New Delhi: The Serum Institute of India (SII) on Friday asked the Drugs Controller General of India (DCGI) to manufacture the COVID-19 vaccine ‘Covovax’ for limited emergency use at its Manjari manufacturing site in Maharashtra. sought approval. 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 raised by the DCGI office.
‘Covovax is safe for the adult population’
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 Covovax is safe for the adult population.
‘Vaccine safety will be ensured as per India’s call’
An official source quoted Singh in the application as saying, “The approval and availability of our Covovax will further strengthen India’s ability to fight the COVID-19 pandemic and in line with our Prime Minister’s call for a self-reliant India.” Will ensure security.
The application states that more than 1400 participants in Phase II/3rd study in India were given at least one dose of the vaccine and no safety concerns have been expressed so far.
Will get another vaccine for children!
On the availability of Covovax for children, Adar Poonawalla said in an interview – We have submitted data for Covovax to WHO. We have chosen Covovax as a vaccine for children for several reasons for a number of reasons. Now there is nothing to worry about in terms of vaccine stock. We have one month of stock available now. By February, we should get the approval of Covovax for children below 2-3 years of age.