It has revoked its suspension of new recruitment for phase two and three trial. They have put up extra conditions to step safety during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study that the Serum Institute has to follow to the dot.
DCGI allows Serum Institute to resume Oxford COVID vaccine trial in India.
It has revoked its suspension of new recruitment for phase two and three trial. They have put up extra conditions to step safety during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study that the Serum Institute has to follow to the dot.
SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events. The DCGI ordered SII on September 11 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.
After the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe, on Saturday, British-Swedish pharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK. SII along with AstraZeneca submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India for manufacturing the vaccine candidate for COVID-19, on Tuesday, and requested permission to restart enrolment in the clinical trial.
DCGI, the DSMB, UK in the order released on Tuesday were subject to certain conditions and recommended that the investigators recommence all immunization in their clinical trials. DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol. SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants according to the order.
The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination. It stated that no serious adverse events were experienced by any of the subjects till the date of the reporting. It also said, the reported adverse events were stated to be mild, resolved on their own and did not have any sequelae.
"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. 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," the order said.