NAV

SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351-B.1.1.7 strains)

Identification

Summary

SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351-B.1.1.7 strains) is a recombinant non-mRNA COVID-19 vaccine.

Generic Name
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351-B.1.1.7 strains)
DrugBank Accession Number
DB18705
Background

Bimervax is an adjuvanted non-mRNA COVID-19 vaccine utilizing a SARS-CoV-2 recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer.3 It is intended to elicit protection against Omicron XBB.1.5, one of the dominant circulating SARS-CoV-2 subvariants in 2023.1 It is produced using recombinant DNA technology in CHO cell lines and is marketed by Hipra Human Health S.L. for the European market.3,4

Bimervax was issued marketing authorization in the EU in March 2023 for use as a booster dose in patients who have previously received an mRNA COVID-19 vaccine.4

Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Recombinant
Synonyms
  • Bimervax
  • SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains
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Pharmacology

Indication

Bimervax is indicated as a booster dose for active immunization to prevent COVID-19 in individuals ≥16 years of age who have previously received an mRNA COVID-19 vaccine.3

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

Bimervax elicits immunity against SARS-CoV-2 infection by priming the immune system with a recombinant spike protein receptor binding domain.3 As with all vaccines, Bimervax carries a risk of hypersensitivity and anaphylaxis, and should therefore be administered under appropriate medical supervision.3 It should be used with caution in patients receiving anticoagulant therapy or in those with coagulation disorders, as bruising or bleeding may be more severe in these patients.3

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.2

The active ingredient in Bimervax is a recombinant SARS-CoV-2 spike protein receptor binding domain (RBD) fusion heterodimer.3 Its administration elicits an immune response against the RBD antigen, resulting in the formation of neutralizing antibodies that prevent the binding of SARS-CoV-2 to ACE2 and, ultimately, viral infection. It also induces an antigen-specific T-cell immune response, which may confer additional protection against COVID-19.3

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

In the event of an overdose, the prescribing information for Bimervax recommends monitoring of vital function and symptomatic treatment as clinically indicated.3

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 SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351-B.1.1.7 strains) can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351-B.1.1.7 strains) can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351-B.1.1.7 strains) can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351-B.1.1.7 strains) can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351-B.1.1.7 strains) can be decreased when used in combination with Alemtuzumab.
Food Interactions
No interactions found.

Categories

Drug Categories
Classification
Not classified
Affected organisms
  • Humans

Chemical Identifiers

UNII
Not Available
CAS number
Not Available

References

General References
  1. Borralleras C, Castrodeza Sanz J, Arrazola P, Camara Hijon C, Eiros JM, Castrodeza Sanz J, Arrazola P, Camara Hijon C, Fernandez-Prada M, Gil de Miguel A, Mirada Masip G, Moraga-Llop F, Ocana Rodriguez D, Puig-Barbera J, Vazquez J, Vergara-Alert J, de Cambra S: Update on Bimervax(R) immunogenicity amplitude. Insights on humoral response against XBB.1.5 from an extension study (NTC05142553). Rev Esp Quimioter. 2023 Dec;36(6):658-660. doi: 10.37201/req/085.2023. Epub 2023 Sep 8. [Article]
  2. 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]
  3. EMA Summary of Product Characteristics: Bimervax (SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains) for intramuscular injection [Link]
  4. EMA EPAR: Bimervax [Link]
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2CompletedPreventionCoronavirus Disease 2019 (COVID‑19) / Influenza, Human1
2RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
Not Available
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created at December 05, 2023 18:40 / Updated at December 07, 2023 08:36