The World Health Organization issued an emergency use listing (EUL) for Nuvaxovid™, 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™ 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 recommendations for Nuvaxovid™ / Covovax™.

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.

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.

About WHO

The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.