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 authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs because of the pandemic and in the interest of the public at large, official sources said.
A day earlier, the Indian arm of US 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 United Kingdom 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 on Sunday (SII), co-sponsored by Indian Council of Medical Research (ICMR), in quite a lot of parts of the country along with clinical studies being carried out by Oxford-AstraZeneca in the United Kingdom and Brazil.
Based on phase two and three clinical trial results, the SII with the assistance of the ICMR will pursue early availability of the vaccine for India, the country’s apex health research body had said final 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.
Official sources, citing the SII application, said the firm has stated that data from four clinical studies, two in the United Kingdom and one every 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 on account of the immense disease burden, Covishield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm is learnt to have said.
“In the case of safety, Covishield was once timed tolerated with respect to solicited adverse events and was once not associated with an increased number of SAEs and deaths. A majority of solicited reactions were gentle in severity and resolved without any sequelae.
“Subsequently, Covishield is secure and well-tolerated and can be utilized 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.
So as 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 fabricate 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 dedicated to make our country ‘aatmanirbhar’ (self-reliant) and fulfil our prime minister’s clarion call of ‘vocal for native’ and ‘making in India’ for the world,” stated the application signed by Prakash Kumar Singh, Extra Director, Government and Regulatory Matters at Serum Institute of India (SII).
In view of these kinds of 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 instant need for a secure, 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 may be stored at two to eight degrees Celsius, which is a perfect temperature for being kept in bloodless storages in the country.
As a rapid regulatory response, the DCGI on August 2 had provided nod to SII for conducting the combined phase two and three human clinical trials of the Oxford COVID-19 vaccine in the country.
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