Expert panel seeks more time to analyse COVID vaccine candidates’ data

Appointed by the drug regulator to evaluate the clinical trial reports of the vaccine candidates, panel says analysis of additional data and information is underway


Making the wait for a COVID-19 vaccine longer, a committee of experts advising the Drugs Controller General of India (DCGI) in its evaluation of the vaccine candidates submitted by Serum Institute of India (SII) and Bharat Biotech has sought more time to analyse the clinical trial data.

The development flies in the face of the assurances of Prime Minister Narendra Modi and the DCGI that the vaccination process will start soon after the vaccine candidates,  especially the one manufactured by Serum Institute of India (SII), get the approval.

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According to reports, the Subject Expert Committee (SEC) set up by DCGI VG Somani is slated to meet on Friday (January 1) and may discuss the application of Pfizer for an emergency licence to import its COVID-19 vaccine to India and for a waiver of the clinical trials in India.

The DCGI gives its nod for the emergency use of a vaccine only after it is cleared by the SEC.

“The analysis of the additional data and information is going on. SEC will convene again on 1 January 2021 (Friday),” the health ministry said in a statement.

Meanwhile, Britain, which is dealing with the spread of a new virulent strain of COVID-19, approved the Oxford-AstraZeneca vaccine for human use on Wednesday.

The delay is significant for SII whose COVID-19 vaccine candidate Covishield is a frontrunner in getting the approval from the DCGI. SII CEO Adar Poonawala had recently said that the vaccine may get the drug regulator’s nod by early January and the company has readied around 50 million dosages, half of which will be used in India.

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Prime Minister Narendra Modi, while laying the foundation stone for AIIMS in Gujarat’s Rajkot on Thursday (December 31), also assured that preparations are in the last stages for the vaccination programme for COVID1-19.