Guwahati: Amid increasing number of COVID-19 positive cases in the country, the Drugs Controller General of India (DCGI) Dr VG Somani has given permission to Serum Institute of India (SII) to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country, while revoking its earlier order of suspending any new recruitment for phase two and three trial.
While giving the permission, Somani has however put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be “scrupulously” followed by SII.
The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of “an unexplained illness” in a participant in the study.
“In view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India and in UK revoke herewith the order dated September 11 issued under Rule 30 of the New Drugs and Clinical Trials Rules, 2019″, Somani said in the order
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The Pune-based vaccine manufacturing firm has submitted a summary of safety follow up of seven days after initial vaccination, informing that no adverse side-effect were noticed in any of the tested volunteers as on the date of the submission, and the noticed side-effects were stated to be mild, resolved on their own and did not have any severe consequences.
“You may recommence the clinical trial as recommended by Data and Safety Monitoring Board (DSMB), India, as per already approved protocol and the provisions laid down under the New Drugs and Clinical Trial Rules, 2019, subject to the conditions mentioned,” the order further added.
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