The World Health Organization issued an emergency use listing (EUL) for Nuvaxovid^TM, following its assessment and approval by the European Medicines Agency (EMA) earlier today.

The new vaccine was developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI), and is the originator product for the Covovax^TM vaccine that received WHO emergency use listing on 17 December.

Both vaccines are made using the same technologies. They require two doses and are stable at 2 to 8 °C refrigerated temperatures. 

WHO’s Strategic Advisory Group of Experts on Immunization has also issued policy recommendationsfor NuvaxovidTM / CovovaxTM.

WHO emergency use listing 

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

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