DCGI notice to Serum Institute after AstraZeneca halts Oxford COVID-19 vaccine trials

The central drug regulator Drug Controller General of India (DCGI) on Wednesday issued a show-cause notice to Serum Institute of India (SII) for not informing it about AstraZeneca suspending the clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and also for not submitting casualty analysis of the "reported serious adverse events".

The show-cause notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a UK participant had an adverse reaction to it.

The drug regulator in its show-cause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country should not be suspended till patient safety is established.

Regarding the show-cause notice issued by the DCGI, Serum Institute of India, said "We are going by DCGI's direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols."

Last month, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.

AstraZeneca, the British-Swedish biopharmaceutical giant in tie-up with the Oxford University to produce the vaccine, described the pause of trials as a "routine" one following what was an "unexplained illness".

Meanwhile, Serum Institute, which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, on Wednesday said it is continuing with the trials in India.

Commenting on the recent reports on AstraZeneca halting the trials in the UK, SII said in a statement: "We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon."

It further said: "As far as Indian trials are concerned, it is continuing and we have faced no issues at all".

With PTI inputs

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