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

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

Serum Institute said in its statement that y were t instructed to pause trials and that y will w adhere to instructions of top drug regulator.

"We (Serum Institute of India), were going by DCGI's direction and were t instructed to pause trials. If DCGI has any safety concerns, we will adhere to ir instructions and abide by standard protocols," it said.

DCGI had instructed SII to suspend 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 USA, UK, Brazil and South Africa.

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DCGI issues tice to Serum Institute of India

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

"In view of above Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause as provided under rule 30 of New Drugs and Clinical Trials Rules 2019 - why permission granted to you on August 2 has t been suspended till patient safety is established," tice to SII read.

It said that Serum Institute has still t informed central licensing authority regarding pausing of a clinical trial carried out by AstraZeneca and has also t submitted a casualty analysis of adverse event during trials, so as to continue phase II/III clinical trial of subject vaccine in country.

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"Your reply shall reach undersign immediately, else it shall be construed that you have explanation to offer and action deemed fit will be taken against you," it added.

On August 2, 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 country to determine its safety and immugenicity.

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 adevirus vector ChAdOx1 containing structural surface glycoprotein (spike protein) antigens of SARS-CoV-2.

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