Identification
- Summary
Recombinant stabilized RSV A prefusion F antigen is one component of a bivalent recombinant RSV vaccine.
- Brand Names
- Abrysvo
- Generic Name
- Recombinant stabilized RSV A prefusion F antigen
- DrugBank Accession Number
- DB18713
- Background
Recombinant stabilized RSV B prefusion F antigen is one component of a bivalent respiratory syncytial virus (RSV) vaccine called Abrysvo. The vaccine comprises two antigens - the other being recombinant stabilized RSV A prefusion F antigen - which have been expressed in Chinese hamster ovary cell lines and then purified and lyophilized.2 In contrast to another RSV vaccine, respiratory syncytial virus vaccine, adjuvanted (Arexvy), Abrysvo is reconstituted with sterile water prior to injection and does not require the co-administration of an adjuvant.2
Abrysvo was first approved by the FDA in May 2023 for use in patients ≥60 years of age, and received subsequent approval in August 2023 for use in pregnant individuals for the protection of infants through six months of age.3 Abrysvo was approved for the same indications in the EU in August 20234 and Canada in December 2023.5 It is the first RSV vaccine approved for use in pregnant patients to prevent RSV in infants.3
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Vaccines
Recombinant - Synonyms
- RSV subgroup A stabilized prefusion F protein
Pharmacology
- Indication
Abrysvo is indicated for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) infection in patients ≥60 years of age.2 It is also indicated for use in pregnant patients between 32 and 36 weeks gestational age for the prevention of LRTD, including severe LRTD, caused by RSV infection in infants from birth through 6 months of age.2
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 Used in combination to prevent Lower respiratory tract disease caused by respiratory syncytial virus (rsv) Combination Product in combination with: Recombinant stabilized RSV B prefusion F antigen (DB18714) •••••••••••• •••••••••• •••••••• Used in combination to prevent Lower respiratory tract disease caused by respiratory syncytial virus (rsv) Combination Product in combination with: Recombinant stabilized RSV B prefusion F antigen (DB18714) •••••••••••• ••••••••• •••••••••• •••••••• - Contraindications & Blackbox Warnings
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Abrysvo induces an active immune response in adult patients and provides passive immunity to infants when administered to pregnant individuals.2 In clinical studies, more patients receiving Abrysvo experienced preterm labor compared to placebo, although data were insufficient to establish or exclude a causal relationship. In order to mitigate this risk, Abrysvo should not be administered until after 32 weeks of gestation.2,5
- Mechanism of action
Respiratory tract infections caused by RSV can be severe in high-risk populations, such as infants and elderly patients. Immunization remains one of the key preventative measures against RSV infection.1
The administration of Abrysvo in adult patients induces an active immune response against RSV prefusion F proteins that protects against lower respiratory tract disease caused by RSV infection.2 When administered to pregnant patients, Abrysvo provides passive immunization to the unborn fetus - which protects from birth through six months of age - via transplacental transfer of antibodies from the vaccinated mother.2
- 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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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.Not Available
- Food Interactions
- Not Available
Products
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Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Abrysvo Recombinant stabilized RSV A prefusion F antigen (0.06 mg/0.5mL) + Recombinant stabilized RSV B prefusion F antigen (0.06 mg/0.5mL) Injection, powder, lyophilized, for solution; Kit Intramuscular Pfizer Laboratories Div Pfizer Inc 2023-07-12 Not applicable US 
Abrysvo Recombinant stabilized RSV A prefusion F antigen (60 mcg / 0.5 mL) + Recombinant stabilized RSV B prefusion F antigen (60 mcg / 0.5 mL) Kit; Powder, for solution Intramuscular Pfizer Canada Ulc Not applicable Not applicable Canada 
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- Not Available
- CAS number
- Not Available
References
- General References
- Biagi C, Dondi A, Scarpini S, Rocca A, Vandini S, Poletti G, Lanari M: Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines. Vaccines (Basel). 2020 Nov 11;8(4):672. doi: 10.3390/vaccines8040672. [Article]
- FDA Approved Drug Products: ABRYSVO (Respiratory Syncytial Virus Vaccine) solution for intramuscular injection (August 2023) [Link]
- FDA Press Announcement: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants [Link]
- EMA EPAR: Abrysvo (Respiratory syncytial virus vaccine, bivalent, recombinant) [Link]
- Health Canada Approved Drug Products: Abrysvo (Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine) for intramuscular injection [Link]
- External Links
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Recruiting Basic Science Coronavirus Disease 2019 (COVID‑19) / Lymphoma 1 Not Available Active Not Recruiting Not Available Respiratory Syncytial Virus (RSV) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for solution; kit Intramuscular Kit; powder, for solution Intramuscular - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Drug created at January 10, 2024 19:10 / Updated at January 13, 2024 23:36