U.S. Food and Drug Administration approval for the BioThrax anthrax vaccine has been expanded to include adults aged 18 to 65 with known or suspected exposure, the agency said in a media release.
The vaccine was first approved in 1970 for people at high risk of anthrax contact.
Exposure to Bacillus anthracis bacteria, especially if inhaled, can cause death if not promptly treated. Anthrax is considered a potential bioterrorism weapon, since it is easy to disperse and is relatively hearty, the agency said. Exposure also is possible by contact with an infected animal or animal products.
Expanded approval for the injected vaccine was granted under the agency’s “animal rule,” which states animals may be used to test a drug or product for purposes that aren’t ethical or feasible among people, the FDA said.
The BioThrax vaccine was tested on exposed rabbits and deemed to provide a “reasonable level of protection,” by providing a survival rate of 70 percent to 100 percent, the agency said.
Adverse reactions among people who have been given the vaccine for pre-disease prevention have included tenderness, pain, swelling, injection-site redness, muscle aches, headache and fatigue.
BioThrax is produced by Michigan-based Emergent BioDefense Operations Lansing LLC.
To learn more about this approval, visit the FDA.
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