Overview
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. It is considered one of the most likely agents to be used in a biological attack. There are currently 2 anthrax vaccines approved by the FDA: BioThrax in August 15, 2016 and CYFENDUS in July 20, 2023. 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.
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. 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. The efficacy of CYFENDUS for post-exposure prophylaxis (PEP) is based solely on studies in animal models of inhalational anthrax.
Associated Conditions
- Disease caused by Bacillus anthracis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/12/09 | Phase 1 | Completed | |||
2019/08/26 | Phase 2 | Completed | |||
2017/11/24 | Phase 1 | Completed | |||
2012/12/20 | Phase 2 | Completed | |||
2005/06/16 | Phase 1 | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BioThrax (Anthrax Vaccine Adsorbed) Supension for Injection 50μg/dose (nominal) | SIN13967P | INJECTION, SUSPENSION | 50μg/dose (nominal) | 6/13/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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