Serum Institute to follow DCGI's direction, says 'not instructed to pause trials'

Shortly after the Drugs Controller General of India (DCGI) issued a show-cause notice to Serum Institute of India (SII) seeking an explanation as to why the ongoing clinical trial of Covishield vaccine candidate has not been suspended till patients' complete safety is ensured, the pharma company has issued a statement in response to the same.  

The Serum Institute said in its statement that they were not instructed to pause trials and that they will now adhere to the instructions of the top drug regulator.

"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 said.

The DCGI had instructed SII to suspend the clinical trials after AstraZeneca, which is developing COVID-19 vaccine candidate of Oxford University, paused its trial as a volunteer developed an ‘unexplained illness’. Its clinical trial has been suspended across the USA, UK, Brazil and South Africa.

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DCGI issues notice to Serum Institute of India

Drugs Controller General of India Dr VG Somani had issued the notice to the Serum Institute, seeking a show-cause notice upon failing to halt the clinical trials for its COVID-19 vaccine candidate.

"In view of the above 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 on August 2 has not been suspended till patient safety is established," the notice to SII read.

It said that Serum Institute has still not informed the central licensing authority regarding pausing of a clinical trial carried out by AstraZeneca and has also not submitted a casualty analysis of the adverse event during the trials, so as to continue phase II/III clinical trial of the subject vaccine in the country.

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"Your reply shall reach undersign immediately, else it shall be construed that you have no explanation to offer and action deemed fit will be taken against you," it added.

On August 2, the DCGI had granted permission to SII to conduct a phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.

The vaccine will be manufactured by Serum Institute under technical collaboration with Oxford University’s AstraZeneca and is called as Covishield (SII-ChAdOx1 nCoV-19). Covishield vaccine contains replication-deficient simian adenovirus vector ChAdOx1 containing structural surface glycoprotein (spike protein) antigens of SARS-CoV-2.

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