The Indian government has permitted the export of 7 crore doses of COVID-19 vaccine ‘Covovax’ produced by Serum Institute of India here to Netherlands, Australia and New Zealand, official sources said on Wednesday.
Director, Government and Regulatory Affairs at Serum Institute of India (SII), Prakash Kumar Singh had submitted an application to the Drugs Controller General of India (DCGI), seeking no objection to export the vaccine doses to the foreign countries, official source said.
“After evaluation, the DCGI office gave no objection to export 7 crore doses of Covovax to Netherlands, Australia and New Zealand,” it said.
This vaccine is not approved till now in these countries.
India’s central drug authority CDSCO had on Tuesday approved Covovax for restricted use in emergency situations in the country. 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, they said.
The World Health Organisation had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.
The Centre had in November permitted the export of 2 crore doses of Covovax to Indonesia before the Indian emergency use authorisation.
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.
The Covovax vaccine of SII is a technology transfer of Novavax USA vaccine.
It is administered through an intramuscular route with two dose schedule of day 0 and 21. The vaccine is stored at 2 degrees to 8 degrees Celsius temperature, and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack, the health ministry had said on Tuesday.
SII has conducted phase 2/3 immuno bridging clinical in the country for comparing safety and immunogenicity of Covovax and Novavax vaccine.
The Novavax has conducted phase 3 efficacy trials in the US and the UK wherein the efficacy of vaccine is reported to be 90.4 per cent and 86.9 per cent, respectively, the ministry added.