Identification
- Summary
Anthrax vaccine is a vaccine indicated for the pre- and post-exposure prophylaxis treatment of diseases caused by exposure to Bacillus anthracis
- Brand Names
- Biothrax, Cyfendus
- Generic Name
- Anthrax vaccine
- DrugBank Accession Number
- DB11003
- Background
Anthrax vaccine is a vaccine used for the pre- or post-exposure prophylaxis of disease in those at high risk of, suspected or confirmed exposure to Bacillus anthracis. It is subcutaneously or intramuscularly administered. It is derived from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis which are grown in a chemically defined protein-free medium.1 It is considered one of the most likely agents to be used in a biological attack.3
There are currently 2 anthrax vaccines approved by the FDA: BioThrax in August 15, 2016 and CYFENDUS in July 20, 2023.4,3 These vaccines are currently stored in the Strategic National Stockpile in preparation for an Anthrax terrorist attack or for pre-exposure prophylaxis of personnel going to specific arenas around the world.3
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Vaccines
Other vaccines - Synonyms
- Anthrax vaccine adsorbed
- Bacillus anthracis inactivated antigen
- Bacillus anthracis strain V770-NP1-R antigen
- Bacillus anthracis strain V770-NP1-R antigens
- Bacillus anthracis strain V770-NP1-R filtrate (attenuated) antigen
- Bacillus anthracis strain V770-NP1-R filtrate antigen
- External IDs
- RPA102
Pharmacology
- Indication
CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted) is a vaccine indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.1 BioThrax is also approved for the same condition but is also used for pre-exposure prophylaxis for people whose occupation or other activities place them at high risk of exposure.2
The efficacy of CYFENDUS for post-exposure prophylaxis (PEP) is based solely on studies in animal models of inhalational anthrax.1
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prevention of Disease caused by bacillus anthracis •••••••••••• •••••••••• Prevention of Disease caused by bacillus anthracis •••••••••••• •••••••••• - Associated Therapies
- Contraindications & Blackbox Warnings
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Limited information is available on the pharmacodynamics of the anthrax vaccine.
- Mechanism of action
The anthrax vaccine induces antibodies raised against PA that may contribute to protection by neutralizing the activities of the cytotoxic lethal toxin and edema toxin of Bacillus anthracis.1,2 Bacillus anthracis proteins other than PA may be present in BioThrax, but their contribution to protection has not been determined.2
- Absorption
Limited information is available on the absorption of the anthrax vaccine.
- Volume of distribution
Limited information is available on the volume of distribution of the anthrax vaccine.
- Protein binding
Limited information is available on the protein binding of the anthrax vaccine.
- Metabolism
Limited information is available on the metabolism of the anthrax vaccine.
- Route of elimination
Limited information is available on the elimination of the anthrax vaccine.
- Half-life
Limited information is available on the half-life of the anthrax vaccine.
- Clearance
Limited information is available on the clearance of the anthrax vaccine.
- Adverse Effects
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There are no adequate and well-controlled studies of CYFENDUS in pregnant individuals. Available human data on CYFENDUS administered to pregnant individuals do not establish the presence or absence of vaccine-associated risks in pregnancy. However, available data on BioThrax (a licensed anthrax vaccine), administered to pregnant individuals are relevant to CYFENDUS because BioThrax and CYFENDUS contain the same active ingredient and are manufactured similarly. BioThrax does not contain CPG 7909 adjuvant. Data are available from a BioThrax observational study and pregnancy exposure registry.1
In the observational study, there were more birth defects in infants born to individuals vaccinated with BioThrax in the first trimester compared to individuals vaccinated post-pregnancy or individuals never vaccinated with BioThrax. Data from the BioThrax pregnancy exposure registry do not establish the presence or absence of vaccine-associated risks in pregnancy.1
In a developmental study with an embryo-fetal development toxicity phase, female rats were administered a full human dose (0.5 mL) of CYFENDUS twice prior to mating and once during gestation. This study revealed no evidence of harm to the fetus, changes in reproductive performance, or adverse effects on post-natal development due to the vaccine.1
The anthrax vaccine has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals. Anthrax vaccine administered to female rats had no effect on fertility.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 softwareAbacavir The therapeutic efficacy of Anthrax vaccine can be decreased when used in combination with Abacavir. Abatacept The therapeutic efficacy of Anthrax vaccine can be decreased when used in combination with Abatacept. Acyclovir The therapeutic efficacy of Anthrax vaccine can be decreased when used in combination with Acyclovir. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Anthrax vaccine. Adefovir dipivoxil The therapeutic efficacy of Anthrax vaccine can be decreased when used in combination with Adefovir dipivoxil. - 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.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image BioThrax Suspension 50 mcg / 0.5 mL Intramuscular; Subcutaneous Emergent Biodefense Operations Lansing Llc Not applicable Not applicable Canada 
BioThrax Injection, suspension 100 ug/1mL Intramuscular; Subcutaneous Emergent BioDefense Operations Lansing, LLC 1970-11-04 Not applicable US 
Cyfendus Injection, suspension 100 ug/1mL Intramuscular Emergent Product Development Gaithersburg Inc. 2023-09-19 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- 873OI62848
- CAS number
- Not Available
References
- General References
- FDA Approved Drug Products: CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted) Suspension for Intramuscular Injection [Link]
- FDA Approved Drug Products: BIOTHRAX® (Anthrax Vaccine Adsorbed) Suspension for Intramuscular or Subcutaneous Injection [Link]
- Emergent BioSolutions Receives U.S. FDA Approval of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use [Link]
- Emergent BioSolutions Receives FDA Approval for Large-Scale Manufacturing of BioThrax in Building 55 [Link]
- External Links
- PubChem Substance
- 347911075
- 404774
- Wikipedia
- Anthrax_vaccine
- FDA label
- Download (363 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Prevention Bacillus Anthracis (Anthrax) 1 4 Completed Prevention Healthy Volunteers (HV) 1 3 Completed Prevention Anthrax 1 3 Completed Treatment Anthrax 1 2 Completed Prevention Anthrax 3
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, suspension Intramuscular; Subcutaneous 100 ug/1mL Injection, suspension Intramuscular; Subcutaneous 50 mcg/0.5ml Suspension Intramuscular; Subcutaneous 50 mcg / 0.5 mL Injection, suspension Intramuscular 50 mcg/dose Injection, suspension Intramuscular 100 ug/1mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at December 01, 2015 20:05 / Updated at July 28, 2023 21:40