Covid-19- Serum Institute to Halt Trial of Oxford Vaccine After DCGI Notice

Business Standard 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”.

A participant in the UK trials —now in phase 3 — fell sick with what may be called a suspected case of serious adverse reaction, and needed hospitalisation. The drug maker voluntarily put trials on hold, saying it was reviewing the event given that such side effects are never ruled out.