BioThrax Anthrax Vaccine Description
BioThrax, Anthrax Vaccine Adsorbed, is made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis.
BioThrax was initially approved in the U.S. in 1970. STN: BL 103821; for the active immunization to prevent disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.
BioThrax is intended to stimulate the production of neutralizing antibodies that recognize the vaccine antigens, protective antigen (PA), lethal factor, and edema factor and are expected to be protective against Bacillus anthracis infection. The efficacy of BioThrax has not been evaluated through clinical trials. However, immunogenicity data has inferred vaccine efficacy, including anti-PA IgG and toxin neutralization titers.
AV7909 is a combination of BioThrax (also called anthrax vaccine, adsorbed or AVA), an FDA-licensed vaccine, and CPG 7909, a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant. The anthrax vaccine AV7909 is being developed as a next-generation vaccine for post-exposure prophylaxis against inhalational anthrax.
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 toxins; 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.
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 Vaccine Revenues
On January 9, 2022, the Company announced that anthrax vaccines revenues are expected to continue at similar levels to 2021 under the terms of the Company's existing contract with the U.S. BARDA.
on March 17, 2017, Emergent was awarded a $100 Million BARDA Contract.
BioThrax Anthrax Vaccine News
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 in a toxin produced by the anthrax bacterium 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®
BioThrax Anthrax Vaccine Clinical Trials
BioThrax has been tested in over 25 clinical studies.