Drug Regulator asks Serum Institute to furnish revised protocol for COVID-19 vaccine clinical trial

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 Central Drugs Standard Control Orgsation (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.

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 .

On July 25, 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'.

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.

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

( With inputs from ANI )