FDA approves increased indication for BioThrax vaccine

This diagram displays the cellular mechanism of the BioThrax vaccine.
This diagram displays the cellular mechanism of the BioThrax vaccine. | Courtesy of Biothrax.com

The Food and Drug Administration (FDA) issued an updated indication for the BioThrax vaccine on Monday.

The vaccine was approved for use in 1970, but its only permitted use has been for those with high risks of exposure to the disease. With this indication, it can be administered to anyone between the ages of 18 and 65.

“With today’s approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to anthrax spores,” Dr. Karen Midthin, director of the Center for Biologics Evaluation and Research of the FDA, said.

In human safety studies, 200 volunteers were given varying doses of the vaccine. Many of the participants showed similar antibody generation results that indicated a 70 percent chance of surviving anthrax exposure that was found in earlier non-human studies.

Anthrax can be a fatal disease if not treated appropriately, and it is considered to be a candidate for biological weapons because of its ease of being spread through spores. The disease was also implemented in an attempted attack on government officials in 2001. Anthrax can be spread naturally from affected animals or consumed animal products.

The vaccine is manufactured in Lansing, Michigan, by Emergent BioDefense Operations Lansing, LLC.

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U.S. Food and Drug Administration (FDA)

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