The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals aged 12 and older.
NVX-CoV2601 is an updated version of Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the Omicron XBB.1.5 subvariant. It 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.
“Today’s MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “We are in ongoing conversations with additional U.K. partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one. We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the U.K.”
The approval for the protein-based vaccine from Novavax was based on non-clinical data showing that Novavax’s updated COVID-19 vaccine induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants.
Additional non-clinical data demonstrated that Novavax’s vaccine induced neutralizing antibody responses to subvariants JN.1, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as 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 induce a broad response against circulating variants.
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.
For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:
The trade name Nuvaxovid™ has not been approved by the U.S. Food and Drug Administration.
Repeated mRNA SARS-CoV-2 vaccination has been associated with increases in the proportion of IgG4 in spike-specific antibody responses and concurrent reductions in Fcγ-mediated effector functions that may limit control of viral infection. Here, we report that the NVX-CoV2373 protein vaccine does not appear to induce notable increases in IgG4, even after multiple exposures, or impair Fcγ-dependent effector responses as observed with mRNA vaccines. Instead, NVX-CoV2373 drove proportional increases in IgG3, perhaps the most potent SARS-CoV-2 neutralizing antibody subclass. MedRxiv pre-print (Jan 2024)
A targeted review of the reactogenicity of authorized/approved messenger RNA (mRNA) and protein-based vaccines demonstrated by clinical trials and real-world evidence. It was found that mRNA-based boosters show a higher incidence and an increased severity of reactogenicity compared with the Novavax protein-based COVID-19 vaccine (NVX-CoV2373). Evidence suggests that NVX-CoV2373, when utilized as a heterologous booster, demonstrates less reactogenicity compared with mRNA vaccines, which, if communicated to hesitant individuals, may strengthen booster uptake rates worldwide. The Journal of Infectious Diseases (Nov 2023)
On 3 Oct 2023 the FDA amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses. Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula). This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. U.S. Food and Drug Administration (Oct 2023)