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Home / India News / Serum Institute asked to revise protocol for Covid-19 vaccine clinical trial

Serum Institute asked to revise protocol for Covid-19 vaccine clinical trial

Serum Institute of India will perform an observer-blind, randomised controlled study enrolling at least 1,600 participants to determine the safety and immunogenicity of ‘Covishield’ for coronavirus treatment.

india Updated: Jul 30, 2020 08:01 IST
Asian News International | Posted by Kanishka Sarkar
Asian News International | Posted by Kanishka Sarkar
New Delhi
Nurse prepares a shot as the world's biggest study of a possible Covid-19 vaccine developed by the National Institutes of Health and Moderna Inc. gets underway on July 27, 2020 in Binghamton, NY.
Nurse prepares a shot as the world's biggest study of a possible Covid-19 vaccine developed by the National Institutes of Health and Moderna Inc. gets underway on July 27, 2020 in Binghamton, NY. (AP File Photo )

The Central Drugs Standard Control Organisation (CDSCO) has advised the Serum Institute of India (SII) to submit a revised protocol to perform the clinical trials in India for potential Covid-19 vaccine.

The move comes when the Subject Expert Committee evaluated the submitted protocol by SII and it has recommended several observations to the pharma giant to furnish revised protocol.

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The domestic pharma giant has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for highly infectious disease Covid-19

“Our Subject Experts Committee reviewed the Serum Institute thoroughly and it has observed several recommendations like--assessment and statistical analysis, drop-out rate, immunity analysis etc. It is a comprehensive scientific analysis,” a senior health ministry official informed ANI.

Also read| Covid-19: What you need to know today

On July 25, ANI reported that SII had submitted its application to the Drugs Controller General of India (DCGI) seeking permission to perform the phase 2/3 human clinical trials of the potential vaccine.

The pharmaceutical company will perform an observer-blind, randomised controlled study enrolling at least 1,600 participants to determine the safety and immunogenicity of ‘Covishield’.

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A Lancet medical journal report has stated that a vaccine candidate developed at the University of Oxford has shown encouraging results and it appears to be “safe, well-tolerated, and immunogenic.

Last week, Oxford University announced the satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world. The clinical trials of a potential Covid-19 vaccine on humans began in April.

Also read: India logs 1 million recoveries in 150 days, 53% from 3 states

There was no immediate response from SII when ANI contacted them to take their version.

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