The Drugs Controller General of India (DCGI), has given its permission to Serum Institute of India (SII) to conduct the phase 2 and phase 3 human clinical trials of a coronavirus vaccine which has been developed by the University of Oxford in India.
The approval for the phase 2 and 3 human clinical trial of the vaccine – Covishield — on healthy adults in India was given by DCGI Dr V G Somani who on Sunday night did a thorough evaluation of the vaccine on the recommendations given by the Subject Expert Committee (SEC) on COVID-19.
A senior official told that before the phase 3 human clinical trial of the vaccine, the firm will have to submit safety data to the Central Drugs Standard Control Organisation (CDSCO) which will be evaluated by the Data Safety Monitoring Board (DSMB).
“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,” news agency PTI quoted the official as saying.
The SII had on Wednesday submitted a revised proposal for the phase 2 and 3 human clinical trials of the vaccine and recommended that the clinical trial sites which have been proposed for the study be distributed across India.
According to the revised proposal by the SII, 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.
“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 told PTI.
The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine.
Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said.
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