According to the sources, the SII submitted an application to the DCGI seeking grant of emergency use authorisation for Covovax on May 21 and it is still awaiting approval from the drug regulator.
The Indian government has permitted export of 5 crore doses of Covovax, a COVID-19 vaccine domestically produced here by the Serum Institute of India (SII), as the jab has not yet been approved for emergency use in the country, official sources said on Monday.
The drug major SII has been allowed to export 50 lakh vials, equivalent to 5 crore doses, of Covovax to Indonesia, they said.
According to the sources, the SII submitted an application to the Drugs Controller General of India (DCGI) seeking grant of emergency use authorisation for Covovax on May 21 and it is still awaiting approval from the drug regulator.
Recently, Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, wrote to the DCGI seeking no objection certification to export 50 lakh vials. He also stated that one crore vaccine doses manufactured by the company will expire in December this year, the official sources said.
“M/s PT Indofarma Tbk, Indonesia wants to purchase these quantities and they have already issued a purchase order of 50 lakh vials to us. If we are not able to export this quantity, then it will be an international wastage of much needed life-saving COVID-19 vaccine during the pandemic,” an official source quoted Singh as having stated in the application.
The expiry date of approximately one crore doses of the Covovax vaccine is December 2021, he said.
This export will not affect COVID-19 vaccine supplies to India as a huge stock of Covishield is available to meet requirements of the country, Singh is learnt to have conveyed.
The DCGI had referred the matter to the Union Health Ministry for approval and after the ministry’s intervention, the DCGI granted export NOC to SII without Indian EUA, the source said.
The DCGI office had granted SII permission to manufacture and stock Covovax on May 17 following which the Pune-based firm manufactured and stockpiled the vaccine doses.
In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.
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