trials of the potential vaccine, “Covishield”, on wholesome adults in India, the officers stated.
“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 medical trials of the Oxford vaccine candidate is occurring within the United Kingdom, section 3 medical trial in Brazil and section 1 and a couple of medical 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 medical trials apart from looking for some further data.
The panel has additionally advisable that the medical 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, 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.
“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 looking for permission for conducting the section 2 and 3 trials of the potential vaccine.
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