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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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
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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prevention of Coronavirus disease 2019 (covid‑19) •••••••••••• •••••••••• •••••••• - Contraindications & Blackbox Warnings
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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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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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The 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. Adalimumab The 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. Aldesleukin The 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. Alefacept The 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. Alemtuzumab The 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
- 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]
- 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]
- 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]
- EMA EPAR: Bimervax [Link]
- External Links
- Not Available
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 data2 Completed Prevention Coronavirus Disease 2019 (COVID‑19) / Influenza, Human 1 somestatus stop reason just information to hide 2 Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide
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