New Delhi: An expert panel from the Central Drug Authority, which recently reviewed the Serum Institute’s application seeking emergency authorization of the COVID-19 vaccine Covovax, has sought additional data from the firm. Official sources said the panel said the jab has not yet been approved in the country of origin.
The Serum Institute of India (SII) submitted an application to the Drug Controller General of India (DCGI) in October for grant of market authorization of Kovovax for restricted use in emergency situations.
The Pune-based firm has obtained interim safety and immunogenicity 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 the US. data has been collected. was introduced to. application, official sources said.
“The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on COVID-19, which deliberated on the application on 24 November, observed that the vaccine is a technology transfer of the Novavax vaccine and has not yet been implemented has gone. in country. Not approved in the original,” said a source.
After detailed deliberations, the committee recommended that the firm should submit additional data and information. This included the exact status of Phase 3 clinical trials in the USA and UK, as well as a comparative description of immunogenicity parameters of subjects from the Safety, Efficacy and Immunogenicity, US, UK, and data from another overseas Phase 3 study. has demanded. The source said that the Phase III study in India, besides the status of review of the application 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. Used to be.
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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