No. Clin Infect Dis. Footnotes* Note: In general, Aetna does not cover immunizations required solely for the purpose of employment, or because of incarceration. Anthim carries a "Boxed Warning" alerting patients and health care providers that the drug can cause allergic reactions, including anaphylaxis. The anthrax attacks 10 years later. Corey A, Migone TS, Bolmer S. Bacillus anthracis protective antigen kinetics in inhalation spore-challenged untreated or levofloxacin/raxibacumab-treated New Zealand white rabbits. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2006. General Information. Human anthrax immune globulin is manufactured from the plasma of individuals vaccinated against anthrax. This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. 2018;9(5). 2007;(1):CD000975. Vaccines: Countering anthrax: Vaccines and immunoglobulins. FDA approves raxibacumab to treat inhalational anthrax. Early initiation of antibiotic treatment is the most important factor in prognosis. Aetna considers raxibacumab injection medically necessary for the prevention and treatment of inhalational anthrax. 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. All surviving animals developed toxin-neutralizing antibodies. Work involving production quantities or concentrations of Bacillus anthracis cultures. } 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. In this study, a partial protection New Zealand White (NZW) rabbit model was used to evaluate the protective effectiveness of the adjunct therapy with the MAb. 13, pp. (Incidence is low in the United States, but veterinarians who travel to work in other countries where incidence is higher should consider being vaccinated.). Because anthrax is considered to be a potential agent for use in biological warfare, the Department of Defense (DOD) has begun mandatory vaccination of all active duty military personnel who might be involved in conflict. Following detection of PA in the blood, NZW rabbits were administered either an antibiotic (doxycycline) alone or the antibiotic in conjunction with ETI-204. Aggarwal S, Somani VK, Gupta S, et al. In a mass anthrax incident with limited anti-toxin supplies, anti-toxin treatment of individuals who have not demonstrated a clinical benefit from anti-microbials, or those who present with more severe illness, may be warranted. Lymph glands in the adjacent area may swell. Only 1 study has directly compared antibiotics plus vaccine with a longer course of antibiotics following aerosol exposure. For additional language assistance: Anthrax vaccine, for subcutaneous or intramuscular use, Contact with and (suspected) exposure to anthrax. Injection: In 2009 to 2010, another type of anthrax infection was identified in heroin-injecting drug users in northern Europe. Anthim may also be used to prevent inhalational anthrax when other therapies are not available or appropriate. 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. Microbiology and pathology testing are used to confirm the diagnosis. Aetna considers obiltoxaximab medically necessary for the prevention of inhalational anthrax when alternative therapies are not available or not appropriate. list-style-type: upper-alpha; 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. often systemic symptoms associated with cutaneous anthrax such as swollen glands, fever, myalgia, malaise, vomiting and headache. Analysis of anthrax immune globulin intravenous with antimicrobial treatment in injection drug users, Scotland, 2009-2010. 2014;20(2). Guidelines for the Surveillance and Control of Anthrax in Humans and Animals. 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). In a pre-event setting, in which the risk for exposure to aerosolized B. anthracis spores is presumably low, vaccination of pregnant women is not recommended and should be deferred until after pregnancy. After several days, the symptoms may progress to severe breathing problems and shock. 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. According to the ACIP guidelines, if concern exists that persons entering an area of a previous release might be at risk for exposure from a re-release of a primary aerosol of the organism or exposure from a high concentration of settled spores in a specific area, initiation of prophylaxis should be considered with antibiotics alone or in combination with vaccine as is outlined in the section below on post-exposure prophylaxis. Elusys Therapeutics submitted the biological license application (BLA) for the drug to the US Food and Drug Administration (FDA) on 20 March 2015. Swartz MN. Questionable efficacy of therapeutic antibodies in the treatment of anthrax. .fixedHeaderWrap { /*margin-bottom: 43px;*/ Anthrax is diagnosed using bacterial cultures from infected tissues. 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). 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. list-style-type: decimal; With delayed treatment, anti-toxin-antimicrobial treatment increased rabbit survival. Anthim is also approved for the prevention of inhalational anthrax when alternative therapies are not available or not appropriate. 2019;4(3). MMWR Recomm Rep. 2019;68(4);1-14. O'Leary ST, Kimberlin DW. 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. 91-97. Injection anthrax can spread throughout the body faster and be harder to recognize and treat. Symptoms of disease vary depending on how the disease was contracted, but symptoms usually occur within 7 days. Vaccines against biologic agents: Uses and developments. Survival in anthrax-infected monkeys treated with anthrax immune globulin ranged from 36 to 70 percent compared to 0 percent survival in the placebo group with a trend toward increased survival at higher doses of anthrax immune globulin. 2008;300(13):1532-1543. BioThrax vaccine will not treat an active in Use of anthrax vaccine in the United States. This vaccine is given by injection by a health care professional. Health Secur. When anthrax affects humans, it is usually due to an occupational exposure to infected animals or their products. Most (about 95 %) anthrax infections occur when the bacterium enters a cut or abrasion on the skin, such as when handling contaminated wool, hides, leather or hair products (especially goat hair) of infected animals. Cochrane Database Syst Rev. 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). On December 14, 2012, FDA approved raxibacumab injection to treat inhalational anthrax. Cutaneous anthrax can usually be successfully treated with antibiotics and some antibiotics have also been approved for post-exposure prophylaxis. Intestinal anthrax results in death in 25 % to 60 % of cases. U.S. Food and Drug Administration (FDA). This prevents super-imposing the adverse effects of the vaccine on the underlying illness or mistakenly attributing a manifestation of the underlying illness to the vaccine. Anthrax is treated by antibiotics. Centers for Disease Control and Prevention (CDC). Vaccination alone after exposure was not protective. In addition, HMO plans usually exclude coverage of immunizations solely for the purpose of travel. King JC Jr, Gao Y, Quinn CP, et al. In addition, ciprofloxacin and ofloxacin have also demonstrated in- vitro activity against Bacillus anthracis. Aetna considers intravenous human anthrax immune globulin (Anthrasil) medically necessary to treat persons with inhalational anthrax in combination with appropriate antibacterial drugs. Toxins (Basel). The safety of raxibacumab was evaluated in 326 healthy human volunteers. U.S. Department of Defense (DoD). Hendricks KA, Wright ME, Shadomy SV, et al; Workgroup on Anthrax Clinical Guidelines. Copyright Aetna Inc. All rights reserved. Clindamycin may be added for its anti-exotoxin effect. 2013;122(4):885-900. 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). According to the ACIP, routine vaccination with Anthrax Vaccine Adsorbed (AVA) is indicated for persons engaged in: The ACIP has concluded that laboratorians using standard Biosafety Level 2 practices in the routine processing of clinical samples are not at increased risk for exposure to Bacillus anthracis spores. Pediatrics. The mortality rate of intestinal and pulmonary anthrax—when the disease is treated—is approximately 50% (19, 21). background: #5e9732; JAMA. Development of a novel multiepitope chimeric vaccine against anthrax. Anthrax most commonly occurs in wild and domestic lower vertebrates (antelopes, camels, cattle, goats, sheep, and other herbivores), but it can also occur in humans when they are exposed to infected animals or tissue from infected animals. The site is secure. It is caused by breathing in the spores of the bacterium Bacillus anthracis. Washington, DC: DoD; 2001. Although the shortened vaccine regimen has been effective when used in a post-exposure regimen that includes antibiotics, the duration of protection from vaccination is not known. In addition, studies suggest an extremely low-risk for exposure related to secondary aerosolization of previously settled Bacillus anthracis spores. Treatment is most effective when started as soon as possible. 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. U.S. Food and Drug Administration (FDA). Ales NC, Katial RK. The type and number of antibiotics used depends on the type of infection. U.S. Food and Drug Administration (FDA). 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. Use of anthrax vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2019. Doctors must use antitoxin together with other treatment options. } Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. Links to various non-Aetna sites are provided for your convenience only. In Scotland, the 2009 outbreak of Bacillus anthracis infection among persons who inject drugs resulted in a 28% death rate. Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: A randomized, double-blinded, controlled, multicenter trial. list-style-type: lower-roman; Among human cases, addition of anti-toxin to combination anti-microbial treatment was associated with survival in 2 of the 3 cases treated. Solution should appear clear to opalescent, colorless to pale yellow to pale brownish-yellow that may contain few translucent-to-white proteinaceous particulates Discard vial if the solution is discolored or contains extraneous particles other than a few translucent-to-white, proteinaceous particles Do not shake the vial This phenomenon of delayed vegetation of spores resulting in prolonged incubation periods has not been observed for routes of infection other than inhalation. mSphere. Skin infection begins as a raised itchy bump that resembles an insect bite but within 1 to 2 days develops into a vesicle and then a painless ulcer, usually 1 to 3 cm in diameter, with a characteristic black necrotic (dying) area in the center. In: Immunisation Against Infectious Disease - 'The Green Book' - 2006 updated edition. However, the ACIP guidelines note that vaccination might be indicated for veterinarians and other high-risk persons handling potentially infected animals in areas with a high incidence of anthrax cases. It is more common in developing countries or countries without veterinary public health programs.  11/20/2020 Little SF. Anthrax. The ACIP guidelines note that recommendations regarding pre-exposure vaccination should be based on a calculable risk assessment. text-decoration: line-through; 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. Antibiotics are effective against the germinated form of Bacillus anthracis but are not effective against the spore form of the organism. J Pediatric Infect Dis Soc. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. .headerBar { Treating providers are solely responsible for medical advice and treatment of members. Ranchers can contract a skin form of anthrax that requires specific antibiotic treatment. Anthim is a monoclonal antibody that neutralizes toxins produced by B. anthracis. 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. .newText { Huang E, Pillai SK, Bower WA, et al. More animals treated with obiltoxaximab lived compared to animals treated with placebo. 2001;345(22):1621-1626. 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. Decontamination personnel and persons who work directly with the organism in the laboratory. Language services can be provided by calling the number on your member ID card. The .gov means it’s official.Federal government websites often end in .gov or .mil. Because of these factors, the ACIP does not recommend pre-exposure vaccination for the above groups. Anthrax in wild livestock has occurred in the United States. Respir Care Clin N Am. Inhalation anthrax is usually fatal. On March 18, 2016, the FDA approved obiltoxaximab (Anthim) injection for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs. } Mild local reactions occur in 30 % of recipients and consist of slight tenderness and redness at the injection site. Recognition and management of anthrax -- an update. People of any age may be affected. 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. Accessed October 11, 2001. The plasma contains antibodies that neutralize toxins produced by the anthrax bacteria. 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. Use doxycycline or any quinolone (eg, ciprofloxacin, levofloxacin) for postexposure prophylaxis (PEP) to prevent inhalational anthrax. 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. The first dose is … In 2013, a team of researchers discovered a new chemical compound from … Anthim should be administered in settings where patients can be monitored and treated for anaphylaxis. The efficacy of human anthrax immune globulin was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans (FDA, 2015). Anthrax is diagnosed by isolating B. anthracis from the blood, skin lesions, or respiratory secretions or by measuring specific antibodies in the blood of persons with suspected cases. .strikeThrough { 2008;14(4). } The vaccine is reported to be 93 % effective in protecting against anthrax. @media print { Stern EJ, Uhde KB, Shadomy SV, Messonnier N. Conference report on public health and clinical guidelines for anthrax. See your physician if you develop a sore or lesions after handling vaccine or livestock. 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