Serum Institute of India Becomes the First Indian Company to Seek DCGI Approval for COVID-19 Vaccine

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 authorization for the Oxford Covid-19 vaccine in the country.

Oxford vaccine.
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). Recently the UK-based corona vaccine, Pfizer got approved for the trials by the Indian arm of the company.

Based on the second and the third trail, the SII with the help of ICMR will start working on early the propagation of the vaccine and its availability for India.

The SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license obtained from the DCGI. Covishield is highly efficacious against symptomatic and most importantly against severe Covid-19 infections as per the SII based on the trials from the UK, Brazil, and India. The SII also commented, “In terms of safety, Covishield was well tolerated concerning 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.”

Over to you.
Corona is a deadly virus whose symptoms range from cough, shortness of breath to death. The Serum Institute of India became the first indigenous company to apply for the approval of their vaccine to DCGI. The company performed trials in the UK, Brazil, and India and has also started the production of the vaccine at the risk of the probability of not getting approved. They also commented that the vaccine is relatively safe and did not fluctuate actual mortality numbers.