Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday (September 15) gave permission to Serum Institute of India (SII) to resume the clinical trials of the Oxford-AstraZeneca COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trials.
The DCGI, 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.
SII has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for the management of adverse events.
The DCGI had on September 11 directed SII 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 unexplained illness in a participant in the study.
On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority’s (MHRA) confirmed that the trials were safe.
SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial.
According to Tuesday’s order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions.
DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to certain conditions.
According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants.
The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale.
“In view of the above, I Dr VG 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,” the DCGI order said.
“You may recommence the clinical trial as recommended by 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,” it added.