New year with something in hand: DCGI on COVID-19 vaccine approval

New Delhi: India is likely to have a Covid-19 vaccine in the New Year, Drug Controller General of India V.G. Somani hinted on Thursday.

Speaking at a webinar, Somani said the most important thing is that the industry and research organisations have stood the test of time.

He 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," Somani said.

The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI 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, allowing 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," he said.

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

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