Dr V G Somani, Drugs Controller General of India (DCGI) has given permission to Serum Institute of India to resume clinical trials of the Oxford COVID-19 vaccine candidate in the country. It has also revoked its earlier order of suspending any new recruitment for phase two and three trials.
The DCGI 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 Serum Institute of India (SII).
SII has also been asked to submit details of medication used in accordance with the protocol for the management of adverse events to the DCGI’s office.
On Saturday, 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 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 the order, SII has submitted revised participant information sheet revised informed consent form and additional safety monitoring plan for the evolved participants.
The company 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 sequel.
“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.