New Delhi (NVI): The Serum Institute of India (SII) has applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for its Oxford Covid-19 vaccine, Covishield, in the country.
The vaccine, developed by SII with Oxford and AstraZeneca, is the first candidate that’s being tested in India to seek emergency approval.
Adar Poonawalla, CEO and Owner of Serum Institute, tweeted, “As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.”
As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.
— Adar Poonawalla (@adarpoonawalla) December 7, 2020
This comes a day after the Indian arm of US pharmaceutical giant Pfizer sought a similar approval from India’s drug regulator to use its Covid-19 vaccine candidate in India.
Currently, phase-three clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the Pune-based SII, co-sponsored by Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.
SII stated that data from four clinical studies, two in the UK and one each in Brazil and India, shows that Covishield is highly efficacious against symptomatic and most importantly against severe COVID-19 infections.
According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
-CHK
