India's Serum Institute applies for full approval of Covishield vaccine
The Serum Institute of India has applied to the country's drug regulator and health ministry for full approval of its Covid-19 vaccine Covishield, CEO Adar Poonawalla said on Friday.
Serum Institute, which produces the AstraZeneca vaccine under the brand name Covishield, has supplied more than 1.25-billion doses in India.
The Indian government has enough data to consider a full market authorisation, 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 2021.
The country's inoculation drive has been dominated by Covishield and Bharat Biotech's inactivated vaccine Covaxin.
Serum Institute has nearly quadrupled its monthly capacity of AstraZeneca shots to about 240-million doses and is prepared to export “large volumes” from January, Poonawalla said in October.
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