The Serum Institute of India (SII) is seeking for emergency use authorization for Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large, an official source said. SII became the first indigenous company to apply to the Drugs Controller General India (DCGI) for the emergency use authorization.

A day earlier, Pfizer became the first drug magnet to seek a similar approval from India’s drug regulator for its own COVID-19 vaccine in the country. It has earlier secured such clearance in the UK and Bahrain.

Covishield is currently under the phase-3 clinical trial, which is conducted by the Pune-based SII and co-sponsored by the 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.

Based on phase 2 and 3 clinical trial results, SII with the help of ICMR will pursue early availability of the vaccine for India, SII said earlier last month. ICMR said that SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.

The firm has 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, official sources said citing the SII application.

The sources further said citing the application, “In terms of safety, Covishield was well tolerated with respect to

Based on phase 2 and 3 clinical trial results, SII with the help of ICMR will pursue early availability of the vaccine for India

solicited adverse events and was not associated with an increased number of SEAs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae.”

“Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield.”

The results of Covishield are in line with other anti-coronavirus vaccines.

SII has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing, a source said.

“In line with our philosophy, we assure you that for COVID-19 vaccines also, we are committed to make our country ‘aatmanirbhar’ and fulfil our Prime Minister’s clarion call for ‘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 SII.

It also said that in the view of the unmet medical needs in the interest of the public at large to save millions of people in the country and across the globe, early availability of a vaccine against COVID-19 is a necessity. The application further stated, “So, in the national interest, we request you to grant us emergency use authorization 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 vaccine is logistically feasible for distribution in the country across the urban and rural areas, said the sources. The vaccine can be stored at two to eight degress Celsius.