The Government of India has allowed the export of 5 crore doses of Covavax which is been domestically produced in India by the Serum Institute of India (SII). However, Covavax is not yet approved for emergency use by India, the official sources said on Monday.
SII is permitted to export 50 lakh (equals to 5 crore doses) vials to Indonesia, the sources added. According to them, the Serum Institute of India (SII) submitted an application to DCGI (Drugs Controller General of India) asking permission for the emergency use of Covavax way back on May 21. They are still waiting for approval from the drug controller.
Recently, the Director of Government and Regulatory Affairs at SII, Prakash Kumar Singh, wrote to the DCGI asking for a NOC (no-objection certification) to export 5 crore doses of Covavax. He also added that the 1 crore vaccine doses that are ready and it will expire in December this year.
The official sources quoted Singh’s statement in the application that M/s PT Indofarma Tbk, Indonesia has requested to purchase Covavax from them and have already issued an order for the same to SII. If the vaccine is not approved and exported then it will be a wastage of 1 crore doses of fundamental vaccine that can save many lives, he said.
As Covavax is not yet approved and Covishield is present in huge quantities in India, it won’t affect the vaccine drives in India. The DCGI had taken the matter to the Union Health Ministry for approval and after that, they granted the NOC to SII without Indian EUA, the sources added.
The DCGI had first permitted to manufacture and stock up Covavax on May 17, following it they have stocked a lot of Covavax. This vaccine was introduced in August 2020 by US-based company Novavax.Inc. They announced a licence agreement with the SII to develop and commercialize this vaccine in low and middle-income countries and India.
Recently the government also decided on Zydus Cadila’s Zy-CovD vaccine price to be set at Rs 265. This is India’s first indigenously developed DNA vaccine that will be given to children. Read the full story here.
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