January 1, 2021 Covidshield, the Coivd-19 vaccine developed by the University of Oxford and drug manufacturer AstraZeneca, has been recommended for emergency use approval in India.The Drugs Controller General of India (DCGI) will take a final call on the matter

Covidshield, the Coivd-19 vaccine developed by the University of Oxford and drug manufacturer AstraZeneca, has become the first vaccine to secure recommendation for emergency use approval in India. The recommendation was made by a government-appointed expert panel on Friday. However, the Drugs Controller General of India (DCGI) will take a final call on the matter.

Prior to this, Argentina and the United Kingdom have already given emergency use approval to Covidshield and started the vaccine rollout process.

On Friday, an expert panel in the Central Drugs Standard Control Organisation (CDSCO) held a meeting to deliberate on the issue of granting emergency use authorisation. The meeting was held to deliberate on the applications submitted by the Serum Institute of India for the Oxford Covid-19 vaccine and Bharat Biotech’s ‘Covaxin’.

In India, the Pune-based Serum Institute of India is manufacturing Covishield.

“As of today, we have 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,” Umesh Shaligram, director (R&D), of the Serum Institute told PTI on Thursday.

On Wednesday, the Subject Expert Committee (SEC) on Covid-19 deliberated and analysed the additional data and information submitted by the Serum Institute and Bharat Biotech for their respective vaccines.

Addressing a webinar on the eve of the New Year, Drug Controller General of India VG Somani indicated that India is likely to grant emergency use approval for a vaccine against Covid-19 in the New Year.

In his address, Somani said the most important thing is that the industry and research organisations have stood the test of time. “Probably we will have a very happy New Year with something in hand. That’s what I can hint at,” he was quoted as saying by PTI.

In India, so far the Serum Institute of India, Bharat Biotech and Pfizer have applied for emergency use authorisation.

Six vaccines are at various stages of clinical trials, of which four are being indigenously developed. The clinical trials by Bharat Biotech of its vaccine ‘Covaxin’ are in phase 3, while the one which is being developed by Zydus Cadila is in phase 2 clinical trial.

Apart from this, the Serum Institute of India 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.

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