Enhanced Protein-Based COVID-19 Vaccine Approved in the UK and Singapore

Novavax, Inc. today announced that its prototype COVID-19 vaccine Nuvaxovid™, was granted full approval for active immunization to prevent COVID-19 in individuals aged 12 and older by Singapore's Health Sciences Authority (HSA) and the U.K. Healthcare products Regulatory Agency (MHRA).

In recent clinical trials, the protein-based Nuvaxovid (NVX-CoV2373) vaccine demonstrated the efficacy and safety of its prototype vaccine as a primary series in individuals aged 12 and older and the immunogenicity and safety of the vaccine as a booster in individuals aged 18 and older.

"Full marketing authorization of our prototype COVID-19 vaccine in the U.K. is a stepping stone to enable authorization of updated strains of our vaccine in the future," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on October 18, 2023.

"We are working with the MHRA to provide the information needed for the rapid review of our updated protein-based non-mRNA COVID-19 vaccine as an important step to ensuring access to vaccine options in the U.K. this coming vaccination season."

Novavax Inc.'s vaccines are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. 

While authorized in the U.S., the trade name Nuvaxovid™ has not been approved by the U.S. Food and Drug Administration (FDA).

On October 3, 2023, the FDA amended its authorization of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 and older, to include the 2023-2024 formula. 

Since December 2021, Novavax's COVID-19 vaccines have been distributed in about 40 countries.