Novavax announced that Nuvaxovid (NVX-CoV2373) has been recommended for full Marketing Authorization (MA) for use as a primary series in individuals aged 12 and older and as a booster in individuals aged 18 and older for the prevention of COVID-19 in the European Union following a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
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The European Commission will review the CHMP recommendation and is expected to make a final decision on the MA.
"The positive CHMP Opinion for full Marketing Authorization for our COVID vaccine brings us one step closer to full authorization and will provide an approval pathway for an updated vaccine in time for the fall," said John C. Jacobs, President and Chief Executive Officer, Novavax.
Novavax has demonstrated the efficacy and safety of Nuvaxovid as a primary series, and the immunogenicity and safety of the vaccine as a booster in individuals aged 12 and older in the Phase 3 PREVENT-19 trial, Phase 2 trials and in real-world evidence.
Novavax's COVID vaccine is authorized for use in more than 40 markets around the world. In the EU, Nuvaxovid has been conditionally authorized as a two-dose primary series in adults and adolescents, and as a booster dose in adults.
The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration (FDA).
NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID.
With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response.
The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.
When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it stronger, broader, and more durable.
The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. ■