Novavax’s Prototype COVID-19 Vaccine Nuvaxovid Receives Full Approval in Singapore – Global Biodefense

Novavax, Inc. today announced that Singapores Health Sciences Authority (HSA) has granted full approval for Novavaxs prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for active immunization to prevent COVID-19 inindividuals 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 Novavaxs unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavaxs 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 8C, 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 Novavaxs vaccine induced CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavaxs vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.

Todays full approval of our prototype vaccine will enable us to file for approval of our updated protein-basednon-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.

In clinical trials, the most common adverse reactions associated withNovavaxs 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 TrialThe PRE-fusion protein subunitVaccineEfficacyNovavaxTrial 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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Vaccine maker Novavax Inc (NVAX.O) on Monday said it has shipped millions of doses its updated COVID-19 shots to distributors after receiving the go-ahead from U.S. regulators. The U.S. FDA authorized the updated vaccine last week for emergency use in individuals aged 12 years and older, but batches of the shots needed additional clearance from the FDA before they could be released. Novavax said it expects the shots to be available at U.S. pharmacies this week. Reuters

The Medicines and Healthcare products Regulatory Agency or MHRA in the United Kingdom has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid or NVX-CoV2373 for individuals aged 12 and older. Business Insider

As the updated COVID vaccines roll out around the country, one more competitor has joined the mix. In early October the U.S. Food and Drug Administration authorized a new booster shot made by the company Novavax. Like the mRNA-based Pfizer and Moderna shots, it targets a SARS-CoV-2 variant, XBB.1.5, which is a descendant of Omicron. It is the first protein vaccine to appear in more than a year, which some public health experts say is encouraging news for people who are hesitant the mRNA vaccines that have been widely used throughout the pandemic. Scientific American

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Novavax's Prototype COVID-19 Vaccine Nuvaxovid Receives Full Approval in Singapore - Global Biodefense