The Serum Institute of India has applied for the Drugs Controller General of India’s (DCGI) nod to manufacture the COVID-19 vaccine - Covovax - for restricted use in emergency situations, stated official sources.

SII submitted the application, interim phase 2/3 clinical trial data on Indian adults, interim report of Novavax UK and USA-Mexico phase-3 clinical trial and its response to the questions asked by the office of the DCGI. In the phase 2/3 study conducted in India, over 1,400 individuals were administered at least the first dose of the vaccine and no safety concerns have been reported thus far, said the application.

Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute, has stated in the application that the vaccine is safe and immunogenic in adults… (ET Healthworld – PTI, October 30, 2021)