DCGI’s New Year wish raises hopes of COVID-19 vaccine approval soon

VG Somani

Photo courtesy: expresspharma.com

New Delhi: India is likely to have a COVID-19 vaccine in the New Year, Drug Controller General of India (DCGI) VG Somani hinted Thursday.        Speaking at a webinar, VG Somani said the most important thing is that the industry and research organisations have stood the test of time.

Somani said vaccine candidates have got the funding and also talked about the efforts made by the Department of Biotechnology. “…And probably we will have a very happy New Year with something in hand. That’s what I can hint at,” Somnai said during his address.

The Serum Institute of India (SII), Bharat Biotech and Pfizer have applied to the DCGI. All the three are seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.

Somani said the approval process was fast-tracked in view of the pandemic by quickly processing all applications. The DCGI allowed parallel phase 1 and 2 trials without waiting for complete data.

“There has been no compromise on the safety or efficacy of the data. The only thing is that the regulator has accepted partial data,” asserted Somani.

An expert panel in the Central Drugs Standard Control Organisation (CDSCO) met on Wednesday. It is considering emergency use authorisation applications by SII for the Oxford COVID-19 vaccine and Bharat Biotech’s’’Covaxin’.  The panel will reconvene January 1 to further deliberate on the matter.

The Subject Expert Committee (SEC) on COVID-19 Wednesday deliberated and analysed the additional data and information submitted by SII and Bharat Biotech.

 

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