CDSCO panel seeks additional data on Covovax from Serum Institute

"The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application on November 24, noted that the vaccine is technology transfer of Novavax vaccine and is not yet approved in the country of origin," a source said.

After detailed deliberation, the committee recommended that the firm should submit additional data and information.

It has sought correct status of the phase 3 clinical trials in USA and UK along with up to date on the safety, efficacy and immunogenicity, comparative statement of immunogenicity parameters of the subjects from the US, UK and other overseas phase 3 studies with data from phase 3 study in India, besides review status of the application with regulatory authorities of the US and the UK, the source said.

The government recently permitted the export of two crore doses of Covid-19 vaccine Covovax to Indonesia, produced in India by the SII, as the jab has not yet been approved for emergency use in the country, official sources had said.

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

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.