SII Seeks Emergency Use Approval for ‘Covishield’ Vaccine in India

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The Serum Institute of India (SII) on Sunday, 6 December, became the first Indian company to seek emergency use authorisation for the Oxford COVID-19 vaccine from Drugs Controller General of India (DCGI). CEO of SII Adar Poonawalla on Monday took to Twitter to announce the decision, saying this move would “save countless lives” and thanked the Government of India and PM Narendra Modi for “their invaluable support.”

SII in its application cited "unmet medical needs due to the pandemic and in the interest of the public at large" as the reason for seeking emergency authorisation of the vaccine, PTI reported.

This comes a day after the Indian arm of the American pharmaceutical company applied for emergency authorisation of its vaccine candidate before the DCGI.

The phase-three clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the SII.

According to The Indian Express, the SII has stated that data from four clinical studies shows that Covishield is highly effective against COVID-19 infections.

As per the Indian Council of Medical Research (ICMR), the SII has manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI, reported PTI.

Covishield ‘Safe, Well-Tolerated’

“In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae,” a source told PTI.

The firm stated that the results were in line with anti-coronavirus vaccines and that the Covishield vaccine is predicted to reduce COVID-19 mortality and morbidity.

“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,” PTI quoted a source as saying.

Serum Institute of India in Pune has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing.

Meanwhile, the DCGI has Pfizer’s application for emergency use approval before a committee of experts, reported The Indian Express.

(With inputs from The Indian Express and PTI)