SII is the first local company applying for emergency use
Vaccine manufacturer Serum Institute of India has applied to the Indian government seeking emergency use authorisation of its COVID-19 vaccine, reported The Hindu.
The SII, the world’s largest vaccine producer by volume, sought approval from the Drugs Controller General of India, becoming the first local company to do so.
Final trials of the vaccine, also known as Covishield, are ongoing among 1,600 participants across the country. The vaccine contains a modified version of the cold-causing adenovirus that was isolated chimpanzees. It was developed in coordination with the University of Oxford and AstraZeneca and has shown 70% efficacy in clinical trials worldwide.
“In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs [severe adverse events] and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae,” a source said reported The Hindu.
The SII has already manufactured 40 million doses of the vaccine on a special license, according to the Indian Council of Medical Research. An advantage the shot holds over others is that it can be transported under normal refrigerator temperatures of two to eight degrees Celsius.
A day earlier, Pfizer in India had become the first pharmaceutical firm to seek emergency use authorisation of its COVID-19 vaccine from the DCGI, reported The Indian Express. The Pfizer vaccine has not been trialled in India.
India has been the second-worst affected country in the world during the pandemic. On Monday, the country reported 9,673,204 confirmed coronavirus cases and 140,868 deaths overall.