Corona Vaccine: Serum Institute Becomes First Indian Pharma To Seek Nod For Emergency Use Of Oxford Vaccine In India

The Pune Based Serum Institute has sought approval for the emergency use of the Oxford University vaccine that it is testing in the country.

(Representative Image/ Getty)

New Delhi: After Pfizer, the Pune-based Serum Institute of India has applied for approval for the emergency use of the Oxford university vaccine, Covishield. It will be the first Indian company to do so. The pharma company has applied for authorisation to the Drugs Controller General of India (DCGI) citing unmet medical needs due to the pandemic and in the interest of the public at large, said sources in a report by PTI.  The report said that in its application SII has said that Covishield is highly efficacious against symptomatic and severe Covid-19 infections.

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

"In line with our philosophy we assure you that for Covid-19 vaccines also, we are committed to make our country 'aatmanirbhar' (self-reliant) and fulfil our prime minister's clarion call of 'vocal for local' and 'making in India' for the world," stated the application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII). "So, in the national interest, we request you to grant us emergency use authorisation of Covishield based on our application and in view of immediate need for a safe, effective, programmatically suitable and affordable vaccine for our country," the application read. SII is conducting the phase-three clinical trials of, Covishield in partnership with the Indian Council of Medical Research (ICMR). This is in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil. Last month, SII  had said that it will apply for early availability of the vaccine in India based on phase two and three clinical trial results. The development has taken place a day after the US-based pharma company Pfizer submitted its application to the DGCI seeking permission to import the vaccine for sale and distribution in the country,