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Identification
- Summary
Nuvaxovid is a recombinant spike (S) protein vaccine for the prevention of COVID-19 caused by SARS-CoV-2.
- Generic Name
- Nuvaxovid
- DrugBank Accession Number
- DB15810
- Background
SARS-CoV-2, the causative agent of COVID-19, relies on the interaction between its trimeric spike (S) glycoprotein and angiotensin-converting enzyme 2 (hACE2) expressed on host cells in order to establish a productive infection in humans.1 Antibodies directed against the S protein are capable of blocking S-hACE2 interactions and neutralizing viral particles and are present in convalescent patients and those who have been inoculated against COVID-19. Nuvaxovid (NVX-CoV2373) contains a recombinant mutant S protein that is codon-optimized for baculovirus-mediated expression in Sf9 cells derived from Spodoptera frugiperda together with a Matrix-M adjuvant (Fractions A and C from Quillaja saponaria extract).1,7 The resulting stable perfusion S protein nanoparticles are thermostable and capable of inducing productive cellular and humoral immune responses in humans and across a wide range of animal models.1,2,3
The European Commission granted Novavax conditional marketing authorization for nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 on December 20, 2021 and full marketing authorization on Jul 06, 2023.7,13 On February 17, 2022, nuvaxovid was approved by Health Canada.8,9 On July 13, 2022, nuvaxovid was granted an emergency use authorization by the FDA for the prevention of COVID-19 in adults, which was expanded to include patients ≥12 years of age in August 2022.10,11 An updated formulation covering the Omicron XBB.1.5 subvariant was approved in October 2023 in the EU14 and in December 2023 in Canada.15 In the fall of 2024, an updated formulation covering the Omicron JN.1 subvariant was approved for use in Canada and the US.16,17
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Vaccines
Recombinant - Synonyms
- NVX-CoV2373
- SARS-CoV-2 rS Nanoparticle Vaccine
- External IDs
- NVX-CoV2373
- NVX-CoV2601
Pharmacology
- Indication
Nuvaxovid is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in patients 12 years of age and older.7,12,16
Nuvaxovid is also available in the US under an emergency use authorization (EUA) for the prevention of COVID-19 in patients ≥12 years of age.11
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prevention of Coronavirus disease 2019 (covid‑19) •••••••••••• ••••••••••• ••••• ••••••••• Prevention of Coronavirus disease 2019 (covid‑19) •••••••••••• ••••• ••••••••• Prevention of Coronavirus disease 2019 (covid‑19) •••••••••••• ••••••••• Prevention of Coronavirus disease 2019 (covid‑19) •••••••••••• ••••••••• - Contraindications & Blackbox Warnings
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Nuvaxovid contains a recombinant spike (S) protein and saponin-based Matrix-M adjuvant that induce strong cellular and humoral immune responses in humans and across several animal models against SARS-CoV-2;1,2,3 a two-dose regimen results in vaccine efficacy rates of ~90%.4,7 As with all vaccines, nuvaxovid carries a risk of hypersensitivity and other injection-related reactions; it should be given with caution to those receiving anticoagulant therapy, those with thrombocytopenia or a coagulation disorder, and in those suffering from an acute infection or febrile illness. Protection may not be complete until at least seven days following the second dose, and immunocompromised individuals may not benefit from the same level of protection as immunocompetent individuals. The duration of protection afforded by the recommended dosing schedule remains unknown.7
- Mechanism of action
Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, is associated with a spectrum of illness from asymptomatic infection to a severe disease requiring hospitalization and supplemental oxygen and can be fatal. The SARS-CoV-2 spike (S) protein is a class I fusion glycoprotein with an RRAR furin-like cleavage site that gives rise to the S2 stalk and S1 cap; non-covalent assembly of three S1/S2 protomers gives rise to the functional S-trimer. Upon binding to its receptor, human angiotensin-converting enzyme 2 (hACE2), the S protein undergoes significant structural rearrangement to expose the hydrophobic fusion peptide that mediates membrane fusion and intracellular viral particle release. The S-hACE2 interaction, therefore, represents a critical step in SARS-CoV-2 infection.1
Given the important role of the S protein in infection, active immunization with S protein mRNA or protein variants remains an important strategy in controlling COVID-19. Nuvaxovid comprises a recombinant S protein, with a mutated furin-like cleavage site (682-QQAQ-685) and two proline substitutions (K986P and V987P), produced using Sf9 cells, together with a saponin-based Matrix-M adjuvant.1,7 The recombinant S protein forms thermostable 27.2 nm nanoparticles that bind hACE2 with an IC50 of 18 ng mL-1. Active immunization in mice with 0.1-10 μg S protein/5 μg Matrix-M had significantly higher anti-S IgG titers, higher CD4+/CD8+ effector cells counts, higher germinal centre Tfh/B cell counts, higher levels of type I (IFN-γ) and type II (IL-4 and IL-5) cytokines, and decreased viral load; these metrics were associated with improved lung histopathology.1 Similar results were obtained in non-human primates and human volunteers during phase I/II clinical trials.1,2,3
Overall, nuvaxovid, given as a two-dose regimen with Matrix-M adjuvant, appears to induce mature antibody subclass (IgG/IgA) production and a general trend towards a Th1 over a Th2 cellular immune response.1,2,3
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Abatacept. Adalimumab The therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Adalimumab. Aldesleukin The therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Aldesleukin. Alefacept The therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Alefacept. Alemtuzumab The therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Alemtuzumab. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image NOVAVAX COVID-19 Vaccine, Adjuvanted Injection, suspension 5 ug/0.5mL Intramuscular Novavax, Inc. 2023-02-01 Not applicable US 
NOVAVAX COVID-19 Vaccine, Adjuvanted Injection, suspension 5 ug/0.5mL Intramuscular Novavax, Inc. 2022-01-31 Not applicable US NOVAVAX COVID-19 Vaccine, Adjuvanted Injection, suspension 5 ug/0.5mL Intramuscular Novavax, Inc. 2023-10-03 Not applicable US Nuvaxovid Suspension 5 mcg / 0.5 mL Intramuscular Novavax Inc. 2022-03-31 2024-02-29 Canada 
Nuvaxovid Suspension 5 mcg / 0.5 mL Intramuscular Novavax Inc. 2023-12-08 Not applicable Canada
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- UK9AK2IN1P
- CAS number
- Not Available
References
- Synthesis Reference
Tian JH, Patel N, Haupt R, Zhou H, Weston S, Hammond H, Logue J, Portnoff AD, Norton J, Guebre-Xabier M, Zhou B, Jacobson K, Maciejewski S, Khatoon R, Wisniewska M, Moffitt W, Kluepfel-Stahl S, Ekechukwu B, Papin J, Boddapati S, Jason Wong C, Piedra PA, Frieman MB, Massare MJ, Fries L, Bengtsson KL, Stertman L, Ellingsworth L, Glenn G, Smith G: SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice. Nat Commun. 2021 Jan 14;12(1):372. doi: 10.1038/s41467-020-20653-8.
- General References
- Tian JH, Patel N, Haupt R, Zhou H, Weston S, Hammond H, Logue J, Portnoff AD, Norton J, Guebre-Xabier M, Zhou B, Jacobson K, Maciejewski S, Khatoon R, Wisniewska M, Moffitt W, Kluepfel-Stahl S, Ekechukwu B, Papin J, Boddapati S, Jason Wong C, Piedra PA, Frieman MB, Massare MJ, Fries L, Bengtsson KL, Stertman L, Ellingsworth L, Glenn G, Smith G: SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice. Nat Commun. 2021 Jan 14;12(1):372. doi: 10.1038/s41467-020-20653-8. [Article]
- Gorman MJ, Patel N, Guebre-Xabier M, Zhu AL, Atyeo C, Pullen KM, Loos C, Goez-Gazi Y, Carrion R Jr, Tian JH, Yuan D, Bowman KA, Zhou B, Maciejewski S, McGrath ME, Logue J, Frieman MB, Montefiori D, Mann C, Schendel S, Amanat F, Krammer F, Saphire EO, Lauffenburger DA, Greene AM, Portnoff AD, Massare MJ, Ellingsworth L, Glenn G, Smith G, Alter G: Fab and Fc contribute to maximal protection against SARS-CoV-2 following NVX-CoV2373 subunit vaccine with Matrix-M vaccination. Cell Rep Med. 2021 Sep 21;2(9):100405. doi: 10.1016/j.xcrm.2021.100405. Epub 2021 Aug 31. [Article]
- Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM: Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020 Dec 10;383(24):2320-2332. doi: 10.1056/NEJMoa2026920. Epub 2020 Sep 2. [Article]
- Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Chadwick DR, Clark R, Cosgrove C, Galloway J, Goodman AL, Heer A, Higham A, Iyengar S, Jamal A, Jeanes C, Kalra PA, Kyriakidou C, McAuley DF, Meyrick A, Minassian AM, Minton J, Moore P, Munsoor I, Nicholls H, Osanlou O, Packham J, Pretswell CH, San Francisco Ramos A, Saralaya D, Sheridan RP, Smith R, Soiza RL, Swift PA, Thomson EC, Turner J, Viljoen ME, Albert G, Cho I, Dubovsky F, Glenn G, Rivers J, Robertson A, Smith K, Toback S: Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. N Engl J Med. 2021 Sep 23;385(13):1172-1183. doi: 10.1056/NEJMoa2107659. Epub 2021 Jun 30. [Article]
- Novavax Pipeline Page [Link]
- Novavex News Release [Link]
- EMA Product Information: Nuvaxovid (recombinant SARS-CoV-2 spike protein and Matrix-M adjuvant) injection [Link]
- Health Canada News: Health Canada authorizes Novavax's Nuvaxovid COVID-19 vaccine [Link]
- Health Canada Product Monograph: NUVAXOVID [COVID-19 Vaccine (Recombinant protein, Adjuvanted)] intramuscular injection [Link]
- FDA News Release: Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted [Link]
- FDA Emergency Use Authorization: Novavax (covid-19 vaccine, adjuvanted) for intramuscular injection [Link]
- Health Canada Approved Drug Products: NUVAXOVID COVID-19 Vaccine (Recombinant protein, Adjuvanted) Suspension for intramuscular injection [Link]
- Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID [Link]
- BioSpace: Novavax's Updated COVID-19 Vaccine Now Approved in the EU [Link]
- Health Canada Approved Drug Products: Nuvaxovid XBB.1.5 (COVID-19 Vaccine, recombinant, adjuvanted) suspension for intramuscular injection [Link]
- Health Canada Product Monograph: Nuvaxovid (COVID-19 vaccine, recombinant, adjuvanted) suspension for intramuscular injection (September 2024) [Link]
- FDA Vaccines, Blood, & Biologics: Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) Authorized For Individuals 12 Years of Age and Older [Link]
- External Links
- Wikipedia
- Novavax_COVID-19_vaccine
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Active Not Recruiting Not Available Coronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines 1 somestatus stop reason just information to hide Not Available Recruiting Not Available Adverse Reaction to Vaccine / Coronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines 1 somestatus stop reason just information to hide 3 Active Not Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide 3 Completed Prevention Coronavirus Disease 2019 (COVID‑19) 4 somestatus stop reason just information to hide 3 Completed Prevention Coronavirus Disease 2019 (COVID‑19) / Seasonal Allergic Rhinitis 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, suspension Intramuscular 5 ug/0.5mL Injection Intramuscular 5 mcg Suspension Intramuscular 5 mcg / 0.5 mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Drug created at September 05, 2020 17:30 / Updated at September 26, 2024 05:46