New Delhi: Adar Poonawalla’s Serum Institute of India has applied to the country’s drug regulator and the health ministry for full approval of its COVID-19 vaccine Kovishield, the chief executive officer said on Friday.
Serum Institute, which produces AstraZeneca’s COVID-19 vaccine under the Covishield brand name, has supplied more than 1.25 billion doses of the shot in India.
Serum Institute CEO Adar Poonawalla said on Twitter, “The Indian government now has enough data to consider a full market authorization.
The supply of COVISHIELD vaccine in India has exceeded 1.25 billion. Government of India now has sufficient data for full market authorization, and therefore @SerumInstIndia have applied for @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission.
— Adar Poonawalla (@adarpoonawalla) December 31, 2021
Serum Institute, which is also the world’s largest vaccine manufacturer, was approved for emergency use of Covishield in India earlier in the year.
The country’s vaccination campaign has so far been dominated by Kovashield and Bharat Biotech’s inactivated vaccine Covaxin.
Mr Poonawalla told Reuters news agency in October that the Serum Institute had quadrupled its monthly capacity of shots of AstraZeneca to about 240 million doses and is ready to export “large quantities” from January.
However, due to insufficient orders from the central government for Kovishield, Serum Institute was reducing monthly production of vaccines by at least 50 per cent, Mr Poonawalla said earlier this month.
“I am really in a dilemma I never imagined… We are producing 250 million doses a month, but the good news is that India has covered a large part of its population. And we have completed all our orders to the Ministry of Health in a week’s time,” Mr. Poonawalla said in an interview to CNBC-TV18.
On its future production strategy, the SII CEO said that since “no other orders were in hand I am going to reduce the production by at least 50 per cent… either in India or in the world”.
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