Serum Institute of India seeks regular marketing authorization from DCGI for Covishield


New Delhi, 25 October

Over 100 crore doses of Covishield have been supplied to India and several other countries, official sources said, adding that the Serum Institute of India on Monday sought routine marketing approval for the COVID-19 vaccine, Which is currently authorized for emergency use in the country. .

The application sent to the Drugs Controller General of India (DCGI) by Prakash Kumar Singh, director of government and regulatory affairs at Serum Institute of India (SII), comes days after Prime Minister Narendra Modi’s meeting with the domestic COVID-19 – 19 vaccine manufacturers.

If DCGI is granted regular marketing authorisation, Kovichid 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 vaccines administered, about 90 per cent are Covashield and about 10 per cent are Bharat Biotech’s Covaxin. Less than one percent of the doses given are Sputnik V.

Pune-based SII has submitted its final phase 2/3 clinical study report of India along with its application for grant of regular market authorization for Covishield, an official source said.

As per Singh’s application, the firm has submitted the results of a phase-3 clinical study of 24,244 subjects from the UK, Brazil and South Africa to the Central Drugs Standard Control Organization (CDSCO) on June 8, 2021.

Also, the results of a Phase III clinical study involving 32,379 subjects from the US, Chile and Peru were presented on July 9.

“In addition to the successful completion of our Phase 2/3 clinical study in India, more than 100 crore doses of our CoviShield have been administered to people in our country and across the world so far.

“Such a massive immunization and prevention of COVID-19 infection with our Kovidshield vaccine is a proof of the safety and efficacy of Kovishield in itself,” the official source said in the application, quoting Singh.

Singh thanked the DCGI office and the subject expert committee for approving the restricted emergency use to Kovidshield on January 3, due to which, he said, the vaccine played a vital role in epidemic control and has been a mainstay of India’s Covid vaccination campaign. .

“It is a matter of pride for us that we have been a part of the world’s largest vaccination campaign under the dynamic and visionary leadership of our Prime Minister Narendra Modi ji,” Singh said in the application.

He said that the team Serum Institute of India under the leadership of Union Health Minister Mansukh Mandaviya, Government of India team and CEO Adar C Poonawalla is working tirelessly to manufacture and supply the Kovishield vaccine to make the world’s largest COVID vaccination campaign a success. Is. .

“In line with our Prime Minister’s call for Atmanirbhar Bharat, we have made our country atmanirbhar for the COVID-19 vaccine. In view of the above facts, we request the regular market authority of Covishield for your kind approval,” Singh wrote in the application. PTI