Nuvaxovid receives full marketing authorization in the EU for the prevention of COVID
Novavax, Inc. has been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU) for Nuvaxovid (NVX-CoV2373)
This decision follows positive opinion for a full MA from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The vaccine is now fully authorized for use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older for the prevention of COVID-19. Nuvaxovid was originally granted a conditional MA in the EU for these indications.
The Phase III PREVENT-19 trial demonstrated Nuvaxovid's reassuring safety profile as well as efficacy as a primary series in adults, the immunogenicity and safety as a booster dose in adults, and the efficacy and safety as a primary series in individuals aged 12 and older. Novavax's COVID vaccine is authorized for use in more than 40 markets around the world. The trade name Nuvaxovid has not yet been approved by the FDA.
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