- Serum Institute seeks Emergency Use Authorisation for COVID-19 vaccine
- Clinical trials were conducted at JSS Medical College in Mysuru in August
New Delhi: The Serum Institute of India (SII) yesterday became the country’s first company to apply to the Drugs Controller General of India (DCGI) seeking Emergency Use Authorisation (EUA) for the Oxford COVID-19 vaccine in India.
On Saturday, the Indian arm of US pharmaceutical giant Pfizer became the first to seek a similar approval from India’s drug regulator for its COVID-19 vaccine in the country, after securing similar clearances in the UK and Bahrain.
The phase-three clinical trial of the Oxford COVID-19 vaccine — Covishield — is being conducted by the Pune-based Serum Institute of India (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 by Oxford-AstraZeneca in the UK and Brazil.
Incidentally, the Phase II clinical trials for Covishield were conducted at JSS Medical College and Hospital in Mysuru in August this year. In Karnataka, JSS Hospital is the only institute that has been selected for the clinical trial. Covishield was administered to about 25 volunteers at JSS Hospital after Phase II trials began on Aug. 29.
Reports from the Hospital then said that there were no adverse impact on any of the volunteers including fever, allergy and side effects and the results were quite encouraging. The results were later sent to AstraZeneca.
Based on Phase II and III clinical trial results, the SII with the help of ICMR will pursue early availability of the vaccine for India. According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling licence 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 effective against symptomatic and most importantly against severe COVID-19 infections.
The results are in line with other Coronavirus vaccines and because of the huge disease burden, Covishield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm is learnt to have said.
“In terms of safety, Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield,” a source said quoting the application.
According to sources, this vaccine is logistically feasible for distribution in the country’s urban and rural regions as it can be stored at two to eight degrees Celsius, which is an ideal temperature for being kept in cold storages in the country.