DCGI, India’s Drug Regulator approves Phase-3 trial of the “Covovax” Covid Vaccine

The Drugs Controller General of India (DCGI) on Wednesday granted permission for conducting the phase-3 clinical trial of Covid-19 vaccine Covovax. According to the DCGI Officials, if successful, Covovax will be administered as a booster dose in adults. Last year, the DCGI approved Covovax for restricted use in emergency situations in adults. Under emergency use, the vaccine was also allowed to inoculate the population between the 12-17 years group, subject to certain conditions.

However, the vaccine has not been included in the country’s inoculation program against Covid-19. “Covovax” is manufactured by technology transfer from US Based Vaccine Maker “Novavax” and is approved by the “European Medicines Agency” for conditional marketing authorization. In December 2020, the World Health Organization granted it under its emergency used listing.

An official source mentioned that Prakash Kumar Singh, who is the Director of Government and Regulatory Affairs at the Serum Institute of India (SII), in the month of February submitted an application to the DCGI. In the application, he requested permission of the regulatory body to conduct a phase-3, observer-blind, randomized, controlled study to evaluate the safety and immunogenicity of Covovax, specifically to be administered as a “Booster dose” in adults.