Oxford Corona Vaccine: Approval for second and third phase human trials of corona vaccine in India
Oxford Corona Vaccine is collaborating with the Clinical Trial Serum Institute of India (SII) for the Corona Vaccine in India.
3th August, 2020
Oxford Vaccine, People await vaccine amidst Corona crisis worldwide. Regarding this, scientists from all over the world are engaged in research and trials. Meanwhile, the second and third phase of human trials of Oxford's Corona vaccine have been approved in India. According to a senior official, the Serum Institute of India (SII), the country's top drug regulator - the Drugs Controller General of India (DCGI), has approved the second and third phase of human trials of Oxford's potential corona vaccine in India.
The official source told ANI that after an in-depth evaluation, DCGI has approved the Serum Institute of India (SII) to conduct a clinical trial based on the recommendations of the Clinical Expert Committee (SEC). Significantly, in India, the Clinical Trial Serum Institute of India (SII) and Oxford are jointly conducting the Corona Vaccine of Oxford.
Earlier, the Subject Expert Committee on Corona Affairs recommended the country's drug regulator Drugs Controller General of India (DCGI) to allow the Serum Institute of India (SII) for the second and third stage human trials of the corona vaccine at Oxford University was. Based on this recommendation, human trials of this vaccine have been approved.
As a swift regulatory response, the official said, the proposal for a human trial of the Oxford vaccine was discussed through a virtual meeting at the SEC earlier this week. After considering data generated on the vaccine in the first phase of the Oxford University trial, the committee recommended permission to conduct.
According to the study, during human trials, each person will be given two doses within 4 weeks (first dose 1 day and second dose 29 days), after which safety and immunity will be evaluated at predetermined intervals. According to the official, the pharma firm has to register the safety data, assessed by the Data Drug Safety Monitoring Board (DSMB), to the Central Drugs Standard Control Organization (CDSCO) before it can proceed to phase-3 of the clinical trial .