SII replied to DCGI: Will abide by standard protocol

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The Serum Institute of India (SII) has stated that it will follow the instructions and protocols of the Central Drugs Standard Control Organisation (CDSCO) after receiving a show-cause notice from the central drug control authority on Wednesday.

The statement by the Pune-based vaccine manufacturer came after the Drug Control General of India (DCGI), VG Somani, issued a show-cause notice to it asking for an explanation as to why the institute decided to go ahead with the clinical trial of Covid-19 vaccine when doubts about patient safety were yet unclear.

The notice was issued in the wake of an advert incident where one of the participants in the United Kingdom reported a suspected severe adverse reaction after being administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and the University of Oxford, on Tuesday.

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“The Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns,” the notice By DGCI read.

The DGCI further asked the institute as to why the authority did not suspend the permission given to SII for the clinical trials of Covishield.

“In view of the above, I, Dr VG Somani, Drugs Controller General of India, and Central Licensing Authority hereby give you an opportunity to show cause as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established,” the notice further said.

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 its instructions and abide by the standard protocols.”

However, earlier in the day, SII had decided that it will continue with trials of Covishield in India as usual as it has faced no issue at all.

“We can’t comment much on the UK trials but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, they are continuing and we have faced no issues at all,” SII had stated.

SII is the partner of the University of Oxford’s Jenner Institute to conduct vaccine trials. SII is currently progressing with the second and third phase study of the vaccine candidate at 17 trial sites across India.

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