The government has allowed the 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 by any Indian manufacturer, official sources said on Friday.
A official source told PTI that the shipment is likely to be dispatched on July 3. In a letter to the government on June 29, Prakash Kumar Singh, director of government and regulatory affairs at SII, asked for permission to export Covovax to the US.
Sources said it will be the first instance of an Indian manufacturer exporting any vaccine Covid or non-Covid to the US. In his communication, Singh said that it was a matter of pride for us and our country that in line with the clarion call of our Prime Minister Narendra Modi Ji'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 the first life-saving vaccine of our country to be exported to the United States of America.
On December 28, 2021, the Drugs Controller General of India DCGI approved Covovax for use in emergency situations in adults, and in the 12 -- 17 year age group on March 9.
On June 29, the drug regulators 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 17, 2020. In August 2020, the US-based vaccine maker Novavax Inc announced a licensing agreement with SII for the development and commercialization of NVX-CoV 2373, its COVID 19 vaccine candidate, in India and low and middle-income countries.