An expert panel of India's Central Drug Authority, which recently reviewed Serum Institute's application seeking emergency authorisation of the 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.
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 United Kingdom and the U.S. 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 correct status of the phase 3 clinical trials held in the U.S. and the UK along with latest data on the safety, efficacy and immunogenicity, comparative statement of immunogenicity parameters of the subjects from the U.S., 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 U.S. and the UK, the source said.
The Government recently permitted the export of two crore doses of COVID-19 vaccine Covovaxn to Indonesia, produced in India by the SII, as the jab has not yet been approved for emergency use in the country, official sources 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.