The Serum Institute of India (SII) on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country, citing unmet medical needs due to the pandemic and in the interest of the public at large, official sources said.
A day earlier, the Indian arm of U.S. pharmaceutical giant Pfizer became the first to seek a similar approval from India’s drug regulator for its own COVID-19 vaccine in the country, after securing such clearance in the UK and Bahrain.
The phase-3 clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the Pune-based 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.
Based on phase 2 and 3 clinical trial results, the SII with the help of the ICMR, will pursue early availability of the vaccine for India, the country’s apex health research body had said last month.
According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
Also read: COVISHIELD completes enrolment of Phase-3 clinical trials under partnership of ICMR and SII
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 efficacious against symptomatic and most importantly against severe COVID-19 infections.
The results are in line with other anti-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 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.
Also read: Vaccine shot ‘painless’, say Covishield trial volunteers
“Therefore, 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.
In order to introduce an urgently needed vaccine against COVID-19 in India, SII, the world’s largest vaccine manufacturer, has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
The SII has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing, a source said.
“In line with our philosophy, we assure you that for COVID-19 vaccines also, we are committed to make our country ‘aatmanirbhar’ (self-reliant) and fulfil our Prime Minister’s clarion call of ‘vocal for local’ and ‘making in India’ for the world,” stated the application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at SII.
In view of all these facts and unmet medical needs in the interest of the public at large to save millions of people in the country and across the globe, early availability of a vaccine against COVID-19 is a necessity, it stated.
“So, in the national interest, we request you to grant us emergency use authorisation of Covishield based on our application and in view of immediate need for a safe, effective, programmatically suitable and affordable vaccine for our country,” the application read.
According to sources, this vaccine is logistically feasible for distribution in the country’s both urban and rural parts 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.
As a rapid regulatory response, the DCGI on August 2 had given nod to SII for conducting the combined phase 2 and 3 human clinical trials of the Oxford COVID-19 vaccine in the country.