NEW DELHI : In a first, the Serum Institute of India (SII) has sought permission from the Indian Government to export their vaccine against Covid-19- Covovax under the brand name Nuvaxovid to the United States.
If granted permission, this will be the first Indian homegrown vaccine to be exported to the US by any Indian manufacturer, officials confirmed on Thursday.
The shipment of 32.4 lakh doses will be dispatched on 3 July, if the approval comes through, according to a communication sent to the government by Prakash Kumar Singh, Director, Government and Regulatory Affairs at the SII.
People familiar with the matter have informed that 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 28 December 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 29 June, 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.
Meanwhile, India registered a 30% spike in covid cases on Thursday with 18,819 new infections reported in a day. The country saw 39 deaths during this time.
The total tally of active caseload has climbed to over 1,04,555, the union health ministry said on Thursday. Total covid-19 cases have reached 4,34,52,164 so far and death toll has also climbed to 525116 so far, the data stated.
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