Gaithersburg: Novavax, Inc., a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, 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.
"This Marketing Authorization establishes the foundation for all future regulatory approvals for updated versions of our COVID vaccine, a necessity to ensure we can quickly get our vaccine to individuals in the EU," said John C. Jacobs, President and Chief Executive Officer, Novavax. "In addition to the EU, we are preparing to file for full approval in the U.S. as well as other markets and are committed to ensuring protein-based options are available worldwide. Vaccine choice remains an integral part of public health measures."
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.
Read also: Novavax Nuvaxovid gets positive CHMP opinion for full marketing authorization for COVID prevention in EU
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