The Drugs Controller General of India (DCGI) has raised queries and sought more data from Serum Institute of India over its application seeking emergency authorisation for Covid vaccine Covovax, official sources said on Thursday.
Serum Institute of India (SII) had sent an application to the DCGI in October for the grant of market authorisation of Covovax for restricted use in emergency situations.
“Noting that the vaccine is technology transfer of Novavax vaccine, DCGI has sought to know the approval status of the application with regulatory authorities in the country of origin, that is the USA.
“The apex drug regulator has also asked the SII to provide details on Matrix component used in the vaccine,” an official source said.
On November 27, the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation had deliberated on SII’s application and sought additional data from SII.
Along with its application, the Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial 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.
The government recently permitted the export of 2 crore doses of COVID-19 vaccine Covovax to Indonesia produced in India by SII, official sources had said.
DCGI office had granted SII permission to manufacture and stock Covovax on May 17. Based on DCGI approval, till now, the Pune-based firm has manufactured and stockpiled vaccine doses.
The World Health Organisation had last week issued emergency use listing for Covovax produced by SII under licence from Novavax, expanding the basket of jabs validated by the global health body against the viral disease.
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.