India’s Serum Institute has broken new ground for itself and the Indian vaccine industry by receiving regulatory approval in the United States for made-in-India vaccines, a first of sorts.

The vaccine major has a manufacturing tie-up with American biotechnology firm Novavax that has just received an emergency use authorization from the US Food and Drug Administration (USFDA) for the use of its adjuvanted Covid-19 vaccine in those over 18 years.

“It is the first vaccine from India to be approved by the USFDA,” Serum Institute of India’s Chief Executive Adar Poonawalla confirmed to BusinessLine, adding that SII’s site was the only one approved by the USFDA amongst all Novavax’s partners. “In India, the vaccine is branded as Covovax, and in other international markets, including the US, it is branded as Nuvaxovid by Novavax,” he added.

Source: The Hindu Business Line

“It is the first vaccine from India to be approved by the USFDA,” Serum Institute of India’s Chief Executive Adar Poonawalla