New Delhi: The government has allowed Serum Institute of India (SII) to supply 32.4 lakh doses of its 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 Friday.
The shipment is likely to be dispatched 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 had sought permission to export Covovax to the US.
The sources said it will be the first instance of any Indian manufacturer exporting any vaccine -- Covid or non-Covid -- 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 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 12-17 year age group on March 9.
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 authorisation.
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.