The Serum Institute of India (SII) is the 1st company to seek emergency use authorisation (EUA) for the Oxford COVID-19 vaccine in India to the Drugs Controller General of India. The official sources citied the unmet medical needs because of the pandemic and at the public interest at large.

After receiving clearance in the UK and Bahrain, Pfizer also seeked a similar approval from Indias drug regulator for their COVID-19 vaccine.

The phase 3 clinical trial of Covishield, which is the Oxford COVID-19 vaccine is conducted by the Pune-based SII on Sunday, co-sponsored by Indian Council of Medical Research (ICMR), in various parts of the country and also clinical studies are being carried out by Oxford-AstraZeneca in the UK and Brazil.

India’s apex health research body said that Based on phase 2 and 3 clinical trial results, the SII with association of the ICMR will try for early availability of the vaccine for India. As per the ICMR, the SII has manufactured 40 million doses of the vaccine already under the at-risk manufacturing and storing license it had obtained from the DCGI.

Official sources, said that the firm has stated that evidence from 4 clinical studies, 2 in the UK and one each in Brazil and India, had shown that Covishield is highly efficient against symptomatic and against severe COVID-19 infections. The results are consistent with other coronavirus vaccines and due to the massive disease burden, Covishield is predicted to lessen significant COVID-19 mortality and morbidity.

Covishield was well tolerated and was not associated with an increased number of solicited adverse events and deaths. Many of solicited reactions were mild in severity and got resolved without any sequelae. Fortesting purposes, the SII has already submitted 12 batches of the vaccine to the Central Drugs Laboratory in Kasauli.

The application that was signed by Prakash Kumar Singh, Additional Director of Government and Regulatory Affairs at Serum Institute of India stated that with their philosophy they assure that for COVID-19 vaccines they are committed to make country aatmanirbhar (self-reliant) and fulfil Prime Ministers call of vocal for local and making in India for the world. It further stated that early availability of a vaccine against COVID-19 is a necessity. Thus, for national interest, they have requested to grant the EAU of Covishield as an immediate need of an effective, safe, programmatically suitable and affordable vaccine is necessary for the country.

As per the sources, this vaccine is logistically reasonable for distribution in the countrys urban and rural parts as it can be easily stored at two to eight degrees Celsius, an ideal temperature for keeping in cold storages.

The DCGI on 2nd August 2 had given affirmation to SII for conducting the combined phase two and three human clinical trials of the Oxford COVID-19 vaccine as a rapid regulatory response.

Source: ET Healthworld