COVID-19 Vaccine: Serum Institute of India gets DCGI nod to resume clinical trials
Serum Institute of India gets DCGI nod to resume clinical trial of Oxford COVID-19
The Serum Institute of India has been given permission by the Drugs Controller General of India (DCGI) to resume its trials of the Oxford Covid-19 vaccine. The DGCI 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. But they have also asked the company certain conditions like taking extra care during screening. Also to provide additional information and close monitoring for adverse events during follow-up.
DCGI VG Somani, in a letter to SII said, “You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the Data Safety Monitoring Board (DSMB), India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up.”
The DGCI has also asked SII to submit the details of the medication used as per protocol for the management of the adverse events.
AstraZeneca has already resumed trials in the UK for the vaccine. The British-Swedish biopharmaceutical giant and the University of Oxford said it had resumed the trials for their coronavirus vaccine after the Medicines Health Regulatory Authority’s (MHRA) confirmed that the trials were safe.