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Govt allows SII to export 5 crore doses of COVID-19 vaccine Covovax to Indonesia

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While Covovax has not yet been approved for emergency use in India, the expiry date of approximately one crore doses of the vaccine is December 2021.

Govt allows SII to export 5 crore doses of COVID-19 vaccine Covovax to Indonesia
The Indian government has permitted export of five 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 November 15. The drug major SII has been allowed to export 50 lakh vials, equivalent to five 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 said 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 the 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 an 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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