This study documented no significant difference in survival for animals treated with doxycycline alone for 30 days or animals treated with 30 days of doxycycline plus two doses of anthrax vaccine post-exposure (9 of 10 versus 9 of 9, p = 0.4). Anthrax, however, can be lethal. The FDA stopped production at BioPort in 1998 because of quality concerns. Health Secur. Anthim is also approved for the prevention of inhalational anthrax when alternative therapies are not available or not appropriate. The case fatality rate for cutaneous anthrax is estimated to be 20% without antibiotic treatment. Anthim carries a Boxed Warning alerting patients and health care providers that the drug can cause allergic reactions (hypersensitivity), including a severe reaction called anaphylaxis. Systemic reactions occur in fewer than 0.2 % of recipients. 2018;9(5). Anti-toxin monotherapy at or shortly after symptom onset demonstrated increased survival compared to no treatment in animals. The most commonly observed side effects were headache, back pain, nausea and infusion site pain and swelling. Following naturally occurring anthrax among livestock, cutaneous and rare gastrointestinal exposures among humans are possible, but inhalation anthrax has not been reported. Although post-exposure chemoprophylaxis using antibiotics alone has been effective in animal models, the definitive length of treatment is unclear. (2) Injection anthrax was recently added as another type of anthrax … Anthrax vaccine precipitated induces edema toxin-neutralizing, edema factor-specific antibodies in human recipients. Microbiology and pathology testing are used to confirm the diagnosis. O'Leary ST, Kimberlin DW. MMWR Recomm Rep. 2019;68(4);1-14. Because the current vaccine is labeled for use in specifically defined pre-exposure situations only, no FDA-approved labeling addresses the optimal number of vaccinations for post-exposure prophylaxis use of the vaccine. This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. After anthrax toxins have been released in the body, one possible treatment is antitoxin. The FDA concluded that the results of studies in research animals provided sufficient evidence that human anthrax immune globulin is reasonably likely to benefit humans with inhalational anthrax (FDA, 2015). About 20 % of untreated cases of cutaneous anthrax will result in death. Several studies have demonstrated that short courses (5 to 10 days) of post-exposure antibiotic therapy are not effective at preventing disease when large numbers of spores are inhaled. The ACIP does state that pre-exposure vaccination may be indicated for the military, decontamination personnel, and other select populations or for groups for which a calculable risk can be assessed. This Clinical Policy Bulletin may be updated and therefore is subject to change. 2015;59(4):2206-2214. Injection anthrax occurs when the bacteria or spores are directly injected into the body. MBio. The ACIP guidelines recommend post-exposure anthrax vaccination for the following indications: Note: Medically necessary post-exposure anthrax vaccinations are covered for medically necessary indications regardless of whether the member has preventive services benefits. The intestinal disease form of anthrax may follow the consumption of contaminated meat and is characterized by an acute inflammation of the intestinal tract. The ACIP guidelines recommend anthrax vaccine as a component of post-exposure prophylaxis in pregnant women exposed to aerosolized B. anthracis spores. /* aetna.com standards styles for templates */ Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: A randomized, double-blinded, controlled, multicenter trial. list-style-type: upper-roman; Grabenstein JD. Treating providers are solely responsible for medical advice and treatment of members. Emerg Infect Dis. Although groups initially considered for pre-exposure vaccination for bioterrorism preparedness included emergency first responders, federal responders, medical practitioners, and private citizens, the ACIP does not recommend vaccination of these groups. In Scotland, the 2009 outbreak of Bacillus anthracis infection among persons who inject drugs resulted in a 28% death rate. Surg Infect (Larchmt). Recently, another type of anthrax infection has been identified in heroin-injecting drug users in northern Europe. Med Microbiol Immunol. Footnotes* Note: In general, Aetna does not cover immunizations required solely for the purpose of employment, or because of incarceration. Anthrax. The FDA has approved obiltoxaximab (Anthim) injection to treat inhalational anthrax in combination with appropriate antibacterial medications. Anthim should be administered in settings where patients can be monitored and treated for anaphylaxis. An anthrax vaccine is available to military personnel and some members of the general public. Currently, there are a few types of antitoxins that can be used for treating anthrax. Anthrax vaccines: A development update. OL OL LI { MMWR Recomm Rep. 2010;59(RR-6):1-30. Although some cases of anthrax respond to antibiotics, advanced inhalation anthrax may not. Such exposure might occur following an inadvertent exposure in the laboratory setting or a biological terrorist incident. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 2019;4(3). Certain regions of the world (South and Central America, Southern and Eastern Europe, Asia, Africa, the Caribbean, and the Middle East) report more anthrax in animals than others. BioThrax Vaccine Adsorbed is an immunization used to help prevent anthrax disease in people exposed to the bacteria through the skin or lungs.BioThrax vaccine works by exposing you to an antigen protein that causes your body to develop immunity to the disease. According to the ACIP guidelines, in the context of the routine pre-exposure program, vaccination of persons with moderate or severe acute illness should be postponed until recovery. 2014;20(2). Update from the Advisory Committee on Immunization Practices. Howdieshell TR, Heffernan D, Dipiro JT; Therapeutic Agents Committee of the Surgical Infection Society. list-style-type: lower-alpha; Delayed treatment studies suggested improved survival with combined anti-toxin-antimicrobial therapy, although a survival difference compared with anti-microbial therapy alone was not demonstrated statistically. N Engl J Med. Respir Care Clin N Am. 2019;208(2):185-195. A comprehensive search of 11 databases and the FDA website was conducted to identify relevant animal studies and human reports: 28 animal studies and 3 human cases were identified. Responder units engaged in response activities that might lead to exposure to aerosolized, Following cutaneous or gastrointestinal exposure to, Activities with a high potential for aerosol production. 2009;361(2):135-144. } We studied anthrax immune globulin intravenous (AIG-IV) use from a 2009–2010 outbreak of Bacillus anthracissoft tissue infection in injection drug users in Scotland, UK, and we compared findings from 15 AIG-IV recipients with findings from 28 nonrecipients. OL OL OL OL OL LI { With early treatment, survival did not differ between anti-microbial monotherapy and anti-microbial-antitoxin therapy in non-human primates and rabbits. The FDA approved intravenous human anthrax immune globulin (Anthrasil, Cangene Corp, Winnipeg, Canada) to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs (FDA, 2015). FDA News Release. Use of anthrax vaccine in the United States. text-decoration: line-through; Aggarwal S, Somani VK, Gupta S, et al. By the later stages of the disease… Gorse GJ, Keitel W, Keyserling H, et al. Ann Intern Med. Treatment is most effective when started as soon as possible. If you’ve been exposed to anthrax and have symptoms, your doctor will treat you with antibiotics for 60 to 100 days . On the basis of studies that demonstrated the effectiveness of ciprofloxacin in reducing the incidence and progression of inhalation anthrax in animal models, the FDA approved the use of ciprofloxacin following aerosol exposure to Bacillus anthracis spores to prevent development or progression of inhalation anthrax in humans. 2008;300(13):1532-1543. For additional language assistance: Anthrax vaccine, for subcutaneous or intramuscular use, Contact with and (suspected) exposure to anthrax. display: block; Grabenstein JD. To compare nonsurvivors and survivors, we obtained data on 11 nonsurvivors and 16 survivors. Antitoxin treatment of inhalation anthrax: A systematic review. Anthrasil [anthrax immune globulin intravenous (human)], sterile solution for infusion. Despite the paucity of human data, limited animal data suggested that adjunctive anti-toxin therapy may improve survival. Pediatric anthrax: Implications for bioterrorism preparedness. The guidelines note that antibiotic chemoprophylaxis can be switched to penicillin VK or amoxicillin once antibiotic susceptibilities are known and the organism is found to be penicillin susceptible with minimum inhibitory concentrations (MICs) attainable with oral therapy. Keep dogs out of pastures and away from carcasses during an anthrax outbreak. However, this type of anthrax has not been reported in the U.S. Injection anthrax is not generally associated with work tasks that lead to this type of occupational exposure. The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site. A bioterrorism attack using anthrax spores is a possibility. A three-dose series of anthrax vaccine 3. Another study in rabbits showed that 82 % of animals treated with antibiotics and raxibacumab survived exposure to anthrax compared with 65 % of animals receiving antibiotic treatment alone. Aetna considers post-exposure anthrax vaccination medically necessary according to the ACIP guidelines. The safety of raxibacumab was evaluated in 326 healthy human volunteers. Raxibacumab’s effectiveness for inhalational anthrax was demonstrated in 1 study in monkeys and 3 studies in rabbits. Immunol Allergy Clin North Am. Workers who are exposed to dead animals and animal products from other countries where anthrax is more common may become infected with Bacillus anthracis (B. anthracis; industrial anthrax). However, with proper treatment, 60% of patients survive. Coverage of medically necessary preventive immunizations is available only to members with preventive service benefits. 2017;24(11). Currently, ciprofloxacin is the only antibiotic approved by the FDA for use in reducing the incidence or progression of disease after exposure to aerosolized Bacillus anthracis. Accessed October 11, 2001. The site is secure. Anthrax. Biron et al (2015) stated that the B. anthracis anti-toxin monoclonal antibody (MAb) ETI-204 is a high-affinity chimeric de-immunized antibody that targets the anthrax toxin protective antigen (PA). list-style-type : square !important; } Bower WA, Schiffer J, Atmar RL, et al. } On March 18, 2016, the FDA approved obiltoxaximab (Anthim) injection for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs. 2013;122(4):885-900. Anthrax is diagnosed using bacterial cultures from infected tissues. Rabbits and monkeys were exposed to a lethal aerosolized dose of B. anthracis spores, then treated with human anthrax immune globulin or a placebo, and evaluated for survival. The authors concluded that whether AIG-IV treatment is effective for systemic anthrax soft tissue infection related to drug injection cannot be answered with currently available data. Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. list-style-type: decimal; Dumas EK, Gross T, Larabee J, et al. } Little SF. 2008;14(4). The .gov means it’s official.Federal government websites often end in .gov or .mil. background: #5e9732; MMWR Recomm Rep. 2000;49(RR-15):1-20. Penicillin and doxycycline are approved by Food and Drug Administration (FDA) for the treatment of anthrax and are considered the drugs of choice for the treatment of naturally occurring anthrax. .headerBar { Raxibacumab is a monoclonal antibody that neutralizes toxins produced by B. anthracis that can cause massive and irreversible tissue injury and death. } Aerosol exposure is unlikely in settings outside a laboratory working with large volumes of Bacillus anthracis, textile mills working with heavily contaminated animal products, or following a biological terrorism or warfare attack. These researchers conducted a systematic review of anti-toxin treatment of inhalation anthrax in humans and experimental animals to inform anti-toxin recommendations during a large-scale or mass anthrax incident. There are four types of anthrax: cutaneous, inhalation, gastrointestinal, and injection. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Guidelines for the Surveillance and Control of Anthrax in Humans and Animals. Severe local reactions are infrequent and consist of extensive swelling of the forearm in addition to the local reaction. } Mild local reactions occur in 30 % of recipients and consist of slight tenderness and redness at the injection site. } color: blue!important; Aetna considers intravenous anthrax immune globulin experimental and investigational for the treatment of systemic anthrax soft tissue infection related to drug injection because of insufficient evidence of its safety and effectiveness. However, the study suggests a possible benefit of post-exposure combination of antibiotics with vaccination. For people who have been exposed to anthrax (but have no symptoms of the disease), providers may prescribe preventive antibiotics, such as ciprofloxacin, penicillin, or doxycycline, depending on the strain of anthrax. Language services can be provided by calling the number on your member ID card. Vaccines for preventing anthrax. color: blue Anthrax can be found globally. Anthim may also be used to prevent inhalational anthrax when other therapies are not available or appropriate. } Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices. li.bullet { Aetna considers intravenous human anthrax immune globulin (Anthrasil) medically necessary to treat persons with inhalational anthrax in combination with appropriate antibacterial drugs. No controlled studies have been conducted in animals or humans to evaluate the use of antibiotics alone or in combination with vaccination following cutaneous or gastrointestinal exposure to Bacillus anthracis. In this case, because inhalational anthrax is a rare and lethal disease, it is not possible to conduct adequate efficacy trials in humans. The FDA’s Animal Rule allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans. In addition, studies suggest an extremely low-risk for exposure related to secondary aerosolization of previously settled Bacillus anthracis spores. Centers for Disease Control and Prevention (CDC). Which single antibiotic or combination of antibiotics will be most effective for you depends on how you were infected with anthrax, your age, your overall health and other factors. Anthim was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans. In addition, ciprofloxacin and ofloxacin have also demonstrated in- vitro activity against Bacillus anthracis. Cui X, Nolen LD, Sun J, et al. 2009;(2):CD006403. For bioterrorist anthrax, use any quinolone or doxycycline for 1-2 weeks. An estimated 83 % of human vaccines develop a vaccine-induced immune response after 2 doses of the vaccine and greater than 95 % develop a fourfold rise in antibody titer after 3 doses. Centers for Disease Control and Prevention (CDC). Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2006. } Following detection of PA in the blood, NZW rabbits were administered either an antibiotic (doxycycline) alone or the antibiotic in conjunction with ETI-204. After several days, the symptoms may progress to severe breathing problems and shock. Injection anthrax has not been reported in the United States. It is more common in developing countries or countries without veterinary public health programs. The drug demonstrated the potential to fill an unmet medical need, has the potential to provide safe and effective treatment where no satisfactory alternative therapy exists, and is intended to treat a rare disease, respectively. U.S. Department of Defense (DoD). Pediatrics. In treatment studies, animals were administered treatment after exhibiting clinical signs or symptoms of systemic anthrax. Drugs.com provides accurate and independent information on more than 24,000 … Common side effects included rash, extremity pain, itching and drowsiness. The safety of Anthim was evaluated in 320 healthy human volunteers. @media print { More animals treated with obiltoxaximab lived compared to animals treated with placebo. mSphere. London, UK: Department of Health; 2007; Ch. Analysis of anthrax immune globulin intravenous with antimicrobial treatment in injection drug users, Scotland, 2009-2010. Human anthrax immune globulin is manufactured from the plasma of individuals vaccinated against anthrax. All surviving animals developed toxin-neutralizing antibodies. 2005;19(4):233-245. Inhalation, ingestion, and injection anthrax, as well as anthrax meningitis are less common. Winnipeg, MB: Cangene Corporation; revised March 2015. Inhalation anthrax is usually fatal. Symptoms include redness and swelling at the injection site. In 2013, a team of researchers discovered a new chemical compound from … With delayed treatment, anti-toxin-antimicrobial treatment increased rabbit survival. Accessed October 11, 2001. Anthrax is a potential bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air. Last Review 11/20/2020. Update: Investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy, October 2001. top: 0px; Anthrax pre-exposure prophylaxis consists of 2 intramuscular injections given 4 weeks apart followed by 3 additional subcutaneous injections given at 6, 12, and 18 months. Overall, the results from this study indicated that a sub-therapeutic regimen consisting of an antibiotic in combination with an anti-PA MAb results in increased survival compared to the antibiotic alone and would provide an effective therapeutic strategy against symptomatic anthrax in non-vaccinated individuals. Washington, DC: DoD; 2001. .fixedHeaderWrap { 91-97. color: red!important; Rabbits treated with a moderate dose of anthrax immune globulin after infection exhibited 26 percent survival compared to 2 percent survival in the placebo group. Injection anthrax can spread throughout the body faster and be harder to recognize and treat. Persons who handle potentially infected animal products in high-incidence areas. Clin Infect Dis. Bradley JS, Peacock G, Krug SE, et al; AAP Committee on Infectious Diseases and Disaster Preparedness Advisory Council. Ranchers can contract a skin form of anthrax that requires specific antibiotic treatment. The ACIP recommends pre-exposure anthrax vaccination for the following groups: The immunization consists of 2 intramuscular injections given 4 weeks apart followed by 3 additional subcutaneous injections given at 6, 12, and 18 months. Vaccine. Anthrax toxins in the body cause severe illness. WHO/EMC/ZDI/98.6. Available at: http://www.anthrax.osd.mil/. 2018;7(4):270-274. O'Leary ST, Campbell JD, Kimberlin DW. Anthim is a monoclonal antibody that neutralizes toxins produced by B. anthracis. Raxibacumab is the first monoclonal antibody approved under the FDA’s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans. On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Most cases are mild and go away with treatment.