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Anthrax vaccine adsorbed

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546:(FDA) first published standards for making, using and storing anthrax vaccine adsorbed. In the mid-1980s, the FDA approved it specifically for two limited preventive indications: 1) individuals who may come in contact with animal products or high-risk persons such as veterinarians and others handling potentially infected animals; and 2) individuals engaged in diagnostic or investigational activities involving anthrax spores. In 1985, the FDA published a Proposed Rule for a specific product review of the anthrax vaccine adsorbed, stating that the vaccine's "efficacy against inhalation anthrax is not well documented" (a statement quoted controversially many years later). For many years, anthrax vaccine adsorbed was a little known product considered to be safe for pre-exposure use in the US in at-risk veterinarians, laboratory workers, livestock handlers, and textile plant workers who process animal hair. In 1990, the State of Michigan changed the name of its original production plant facility to the Michigan Biologic Products Institute (MBPI) as it gave up state ownership and converted it to a private entity. The same year (as later revealed) MBPI changed both the fermenters and the filters used in manufacturing anthrax vaccine adsorbed without notifying the FDA, thus reportedly causing a 100 fold increase in the PA levels present in vaccine lots. 730:." With regard to safety, "The committee found no evidence that people face an increased risk of experiencing life-threatening or permanently disabling adverse events immediately after receiving anthrax vaccine adsorbed, when compared with the general population. Nor did it find any convincing evidence that people face elevated risk of developing adverse health effects over the longer term, although data are limited in this regard (as they are for all vaccines)." Side effects of anthrax vaccine adsorbed were found to be "comparable to those observed with other vaccines regularly administered to adults". The committee concluded that anthrax vaccine adsorbed is "safe and efficacious" for pre-exposure prevention of inhalational anthrax. It also asserted that a new and improved anthrax vaccine might have greater assurance of consistency than anthrax vaccine adsorbed and recommended licensure of a new vaccine requiring fewer doses and producing fewer local reactions. 757:
findings centered on FDA procedural issues, stating that additional public comment should have been sought before the FDA issued its Final Rule declaring the vaccine safe and effective on 30 December 2003. The FDA's incomplete rulemaking from 1985 effectively rendered the anthrax vaccine program illegal. The basis was the never finalized FDA Proposed Rule. In that rulemaking the FDA published, but never finalized, a licensing rule for the anthrax vaccine in the Federal Register, which included an expert review panel's findings. Those findings included the fact that the "Anthrax vaccine efficacy against inhalation anthrax is not well documented," and that "No meaningful assessment of its value against inhalation anthrax is possible due to its low incidence," and that "The vaccine manufactured by the Michigan Department of Public Health has not been employed in a controlled field trial."
49: 702:, assessed adverse events among 603 military health-care workers. Rates of events that resulted in seeking medical advice or taking time off work were 7.9% after the first dose; 5.1% after the second dose; 3.0% after the third dose; and 3.1% after the fourth dose. Events most commonly reported included muscle or joint aches, headache, and fatigue. However, these studies are subject to several methodological limitations, including sample size, the limited ability to detect adverse events, loss to follow-up, exemption of vaccine recipients with previous adverse events, observational bias, and the absence of unvaccinated control groups. 586:
satisfaction and various quality control failures, including reuse of expired vaccine, inadequate testing procedures, and use of lots that had failed testing. All of these developments vexed the Army, not only in its efforts to obtain sufficient vaccine for the troops, but in its desire to have anthrax vaccine adsorbed validated and fully licensed for prevention of inhalational anthrax, which is the expected weaponized form of the disease (as opposed to the cutaneous form for which the vaccine had been licensed in 1970). In 1995, the Army contracted with the
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cases). The vaccine was judged to have a 92.5% vaccine efficacy against all types of anthrax experienced. Subsequently, there were no controlled clinical trials in humans of the efficacy of anthrax vaccine adsorbed due to the rarity of the condition (especially in the inhalational form) in humans and the ethical inadmissibility of conducting dangerous challenge studies in human subjects. Supportive animal challenge studies were done, however, showing that unvaccinated animals uniformly die whereas vaccinated animals are protected. About 95% of
623: 674:(jointly with former MBPI laboratory directors) for approximately $ 24 million. The same year, a particularly damning FDA report was issued resulting in the temporary suspension of anthrax vaccine adsorbed shipments from the production plant. Much controversy ensued due to the FDA infractions, the mandatory nature of the program, and to a public perception that anthrax vaccine adsorbed was unsafe — possibly causing sometimes serious side effects — and might be contributing to the highly politically charged malady known as " 1062:
thermostabilize PA molecule by solvent engineering and genetic engineering approaches to generate a thermostable anthrax vaccine formulation without compromising on the immunogenicity and its protective potential. The generation of a thermostable anthrax vaccine would minimize the current cold chain requirement for its storage and transport. Anthrax vaccines which would be amenable to other modes of administration such as oral, nasal, skin patch etc., are also being experimented.
690:, data were collected at the time of anthrax vaccination from 4,348 service personnel regarding adverse events experienced from a previous dose of anthrax vaccine. Most reported events were localized, minor, and self-limited. After the first or second dose, 1.9% reported limitations in work performance or had been placed on limited duty. Only 0.3% reported >1 day lost from work; 0.5% consulted a clinic for evaluation; and one person (0.02%) required hospitalization for an 726:
likely to have. Primates and rabbits were considered the best models for human disease. As regards vaccine effectiveness, "The committee finds that the available evidence from studies with humans and animals, coupled with reasonable assumptions of analogy, show that anthrax vaccine adsorbed as licensed is an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains of
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ABthrax. In 2009, HGS announced that they had made first delivery of 20,000 doses of ABthrax to the United States Department of Defense. Currently three anthrax antitoxin antibodies, namely, Anthrax immune globulin intravenous or 'AIGIV' (polyclonal), 'Obiltoxaximab' or 'ANTHIM' (monoclonal), and 'Raxibacumab' or 'ABthrax' (monoclonal) are approved for the treatment of inhalation anthrax.
3698: 1237: 1163: 590:(SAIC) to develop a plan to obtain FDA approval for a license amendment for anthrax vaccine adsorbed in order to add inhalational anthrax exposure to the product license thus enabling the manufacturer to list on the product license that the vaccine was effective against that form of the disease. The following year, MBPI submitted an " 799:. A modification of previous policy allowed military personnel no longer deployed to higher threat areas to receive follow up doses and booster shots on a voluntary basis. As of June 2008, over 8 million doses of anthrax vaccine adsorbed had been administered to over 2 million US military personnel as part of the AVIP. 914:
Pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this product, the patient should be apprised of
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On 15 December 2005, the FDA re-issued a Final Rule & Order on the license status of the anthrax vaccine. After reviewing the extensive scientific evidence and carefully considering comments from the public, the FDA again determined that the vaccine is appropriately licensed for the prevention of
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Vaccination of humans with anthrax vaccine adsorbed induces an immune response to PA. More than 1/3 of subjects develop detectable anti-PA IgG after a single inoculation; 95% do so after a 2nd injection; and 100% after 3 doses. The peak IgG response occurs after the 4th (6 month) dose. The potency of
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While effective in protecting against anthrax, the licensed vaccine schedule is not very efficient, involving a cumbersome five (previously six) dose injection series. Typically, five injections are given over a period of 18 months in order to induce a protective immune system response. In addition,
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Human Genome Sciences announced in 2007, the development of a new anthrax neutralizing monoclonal antibody with the trademark name of 'ABthrax'. The vaccine sensitizes the human immune system to the presence of the Anthrax Toxin Factor. In 2008, HGS reported on testing on 400 human volunteers given
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to review anthrax vaccine adsorbed according to the best available evidence. It issued its study in March 2002. The IOM panel noted that human data on inhalational anthrax prevention is limited due to the natural low incidence of disease and that therefore animal model data are the best we are ever
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anthrax vaccine, for $ 877 million. To be acceptable to HHS, this vaccine was to be protective against anthrax in three doses or less. On 19 December 2006, HHS voided the contract, because of stability problems with the vaccine, and a failure to start a Phase 2 clinical trial on time. In May 2008,
991:(ACIP), the Johns Hopkins Working Group on Civilian Biodefense, and the 2002 Institute of Medicine report on the vaccine. However, anthrax vaccine adsorbed is not licensed for post-exposure prophylaxis for inhalational anthrax or for use in a 3-dose regimen. Any such use, therefore, would be on an 773:
reports that 4 million doses of the inventory will expire every year, requiring vaccine destruction services.) These would be used for pre- or post-exposure vaccination — of emergency first responders (police, firefighters), federal responders, medical practitioners, and private citizens — in the
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with small amounts of edema factor (EF) and lethal factor (LF) that may vary from lot to lot. Other uncharacterized bacterial byproducts are also present. Whether or not the EF and LF contribute to the vaccine's efficacy is not known. Anthrax vaccine adsorbed has smaller amounts of EF and LF than
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On 16 October 2006, the DoD announced the reinstatement of mandatory anthrax vaccinations for more than 200,000 troops and defense contractors. (Another lawsuit was filed by the same attorneys as before, challenging the basis of the vaccine's license on scientific grounds.) The reinstated policy
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In 1996, the US Department of Defense (DoD) sought and received permission from the FDA to begin vaccinations of all military personnel without obtaining a new licensed indication for anthrax vaccine adsorbed. It announced a plan the following year for the mandatory vaccination of all US service
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where employees were sometimes exposed to anthrax spores in the course of their work. Over the five years, 379 vaccinees were compared against 414 unvaccinated control subjects. There were 23 cases among controls (5 of them inhalation anthrax) compared with 3 cases among vaccinated (0 inhalation
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Based on a retrospective cohort study of female military members inoculated during pregnancy, there may be a small risk of birth defect for inoculation during first trimester. However, the difference between the vaccinated and unvaccinated control groups was not large enough to be conclusive.
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Despite the positive IOM assessment, mandatory vaccinations of military personnel were halted due to an injunction which was put into place on 27 October 2004. The injunction cast questions about numerous substantive challenges regarding the anthrax vaccine in footnote #10, yet the procedural
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Meanwhile, MBPI fell afoul of FDA inspectors and reviewers when it failed inspections (1993, 1997) and received warning letters (1995) and Notices of Intention to Revoke (1997) from the agency. At issue were a failure to validate the anthrax vaccine adsorbed manufacturing process to the FDA's
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Research is being continuously done to develop and test new improved candidate anthrax vaccines. The primary immunogen of acellular existing vaccines, i.e., Protective Antigen (PA), is highly thermolabile due to inherent structural and chemical instability. Various endeavors are underway to
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Use of anthrax vaccine adsorbed expanded dramatically in 1991, when the US military, concerned that Iraq possessed anthrax bioweapons, administered it to some 150,000 service members deployed for the Gulf War. Hussein never deployed his bio-weapons, but subsequent confirmation of an
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The loss of memory B-Cells leads to declining concentrations of IgG which can sequester APA, and therefore declining tolerance to the presence of anthrax bacteria. There is the potential that other memory B-Cell populations will be adversely affected as well.
582:— including 8,500 liters of concentrated anthrax spores (6,500 liters of it filled into munitions) — came in 1995 and later when the Iraqi government began to fully disclose the scope and scale of the effort, which it had pursued since the 1980s. 737:, Washington and New York area mail sorters were advised to receive prophylactic vaccination with anthrax vaccine adsorbed. Owing to the controversy surrounding the administration of the vaccine to military personnel, however, some 6,000 1025:) concluded that this anthrax vaccine is as safe as other vaccines. The academy considered more than a dozen studies using various scientific designs, and heard personally from many concerned US military service members. 594:" to modify the product's license to add an indication for inhalation anthrax, thus formally establishing anthrax vaccine adsorbed as an "experimental" vaccine when used to prevent anthrax in the inhalational form. 392:
in people aged 18 through 65 years of age. It is approved for both pre-exposure prophylaxis of disease in persons at high risk of exposure and post-exposure prophylaxis of disease following suspected or confirmed
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The approved FDA package insert for anthrax vaccine adsorbed contains the following notice: "The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain,
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Singh S, Ahuja N, Chauhan V, Rajasekaran E, Mohsin Waheed S, Bhat R, et al. (September 2002). "Gln277 and Phe554 residues are involved in thermal inactivation of protective antigen of Bacillus anthracis".
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Adverse events following anthrax vaccine adsorbed administration were assessed in several studies conducted by the DoD in the context of the routine anthrax vaccination program. Between 1998 and 2000, at
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for their efforts in supplying the US military with increased amounts of anthrax vaccine adsorbed for use during the conflict in which the use of anthrax bio-weapons by Iraq had been anticipated.
1346: 530:(62 of 65) survived challenge, as did 97% of rabbits (114 of 117). Guinea pigs (which are a poorer model for human anthrax than are monkeys or rabbits) showed a 22% protection (19 of 88). 471:, immunity. Each dose of the vaccine contains no more than 0.83 mg aluminum per 0.5 mL dose. (This is near the allowed upper limit of 0.85 mg/dose.) It also contains 0.0025% 2211:
Singh S, Singh A, Aziz MA, Waheed SM, Bhat R, Bhatnagar R (September 2004). "Thermal inactivation of protective antigen of Bacillus anthracis and its prevention by polyol osmolytes".
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The US federal government has a goal to stockpile 75 million doses of anthrax vaccines. The new facility and its capacity will help Emergent meet the government's security needs.
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anthrax attack. The product has attracted some controversy owing to alleged adverse events and questions as to whether it is effective against the inhalational form of anthrax.
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Anthrax vaccine adsorbed originated in studies done in the 1950s and was first licensed for use in humans in 1970. In the US, the principal purchasers of the vaccine are the
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Emergent Biosolutions, the Maryland-based successor to BioPort, both controlled by former Lebanese banker Faud el Hibri, acquired rights to Vaxgen's patents and processes.
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Centers for Disease Control Prevention (CDC) (April 2000). "Surveillance for adverse events associated with anthrax vaccination--U.S. Department of Defense, 1998-2000".
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members. Under the plan all military personnel, including new recruits, would begin receiving what was then a six-shot series of inoculations in the following fashion:
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Administer with caution to patients with a possible history of latex sensitivity because the vial stopper contains dry natural rubber and may cause allergic reactions.
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and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache." Also, "Serious allergic reactions, including
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for initial work on a potential future anthrax vaccine that could be delivered through the nasal passage instead of via a needle. The HPA has long produced the UK's
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In December 2008, the FDA approved Biothrax for intramuscular injections thus reducing the immunization schedule from a total of 6 shots to 5 shots (see below).
2638: 110: 2248:"Multiple asparagine deamidation of Bacillus anthracis protective antigen causes charge isoforms whose complexity correlates with reduced biological activity" 1111: 2789: 2784: 988: 496:(ELISA). The shelf-life of anthrax vaccine adsorbed is reported to be three years when stored between 2 and 8 Â°C (36 and 46 Â°F) and never frozen. 658:
in 1997, made the vaccine mandatory for active duty US service personnel. Vaccinations began in March 1998 with personnel sent to high-risk areas, such as
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of the known adverse events (local or systemic reactions) and no pattern of frequently reported serious adverse events for anthrax vaccine adsorbed.
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Anthrax vaccine adsorbed, adjuvanted (Cyfendus) is indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to
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Manish M, Verma S, Kandari D, Kulshreshtha P, Singh S, Bhatnagar R (August 2020). "Anthrax prevention through vaccine and post-exposure therapy".
365: 566: 2799: 2374: 3652: 3580: 2149: 1692: 1643: 633: 3186: 644: 31: 3218: 2901: 2754: 2333:"Rapid deamidation of recombinant protective antigen when adsorbed on aluminum hydroxide gel correlates with reduced potency of vaccine" 2061: 836:, "The use of Building 55 to manufacture Biothrax could expand manufacturing capacity to an estimated 20 to 25 million doses annually." 514: 361: 1083: 3628: 2970: 2940: 2573: 999:(officially experimental) basis. "... the safety and efficacy of Biothrax for post-exposure setting have not been established.". 652: 3040: 806: 493: 420:
Anthrax vaccine adsorbed is classified as a subunit vaccine that is cell-free and containing no whole or live anthrax bacteria. The
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Although many individuals have expressed health concerns after receiving anthrax vaccine, a congressionally directed study by the
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Friedlander AM, Grabenstein JD, Brachman PS (1 January 2013). "Anthrax vaccines". In Plotkin SA, Orenstein WA, Offit PA (eds.).
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required vaccinations for most military units and civilian contractors assigned to homeland bioterrorism defense or deployed in
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employees balked at this, preferring to take their chances with the risks of residual anthrax spores in the workplace.
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US FDA, Center for Biologics Evaluation and Research CBER, Product Approval Information for Anthrax Vaccine Adsorbed
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anthrax vaccine adsorbed vaccine lots is routinely determined both by the survival rates of parenterally challenged
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in people aged 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
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Maj. Timothy Ballard (right) administers the final shot in the six-dose series of anthrax vaccine adsorbed to
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entered into an agreement for the manufacture of the vaccine. Later that year, the Army awarded MBPI the
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Leppla SH, Klimpel KR, Singh Y, et al (June 1996), "Interaction of anthrax toxin with mammalian cells",
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There were no published studies of anthrax vaccine adsorbed's safety in humans until the advent of the
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By 2000, some 425,976 US service members had received 1,620,793 doses of anthrax vaccine adsorbed.
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on the project. The facility's value is estimated at $ 104 million, according to Yahoo Finance.
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to a state-owned facility operated by the Michigan Department of Public Health. In 1973, the US
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Bower WA, Schiffer J, Atmar RL, Keitel WA, Friedlander AM, Liu L, et al. (December 2019).
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The approved US FDA package insert for anthrax vaccine adsorbed contains the following notice:
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retains a current unexpired inventory of 60 million doses of anthrax vaccine adsorbed. (The US
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Only several thousand people had ever received the vaccine up to 1991 when — coincident with
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of anthrax vaccine adsorbed in humans was initially established by Philip S. Brachman of the
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Baylor NW, Egan W, Richman P (May 2002). "Aluminum salts in vaccines—US perspective".
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undertaken between 1954 and 1959. The study field sites were four wool-sorting mills in the
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administration of anthrax vaccine adsorbed is the most beneficial approach for purposes of
602:: Forces assigned now, or soon rotating, to high threat areas in Southwest Asia and Korea; 306: 3702: 3526: 3324: 3131: 3089: 2960: 2930: 2913: 2839: 2829: 2759: 2698: 2694: 2643: 2378: 2021: 1776: 1283:"Large-scale production of protective antigen of Bacillus anthracis in anaerobic cultures" 1039: 80: 30:
This article is about the US-licensed vaccine product. For the US government program, see
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Powell BS, Enama JT, Ribot WJ, Webster W, Little S, Hoover T, et al. (August 2007).
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In 1970, anthrax vaccine adsorbed was first licensed by the USPHS for protection against
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Ryan MA, Smith TC, Sevick CJ, Honner WK, Loach RA, Moore CA, et al. (August 2008).
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Brachman PS and Friedlander AM (1994), "Anthrax", In: Plotkin SA and Mortimer EA (eds):
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D'Souza AJ, Mar KD, Huang J, Majumdar S, Ford BM, Dyas B, et al. (February 2013).
2141: 1930: 1897: 1745: 1531: 1506: 1309: 1282: 1112:"Drug and medical device highlights 2018: Helping you maintain and improve your health" 762: 663: 629: 550: 368:. Ten million courses (60 million doses) of the vaccine have been purchased for the US 2309: 2109: 2084: 1769: 1483: 1362: 1269: 3712: 3546: 3531: 3501: 3496: 3351: 3114: 3109: 3104: 3099: 3008: 2854: 2653: 2197: 1955:"Birth defects among infants born to women who received anthrax vaccine in pregnancy" 1448: 1409: 1241: 1167: 1116: 1088: 679: 655: 637: 527: 479:
as a stabilizer. The mechanism of action of the adjuvant is not entirely understood.
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Pesu M, Watford WT, Wei L, Xu L, Fuss I, Strober W, et al. (September 2008).
1845:"FDA approves sBLA for Biothrax manufacture at Emergent BioSolutions' Building 55" 1299: 678:". Hundreds of service members were compelled to leave the military (some of them 2002: 397:
exposure, when administered in conjunction with recommended antibacterial drugs.
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Brachman PS, Gold H, Plotkin SA, Fekety FR, Werrin M, Ingraham NR (April 1962).
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Severe allergic reaction (e.g., anaphylaxis) after a previous dose of Biothrax.
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The approved US FDA package insert for Biothrax contains the following notice:
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The approved US FDA package insert for Biothrax contains the following notice:
809:(DGCI) had approved licensing of Biothrax for distribution by Biological E. of 3536: 3511: 3201: 3151: 734: 489: 281: 3585: 3156: 3029: 2598: 1253: 992: 817: 682:) for resisting the inoculations during the first six years of the program. 562: 385: 114: 2485: 2431: 2412: 2358: 2317: 2273: 2232: 2189: 2118: 1980: 1939: 1653: 1607: 1540: 1491: 1370: 1318: 1522: 1456: 1417: 412:
Anthrax vaccine adsorbed was developed by Emergent Biodefense Operations.
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Turnbull PC (August 1991). "Anthrax vaccines: past, present and future".
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Immunosuppressive therapies may diminish the immune response to Biothrax.
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The FDA approved the company's license (officially called a supplemental
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Vollum strain. (The Vollum strain was the same one weaponized by the old
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in 2004 the US Department of Health and Human Services contracted with
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Some studies show that use of antibiotics effective against anthrax
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for the active immunization for the prevention of disease caused by
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in anticipation of the need for mass vaccinations owing to a future
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Vaccine: The Controversial Story of Medicine's Greatest Lifesaver
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This article incorporates text from this source, which is in the
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This article incorporates text from this source, which is in the
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anthrax, regardless of the route of exposure. Also in 2005, the
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Joellenbeck LM, Zwanziger LL, Durch JS, Strom BL (April 2002).
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Office of the Assistant Secretary for Preparedness and Response
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In February 2009, Emergent BioSolutions announced that the
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American Journal of Public Health and the Nation's Health
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agreed to provide $ 6.5 million to the United Kingdom's
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BioWatch: HGS shipping anthrax treatment in $ 150M deal
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administration established a policy to ensure that the
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The AVIP and initial mandatory military use (1997–2000)
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Biomedical Advanced Research and Development Authority
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National Institute of Allergy and Infectious Diseases
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United States Department of Health and Human Services
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Puziss M, Manning LC, Lynch JW, et al. (1963).
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and their anti-PA antibody titres as measured by an
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Biochemical and Biophysical Research Communications
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Biochemical and Biophysical Research Communications
296: 280: 260: 255: 219: 214: 189: 171: 141: 127: 109: 101: 91: 86: 74: 62: 55: 2381:Gazette.Net - Maryland Community Newspapers Online 534:Licensure and limited occupational use (1970–1991) 438:and the similar British anthrax vaccine (known as 3602:Cedillo v. Secretary of Health and Human Services 606:: Early deploying forces into high threat areas; 1998: 1996: 1994: 1992: 1990: 1589: 1587: 968: 926: 912: 610:: Remainder of the force and new recruits; and 2450:Donegan S, Bellamy R, Gamble CL (April 2009). 2035:"U.S. cancels VaxGen anthrax vaccine contract" 1627:The Anthrax Vaccine: Is It Safe? Does It Work? 1213: 1211: 1209: 1139: 1137: 1135: 1084:"Summary Basis of Decision (SBD) for Biothrax" 588:Science Applications International Corporation 2567: 2085:"Taking the sting out of the anthrax vaccine" 1557:, 2nd ed.; Philadelphia, WB Saunders, pg 729. 1507:"Field Evaluation of a Human Anthrax Vaccine" 8: 2015:Vaxgen anthrax vaccine contract information. 989:Advisory Committee on Immunization Practices 820:by the Singapore Health Sciences Authority. 505:Initial research and development (1954–1970) 160: 39: 2456:The Cochrane Database of Systematic Reviews 1596:MMWR. Morbidity and Mortality Weekly Report 1351:Infectious Disease Clinics of North America 1038:Inc. to supply up to 75 million doses of a 816:In 2011, Biothrax was approved for sale in 2819: 2574: 2560: 2552: 2533:Centers for Disease Control and Prevention 1693:"John Doe #1 v. Donald H. Rumsfeld, et al" 1265: 1263: 1261: 752:Injunctions and FDA re-reviews (2004–2006) 436:Sterne (veterinary) anthrax vaccine strain 47: 2544:at the U.S. National Library of Medicine 2475: 2421: 2411: 2348: 2263: 2108: 1970: 1929: 1530: 1431:Welkos SL, Friedlander AM (August 1988). 1308: 1298: 1254:https://www.fda.gov/media/170445/download 987:. This practice has been endorsed by the 305: 1739:"50 FR 51002 published on Dec. 13, 1985" 893:membrane type-1 matrix metalloproteinase 3693: 2527:"Anthrax Vaccine Information Statement" 1075: 871:Furin is the protein activator for pro- 647:(AVIP). This program, initiated by the 459:to adsorb PA as well as to serve as an 384:Anthrax vaccine adsorbed (Biothrax) is 366:Department of Health and Human Services 269: 133: 666:. Also in 1998, MBPI was purchased by 573:Initial use in US military (1991–1997) 38: 2163: 2161: 2089:The Journal of Clinical Investigation 1839: 1837: 782:Reinstatement of the AVIP (2006–2016) 634:Chairman of the Joint Chiefs of Staff 119: 7: 2170:Expert Opinion on Biological Therapy 1728:, 5 January 2006, vol 69: pp 255-67. 1029:Development of a replacement vaccine 735:October 2001 anthrax letters attacks 713:In October 2000, a committee of the 645:Anthrax Vaccine Immunization Program 567:Commander's Award for Public Service 202: 32:Anthrax Vaccine Immunization Program 515:United States Public Health Service 3629:Eradication of infectious diseases 3386:Androvax (androstenedione albumin) 2337:Journal of Pharmaceutical Sciences 2142:10.1016/b978-1-4557-0090-5.00022-7 1817:"Emergent gets entry to Singapore" 1804:(Press release). 12 February 2009. 915:the potential hazard to the fetus. 455:Anthrax vaccine adsorbed contains 25: 3219:Respiratory syncytial virus (RSV) 2452:"Vaccines for preventing anthrax" 2400:MMWR. Recommendations and Reports 1223:U.S. Food and Drug Administration 1149:U.S. Food and Drug Administration 877:transforming growth factor beta 1 807:Drugs Controller General of India 494:enzyme linked immunosorbant assay 3696: 3608:Alternative vaccination schedule 2583:Artificial induction of immunity 1959:American Journal of Epidemiology 1335:, Special Supplement #87, pg 91. 1235: 1161: 457:aluminium hydroxide (alhydrogel) 444:anthrax protective antigen (PA) 432:U.S. biological warfare program 3440:Ovandrotone albumin (Fecundin) 2468:10.1002/14651858.CD006403.pub2 475:as a preservative and 0.0037% 1: 2976:Group B streptococcal disease 2795:Vaccines for Children Program 2310:10.1016/s0006-291x(02)02049-1 2182:10.1080/14712598.2020.1801626 2033:Heavey S (20 December 2006). 1484:10.1016/S0264-410X(02)00166-4 1363:10.1016/s0891-5520(05)70050-7 1300:10.1128/AEM.11.4.330-334.1963 942:There have been no long-term 830:Biologics License Application 2499:Clinicians' Biosecurity News 1630:. National Academies Press. 1449:10.1016/0882-4010(88)90015-0 1410:10.1016/0264-410x(91)90237-z 1023:National Academy of Sciences 767:Strategic National Stockpile 744:BioPort changed its name to 719:National Academy of Sciences 544:Food and Drug Administration 370:Strategic National Stockpile 339:, sold under the brand name 1821:Washington Business Journal 1815:Clabaugh J (24 June 2011). 824:Building 55 approval (2016) 696:Tripler Army Medical Center 3750: 2225:10.1016/j.bbrc.2004.08.020 2083:Goodman L (October 2004). 1849:Homeland Preparedness News 1333:Salisbury Medical Bulletin 834:Homeland Preparedness News 709:The IOM review (2000–2004) 523:northeastern United States 29: 3647: 1789:Mandatory Vaccine Article 985:post-exposure prophylaxis 975:Post-exposure vaccination 842:Emergent worked with the 316: 46: 2971:Clostridioides difficile 2546:Medical Subject Headings 2020:31 December 2006 at the 1779:Issued 15 December 2005. 1052:Health Protection Agency 1046:In October 2012, the US 733:In the months after the 580:Iraqi bioweapons program 337:Anthrax vaccine adsorbed 41:Anthrax vaccine adsorbed 18:Anthrax Vaccine Adsorbed 3229:Tick-borne encephalitis 1775:2 November 2012 at the 1270:Biothrax Package Insert 692:injection site reaction 3639:List of vaccine topics 2639:Mathematical modelling 2493:Borio LL (July 2005). 2413:10.15585/mmwr.rr6804a1 2068:. 2008. Archived from 1674:Allen, Arthur (2007), 1566:21 CFR Section 620.20. 1437:Microbial Pathogenesis 972: 935: 917: 649:Clinton administration 640: 483:Potency/immunogenicity 3634:Vaccinate Your Family 3085:Japanese encephalitis 1680:W.W. Norton & Co. 1523:10.2105/ajph.52.4.632 1345:Nass M (March 1999). 1019:Institute of Medicine 881:von Willebrand factor 746:Emergent BioSolutions 715:Institute of Medicine 625: 473:benzethonium chloride 362:Department of Defense 3517:John Franklin Enders 1357:(1): 187–208, viii. 1013:In the United States 863:Vaccination schedule 653:Secretary of Defense 347:intended to provide 2703:Virus-like particle 2627:Vaccine ingredients 2377:22 May 2011 at the 2072:on 9 February 2009. 2040:The Washington Post 1922:10.1038/nature07210 1914:2008Natur.455..246P 1478:(Suppl 3): S18-23. 1056:AVP anthrax vaccine 1003:Society and culture 901:nerve growth factor 873:parathyroid hormone 846:(BARDA) within the 668:BioPort Corporation 557:and the subsequent 343:among others, is a 57:Vaccine description 43: 3724:Biological warfare 3674:Never to phase III 3473:Hexavalent vaccine 3287:Epstein–Barr virus 3182:Oxford–AstraZeneca 2875:NmVac4-A/C/Y/W-135 2505:on 26 January 2020 2265:10.1002/prot.21432 1972:10.1093/aje/kwn159 1194:. 15 November 2015 956:anaphylactic shock 688:U.S. Forces, Korea 641: 402:Bacillus anthracis 395:Bacillus anthracis 390:Bacillus anthracis 354:Bacillus anthracis 97:Biothrax, Cyfendus 68:Bacillus anthracis 3684: 3683: 3596:Vaccines and SIDS 3483: 3482: 3257:Hepatitis A and B 3233:Varicella zoster 2695:Subunit/component 2537:. 8 January 2020. 2350:10.1002/jps.23422 2176:(12): 1405–1425. 2151:978-1-4557-0090-5 1705:on 25 August 2009 1645:978-0-309-08309-6 1575:Brachman (1994), 1377:on 9 January 2013 1120:. 14 October 2020 1092:. 23 October 2014 962:Drug interactions 938:Adverse reactions 920:Contraindications 739:US Postal Service 721:was asked by the 676:Gulf War syndrome 672:Lansing, Michigan 651:and announced by 540:cutaneous anthrax 349:acquired immunity 334: 333: 244: 232: 154: 16:(Redirected from 3741: 3729:Subunit vaccines 3701: 3700: 3699: 3692: 3575:MMR autism fraud 3522:Maurice Hilleman 3507:Hilary Koprowski 2820: 2576: 2569: 2562: 2553: 2542:Anthrax Vaccines 2538: 2514: 2512: 2510: 2501:. Archived from 2489: 2479: 2436: 2435: 2425: 2415: 2397: 2388: 2382: 2369: 2363: 2362: 2352: 2328: 2322: 2321: 2292: 2286: 2285: 2267: 2243: 2237: 2236: 2208: 2202: 2201: 2165: 2156: 2155: 2129: 2123: 2122: 2112: 2101:10.1172/JCI23259 2080: 2074: 2073: 2058: 2052: 2051: 2049: 2047: 2030: 2024: 2012: 2006: 2000: 1985: 1984: 1974: 1950: 1944: 1943: 1933: 1908:(7210): 246–50. 1893: 1887: 1886: 1884: 1882: 1877:. 15 August 2016 1867: 1861: 1860: 1858: 1856: 1851:. 16 August 2016 1841: 1832: 1831: 1829: 1827: 1812: 1806: 1805: 1798: 1792: 1786: 1780: 1770:FDA Final Order. 1767: 1761: 1760: 1758: 1756: 1750: 1744:. Archived from 1743: 1735: 1729: 1725:Federal Register 1721: 1715: 1714: 1712: 1710: 1704: 1697: 1689: 1683: 1672: 1666: 1665: 1621: 1612: 1611: 1591: 1582: 1573: 1567: 1564: 1558: 1551: 1545: 1544: 1534: 1502: 1496: 1495: 1467: 1461: 1460: 1428: 1422: 1421: 1393: 1387: 1386: 1384: 1382: 1373:. Archived from 1342: 1336: 1329: 1323: 1322: 1312: 1302: 1278: 1272: 1267: 1256: 1251: 1245: 1239: 1238: 1234: 1232: 1230: 1215: 1204: 1203: 1201: 1199: 1184: 1171: 1165: 1164: 1160: 1158: 1156: 1141: 1130: 1129: 1127: 1125: 1108: 1102: 1101: 1099: 1097: 1080: 778:anthrax attack. 519:controlled study 511:vaccine efficacy 330: 329: 322: 309: 273: 242: 239: 231: 228: 206: 164: 153: 150: 137: 123: 51: 44: 42: 21: 3749: 3748: 3744: 3743: 3742: 3740: 3739: 3738: 3709: 3708: 3707: 3697: 3695: 3687: 3685: 3680: 3679: 3664:Clinical trials 3643: 3612: 3551: 3527:Stanley Plotkin 3489: 3479: 3391:Cancer vaccines 3374: 3368:Schistosomiasis 3346: 3340:Trypanosomiasis 3313: 3277:Cytomegalovirus 3187:Pfizer–BioNTech 2987: 2811: 2760:Vaccine wastage 2730: 2658: 2610: 2580: 2525: 2522: 2517: 2508: 2506: 2492: 2462:(2): CD006403. 2449: 2445: 2443:Further reading 2440: 2439: 2395: 2390: 2389: 2385: 2379:Wayback Machine 2370: 2366: 2330: 2329: 2325: 2294: 2293: 2289: 2245: 2244: 2240: 2210: 2209: 2205: 2167: 2166: 2159: 2152: 2131: 2130: 2126: 2082: 2081: 2077: 2066:Forbes Magazine 2060: 2059: 2055: 2045: 2043: 2032: 2031: 2027: 2022:Wayback Machine 2013: 2009: 2005:(December 2008) 2001: 1988: 1952: 1951: 1947: 1895: 1894: 1890: 1880: 1878: 1869: 1868: 1864: 1854: 1852: 1843: 1842: 1835: 1825: 1823: 1814: 1813: 1809: 1800: 1799: 1795: 1787: 1783: 1777:Wayback Machine 1768: 1764: 1754: 1752: 1751:on 3 March 2012 1748: 1741: 1737: 1736: 1732: 1722: 1718: 1708: 1706: 1702: 1695: 1691: 1690: 1686: 1673: 1669: 1646: 1623: 1622: 1615: 1593: 1592: 1585: 1574: 1570: 1565: 1561: 1552: 1548: 1504: 1503: 1499: 1469: 1468: 1464: 1430: 1429: 1425: 1395: 1394: 1390: 1380: 1378: 1344: 1343: 1339: 1330: 1326: 1280: 1279: 1275: 1268: 1259: 1252: 1248: 1236: 1228: 1226: 1217: 1216: 1207: 1197: 1195: 1186: 1185: 1174: 1162: 1154: 1152: 1143: 1142: 1133: 1123: 1121: 1110: 1109: 1105: 1095: 1093: 1082: 1081: 1077: 1072: 1031: 1015: 1010: 1005: 977: 964: 940: 922: 865: 860: 826: 784: 754: 711: 680:court-martialed 620: 592:IND application 575: 561:— MBPI and the 553:'s invasion of 536: 507: 502: 485: 453: 434:.) As with the 418: 410: 382: 325: 323: 320:(what is this?) 317: 312: 292: 276: 251: 210: 174: 167: 35: 28: 23: 22: 15: 12: 11: 5: 3747: 3745: 3737: 3736: 3731: 3726: 3721: 3711: 3710: 3706: 3705: 3682: 3681: 3678: 3677: 3676: 3675: 3672: 3661: 3655: 3649: 3648: 3645: 3644: 3642: 3641: 3636: 3631: 3626: 3620: 3618: 3614: 3613: 3611: 3610: 3605: 3598: 3593: 3588: 3583: 3578: 3565: 3559: 3557: 3553: 3552: 3550: 3549: 3544: 3542:Katalin KarikĂł 3539: 3534: 3529: 3524: 3519: 3514: 3509: 3504: 3499: 3493: 3491: 3485: 3484: 3481: 3480: 3478: 3477: 3476: 3475: 3470: 3465: 3460: 3452: 3447: 3442: 3437: 3432: 3431: 3430: 3425: 3424: 3423: 3418: 3408: 3403: 3398: 3388: 3382: 3380: 3376: 3375: 3373: 3372: 3371: 3370: 3365: 3356: 3354: 3348: 3347: 3345: 3344: 3343: 3342: 3334: 3333: 3332: 3321: 3319: 3315: 3314: 3312: 3311: 3310: 3309: 3304: 3299: 3297:Herpes simplex 3294: 3289: 3284: 3279: 3271: 3270: 3269: 3264: 3259: 3251: 3246: 3245: 3244: 3239: 3231: 3226: 3221: 3216: 3215: 3214: 3209: 3204: 3199: 3197:Sinopharm BIBP 3194: 3189: 3184: 3179: 3174: 3169: 3164: 3159: 3154: 3149: 3147:Bharat Biotech 3144: 3134: 3129: 3124: 3119: 3118: 3117: 3112: 3102: 3097: 3092: 3087: 3082: 3081: 3080: 3075: 3065: 3060: 3055: 3050: 3045: 3044: 3043: 3038: 3033: 3018: 3017: 3016: 3006: 3001: 2995: 2993: 2989: 2988: 2986: 2985: 2984: 2983: 2978: 2973: 2965: 2964: 2963: 2958: 2950: 2945: 2944: 2943: 2938: 2928: 2927: 2926: 2916: 2911: 2906: 2905: 2904: 2899: 2889: 2884: 2879: 2878: 2877: 2872: 2862: 2857: 2852: 2847: 2842: 2837: 2832: 2826: 2824: 2817: 2813: 2812: 2810: 2809: 2808: 2807: 2802: 2797: 2792: 2787: 2779: 2778: 2777: 2775:Vaccine injury 2772: 2767: 2762: 2757: 2752: 2747: 2738: 2736: 2735:Administration 2732: 2731: 2729: 2728: 2723: 2718: 2709: 2692: 2691: 2690: 2685: 2677: 2672: 2666: 2664: 2660: 2659: 2657: 2656: 2651: 2646: 2641: 2636: 2635: 2634: 2624: 2618: 2616: 2612: 2611: 2581: 2579: 2578: 2571: 2564: 2556: 2550: 2549: 2539: 2521: 2520:External links 2518: 2516: 2515: 2490: 2446: 2444: 2441: 2438: 2437: 2383: 2364: 2323: 2304:(5): 1058–62. 2287: 2238: 2219:(3): 1029–37. 2203: 2157: 2150: 2124: 2075: 2053: 2025: 2007: 1986: 1945: 1888: 1862: 1833: 1807: 1793: 1781: 1762: 1730: 1716: 1684: 1667: 1644: 1636:10.17226/10310 1613: 1583: 1568: 1559: 1546: 1497: 1462: 1423: 1388: 1337: 1324: 1293:(4): 330–334. 1287:Appl Microbiol 1273: 1257: 1246: 1225:. 19 July 2023 1205: 1172: 1131: 1103: 1074: 1073: 1071: 1068: 1030: 1027: 1014: 1011: 1009: 1006: 1004: 1001: 976: 973: 963: 960: 939: 936: 934: 933: 930: 921: 918: 889:beta-secretase 864: 861: 859: 858:Administration 856: 825: 822: 783: 780: 763:George W. Bush 753: 750: 710: 707: 664:Southwest Asia 630:flight surgeon 619: 616: 574: 571: 551:Saddam Hussein 535: 532: 528:rhesus monkeys 506: 503: 501: 498: 484: 481: 452: 449: 417: 414: 409: 406: 381: 378: 332: 331: 314: 313: 311: 310: 302: 300: 294: 293: 291: 290: 286: 284: 278: 277: 275: 274: 266: 264: 258: 257: 253: 252: 250: 249: 237: 225: 223: 217: 216: 212: 211: 209: 208: 195: 193: 187: 186: 177: 175:administration 169: 168: 166: 165: 147: 145: 139: 138: 131: 125: 124: 117: 107: 106: 103: 99: 98: 95: 89: 88: 84: 83: 78: 72: 71: 64: 60: 59: 53: 52: 26: 24: 14: 13: 10: 9: 6: 4: 3: 2: 3746: 3735: 3732: 3730: 3727: 3725: 3722: 3720: 3717: 3716: 3714: 3704: 3694: 3690: 3673: 3671: 3668: 3667: 3665: 3662: 3659: 3656: 3654: 3651: 3650: 3646: 3640: 3637: 3635: 3632: 3630: 3627: 3625: 3622: 3621: 3619: 3615: 3609: 3606: 3604: 3603: 3599: 3597: 3594: 3592: 3589: 3587: 3584: 3582: 3579: 3576: 3574: 3569: 3566: 3564: 3561: 3560: 3558: 3554: 3548: 3547:Drew Weissman 3545: 3543: 3540: 3538: 3535: 3533: 3532:H. Fred Clark 3530: 3528: 3525: 3523: 3520: 3518: 3515: 3513: 3510: 3508: 3505: 3503: 3502:Louis Pasteur 3500: 3498: 3497:Edward Jenner 3495: 3494: 3492: 3486: 3474: 3471: 3469: 3468:DTwP-HepB-Hib 3466: 3464: 3463:DTaP-IPV-HepB 3461: 3459: 3456: 3455: 3454:combination: 3453: 3451: 3448: 3446: 3443: 3441: 3438: 3436: 3433: 3429: 3426: 3422: 3419: 3417: 3414: 3413: 3412: 3409: 3407: 3404: 3402: 3399: 3397: 3394: 3393: 3392: 3389: 3387: 3384: 3383: 3381: 3377: 3369: 3366: 3364: 3361: 3360: 3358: 3357: 3355: 3353: 3352:Helminthiasis 3349: 3341: 3338: 3337: 3335: 3331: 3328: 3327: 3326: 3323: 3322: 3320: 3316: 3308: 3305: 3303: 3300: 3298: 3295: 3293: 3290: 3288: 3285: 3283: 3280: 3278: 3275: 3274: 3272: 3268: 3265: 3263: 3260: 3258: 3255: 3254: 3253:combination: 3252: 3250: 3247: 3243: 3240: 3238: 3235: 3234: 3232: 3230: 3227: 3225: 3222: 3220: 3217: 3213: 3210: 3208: 3205: 3203: 3200: 3198: 3195: 3193: 3190: 3188: 3185: 3183: 3180: 3178: 3175: 3173: 3170: 3168: 3165: 3163: 3160: 3158: 3155: 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Index

Anthrax Vaccine Adsorbed
Anthrax Vaccine Immunization Program

Vaccine description
Bacillus anthracis
Vaccine type
Subunit
Trade names
AHFS
Drugs.com
Monograph
MedlinePlus
a607013
License data
DailyMed
Biothrax
Routes of
administration

Subcutaneous
intramuscular
ATC code
J07AC01
WHO
Legal status
â„ž-only
â„ž-only
DrugBank
DB11003
ChemSpider
UNII
873OI62848

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