Serum Institute gets DCGI nod to resume clinical trial of Oxford vaccine

DCGI gave permission to Serum Institute to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country

Drugs Controller General of India (DCGI) Dr V G 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). 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 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. On Saturday, British-Swedish biopharmaceutical giant 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…

Covid-19: Serum Institute to halt trial of Oxford vaccine after DCGI notice

On Tuesday, AstraZeneca had decided to stop trials after a participant fell sick with an unexplained illness.

In a major turn of events, the Indian drug regulator on Wednesday issued a show cause notice to Serum Institute of India (SII), which had earlier said it would proceed with clinical trials of AZD1222, the vaccine candidate developed by the University of Oxford, despite a halt on the same by AstraZeneca in the UK. On Tuesday, the British-Swedish drug major had decided to stop trials after a participant fell sick with an unexplained illness. Reacting to the show cause notice, a Serum spokesperson said:

“We were going by the DCGI’s direction, and so far had not been told to pause trials. If the DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.” Earlier during the day, the company had said that as far as Indian trials were concerned, they would continue as SII had faced “no issues at all”.

Investigators here, however, had expressed concerns during the day. The lead investigator of one of the clinical trial sites in western India had said trials here should have, ideally, been paused as it was the same vaccine being administered to volunteers. The person added that investigators were waiting to hear from the Indian Council of Medical Research (ICMR) and SII on this. In a strongly worded show cause notice to SII, V G Somani, the DCGI, asked the Pune-based firm why the permission granted to it on August 2 should not be suspended till “patient safety is established”…Read More