The World Health Organization (WHO) 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 (EUL) on 17th December.
Both vaccines are made using the same technologies. They require two doses and are stable at two-to-eight °C refrigerated temperatures.
WHO’s Strategic Advisory Group of Experts on Immunization has also issued policy recommendations for Nuvaxovid/Covovax.
The 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.