The Pune-based SII has submitted the final phase 2/3 clinical study report of India with its application for grant of regular market authorization for Covishield, an official source said.
Pointing out that over 100 crore doses of Covishield have been supplied in India and many other countries, Serum Institute of India on Monday sought regular marketing approval for the COVID-19 vaccine, which is currently authorized for emergency use in the country, official sources said.
The application sent to the Drugs Controller General of India (DCGI) by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) comes just a couple of days after Prime Minister Narendra Modi held a meeting with domestic COVID-19 vaccine manufacturers.
If the DCGI grants regular marketing authorisation, Covishield will be the second vaccine in the world to receive such approval. Pfizer-BioNTech's COVID-19 vaccine has received full US FDA approval for use in individuals 16 years of age and older.
The cumulative COVID-19 vaccines administered in the country has exceeded 102.27 crore. Of all the vaccine doses administered, around 90 per cent are Covishield and close to 10 per cent are Bharat Biotech's Covaxin. Less than one per cent of the doses given are Sputnik V.
The Pune-based SII has submitted the final phase 2/3 clinical study report of India with its application for grant of regular market authorization for Covishield, an official source said.
According to the application by Singh, the firm has already submitted phase-3 clinical study results of 24,244 subjects from the UK, Brazil and South Africa on June 8, 2021, to the Central Drugs Standard Control Organisation (CDSCO).
Also, phase-3 clinical study results of 32,379 subjects from the US, Chile and Peru were submitted on July 9.
"In addition to the successful completion of our phase 2/3 clinical study in India, till now more than 100 crore doses of our Covishield has been administered to people in our country and worldwide.
"Such a large-scale vaccination with our Covishield vaccine and containment of COVID-19 infection is in itself a testimony to the safety and efficacy of Covishield," the official source quoted Singh as having stated in the application.
Singh thanked the DCGI office and Subject Expert Committee for granting restricted emergency use approval to Covishield on January 3, because of which, he said, the vaccine played a crucial role in the pandemic control and has been the mainstay of India's Covid inoculation drive.
"It is a matter of pride for us that we have been a part of the world's largest vaccination drive under the dynamic and visionary leadership of our Prime Minister Narendra Modi Ji," Singh is learnt to have said in the application.
Under the kind guidance of Union Health Minister Mansukh Mandaviya, Team Government of India and leadership of CEO Adar C Poonawalla, Team Serum Institute of India has been working relentlessly to manufacture and supply Covishield vaccine for making the world's largest Covid vaccination drive successful, he said.
"In line with our prime minister's clarion call of Aatmanirbhar Bharat, we have made our country Aatmanirbhar for COVID-19 vaccine. In view of the above-mentioned facts, we request for your kind approval for regular market authorization of Covishield," Singh is learnt to have written in the application.
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