Covovax not approved in country of origin yet, notes govt panel as it seeks data from SII
Highlights
- SII had put in an application to DCGI for grant of market authorization of Covovax.
- The Pune-based firm had submitted interim safety and immunogenicity data.
- The committee recommended that the firm should submit additional data and information.
An expert panel of India's Central Drug Authority on Sunday noted that Covovax has not yet been approved in the country of origin, official sources said. The panel recently reviewed Serum Institute's application seeking emergency authorization of COVID-19 vaccine Covovax. It has sought additional data from the firm,
SII had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorization of Covovax for restricted use in emergency situations.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trials conducted in the country as well as interim clinical trial data of safety and efficacy from phase 3 clinical trials conducted in the UK and the US along with its application, official sources said.
"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 the correct status of 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 phases 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.
(With PTI Inputs)
