Novavax has announced that its COVID-19 vaccine, Nuvaxovid, has been granted full marketing authorisation in the EU.
The vaccine is now fully authorised for use as a primary series in individuals aged 12 and older for COVID-19 prevention and as a booster dose in adults aged 18 and older, the company said.
Novavax’s protein-based vaccine, which was originally granted a conditional marketing authorisation in the EU for these indications, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralising antibodies.
The European Commission’s latest decision follows a recommendation by the European Medicines Agency’s human medicines committee earlier this year and is supported by positive results from the phase 3 PREVENT trial that evaluated the safety, immunogenicity, and efficacy of Nuvaxovid.
John Jacobs, president and chief executive officer of Novavax, said: “This marketing authorisation establishes the foundation for all future regulatory approvals for updated versions of our COVID-19 vaccine, a necessity to ensure we can quickly get our vaccine to individuals in the EU.”
Jacob’s added: “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.”
The authorisation comes less than a month after a US Food and Drug Administration (FDA) panel of advisors has unanimously recommended that updated COVID-19 vaccines being developed for the US autumn vaccination campaign target one of the currently circulating XBB variants.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to zero in favour of the monovalent XBB-lineage vaccines and generally agreed that vaccines targeting the XBB.1.5 subvariant would be preferred.
Novavax, Pfizer/BioNTech, and Moderna are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating subvariants.
Selecting XBB.1.5 as the target strain would be particularly beneficial for Novavax, as the biotech’s protein-based vaccine takes longer to manufacture than its rivals’ mRNA vaccines.
In a statement published after the advisory meeting, Jacobs, said: “[The company] expects to be ready for the commercial delivery of a protein-based monovalent XBB COVID-19 vaccine this autumn in line with [the] VRBPAC recommendation.”