While calls to follow the EU's authorisation are growing, Nuvaxovid has not been approved or licensed by the US Food and Drug Administration, although it has received Emergency Use Authorisation (EUA) to prevent COVID-19 as a primary series in individuals aged 12 and older. Novavax's COVID vaccine is – at the time of writing – authorised for use in more than 40 markets around the world. Vaccine choice remains an integral part of public health measures.' In addition to the EU, we are preparing to file for full approval in the US as well as other markets and are committed to ensuring protein-based options are available worldwide.

John C Jacobs, president and chief executive officer of Novavax, expressed the significance of the decision, stating, 'This marketing authorisation 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. The vaccine is now fully authorised 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. This milestone marks Novavax's first full marketing authorisation in the region, replacing the conditional MA granted for the same indications in 2021. The decision was based on positive recommendations from the Committee for Medicinal Products for Human Use of the European Medicines Agency, which concluded that results from the randomised, placebo-controlled, observer-blinded PREVENT-19 Phase 3 trial demonstrated Nuvaxovid's safety and efficacy as a primary series in individuals aged 12 and older, and as a booster dose in adults. In the first of a double dose of wins for US biotech Novavax, the company has been granted full marketing authorisation (MA) by the European Commission in the EU for Nuvaxovid (NVX-CoV2373) a vaccine for preventing coronavirus disease in people aged 12 years and older.

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