Novavax, Inc. today announced that Singapore’s Health Sciences Authority (HSA) has granted full approval for Novavax’s prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for active immunization to prevent COVID-19 in individuals aged 12 and older.
The company announced the approval in an Oct. 18 press release.
NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. 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.
For the 2023-2024 vaccination season, Novavax has developed an updated COVID-19 vaccine which has been authorized for use in the U.S. The updated vaccine induces neutralizing antibody responses against currently circulating variants XBB.1.5, XBB.1.16, XBB.2.3, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6. Additional non-clinical data demonstrated that Novavax’s vaccine induced CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax’s vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.
“Today’s full approval of our prototype vaccine will enable us to file for approval of our updated protein-based non-mRNA COVID-19 vaccine in the coming weeks. “We continue to work closely with HSA to ensure a protein-based vaccine is part of the portfolio for Singaporeans to protect themselves against COVID-19.”
John C. Jacobs, President and Chief Executive Officer, Novavax
In clinical trials, the most common adverse reactions associated with Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.
About the PREVENT-19 Phase 3 Trial
The PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19 (PREVENT-19) was a randomized, placebo-controlled, observer-blinded Phase 3 trial conducted in the U.S. and Mexico to evaluate the efficacy and safety of NVX-CoV2373 as a primary series and as a booster in adults and adolescents to prevent SARS-CoV-2 infection. As a primary series, the primary endpoint was the first occurrence of polymerase chain reaction (PCR)-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second dose in 29,960 adult participants aged 18 and older at baseline without protocol violations prior to illness. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Full results of the trial were published in The New England Journal of Medicine.
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