An expert panel of the Central Drugs Authority of India, which recently reviewed the Serum Institute’s application seeking emergency authorization of the COVID-19 vaccine Covovax, has sought additional data from the firm, while the jab is yet to be administered in the country of origin. has not been approved, the official source said. Serum Institute India (SII) had in October submitted an application to the Drug Controller General of India (DCGI), granting market authorization of Kovovax for restricted use in emergency situations.
The Pune-based firm has collected interim safety and immunogenicity data from 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 US. was presented to. application, official sources said. “The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO), which deliberated on the application on 24 November, noted that the vaccine is a technology transfer of the Novavax vaccine and as of now It has not been approved in the country. Original,” said a source.
After detailed deliberations, the committee recommended that the firm should submit additional data and information. It compared the exact status of Phase 3 clinical trials in the USA and UK, as well as up to date, immunogenicity parameters of subjects with data from US, UK and other overseas phase 3 studies on safety, efficacy and immunogenicity. Details requested. The source said a Phase III study in India, besides the status of the application review with regulatory authorities in the US and UK.
Official sources had said that the government had recently allowed export of 20 million doses of COVID-19 vaccine Kovovax produced in India by SII, as the jab is yet to be approved for emergency use in the country. Has been. On May 17, the DCGI office had given permission to SII to manufacture and stock Kovovax. Based on DCGI’s approval, the Pune-based firm has so far manufactured and stocked the vaccine doses, he said.
In August 2020, US-based vaccine maker Novavax, Inc. had announced a license agreement with SII to develop and commercialize its COVID-19 vaccine candidate NVX-CoV2373 in low- and middle-income countries and India.
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