The Serum Institute of India (SII) on Friday sought the approval of the Drug Controller General of India (DCGI) for the production of COVID-19 vaccine Kovovax in Maharashtra for limited use in emergency situations. Official sources gave this information.
The company has submitted Phase II/III clinical study reports on Indian adults, Novavax UK interim reports and USA-Mexico Phase III clinical studies and responses to queries from the DCGI office.
Prakash Kumar Singh, Director of Government and Regulatory Affairs, SII, is understood to have said in an application to DCGI that the study data does not raise any safety concerns and Kovovax is safe for the adult population. An official source quoted Singh in the application as saying that the approval and availability of our Kovovax will further strengthen India’s ability to fight the COVID-19 pandemic.
Also, the vaccine will ensure safety in line with our Prime Minister’s call for self-reliant India. The application states that in the Phase II/Third study in India, more than 1400 participants were given at least one dose of the vaccine and no safety concerns have been expressed so far.