SEC grants EUA for anti-COVID pill Molnupiravir after application from 6 pharma firms

This was first reported by CNBC-TV18 today.

The SEC on COVID-19 of the CDSCO, which reviewed the EUA applications of Serum Institute of India (SII) for the second time on Monday, after detailed deliberation also recommended granting EUA to Covovax.

"The committee noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO," an official source was quoted as saying in PTI report.

Prakash Kumar Singh, director, government and regulatory affairs at SII, had submitted an application to the DCGI in October for grant of market authorisation for Covovax for restricted use in emergency situations.

The DCGI office had granted SII permission to manufacture and stock Covovax on May 17. Based on DCGI approval, till now, the Pune-based firm has manufactured and stockpiled the vaccine doses.

In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

The World Health Organisation (WHO) had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.