The US Food and Drug Administration (FDA) has amended the emergency use authorisation of Novavax’s adjuvanted Covid-19 vaccine (NVX-CoV2601) to incorporate the 2023–24 formula.
The updated vaccine is indicated for active vaccination for disease prevention in those aged 12 years and above.
Following the release of new vaccine batches by the US Center for Biologics Evaluation and Research, it will be made available across the US in early October 2023.
This latest authorisation was based on non-clinical findings where the vaccine was shown to elicit functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants of the SARS-CoV-2 virus.
Updated to incorporate the viral spike protein from XBB.1.5 lineage of the omicron variant, this protein-based vaccine can address variants that are circulating currently.
The new 2023–24 formula of the vaccine is currently not approved or licensed for usage by the US regulator in the region.
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By GlobalData
Novavax president and CEO John Jacobs stated: “Novavax’s authorisation means people will now have the choice of a protein-based non-mRNA option to help protect themselves against Covid-19, which is now the fourth leading cause of death in the US.
“In the coming days, individuals in the US can go to pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.”
In July 2023, the company obtained full marketing authorisation for its Covid-19 vaccine Nuvaxovid (NVX-CoV2373) from the European Medicines Agency.