Drug authority seeks additional data to approve SII's Covovax Covid-19 vaccine

Noting that the vaccine is yet to be approved in the country of its origin, the DCGI has sought detailed reports on Phase 2 and Phase 3 studies

An expert panel of India's central drug authority, which recently reviewed the Serum Institute's application seeking emergency authorisation of Covid-19 vaccine Covovax, has sought additional data from the firm, while noting the jab has not yet been approved in the country of origin, official sources said.

The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations. 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.

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.

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"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 the US and UK, along with up-to-date safety, efficacy and immunogenicity, comparative statement of immunogenicity parameters of the subjects from the US, UK and other overseas Phase 3 studies — along with data from the Phase 3 study in India — besides the review status of the application with the regulatory authorities of the US and UK, the source said.

The government recently permitted the export of 20 million 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 had granted SII permission to manufacture and stock Covovax on May 17.

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