Covovax, the coronavirus vaccine developed by the Serum Institute of India (SII) in partnership with the US-based Novavax, has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) on Friday. This is the ninth COVID-19 vaccine WHO has listed for emergency use in order to increase access to vaccination in lower-income countries.
“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 Covovax, is produced by the Serum Institute of India under license 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 organization said in a statement.
Announcing the development, Adar Poonawalla, CEO, SII said, “This is yet another milestone in our fight against COVID-19, Covovax is now WHO approved for emergency use, showing excellent safety and efficacy.”
WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
As per WHO’s 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.
“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
The aim of the listing is to increase access particularly in lower-income countries. It is to be noted that 41 countries have still not been able to vaccinate 10 per cent of their populations, while 98 countries have not reached 40 per cent.
