BioThrax® Anthrax Vaccine
Emergent BioSolutions's BioThrax®, Anthrax Vaccine Adsorbed (AVA), is made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis. BioThrax was initially licensed in the U.S. in 1970 (STN: BL 103821) for active immunization to prevent disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure. The U.S. Food and Drug Administration (FDA) updated the BL on July 6, 2023. BioThrax is intended to stimulate the production of neutralizing antibodies that recognize the vaccine antigens, protective antigen, lethal factor, and edema factor and are expected to be protective against Bacillus anthracis infection.
As of January 11, 2023, BioThrax is approved for pre-exposure prophylaxis of disease in persons at high risk of exposure. BioThrax is approved for post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure when administered in conjunction with recommended antibacterial drugs. The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.
The U.S. Centers for Disease Control and Prevention published updated Guidelines for the Prevention and Treatment of Anthrax on November 17, 2023. Although data indicated that the polyclonal antitoxin AIGIV should not be coadministered with anthrax vaccine adsorbed, noninterference was demonstrated between raxibacumab and AVA, allowing their coadministration. No data were available on the coadministration of obiltoxaximab and AVA.
Gaithersburg, Maryland-based Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life.
BioThrax Anthrax Vaccine Indication
BioThrax is a vaccine indicated for active immunization to prevent disease caused by Bacillus anthracis in persons 18 through 65 years of age whose occupation or other activities place them at high risk of exposure. There are two kinds of anthrax toxin: edema toxin and lethal toxin. Both toxins share a key protein called PA (protective antigen). PA has been likened to a Trojan horse, helping to ferry either the edema factor (EF) protein or the lethal factor (LF) protein into a cell. Research published on December 20, 2021, demonstrated how the edema toxin (composed of PA and EF) could selectively target and silence pain-signaling neurons in the dorsal root ganglion.
Do not administer BioThrax to individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax or any vaccine component, including aluminum, benzethonium chloride, and formaldehyde.
BioThrax Anthrax Vaccine Dosage
BioThrax Anthrax Vaccine consists of 3 doses, each of 0.5 mL, given at 0, 1, and 6 months. Booster: 0.5 mL at three-year intervals OR as per official recommendations. The vaccine is given by deep intramuscular (IM) injection in the deltoid region. BioThrax is administered as a deep intramuscular injection in the deltoid region.
BioThrax Anthrax Vaccine Side Effects
People with a weakened immune system due to autoimmune conditions, HIV, or medications such as cancer treatments, pregnant women, and those who have had serious life-threatening reactions in the past to the anthrax vaccine should not get it. The most common (≥10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema, edema, and arm motion limitation. The most common (≥5%) systemic adverse reactions were muscle aches, headaches, and fatigue.
BioThrax and Pregnant Women
Advise pregnant women of potential risk to the fetus. People should weigh the potential benefits of vaccination against the potential risk to the fetus.
BioThrax for Pediatric and Geriatric Populations
The safety and effectiveness of BioThrax have not been established in pediatric or geriatric populations.
BioThrax For Immunocompetence
The immune response may be diminished if BioThrax is administered to immunocompromised persons, including those receiving immunosuppressive therapy.
BioThrax Coadministration with Other Vaccines
The safety and efficacy of concomitant administration of BioThrax with other licensed vaccines has not been evaluated. If BioThrax is to be given simultaneously as another injectable vaccine(s), the vaccine(s) should be administered at different injection sites.
BioThrax History
In the 1990s, with growing concerns about the possible use of anthrax as a biological weapon, the use of the vaccine was substantially expanded. The U.S. DOD vaccinated some of the military personnel deployed for the Gulf War in 1991 and, in 1998, initiated the Anthrax Vaccine Immunization Program, calling for mandatory vaccination of all U.S. service members. By late 2001, roughly 2.1 million doses of AVA had been administered. In October 2000, the Institute of Medicine convened the Committee to Assess the Safety and Efficacy of the Anthrax Vaccine. The committee reviewed all available data. After the bioterrorism of the fall of 2001, the committee accelerated its original timetable for its review. The committee concluded that AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalational anthrax. Moreover, because the vaccine exerts its protection via an antigen crucial to the action of the bacterium's toxins, AVA should be effective against anthrax toxicity from all known strains of B. anthracis, as well as from any potential bioengineered strains.
BioThrax Anthrax Vaccine News
January 11, 2024 - Emergent BioSolutions Inc. announced that it has secured an indefinite-delivery, indefinite-quantity procurement contract with a maximum value of up to $235.8 million to supply BioThrax® for use by all branches of the U.S. military.
July 6, 2023 - Emergent BioDefense Operations Lansing LLC's STN: BL 103821 was updated by the U.S. FDA.
January 13, 2022 - The Company presented a BioThrax vaccine update at the 40th Annual J.P. Morgan Virtual Healthcare Conference.
December 20, 2021 - Preclinical work led by researchers from Harvard Medical School has found some aspects of a toxin produced by the anthrax bacterium that can silence activity in pain-signaling brain neurons. This study highlights interactions between a bacterial toxin and nociceptors, which may lead to new pain therapeutics.
April 1, 2021 - A market research report analyzed BioThrax's industry growth rate, size, share, regional analysis, and global forecast to 2027.
July 30, 2019 - Emergent BioSolutions Inc. announced that the Biomedical Advanced Research and Development Authority had exercised its first contract option valued at $261 million to procure doses of AV7909 (BioThrax adsorbed with adjuvant) for delivery into the Strategic National Stockpile (SNS) over 12 months.
December 17, 2018 - Emergent BioSolutions Receives Health Canada Approval of BioThrax®.
March 17, 2017, Emergent was awarded a $100 Million BARDA Contract.
BioThrax Anthrax Vaccine Clinical Trials
BioThrax has been tested in over 25 clinical studies.
