Anthrax Vaccine & Treatment Approved by FDA

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Anthrasil, Anthrax Immune Globulin Intravenous has been approved by the U.S. Food and Drug Administration (FDA) on Wednesday, Mar 25, 2015, for use in patients with inhalational anthrax alongside other antibiotics.

Anthrax is an infection caused when a person is exposed to the bacterium Bacillus anthracis or its spores. Inhalation anthrax is acquired when a person breathes in the spores from infected animals or the animal products and in some cases, an intentional release of spores of the bacterium in human population, reported in the FDA press release.  

Upon inhalation of anthrax spores, a patient suffers flu-like symptoms, fatigue, sore throat, muscle-pain, shortness of breath, painful swallowing, nausea and coughing up blood. If the disease is not treated as soon as the symptoms are observed, it would lead to severe fever, troublesome breathing, shock, and result in life threatening meningitis, according to Mayo Clinic.

This disease is dreadful because it causes the spores of the organism to replicate as soon as they enter the body and produce a fatal toxin that cause massive irreversible damage to body tissues resulting in death. Anthrasil is an anti-toxin produced from blood plasma of an individual vaccinated against anthrax. The plasma thus obtained contains the antibodies capable of neutralizing the toxins produced by the bacterium.

Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the press release that, "Today's approval provides an important additional treatment to other FDA-approved therapies for inhalational anthrax, a life-threatening disease." She also added that "This product will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency."

Since anthrasil is an anti-toxin and not an antibiotic, it is only capable of neutralizing the toxin and not kill the bacterium. Therefore, these are used along with potential antibiotics. Anthrasil when tested in monkeys exposed to the spores showed 36 to 70 percent survival rate and rabbits exposed to the spores exhibited 26 percent survival rate. When anthrasil is used along with antibiotics in rabbits, a survival rate of 71 percent is observed, reported another study according to the press release.

"The safety of the product was tested in 74 healthy human volunteers. The most commonly observed side effects were headache, back pain, nausea and infusion site pain and swelling", reported the press release. It is also stated that anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada with support from BARDA within HHS' Office of the Assistant Secretary for Preparedness and Response.