Official sources said the Serum Institute of India applied to the Drugs Controller General of India (DCGI) on Friday for approval to manufacture COVID-19 vaccine Covovax for restricted usage in emergency scenarios at its Manjari production facility.
Along with its application, the business has filed an interim phase 2/3 clinical research report on Indian adults, as well as interim reports from Novavax UK and the USA-Mexico phase-3 clinical study, as well as responses to the DCGI office’s questions.
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 so far, stated the application.