Pharma Focus Asia

Novavax's COVID-19 Vaccine Nuvaxovid™ Granted Full Approval in Singapore

Thursday, October 19, 2023

Novavax, Inc. (Nasdaq: NVAX) has received full approval from the Health Sciences Authority (HSA) in Singapore for its prototype COVID-19 vaccine, Nuvaxovid™ (NVX-CoV2373). This approval permits the use of the vaccine for active immunization against COVID-19 in individuals aged 12 and older. Singapore's Ministry of Health has incorporated Nuvaxovid into its National Vaccination Programme as a protein-based alternative to mRNA vaccines for the prevention of COVID-19.

Novavax, expressed satisfaction with the full approval and highlighted that this milestone will enable the submission of an updated protein-based non-mRNA COVID-19 vaccine for approval in the near future. Novavax is maintaining close collaboration with HSA to ensure that a protein-based vaccine option is available for the protection of Singaporeans against COVID-19.

For the 2023-2024 vaccination season, Novavax has developed an updated COVID-19 vaccine that has received authorization for use in the United States. This updated vaccine has been shown to trigger neutralizing antibody responses against various currently circulating variants, including XBB.1.5, XBB.1.16, XBB.2.3, BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6. In addition, non-clinical data has demonstrated that Novavax's vaccine induces CD4+ polyfunctional T-cell responses against certain variants, indicating its potential to stimulate a comprehensive immune response.

Clinical trials have revealed that the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) include headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise. It's important to note that the trade name Nuvaxovid™ has not been approved by the U.S. Food and Drug Administration.

Nuvaxovid™ (NVX-CoV2373) is a protein-based vaccine created by replicating the surface spike protein of the SARS-CoV-2 virus responsible for COVID-19. Novavax's innovative recombinant nanoparticle technology is used to produce this non-infectious spike protein, which acts as the vaccine's antigen, priming the immune system to recognize the virus. The Matrix-M adjuvant developed by Novavax enhances and broadens the immune response. The vaccine is available in a ready-to-use liquid form and can be stored at 2° to 8°C, allowing for use within existing vaccine supply and cold chain distribution channels.

The PREVENT-19 Phase 3 Trial, or the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19 (PREVENT-19), was conducted in the United States and Mexico. It was a randomized, placebo-controlled, observer-blinded trial aimed at evaluating the efficacy and safety of NVX-CoV2373 as both a primary series and a booster in adults and adolescents for preventing SARS-CoV-2 infection. As a primary series, the trial assessed the prevention of PCR-confirmed symptomatic COVID-19, with full results published in The New England Journal of Medicine.

Novavax's Matrix-M™ Adjuvant, when added to vaccines, enhances the immune system response by making it broader and more durable. This patented saponin-based adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.



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