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.
