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Anthrax Vaccine Adsorbed

Medically reviewed by Drugs.com. Last updated on Aug 16, 2020.

Pronunciation

(AN thraks vak SEEN ad SORBED)

Index Terms

  • AVA

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, suspension:

BioThrax: Bacillus anthracis proteins (5 mL) [contains formaldehyde; contains aluminum, natural rubber/natural latex in packaging]

Brand Names: U.S.

  • BioThrax

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

Active immunization against Bacillus anthracis. The vaccine is prepared from a cell-free filtrate of B. anthracis, but no dead or live bacteria. Completion of the entire vaccination series is required for full protection; annual boosters are required to maintain immunity.

Use: Labeled Indications

Anthrax prevention: Active immunization against Bacillus anthracis in persons 18 to 65 years of age.

Preexposure: For preexposure prophylaxis (PrEP) of disease in persons whose occupation or other activities place them at high risk of exposure.

The Department of Defense continues to implement an anthrax vaccination program against the biological warfare agent anthrax, which will be administered to all active duty and reserve personnel.

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination (preexposure vaccination) for the following (CDC [Wright 2010]):

• Persons who work directly with the organism in the laboratory

• Persons who handle animals or animal products only when

- potentially infected in research settings;

- in areas of high incidence of enzootic anthrax; or

- where standards and restrictions are not sufficient to prevent exposure

• Military personnel deployed to areas with high risk of exposure as recommended by the Department of Defense (DoD)

• Persons engaged in environmental investigations or remediation efforts

Routine immunization for the general population is not recommended. Routine vaccination may be offered to emergency and other responders (eg, police and fire departments, the National Guard) on a voluntary basis under the direction of a comprehensive occupational health and safety program (CDC [Wright 2010]).

Postexposure: For postexposure prophylaxis (PEP) of disease following suspected or confirmed B. anthracis exposure, when administered in conjunction with recommended antibacterial drugs.

The ACIP recommends PEP after inhalation exposure to aerosolized B. anthracis spores for the following (in the absence of completing a preexposure, routine vaccination schedule) (CDC [Wright 2010]):

• The general public, including pregnant and breastfeeding women

• Medical professionals

• Children ages 0 to 18 years as determined on an event-by-event basis

• Persons engaged in handling certain animals or animal products

• Persons who work directly with the organism in the laboratory (postexposure vaccination dependent upon pre-event vaccination status)

• Military personnel as recommended by the DoD

• Persons engaged in environmental investigations or remediation efforts (postexposure vaccination dependent upon pre-event vaccination status)

• Emergency and other responders (eg, police and fire departments, the National Guard)

• Persons working in postal facilities

Contraindications

Anaphylactic or anaphylactic-like reaction following a previous dose of anthrax vaccine or any component of the formulation including aluminum, benzethonium chloride, and formaldehyde.

Dosing: Adult

Preexposure prophylaxis (PrEP): Note: If the vaccination schedule is interrupted, the series does not need to be restarted (CDC [Bower 2019]). IM administration is preferred; SubQ administration is only to be used for primary immunization in persons who are at risk for hematoma formation following IM injection.

Adults ≤65 years of age:

IM (preferred):

Primary immunization: One injection (0.5 mL) given at day 0, 1 month, and 6 months (CDC [Bower 2019]).

Booster injections:

Persons not at high risk for exposure: One injection (0.5 mL) given at 6 and 12 months after completion of the primary series and at 3-year intervals thereafter (CDC [Bower 2019]); Wright 2014).

Persons at high risk for exposure: One injection (0.5 mL) given 6 and 12 months after completion of the primary series and at 1-year intervals thereafter (CDC [Bower 2019]).

Note: If the patient has completed the entire priming and booster series but has not received a booster dose in >12 months, administer an IM booster dose and wait 2 weeks to enter the high-risk area. If immediate access is required, administer the booster dose and initiate postexposure prophylaxis (PEP) antibiotics for 2 weeks (CDC [Bower 2019]).

If a person requires immediate entrance into an area where B. anthracis is suspected to be present in the environment or be in use and they have not completed the initial priming and booster series, a transition from PrEP to PEP with anthrax vaccine adsorbed and antibiotics should occur as follows (CDC [Bower 2019]):

Transition from PrEP to PEP Schedule (CDC [Bower 2019])

Previous PrEP doses

Interval since last dose

PEP vaccine

PEP antibiotics

0

Dose 1 (week 0)

Administer until 42 days after first dose of anthrax vaccine adsorbed or 14 days after last dose, whichever occurs later.

Dose 2 (week 2)

Dose 3 (week 4)

1

Dose 2 (week 0)

Administer until 28 days after second dose of anthrax vaccine adsorbed or 14 days after the last dose, whichever occurs later.

Dose 3 (week 2)

2

Dose 3 (week 0)

Administer until 14 days after last dose.

3, 4

>6 months

Booster dose

Administer until 14 days after booster dose.

3, 4

≤6 months

No booster dose

No antimicrobials needed.

SubQ:

Primary immunization: One injection (0.5 mL) given at day 0, 2 weeks, 4 weeks, and 6 months.

Booster injections: One injection (0.5 mL) given at 6 and 12 months after completion of the primary series and at 1- to 3-year intervals thereafter based on continued risk of exposure.

PEP (inhalation exposure): Refer to the guidelines provided as part of an emergency use authorization or investigational new drug application at the time of the event. Initiation: Vaccination should begin within 10 days of exposure (CDC [Wright 2010]). Antibody titers among vaccinated persons peak at 14 days after the last administered dose and all dosing schedules maintain a high level of predicted survival through week 9 (Bernstein 2014; Sivko 2016; Stark 2016). Route of administration: Under normal circumstances, the SubQ route is preferred for PEP due to the resultant higher antibody concentrations and 4-week survival estimates following this route of administration (CDC [Bower 2019]; Wright 2014). In the event of a wide-area aerosolized release of B. anthracis, IM administration may be considered to allow for rapid and efficient administration (CDC [Bower 2019]). Concomitant antibiotics: Administer with a ≥42-day course of appropriate antibiotics (CDC [Bower 2019]). If the PEP anthrax vaccine series is administered on schedule (for all regimens), antibiotics may be discontinued in immunocompetent adults 18 to 65 years of age at 42 days after initiation of vaccine or 2 weeks after the last dose of the vaccine (whichever comes last and not to exceed 60 days); if the vaccination series cannot be completed, antibiotics should continue for 60 days (CDC [Bower 2019]). In addition, patients with immunocompromising conditions or receiving immunosuppressive therapy, patients >65 years of age, and patients who are pregnant or breastfeeding should receive antibiotics for 60 days (CDC [Bower 2019]).

SubQ, IM: One injection (0.5 mL) given at day 0, 2 weeks, and 4 weeks postexposure.

Alternative dose-sparing schedules: Note: If demand were to exceed supply (eg, following a wide-area aerosolized release over a densely populated area where vaccination needs would not be met by current stockpiles), alternative dose-sparing regimens should be utilized (CDC [Bower 2019]).

SubQ, IM:

Two-dose regimen: One injection (0.5 mL) given at day 0, and 2 weeks or 4 weeks postexposure (Bernstein 2014).

Half-dose regimen: One injection (0.25 mL) given at day 0, 2 weeks, and 4 weeks postexposure (Bernstein 2014).

Note: Additional considerations for postexposure prophylaxis following occupational exposures (CDC [Bower 2019]; CDC [Wright 2010]):

Fully vaccinated: Personnel who have completed the primary vaccination series and booster injections do not require postexposure prophylaxis if wearing protective equipment. If respiratory protection is disrupted, a 30-day course of antimicrobial therapy is recommended.

Previously unvaccinated: Workers should receive the vaccine as directed per postexposure prophylaxis along with the recommended course of antimicrobial therapy (antimicrobial therapy should continue for 14 days after the last dose of PEP vaccine), then switch to the licensed regimen at the 6-month dose.

Partially vaccinated: Any person who started but did not complete the primary vaccination series should receive antibiotics to continue until 28 days after second dose of PEP vaccine or 14 days after the last dose of PEP vaccine, whichever occurs later; and continue with the primary vaccination schedule.

Dosing: Geriatric

Safety and efficacy have not been established in persons >65 years of age.

Dosing: Pediatric

Note: Routine preexposure immunization with anthrax vaccine in pediatric patients is not recommended; use in pediatric patients is determined on an event-by-event basis (AAP [Bradley 2014]; CDC [Wright 2010]). Due to increased risk of adverse effects postvaccination and unknown effects on immunogenicity, anthrax vaccine should not be administered at the same time as routine childhood immunizations. Postexposure immunization with anthrax vaccine should take priority over routine childhood immunizations; any routine childhood immunization should be postponed until 4 weeks after completion of the anthrax series (AAP [Bradley 2014]).

Postexposure prophylaxis: Use should be in conjunction with public health official guidance and recommendations on an event-by-event basis; refer to guidelines provided as part of emergency use authorization (EUA) or investigational new drug (IND) application at the time of the event. Use in combination with a 60-day systemic antimicrobial course; vaccination should begin within 10 days of exposure (AAP [Bradley 2014]).

Infants ≥6 weeks, Children, and Adolescents <18 years of age: Very limited data available; use in pediatric patients extrapolated from adult experience (AAP [Bradley 2014]). SubQ: 0.5 mL as a 3-dose series administered at 0, 2, and 4 weeks after exposure (AAP [Bradley 2014]; CDC [Wright 2010]).

Adolescents ≥18 years: SubQ: 0.5 mL as a 3-dose series administered at 0, 2, and 4 weeks after exposure (CDC [Wright 2010]).

Administration

Shake well before use. Do not use if discolored or contains particulate matter. Do not use the same site for more than one injection. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Ezeanolue 2020]). If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Preexposure (routine vaccination): For IM administration into the deltoid muscle; do not inject IV or intradermally. For patients at risk of bleeding/hematoma following IM injection, the vaccine can be administered SubQ over the deltoid muscle.

Postexposure prophylaxis: Administer SubQ over the deltoid muscle. Under normal circumstances, the SubQ route is preferred for PEP due to the resultant higher antibody concentrations and 4-week survival estimates following this route of administration (Wright 2014). In the event of a wide-area aerosolized release of B. anthracis, IM administration may be considered to allow for rapid and efficient administration (CDC [Bower 2019]).

Storage

Store at 2°C to 8°C (36°F to 46°F); do not freeze.

Drug Interactions

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Burning sensation (45% to 97%), fatigue (6% to 13%), headache (2% to 11%)

Endocrine & metabolic: Edema at insertion site (subcutaneous: 17% to 46%; intramuscular: 5% to 30%)

Local: Tenderness at injection site (subcutaneous: 48% to 72%; intramuscular: 41% to 51%), erythema at injection site (subcutaneous: 53% to 71%; intramuscular: 15% to 48%), warm sensation at injection site (subcutaneous: 29% to 51%; intramuscular: 4% to 19%), injection site nodule (subcutaneous: 21% to 42%; intramuscular: 3% to 9%), induration at injection site (subcutaneous: 26% to 40%; intramuscular: 7% to 23%), itching at injection site (subcutaneous: 3% to 26%; intramuscular: 1% to 10%), pain at injection site (12% to 22%)

Neuromuscular & skeletal: Decreased range of motion (5% to 15%; arm), myalgia (3% to 13%)

1% to 10%:

Hematologic & oncologic: Lymphadenopathy (≤2%; painful axillary nodes)

Local: Bruising at injection site (2% to 7%)

<1%, postmarketing, and/or case reports: Alopecia, anaphylactoid reaction, anaphylaxis, angioedema, arthralgia, arthropathy, cellulitis, dizziness, erythema multiforme, flu-like symptoms, flushing, hypersensitivity reaction, insomnia, lymphadenopathy, malaise, nausea, pain, paresthesia, pruritus, rhabdomyolysis, skin rash, Stevens-Johnson syndrome, syncope, tremor, ulnar nerve neuropathy, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Ezeanolue 2020]).

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinitis) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Ezeanolue 2020]).

Disease-related concerns:

• Acute illness: May consider deferring administration in patients with moderate or severe acute illness (with or without fever) in preexposure vaccination programs; may administer to patients with mild acute illness (with or without fever). When used for postexposure prophylaxis, consider the benefits versus risks in patients with moderate or severe acute illness (CDC [Wright 2010]).

• Anthrax disease: Persons with a history of anthrax disease may have an increased risk for severe local adverse reactions from the vaccine.

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Ezeanolue 2020]). For patients at risk of hemorrhage following IM injection, the vaccine can be administered SubQ.

• Cutaneous or gastrointestinal anthrax exposure: Vaccination is not recommended after cutaneous or gastrointestinal exposures that pose no risk of inhalational exposure to Bacillus anthracis spores; antimicrobial postexposure prophylaxis may be considered in these patients (CDC [Wright 2010]).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Ezeanolue 2020]). For patients at risk of hemorrhage following IM injection, the vaccine can be administered SubQ.

• Vaccines: Anthrax vaccine should not be administered with routine childhood immunization doses due to increased potential for adverse reactions and unknown effects on immunogenicity; routine childhood immunizations should be postponed until 4 weeks after completion of anthrax series (AAP [Bradley 2014]).

Special populations:

• Altered immunocompetence: Consider deferring preexposure immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Ezeanolue 2020]; IDSA [Rubin 2014]).

• Elderly: Safety and efficacy have not been established in adults ≥65 years of age.

Dosage form specific issues:

• Latex: Packaging may contain natural latex rubber.

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).

Monitoring Parameters

Monitor for local reactions, chills, fever, anaphylaxis. Monitor for syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Reproductive Considerations

Male fertility is not affected by vaccine administration (Catherino 2005).

Pregnancy Considerations

Initial data from the Department of Defense suggest the vaccine may be linked with a slightly increased number of atrial septal defects when given during the first trimester of pregnancy; however, when premature infants are excluded from analysis, the association was not statistically significant (Ryan 2008). Additional data from the Department of Defense registry has not found an increased risk of adverse pregnancy outcomes following maternal vaccination with anthrax vaccine adsorbed (CDC [Bower 2019]; Conlin 2015; Conlin 2017).

Information related to anthrax infection in pregnancy is limited; however, maternal infection may be associated with preterm labor and an increased risk of maternal and fetal death (Meaney-Delman 2012).

Although anthrax vaccine may be administered during pregnancy, use in pregnant women in a preanthrax event setting, where the risk to anthrax exposure is low, is not recommended. Vaccination is not a contraindication for pregnant women at high risk for exposure (Meaney-Delman 2014). Postexposure prophylaxis is recommended using anthrax vaccine adsorbed (in combination with appropriate antibiotic therapy) in pregnant women following inhalation exposure to aerosolized Bacillus anthracis (CDC [Bower 2019]).

Data collection to monitor pregnancy and infant outcomes following exposure to anthrax vaccine adsorbed is ongoing. Health care providers are encouraged to enroll pregnant women exposed to this vaccine in Emergent’s vaccination pregnancy registry (1-619-553-9255).

Patient Education

What is this drug used for?

• It is used to prevent anthrax.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Injection site irritation, redness, or swelling

• Trouble moving arm where shot was given

• Muscle pain

• Headache

• Loss of strength and energy

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe dizziness

• Passing out

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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