Covishield in India: Serum Institute seeks emergency use authorisation

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Covishield is in the line of vaccines for the novel corona virus. The Serum Institute of India on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large, as per the official sources.

A day earlier, the Indian arm of US pharmaceuticals giant Pfizer became; the first to seek a similar approval from India’s drug regulator for its own COVID-19 vaccines; in the country, after securing such clearance in the UK and Bahrain.

Covishield in India: Serum Institute seeks emergency use authorisation
National Herald

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 the Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being carried out b 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.

Official sources, citing the 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.

The results are in line with other anti-corona virus vaccines and because of the huge disease burden, the Oxford COVID-19 vaccine is predicated to alleviate substantial COVID-19 mortality and morbidity, the firm is learnt to have said.

A source said quoting the application that “In terms of safety, Oxford COVID-19 vaccine 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. Therefore, this vaccine is safe and well-tolerated and can be used effectively; for the prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of the vaccine.”

In order to introduce an urgently needed; vaccine against COVID-19 in India, SII, the world’s largest vaccine manufacturer, has entered into a collaboration; with the University of Oxford and AstraZeneca to manufacture the vaccine.

 

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