Novavax's Nuvaxovid Gets Full Marketing Authorization In EU To Prevent COVID-19
(RTTNews) - Novavax, Inc. (NVAX) on Thursday 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 3 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.
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