Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday gave permission to Serum Institute of India 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.
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 Serum Institute of India (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.
India’s drug regulator on Tuesday gave permission to Serum Institute of India (SII) to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country. The drug controller had earlier put on hold the trials after an adverse event was reported in a participant.
The DCGI on Tuesday revoked its earlier order of suspending any new recruitment for phase two and three trial.
The permission however comes with a caveat. The DCGI has asked the company 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 has to be “scrupulously” followed by Serum Institute of India (SII).
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 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 after AstraZeneca halted the clinical trials in other countries because of “an unexplained illness” in a participant in the study.
