Identification
- Summary
Famtozinameran is a component of a bivalent COVID-19 mRNA vaccine encoding the viral spike protein of Omicron variant lineages BA.4 and BA.5.
- Generic Name
- Famtozinameran
- DrugBank Accession Number
- DB17088
- Background
The Omicron variant of SARS-CoV-2 is a variant of concern that was first reported in November 2021.4 It tends to cause less severe disease but is significantly more virulent than both the original virus and earlier variants (e.g. Delta).3 As of November 2022, it is the primary circulating variant of concern according to the World Health Organization.4 The Omicron variant comprises several distinct lineages and sublineages (e.g. BA.4, BA.5) which, although similar, may behave differently from one another.3
Famtozinameran is an mRNA vaccine encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5. It is administered in combination with tozinameran for active immunization against COVID-19 caused by SARS-CoV-2, including infection caused by Omicron BA.4/BA.5.1,2
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Vaccines
Other vaccines - Synonyms
- Famtozinameran
- External IDs
- BNT162B2 Omicron (BA.4/BA.5)
Pharmacology
- Indication
In the US, famtozinameran in combination with tozinameran (Comirnaty Original & Omicron BA.4/BA.5 Bivalent mRNA vaccine), is indicated as a booster dose for active immunization against COVID-19. It may be given as the third dose of the three-dose primary series with the monovalent Pfizer BioNTech COVID-19 vaccine to patients between 6 months and 4 years of age, and may be used in patients ≥5 years of age as a single booster dose at least two months following the completion of primary vaccination with any COVID-19 vaccine, or following receipt of the most recent booster dose of any approved monovalent COVID-19 vaccine.5
In Canada, famtozinameran is indicated in combination with tozinameran as a booster dose in patients ≥12 years of age.1
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 Novel coronavirus infectious disease (covid-19) Combination Product in combination with: Tozinameran (DB15696) •••••••••••• •••••••••• •••••••••• Used in combination to prevent Novel coronavirus infectious disease (covid-19) Combination Product in combination with: Tozinameran (DB15696) •••••••••••• •••••••••• •••••••••• Used in combination to prevent Novel coronavirus infectious disease (covid-19) Combination Product in combination with: Tozinameran (DB15696) •••••••••••• •••••••••• •••••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Not Available
- Mechanism of action
Famtozinameran comprises a nucleoside-modified mRNA encapsulated in lipid nanoparticles that deliver the mRNA into host cells. The lipid nanoparticle formulation facilitates the delivery of the RNA into human cells.2 Once inside these cells, the mRNA is translated by host machinery to produce a modified SARS-CoV-2 spike (S) protein - specifically the S protein of the Omicron BA.4/BA.5 variant lineages - which is subsequently recognized by the host immune system. Comirnaty has been shown to elicit both neutralizing antibody and cellular immune responses to the S protein, which helps protect against subsequent SARS-CoV-2 infection.2,1
- 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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There are no data available regarding overdose with famtozinameran. In the event of a suspected overdose, monitoring of vital functions and symptomatic treatment is recommended.1
- 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 Famtozinameran can be decreased when used in combination with Abatacept. Adalimumab The therapeutic efficacy of Famtozinameran can be decreased when used in combination with Adalimumab. Aldesleukin The therapeutic efficacy of Famtozinameran can be decreased when used in combination with Aldesleukin. Alefacept The therapeutic efficacy of Famtozinameran can be decreased when used in combination with Alefacept. Alemtuzumab The therapeutic efficacy of Famtozinameran 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.- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Comirnaty Original & Omicron Ba.4/ba.5 Famtozinameran (15 mcg / 0.3 mL) + Tozinameran (15 mcg / 0.3 mL) Suspension Intramuscular Biontech Manufacturing Gmbh 2022-10-11 Not applicable Canada 
Comirnaty Original & Omicron Ba.4/ba.5 Famtozinameran (1.5 mcg / 0.2 mL) + Tozinameran (1.5 mcg / 0.2 mL) Suspension Intramuscular Biontech Manufacturing Gmbh Not applicable Not applicable Canada Comirnaty Original & Omicron Ba.4/ba.5 Famtozinameran (5 mcg / 0.2 mL) + Tozinameran (5 mcg / 0.2 mL) Suspension Intramuscular Biontech Manufacturing Gmbh 2022-12-19 Not applicable Canada
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- Not Available
- CAS number
- Not Available
References
- General References
- Health Canada Product Monograph: Comirnaty Original & Omicron BA.4/BA.5 (tozinameran/famtozinameran) suspension for intramuscular injection [Link]
- FDA Emergency Use Authorization: Pfizer-BioNTech COVID-19 Vaccine (Original & Omicron BA.4/BA.5 strain) suspension for intramuscular injection [Link]
- CDC COVID-19: Variants of the Virus [Link]
- WHO: Tracking SARS-CoV-2 Variants [Link]
- FDA News Release: Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age [Link]
- External Links
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 2 Completed Basic Science Coronavirus Disease 2019 (COVID‑19) / Systemic hypersensitivity reaction 1 2 Completed Prevention Coronavirus Disease 2019 (COVID‑19) / Juvenile Dermatomyositis (JDM) / Juvenile Idiopathic Arthritis (JIA) / Multiple Sclerosis / Pediatric Onset Multiple Sclerosis (POMS) / Pediatric SLE / Pemphigus Vulgaris (PV) / Rheumatoid Arthritis / Systemic Lupus Erythematosus / Systemic Sclerosis (SSc) 1 Not Available Active Not Recruiting Not Available Anesthetics Adverse Reaction / Coronavirus Disease 2019 (COVID‑19) / Safety / Vaccines 1 Not Available Recruiting Not Available Coronavirus Disease 2019 (COVID‑19) / Post-acute COVID-19 (PACS), or "Long COVID" Syndrome 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Suspension Intramuscular Injection, suspension Intramuscular - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at November 04, 2022 17:31 / Updated at March 11, 2023 21:11