US FDA Thumbs Up on new anti-anthrax vaccine

The inhalation of a toxin known as anthrax causes severe tissue damage, which can often lead to very serious injury and even death, according to U.S. health officials.

In recent decades, if you may recall, an anthrax scare used to circulate around, that the toxin could be utilized by terrorist as a biological weapon during the Afghanistan and other Middle East conflict.

According to the U.S. FDA, a drug Anthrasil, was purchased by The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), in 2011, as an experimental treatment, to keep in the U.S. Strategic National Stockpile under Project BioShield.

Researchers have developed a new treatment using the plasma of people who had already received anthrax vaccination from this stockpile.  Important antibodies that can combat the dangerous toxins produced by the bacteria associated with this infection are contained in the Plasma from vaccinated people.

Karen Midthan, the director of the Center for Biologics Evaluation and Research, at the FDA, comments, “In response to the FDA approval Today’s approval provides a significant additional treatment to other FDA-approved therapies for inhalational anthrax, a lethal disease. This product will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”

“The results of studies in research animals provided adequate evidence that Anthrasil is practically likely to benefit humans with inhalational anthrax. The FDA’s Animal Rule allows effectiveness findings from tolerable and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans,” the FDA also stated.

 

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