Additional Indication Approved for Anthrax Vaccine
November 23, 2015 – The U.S. Food and Drug Administration (FDA) approved a new indication for BioThrax (anthrax vaccine adsorbed) manufactured by Emergent BioSolutions. BioThrax was previously approved to prevent anthrax before exposure for individuals aged 18 years to 64 years old, and is now indicated for patients in the same age range who have already been or suspect they have been exposed to anthrax. It is injected subcutaneously in three doses – one dose is injected immediately after exposure or suspected exposure, a second dose is injected two weeks later, and the third is injected four weeks after exposure. When taking BioThrax, patients should also take an effective antibiotic, such as ciprofloxacin or doxycycline, along with one or more other antibiotics, for at least 60 days. Although the safety of post-exposure BioThrax was confirmed on healthy individuals in human clinical trials, its effectiveness for preventing anthrax after exposure was tested only in laboratory animals because deliberately exposing humans to anthrax is unethical. Between 70% and 100% of treated test animals survived anthrax exposure. BioThrax is the first vaccine to be approved based only on data from animal studies.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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