The Serum Institute of India on Friday sought permission from the Drugs Controller General of India (DCGI) to provide emergency use authorization to the COVID-19 vaccine Covovax, based on the US-based Novovax’s protein vaccine.
After Covishield, the Serum Institute of India has sought emergency use authorization in India from the Drug Controller General of India (DCGI) for another COVID-19 vaccine, Covovax. The Pune based Serum Institute is manufacturing the Covovax in its Manjari manufacturing site. Covovax is Adar Poonawalla-helmed SII’s version of the protein-based COVID-19 vaccine developed by Novavax, USA.
Along with its application, the company filed an interim phase 2/3 clinical research report on Indian adults, as well as an interim report on Novavax UK and USA-Mexico phase-3 clinical study to provide sufficient data to answer DCGI’s questions. As per the PTI report, the study data raised no safety concerns, and Covovax is safe and immunogenic in adults, emphasized Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), who had sent the application to the DCGI.
In the phase 2/3 study in India, more than 1,400 participants have received at least the first dose of the vaccine with no safety concerns reported so far, stated the application. In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of its COVID-19 vaccine candidate, in low and middle-income countries and India.
Adar Poonawalla’s Serum Institute, which manufactures COVID-19 vaccine Covishield, will produce Covovax at its Manjari plant in Maharashtra on a larger scale. Serum Institute of India has also sought a partnership with Russia, to manufacture Sputnik V in India. Serum Institute plans to produce three types of COVID-19 vaccine by November end, expanding its capacity to 250 million doses a month.