Serum Institute Seeks Emergency Use Nod For ‘Covishield’ Vaccine In India
Oxford COVID-19 vaccine: Serum Institute seeks emergency use nod for Covishield vaccine in India
Serum Institute of India has sought government approval for emergency use authorization of Covidshield. The Pune-based pharmaceutical firm is the second to do so after American firm Pfizer. SII is the first indigenous company to apply to the Drugs Controller General of India (DCGI). They are seeking emergency use authorisation for the Oxford COVID-19 vaccine in the interest of the public at large.
“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,” tweeted Adar Poonawala, who leads the SII.
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
As reported by sources to NDTV, The Pune-based institute has shared interim data with the DCGI of four clinical trials – one in India, two trials in the UK and one in Brazil.
The Indian arm of US pharmaceutical giant Pfizer had a day earlier had asked for approval from DCGI for its own COVID-19 vaccine in the country. They have already secured clearance in the UK and Bahrain.
The phase-three clinical trial of Covishield is being conducted by the Pune-based Serum Institute of India. It is co-sponsored by Indian Council of Medical Research (ICMR). The trails are being held in various parts of the country. Also, clinical studies are being carried out by Oxford-AstraZeneca in the UK and Brazil.
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.