WHO approval is a prerequisite for being on the COVAX drug list, as well as for international procurement
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The World Health Organization (WHO) said it had approved the Covovax coronavirus vaccine, which is manufactured by the Serum Institute of India under license from US company Novavax, for emergency use.
"Today, the World Health Organization issued and emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named CovovaxTM, is produced by the Serum Institute of India under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries," the global health body said in a statement.
WHO approval is a prerequisite for being on the COVAX drug list, as well as for international procurement.
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According to the statement, Covovax was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India.
The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally.
Covavax is the Indian version of the Novavax vaccine brought in India by the Serum Institute of India for children.
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