The Serum Institute has sought the Centre's approval to export 32.4 lakh doses of the Covid-19 jab Covovax under the brand name Nuvaxovid to the US, which will be the first vaccine to be exported to the country by any Indian manufacturer, official sources said on Thursday.
According to a communication sent to the government by Prakash Kumar Singh, Director, Government and Regulatory Affairs at the SII, the shipment is likely to be dispatched on July 3 if due approval come in time, an official source told PTI.
The sources said it will be the first instance of any Indian manufacturer’s vaccine -- Covid or non-Covid -- to be exported to the US.
"It is a matter of pride for us and our country that in line with clarion call of our Prime Minister Narendra Modi ji’s 'Making in India for the world' and under leadership of our CEO, Dr Adar C Poonawalla, our made in India world class Covovax vaccine will be the first life-saving vaccine of our country to be exported to United States of America. Also, our firm is committed to fulfill the dream of our PM to make India a pharmacy hub of the world," Singh has 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 12-17 year age group on March 9 this year.
On June 29, the drug regulator approved it for restricted emergency use in children aged 7 to 11 years.
Covovax is manufactured through technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorization.
It was granted emergency use listing by the World Health Organization on December 2017, 2020. In August 2020, the US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in India and low and middle-income countries.