Pune: Serum Institute gets approval for COVID vaccine human trial phase 2 and 3
Pune, 3 August 2020: Scientists from all over the world are engaged in research and trials for a vaccine of the Coronavirus disease (COVID19). Meanwhile, the second and third phase of human trials of Oxford University’s Corona vaccine, COVISHIELD, has been approved in India.
According to the Union Ministry of Health and Family Welfare, the country’s top drug regulator – the Drugs Controller General of India (DCGI), has given approval to Serum Institute of India (SII), Pune to conduct Phase II+III clinical trials of Oxford University-AstraZeneca COVID19 vaccine (COVISHIELD) in India.
Officials said that after an in-depth evaluation, DCGI has given the approval to conduct a clinical trial based on the recommendations of the Subject Expert Committee (SEC). Based on this recommendation, human trials of this vaccine have been approved.
An official said that the proposal for a human trial of the Oxford vaccine was discussed through a virtual meeting earlier this week. After considering the 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 assessed at predetermined intervals. According to the official, the pharma firm has to register the safety data, assessed by the Data and Safety Monitoring Board (DSMB), to the Central Drugs Standard Control Organization (CDSCO) before it can proceed to phase-3 of the clinical trial.
