Serum seeks emergency use authorisation for vaccine

New Delhi, Dec. 7: Vaccine major Serum Institute of India (SII) on Monday said it has applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for AstraZeneca-Oxford Covid-19 vaccine in the country.

Earlier, the Indian arm of US pharmaceutical giant Pfizer became the first company to seek a similar approval from India’s drug regulator for Pfizer/BioNTech vaccine against Covid-19 in the country, after securing such clearance in the UK and Bahrain. Pune-based SII has collaborated with AstraZeneca and Oxford University for manufacturing the vaccine and is conducting phase-three clinical trials of the Covishield vaccine in India.

“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD,” Serum Institute of India (SII) CEO Adar Poonawala said in a tweet.

He further added, “This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support”.

According to the Indian Council of Medical Research (ICMR), SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the Drugs Controller General of India (DCGI).

Official sources, citing the Serum Institute of India (SII) application, said 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.

According to sources, this vaccine is logistically feasible for distribution in the country’s both urban and rural parts as it can be stored at two to eight degrees celsius.

Earlier on November 29, Poonawalla in a virtual press conference had said that the company was in the process of applying in the next two weeks for an emergency use licensure for Covishield.