SII in anticipation of DCGI approval for emergency use of Covidshield

On December 6, the Serum Institute of India applied for emergency use authorization of the Oxford-Astrazeneca COVID-19 vaccine. SII is the primary to apply for authorization for coronavirus vaccine in the country through the Drug Controller General of India.

The phase–three clinical trials of the Oxford COVID-19 vaccine, Covidshield is underway by the Pune-based Serum Institute of India and it is backed by the India Council of Medical Researcher (ICMR). The clinical trial is being carried out in various parts of countries.

SII informed that four clinical studies are currently undergoing in the UK, Brazil, and India. Moreover, Covidshield is highly effective against symptomatic and severe COVID-19 infections. The results are in line with other anti-coronavirus vaccines and because of the huge disease burden, Covidshield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm told DGCI.

A source said to PTI, “In terms of safety, Covidshield 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, Covidshield 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 Covidshield.”

As per ICMR, the SII has manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license is obtained from the DCGI.

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