The Drug Controller General Of India (DCGI) V.G. Somani on Tuesday gave approval to the Serum Institute of India (SII) for conducting Phase II and Phase III clinical trials of Oxford University-AstraZeneca COVID-19 vaccine COVISHIELD.
The SII is manufacturing the vaccine developed by the Jenner Institute (Oxford University) in association with AstraZeneca.
The DCGI approval comes after thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19, reported India Today.
Earlier in July, the SII had submitted an application seeking permission for conducting the trials. Following, the institute submitted a revised proposal according to which 1,600 people aged above 18 years will participate in the trials across 17 selected sites in India.
This includes 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.
However, the firm has to submit safety data, assessed by the Data Safety Monitoring Board (DSMB), to the Central Drugs Standard Control Organisation (CDSCO) before moving forward to Phase III trials, a senior official told the media.
‘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 as quoted.
The United Kingdom and South Africa have started with Phase II and III trials of the vaccine, while Brazil has initiated the third phase and has shown an acceptable profile.
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