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Serum Institute applies for full approval of Covishield COVID vaccine

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INDIA: The Serum Institute Of India has applied to the country’s drug regulator and the health ministry for full approval of its COVID-19 vaccine Covishield, the company’s chief executive said on Friday.

Serum Institute, which produces AstraZeneca’s COVID-19 vaccine under the brand name Covishield, has supplied more than 1.25 billion doses of the shot in India.

The Indian government now has enough data to consider a full market authorisation, Serum Institute CEO Adar Poonawalla said on Twitter.

Serum Institute, which is also the world’s biggest vaccine maker, was granted approval for emergency use of Covishield in India at the beginning of the year.

The country’s inoculation drive so far has been dominated by Covishield and Bharat Biotech’s inactivated vaccine Covaxin.

Serum Institute has nearly quadrupled its monthly capacity of AstraZeneca’s shots to as many as 240 million doses and is prepared to export “large volumes” from January, Poonawalla told Reuters in October.

Meanwhile, Bharat Biotech’s Covaxin has been cleared for emergency use among kids above the age of 12 years, people familiar with the development said. The nod from the Drug Controller General of India came on Saturday, while the subject expert committee had recommended Covaxin for children of the age group of 12 to 18 years in October. This is the second vaccine to have received clearance for this age group, the first being Zydus Healthcare’s ZyCoV-D. No vaccine has been approved yet for children below the age of 12 years in India. The development comes as India is facing the threat of Omicron, the latest variant of SARS-CoV-2, which is spreading very fast in the country.

Hyderabad-based Bharat Biotech conducted a clinical trial of Covaxin in healthy volunteers aged 2 to 18 years. Recently, the Union ministry informed Parliament that the Central Drugs Standard Control Organisation sought additional information from Bharat Biotech in this regard.

The ministry has not yet announced when children will be getting the vaccines against COVID-19. The decision will be taken in consultation with the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) and the National Technical Advisory Group on Immunisation (NTAGI). – THE HINDUSTAN TIMES

Saturday, January 1, 2022 – 01:00

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