India's Serum Institute seeks emergency use nod for AstraZeneca's COVID-19 vaccine - local media
December 7, 2020 09:23 AM NPT
INDIA, Dec 7: Serum Institute of India, the world’s largest vaccine producer by volume, has sought emergency use authorization in the country for AstraZeneca Plc’s COVID-19 vaccine on Sunday, according to several reports in Indian media, citing PTI.
The company applied to the Drugs Controller General of India, citing unmet medical needs due to the pandemic and in the interest of the public at large, the agency report said, citing official sources.
Serum was not immediately available to Reuters request for comment.
The move comes close on the heels of Pfizer Inc applying for a similar authorization of its coronavirus vaccine in India on Saturday.
“We remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country,” a Pfizer spokeswoman told Reuters. Serum’s application stated that data from four clinical studies, two in the UK and one each in Brazil and India, showed that the vaccine, Covishield, was highly effective against severe COVID-19 infections, the report said.
AstraZeneca’s vaccine is logistically feasible for distribution in India since it could be stored at two to eight degrees Celsius.