India’s Serum Institute applies for full approval of Covishield vaccine

BENGALURU (Reuters) – 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.

(Reporting by Shivani Singh in Bengaluru; Editing by Shounak Dasgupta)