New Anthrax Vaccine Receives FDA Approval

Emergent BioSolutions was granted approval from the U.S. Food and Drug Administration (FDA) on July 20, 2023, for Cyfendus™ (anthrax vaccine adsorbed, adjuvanted) injection. As a two-dose series, it will be given intramuscularly (IM) 14 days apart to prevent infection with anthrax after a known or suspected exposure. Cyfendus is indicated for patients between the ages of 18 years and 65 years old. It will be used along with antibacterials, such as ciprofloxacin and doxycycline, which effectively protect against anthrax. According to the Centers for Disease and Prevention (CDC), anthrax symptoms usually appear within one week of exposure, but anthrax can be dormant in the body for up to two months, meaning that antibacterial treatment should last for at least 60 days. Cyfendus may cause severe injection reactions or anaphylaxis, so it should be administered in a healthcare facility that is equipped and staffed to manage any serious adverse reactions that occur. For the past few years, Cyfendus has been added to the National Strategic Stockpile (secure locations with reserves of drugs and medical equipment) in case of a national emergency involving anthrax. It was not tested in humans; its approval is based only on the results of laboratory animal studies because deliberately exposing humans to anthrax is unethical. Emergent BioSolutions also contracts with the federal government for supplies of its other vaccines and treatments for anthrax and other potential biological warfare agents. Check here for Cyfendus’ prescribing information.