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What is Anthrax vaccine?

Updated December 29, 2023


There are two anthrax vaccines approved for use by the U.S. Food & Drug Administration (FDA) for use in the US. No anthrax vaccine is approved for persons under 18 or over 65 years of age.   

Read the Product Information Insert

NVIC strongly recommends reading the vaccine manufacturer product information insert before receiving any vaccine, including the anthrax vaccine. Package inserts are published by drug companies making vaccines and list important information about vaccine ingredients, reported health problems (adverse events) associated with the vaccine, and directions for who should and should not get the vaccine.

Links to the anthrax vaccine package inserts are available on NVIC’s Anthrax Quick Facts page and below for each vaccine. You may also ask your doctor to give you a copy of the vaccine package insert to read before vaccination. It is best to ask your doctor for a copy of the package inserts for the vaccines you are scheduled to receive well before your vaccination appointment.

 

Biothrax, Anthrax Vaccine Adsorbed

Ages: Biothrax is approved for use in adults between 18 and 65 years of age

Vaccine ingredients: cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, 83kDa protective antigen protein, aluminum hydroxide, sodium chloride, benzethonium chloride, and formaldehyde.

Commonly reported adverse events: redness, swelling, and pain at the injection site, arm motion limitation, muscle aches, fatigue, and headache.

Reported serious adverse events: anaphylaxis, angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reaction, Stevens-Johnson syndrome (a severe skin and mucus membrane reaction), paresthesia syncope, dizziness, tremor, ulnar nerve neuropathy, lymphadenopathy, nausea, malaise, pain, cellulitis, flu-like symptoms, insomnia, pruritis, rash, urticaria, flushing, arthralgia, arthropathy, myalgia, rhabdomyolysis, and alopecia.

Biothrax anthrax vaccine is a Pregnancy Category D vaccine, which means that there is evidence of harm in human studies or fetal risk demonstrated in pre- or post-marketing surveillance data. Pregnant women should not be vaccinated with Biothrax unless the possible benefits of vaccination outweigh the risks. Vaccination of a breastfeeding mother is cautioned as it is not known whether the vaccine is excreted in human milk.

Biothrax has never been evaluated for safety or efficacy when given with any other licensed vaccine product. 

Biothrax Anthrax Vaccine for Pre-exposure prophylaxis

Biothrax anthrax vaccine is approved to be administered intramuscularly (IM) as 3-dose primary series (0, 1, and 6 months) with an initial 2- dose booster (12 months and 18 months). A yearly booster dose is recommended for persons considered at high risk for infection (lab workers handling anthrax, military personnel). For persons who have completed the initial five doses and are not considered high risk but would like to maintain vaccine acquired protection, ACIP recommends a booster dose every three years. 

Biothrax Anthrax Vaccine for Post-Exposure Prophylaxis

Biothrax anthrax vaccine can be administered to persons with known or suspected anthrax exposure as a 3-dose series (0, 1, and 4 weeks) in conjunction with antibiotic therapy. The CDC’s ACIP recommends that the anthrax vaccine be administered by subcutaneous (SC) injection because higher levels of vaccine-acquired antibodies occur within four weeks; however, IM injection is still acceptable. 

CYFENDUS Anthrax vaccine absorbed, adjuvanted

Ages: CYFENDUS is approved for use in adults between 18 and 65 years of age following confirmed or suspected exposure to anthrax. This vaccine must be given in conjunction with antibiotics. 

Vaccine ingredients: cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, 83kDa protective antigen protein, aluminum hydroxide, sodium chloride, benzethonium chloride, and formaldehyde. The CPG 7909 adjuvant, a synthetic DNA molecule 24 nucleotides in length and made on a nuclease-resistant phosphorothioate backbone, is added to the preservative solution containing the absorbed proteins of the vaccine. 

Commonly reported adverse events: redness, swelling, and pain at the injection site, arm motion limitation, muscle aches, fever, fatigue, and headache. 

Serious adverse events reported during clinical trials: Ulcerative Colitis, diffuse alopecia, spontaneous urticaria, acute cholecystitis, spontaneous abortion, pre-term premature rupture of membranes resulting in fetal death, Graves’ disease, autoimmune thyroiditis, celiac disease, Polymyalgia rheumatica, Psoriatic arthropathy, Systemic lupus erythematosus, Subacute cutaneous lupus erythematosus, Guttate psoriasis, Alopecia areata, and death. 

CYFENDUS contains the CpG 7909 adjuvant which binds to the Toll-like receptor 9 to enhance the body’s immune response to the anthrax antigen. This product contains

0.5 ml of anthrax vaccine and 0.25 ml of CpG 7909 adjuvant and is FDA approved to be administered at 0 and 2 weeks, in conjunction with antibiotic therapy, in persons with a confirmed or suspected exposure to anthrax. 

Cytosine phosphoguanine (CpG) is a synthetic form of DNA that mimics viral and bacterial genetic material. Only one FDA-approved vaccine, Heplisav-B Hepatitis B vaccine, uses a CpG adjuvant - CpG 1018. The FDA twice rejected licensing of Heplisav-B due to outstanding safety concerns. In 2013, the FDA rejected the vaccine due to concerns that this adjuvant could trigger autoimmune disorders. It was rejected again in November 2016 due to concerns over cardiovascular events and deaths. One year later, in November 2017, the FDA approved the vaccine despite these unresolved safety concerns. In pre-licensing clinical trials, those who received Heplisav-B had a 7-times higher risk of heart attack than those receiving the control vaccine, Engerix-B hepatitis B vaccine.     

IMPORTANT NOTE: NVIC “Quick Facts” is not a substitute for becoming fully informed about anthrax and the anthrax vaccine. NVIC recommends consumers read comprehensive information NVIC provides on anthrax, the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.


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