An expert panel of the country’s central drug authority has recommended granting emergency use authorisation to Serum Institute of India’s COVID-19 vaccine ‘Covovax’ with certain conditions, official sources said on Monday.
Prakash Kumar Singh, director, Government and Regulatory Affairs at Serum Institute of India (SII) had submitted an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation for Covovax for restricted use in emergency situations.
“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) reviewed the emergency use authorisation (EUA) application for the second time on Monday and after detailed deliberation recommended granting emergency use authorisation to Covovax,” an official source said.
Noting the vaccine is the technology transfer of Novavax vaccine, the DCGI recently had 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 had also asked the Serum Institute to provide details on Matrix component used in the vaccine.
On November 27, the Subject Expert Committee on COVID-19 had evaluated and deliberated on SII’s application and sought additional data from the pharma company.
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 phase3 clinical trials conducted in the UK and the US along with its application.
The government had recently permitted the export of 2 crore doses of COVID-19 vaccine Covovax to Indonesia produced in India by SII, as the jab had not yet been approved for emergency use in the country, official sources had said.
The 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 the vaccine doses.
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.