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.
The reason for the event gaining significance is that the sickness was not only serious, but also unexplained. The firm, however, seeks to ensure the event will not result in any delay to the trials.
There will be a meeting of the Data and Safety Monitoring Board (DSMB) for a review of the situation, the person told Business Standard.
Virologists point out that events of unexplained sickness were not uncommon in trials. It could also be someone who received a placebo shot, which will be unravelled when the DSMB analyses the event, said senior virologist Jacob John, former professor at Christian Medical College (Vellore). He explained that in case it was a placebo shot, trials would be back on track.
He added that trials in Indian need not be halted because it is an independent arm, and there would be no need to conduct trials here if a decision was taken based on data from the UK trials alone.
This candidate was recently described by the World Health Organization (WHO) as the world’s leading one, which was in advanced stages of investigation or trials.
All eyes were on this vaccine, and shares prices reacted negatively to the news — with the Indian arm of AstraZeneca shedding up to 12 per cent in intra-day trade on Wednesday. It ended the session at Rs 4,070 apiece, down 3.8 per cent. In London, the news triggered a 2 per cent fall in shares.
International agencies said the final decision on resumption in trials will be taken by British medical regulator MHRA.
If trials go off gear, it could have financial implications for SII. It is conducting phase-2 and phase-3 trials in India to have data on Indian demographics. SII CEO Adar Poonawalla had said he would start manufacturing the vaccine at his ‘personal risk’, even before results were out.