NAV

Nuvaxovid

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

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Vaccines
Recombinant
Synonyms
  • NVX-CoV2373
  • SARS-CoV-2 rS Nanoparticle Vaccine
External IDs
  • NVX-CoV2373
  • NVX-CoV2601
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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

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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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Prevention ofCoronavirus disease 2019 (covid‑19)••••••••••••••••••••••• ••••••••••••••
Prevention ofCoronavirus disease 2019 (covid‑19)••••••••••••••••••••••••••
Prevention ofCoronavirus disease 2019 (covid‑19)•••••••••••••••••••••
Prevention ofCoronavirus disease 2019 (covid‑19)•••••••••••••••••••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

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
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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.
DrugInteraction
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interactions in your software
AbataceptThe therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Nuvaxovid can be decreased when used in combination with Alemtuzumab.
Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
NOVAVAX COVID-19 Vaccine, AdjuvantedInjection, suspension5 ug/0.5mLIntramuscularNovavax, Inc.2022-01-31Not applicableUS flag
NOVAVAX COVID-19 Vaccine, AdjuvantedInjection, suspension5 ug/0.5mLIntramuscularNovavax, Inc.2023-10-03Not applicableUS flag
NOVAVAX COVID-19 Vaccine, AdjuvantedInjection, suspension5 ug/0.5mLIntramuscularNovavax, Inc.2023-02-01Not applicableUS flag
NuvaxovidInjection5 mcgIntramuscularNovavax Cz, A.S.2022-01-17Not applicableEU flag

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
  1. 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]
  2. 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]
  3. 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]
  4. 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]
  5. Novavax Pipeline Page [Link]
  6. Novavex News Release [Link]
  7. EMA Product Information: Nuvaxovid (recombinant SARS-CoV-2 spike protein and Matrix-M adjuvant) injection [Link]
  8. Health Canada News: Health Canada authorizes Novavax's Nuvaxovid COVID-19 vaccine [Link]
  9. Health Canada Product Monograph: NUVAXOVID [COVID-19 Vaccine (Recombinant protein, Adjuvanted)] intramuscular injection [Link]
  10. FDA News Release: Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted [Link]
  11. FDA Emergency Use Authorization: Novavax (covid-19 vaccine, adjuvanted) for intramuscular injection [Link]
  12. Health Canada Approved Drug Products: NUVAXOVID COVID-19 Vaccine (Recombinant protein, Adjuvanted) Suspension for intramuscular injection [Link]
  13. Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID [Link]
  14. BioSpace: Novavax's Updated COVID-19 Vaccine Now Approved in the EU [Link]
  15. Health Canada Approved Drug Products: Nuvaxovid XBB.1.5 (COVID-19 Vaccine, recombinant, adjuvanted) suspension for intramuscular injection [Link]
Wikipedia
Novavax_COVID-19_vaccine

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)2
3CompletedPreventionCoronavirus Disease 2019 (COVID‑19)3
3CompletedPreventionCoronavirus Disease 2019 (COVID‑19) / Seasonal Allergic Rhinitis1
3CompletedPreventionCoronavirus Disease 2019 (COVID‑19) / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)1
2CompletedPreventionCoronavirus Disease 2019 (COVID‑19)2

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, suspensionIntramuscular5 ug/0.5mL
InjectionIntramuscular5 mcg
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created at September 05, 2020 17:30 / Updated at December 09, 2023 17:37