The company has submitted 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.
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.
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.
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