The Center has granted Serum Institute of India (SII) permission to export 32.4 lakh doses of its Covid-19 Covovax vaccine to the United States.
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The government has authorized the Serum Institute of India (SII) to supply the United States with 32.4 lakh doses of its Covid-19 Covovax vaccine under the brand name Nuvaxovid, which will be the first vaccine to be exported to the country by a Indian manufacturer, official sources said on Friday.
The shipment is expected to be shipped on July 3, an official source told PTI.
In a letter to the government on June 29, Prakash Kumar Singh, Director (Government and Regulatory Affairs) at SII, requested permission to export Covovax to the United States.
The sources said it would be the first time an Indian manufacturer has exported a vaccine – Covid or non-Covid – to the United States.
“It is a matter of pride for us and our country that, in line with the clarion call of our Prime Minister Narendra Modiji’s ‘Making in India for the World’ and under the leadership of our CEO, Dr Adar C Poonawalla , our made-in-India, world-class Covovax vaccine will be our country’s first life-saving vaccine to be exported to the United States of America,” Singh had said in his communication, according to an official source.
On December 28, 2021, the Drugs Controller General of India (DCGI) had approved Covovax for restricted use in emergency situations in adults and in the age group of 12 to 17 years on March 9.
On June 29, the drug regulator approved it for restricted emergency use in children aged 7 to 11.
Covovax is manufactured through technology transfer from Novavax and has been approved by the European Medicines Agency for conditional marketing authorisation.
It was granted an emergency use list by the World Health Organization in December 2017, 2020. In August 2020, US vaccine manufacturer Novavax Inc. announced a license agreement with SII for the development and commercialization of NVX-CoV2373, its Covid -19 vaccine candidates, in India and low- and middle-income countries.