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Serum Institute halts Covishield vaccine trials in India after UK incident followed by DCGI’s notice

We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following DCGI’s instructions.

Serum Institute halts Covishield vaccine trials in India after UK incident followed by DCGI’s notice

(Photo: AFP)

Serum Institute of India on Thursday said it will stop the Phase 3 trials of vaccine that were to begin in India next week.

The Serum Institute of India, which is manufacturing the coronavirus vaccine Covishield, developed by the Oxford University along with pharma major AstraZenca.

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“We are reviewing the situation and pausing India trials till @AstraZeneca restarts them. We are following DCGI’s instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front,” it said in a tweet.

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Yesterday, drug controller DCGI had issued a notice where it was questioned why it was continuing the trials in India even though it has been stopped elsewhere.

“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials,” read a statement from the Serum Institute.

“We are following DCGI’s instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front,” it added.

Last evening, after the DCGI notice, the Serum Institute 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.”

“We (Serum Institute of India) can’t comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all,” it had said in a tweet.

“We (Serum Institute of India), were going by DCGI’s direction and were not instructed to pause the trials. If DCGI has any safety concerns, we will adhere to their instructions and abide by the standard protocols,” it had said.

AstraZeneca had said it had voluntarily paused vaccination in its ongoing global trials to allow review of safety data by an independent committee after the event triggered its standard review process.

According to the New York Times reports, a volunteer in the UK trials was diagnosed with transverse myelitis, an inflammation of the spinal cord generally caused by infections, citing a person close to the situation that it didn’t name.

“I was horrified to read last night @8:15pm that Serum Institute said it was continuing with its vaccine trials. I immediately got in touch with senior govt officials & am glad the Drug Controller has since issued show-cause notice. Safety standards ARE & MUST be same world over,” former Union minister Jairam Ramesh had tweeted.

India registered the biggest single-day spike in the coronavirus cases on Thursday with 95,735 coronavirus cases reported in last 24 hours taking the total number of infections to over 44.65 lakh, government data said.

The country also recorded the highest deaths in a day with 1,172 fatalities.

In terms of recovery, 72,939 have recovered in the last 24 hours taking the total recoveries to 34,71,783. The recovery rate in the country is 77.7 per cent.

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