STOCK MARKET BSE NSE

Serum Institute seeks DCGI nod for Covid vaccine Covovax

In the phase 2/3 study in India, more than 1,400 participants have received at least first dose of the vaccine with no safety concerns reported so far, stated the application.

Published: 29th October 2021 07:29 PM  |   Last Updated: 29th October 2021 07:29 PM   |  A+A-

Serum Institute of India CEO Adar Poonawalla

Serum Institute of India CEO Adar Poonawalla (Photo | PTI)

By PTI

NEW DELHI: The Serum Institute of India on Friday sought permission from the Drugs Controller General of India (DCGI) to manufacture COVID-19 vaccine Covovax for restricted use in emergency situations at its Manjari manufacturing site, official sources said.

The company has submitted an interim phase 2/3 clinical study report on Indian adults, the interim report of Novavax UK and USA-Mexico phase-3 clinical study and response to the queries raised by the DCGI office, along with its application.

There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.

"In our government's endeavour to fight against COVID-19 pandemic, we have also been working shoulder to shoulder with the Government of India to make available one more safe and efficacious world-class COVID-19 vaccine for our country and the world at large.

"Approval of our COVOVAX and its availability will further strengthen India's capability to fight COVID-19 pandemic and ensure vaccine security in line with our prime minister's clarion call of Atmanirbhar Bharat," an official source quoted Singh as having said in the application.

In the phase 2/3 study in India, more than 1,400 participants have received at least first dose of the vaccine with no safety concerns reported so far, stated the application.

In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

SII, which manufactures Covishield, plans to produce Covovax at its Manjari plant in Maharashtra. India has given emergency use permission to several COVID-19 vaccines, including Covishield, Covaxin of Bharat Biotech and Russian-made Sputnik V.



Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

edexworks
flipboard facebook twitter whatsapp