The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) for granting emergency use authorisation for the Oxford-AstraZeneca coronavirus vaccine. The CEO and owner of the institute confirmed the news via a tweet and thanked the Indian Prime Minister Narendra Modi and government for their “invaluable support”.
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
This comes a day after the Indian arm of US pharmaceutical giant Pfizer sought a similar approval from India’s drug regulator to use its Covid-19 vaccine candidate in India. Citing the SII application, official sources 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.
The phase-three clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the Pune-based Serum Institute of India on Sunday (SII), co-sponsored by 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 two and three clinical trial results, the SII with the help of the ICMR will pursue early availability of the vaccine for India, the country’s apex health research body had said last month. 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.
Serum Institute of India’s move comes on the heels of the US pharmaceutical giant, Pfizer, applying for a similar approval with the DCGI. The Pfizer vaccine, which was found to be 95% effective, is likely to cost about five times more than the Oxford vaccine and has to be stored at -70 degrees Celsius. Top government sources underlined that the regulatory process of emergency authorisation approvals for vaccine candidates being tested in India, specifically the one being developed at SII and ICMR-Bharat Biotech’s Covaxin vaccine candidate, are set to take place in the next few days.
