The Serum Institute of India on Sunday became the first indigenous company to submit an application to the Comptroller General of Drugs of India (DCGI) seeking an emergency use authorization for the Oxford COVID-19 vaccine in the country citing needs not covered due to the pandemic and in the interest of the general public, official sources said.
A day earlier, the Indian branch of US pharmaceutical giant Pfizer became the first to apply for similar approval from India’s drug regulator for its own COVID-19 vaccine in the country, after obtaining such authorization in the UK and Bahrain.
The Oxford COVID-19 vaccine phase three clinical trial, Covishield, is being conducted by the Pune-based Serum Institute of India on Sunday (SII), co-sponsored by the Indian Council of Medical Research (ICMR), in various parts of the country, in addition to the clinical studies carried out by Oxford-AstraZeneca in the United Kingdom and Brazil.
Based on the results of phase two and three clinical trials, IBS, with the help of ICMR, will seek early availability of the vaccine for India, the country’s lead health research body said last month.
According to the ICMR, IBS has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and storage license it obtained from DCGI.
Official sources, citing the IBS request, said the firm has stated that data from four clinical studies, two in the UK and one in Brazil and India, show that Covishield is highly effective against symptomatic infections and, most importantly , against serious COVID-19 infections.
The results are in line with other coronavirus vaccines and, due to the enormous disease burden, Covishield is predicted to alleviate substantial mortality and morbidity from COVID-19, the firm was known to have said.
“In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with increased numbers of SAAs and deaths. Most solicited reactions were mild in severity and resolved without sequelae.
“Therefore, Covishield is safe and well-tolerated and can be used effectively for the prevention of COVID-19 in the target population. Therefore, the benefit / risk ratio strongly supports the widespread use of Covishield,” said a source citing the app.
In order to introduce an urgently needed COVID-19 vaccine in India, SII, the world’s largest vaccine manufacturer, has established a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
The SII has also sent 12 lots of the vaccine to the Central Drug Laboratory (CDL) in Kasauli for analysis, a source said.
“In keeping with our philosophy, we assure you that for COVID-19 vaccines as well, we are committed to making our country ‘aatmanirbhar’ (self-sufficient) and fulfilling our prime minister’s call for ‘vocal for local’ and ‘Made in India’ for the world, ‘read the application signed by Prakash Kumar Singh, Additional Director of Government and Regulatory Affairs at the Serum Institute of India (SII).
In view of all these facts and unmet medical needs in the interest of the general public to save millions of people in the country and around the world, the early availability of a vaccine against COVID-19 is a must, he stated.
“Therefore, in the national interest, we request that you grant us the emergency use authorization of Covishield based on our request and in light of the immediate need for a safe, effective, programmatically appropriate and affordable vaccine for our country. “the application reads.
According to sources, this vaccine is logistically feasible for distribution in urban and rural areas of the country, since it can be stored between two and eight degrees Celsius, which is an ideal temperature to be kept in cold rooms in the country.
As a swift regulatory response, the DCGI on August 2 gave its go-ahead to IBS to conduct the combined phase two and three clinical trials of the Oxford COVID-19 vaccine in the country.
This story has been published from a news agency feed with no changes to the text. Only the title has been changed.
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