After US pharmaceutical giant Pfizer, Serum Institute of India (SII) applied on Sunday to the Comptroller General of Medicines of India (DCGI) for an emergency use authorization for the COVID-19 Covidshield vaccine from Oxford in the country. On Twitter, SII CEO Adar Poonawalla reported that the company has applied for an emergency use authorization for Covidshield. Stating that this vaccine will save many lives, the CEO of SII also thanked Prime Minister Narendra Modi.
As promised, before the end of 2020, @SerumInst has applied for emergency use authorization for the first vaccine manufactured in India, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @Narendra Modi hee for your invaluable support.
– Adar Poonawalla (@adarpoonawalla) December 7, 2020
IBS is the first indigenous company to apply for emergency approval for the vaccine developed together with the global pharmaceutical giant AstraZeneca and the University of Oxford.
READ | Serum Institute to seek Covishield emergency clearance from DCGI in the next 2 weeks
‘Covishield is safe and well tolerated’
A day earlier, the Indian branch of US pharmaceutical giant Pfizer became the first to apply for similar approval from India’s drug regulator for its own COVID-19 vaccine in the country, after obtaining such authorization in the UK and Bahrain. Oxford’s COVID-19 vaccine phase three clinical trial, Covishield, is being conducted by the Pune-based Serum Institute of India (SII), co-sponsored by the Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being conducted by Oxford-AstraZeneca in the UK and Brazil.
READ | Serum Institute Seeks Emergency Use for Covid-19 Vaccine in India, Second to Pfizer
Based on the results of phase two and three clinical trials, IBS, with the help of ICMR, will seek early availability of the vaccine for India, the country’s lead health research body said last month. According to the ICMR, the IBS has already manufactured 40 million doses of the vaccine under the manufacturing and storage at risk license obtained from the DCGI.
“In terms of safety, Covishield was well tolerated with respect to requested adverse events and was not associated with a higher number of serious adverse events and deaths. Most of the requested reactions were mild in severity and resolved without sequelae. Therefore, Covishield is safe and well tolerated and can be used effectively for the prevention of COVID-19 in the target population. Therefore, the benefit / risk ratio strongly supports the widespread use of Covishield, “said a source citing the application .
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Official sources, citing the IBS request, said the firm has stated that data from four clinical studies, two in the UK and one in Brazil and India, show that Covishield is highly effective against symptomatic infections and, most importantly , against serious COVID-19 infections. The results are in line with other coronavirus vaccines, and due to the huge disease burden, Covishield is expected to alleviate substantial mortality and morbidity from COVID-19, the firm was reported to have said.
READ | Serum CEO Adar Poonawalla is “ delighted ” that Oxford’s COVID-19 vaccine shows greater than 70% efficacy
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