NEW DELHI: Dr. Venugopal G Somani, Drugs Controller General of India (DCGI), on Tuesday, September 15, withdrew the earlier order of suspension of Oxford COVID-19 vaccine trials in the country and gave permission to Serum Institute of India (SII) for recommencing the trials.
However, the DCGI has put certain conditions which have to be meticulously followed by SII. These include extra care should be taken during screening, additional information should be provided in informed consent and during the follow-up of the study, close attention must be given to possibility of occurrence of adverse events. Details of medication which are used according to the protocol for management of adverse event have been asked by the DCGI from SII.
Pharma giant AstraZeneca had paused the clinical trials in other countries because of an unexplained illness in a participant during the study. Following this, on September 11, SII had been directed by the DCGI under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, to suspend any new recruitment in the phase two and three clinical trials of the Oxford COVID-19 vaccine candidate till further orders.
After the Medicines Health Regulatory Authority (MHRA) confirmed the trial’s safety, the British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford on Saturday, September 12, said that the clinical trials for their coronavirus vaccine have resumed in the UK.
After submitting the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, on Tuesday, September 15, SII requested for permission to recommence enrolment in the clinical trial.
The DSMB, UK, has recommended that investigators resume all immunization in their clinical trials pertaining to certain conditions, as per Tuesday’s order issued by DCGI. Recommendation for continual of the study and enrollment of the remaining participants in the clinical trial as per protocol subject to certain conditions has also been given by DSMB, India. As per order, the revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants has been submitted by SII.
A summary of safety follow up of seven days’ post first vaccination has also been submitted by the Pune-based firm, which states that till the date of the reporting, no serious adverse events were experienced by any of the subjects. The adverse events that were reported were stated to be mild which resolved on their own and didn’t have any sequela.
Dr Somani, after careful examination of SII’s reply and the recommendations of the DSMB in India and in UK, revoked his previous order.