Most likely we can have a really pleased New 12 months: DCGI on COVID-19 vaccine

New Delhi, December 31

India is likely to have a COVID-19 vaccine in the New Year, Drug Controller General of India VG Somani hinted on Thursday.

Speaking at a webinar organised by the Department of Biotechnology, Somani said the most important thing was that the industry and research organisations had stood the test of time.

He talked about the efforts made by the Department of Biotechnology and said vaccine candidates have got funding.

“…and probably we will have a very happy New Year with something in hand. That’s what I can hint at,” Somnai said.

The Serum Institute of India (SII), 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.

For restricted emergency use authorisation, he said: “There are certain parameters that if we get limited data or partial data of reasonable safety and efficacy, we will allow that vaccine to come into the immunisation programme into the market.”

“As such, there is no compromise at all in the safety, efficacy and quality except for accepting the partial data for emergency use authorisation,” he added.

An expert panel in the Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider emergency use authorisation applications by SII for the Oxford COVID-19 vaccine and Bharat Biotech’s ‘Covaxin’, and it 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 SII and Bharat Biotech.

Six vaccines are at various stages of clinical trials, of which four are being indigenously developed.

The clinical trials by Bharat Biotech are in phase 3 while the one which is being developed by Zydus Cadila is in phase 2 clinical trial.

SII is also conducting phase 2 and 3 clinical trials of the Oxford-Astrazeneca vaccine.

Similarly, Dr Reddy’s Laboratories is conducting phase 2 and 3 clinical trials for Russian vaccine Sputnik V.

Umesh Shaligram, director (R&D), SII said it had the strategy of working on several platforms to address the pandemic.

“As of today, it has 75 million doses of Oxford-Astrazeneca vaccine. By the first week of January, we (will) have something around 100 million doses of the Oxford vaccine. On the global platform we are working with Astrazeneca. If all goes well, and if experts are true, we may have an emergency authorisation in the coming few days,” Shaligram said.

He said the company had also collaborated with Novavax for another vaccine.

V Krishna Mohan, executive director of Bharat Biotech, said the company was also working on a nasal vaccine.

“This will not require syringes and various infrastructure that it requires for vaccine administration. Hopefully, that should be making it a lot easier from the immunisation perspective and make the whole programme smoother,” he said.

He urged organisations such as the DBT and Indian Council for Medical Research (ICMR) to bring up capacity to do large-scale efficacy trials in the country. PTI

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