Coronavirus | Serum Institute pauses COVID-19 vaccine trials

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The Serum Institute of India (SII) in Pune on Thursday paused the clinical trial of COVID-19 vaccine candidate being developed by Oxford University’s Jenner Institute and Astra Zeneca following a notice from the Drug Controller General of India (DCGI) on Wednesday.

Also read: Coronavirus | Serum Institute pulled up for not pausing vaccine trial

Trials of the vaccine were stopped globally after one of the recipients in the U.K. showed adverse symptoms.

In a statement released on Thursday, the SII said, “We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. 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’’.

While trials of the vaccine were stopped in four countries as a precautionary measure. the DCGI, in its notice to the SII, asked as to why it was progressing with the trials and why it had not sent a detailed report about the U.K. patient.

Also read: Editorial | Vaccine for all: On COVID-19 vaccine policy

The SII had maintained that they were going by the DCGI’s direction and so far were not told to pause the trials. “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”, it had said.

British-Swedish pharma giant AstraZeneca had stated that the said volunteer suffered “an unexplained illness” and such pauses in drug trials are “routine”.

Earlier statement

Earlier, the SII has come out with a statement, saying nothing untoward has been reported during the trials and that they would be continuing them. “We cannot comment on reports of the UK trials, other than that they have been paused for further review and that they hope to restart soon. As far as Indian trials are concerned, they are continuing and we have faced no issues at all,” said a statement issued earlier today by the SII, the world’s third largest vaccine manufacturer.

Also read: Russian vaccine generated strong immune response, says Lancet study

Till date, 100 volunteers have been administered the vaccine shots following the commencement of the phase two trials that began in India on August 26.

Of these volunteers who were administered the shots, 34 were from the Pune-based Bharti Vidyapeeth Medical College and Hospital. According to the medical authorities in Pune, none of these volunteers had shown signs of ill-health and all their vital parameters were appearing normal more than a week after being administered the vaccine shots.

(With inputs from Shoumojit Banerjee in Pune)

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Printable version | Jul 29, 2021 7:59:45 PM |

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