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.
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