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Cyfendus™ Anthrax Vaccine Approved by FDA

 07/23/2023

The U. S. Food and Drug Administration (FDA) has approved Cyfendus™ Anthrax Vaccine for post-exposure prophylaxis of disease following exposure to Bacillus anthracis.  The vaccine can be administered to those aged 18 through 65 years with confirmed exposure and in conjunction with an approved antibacterial drug.

 

The adjuvanted vaccine was developed in collaboration with the Defense Advance Research Projects Agency and the National Institute of Allergy and Infectious Diseases.  Funding was provided through the Biomedical Advance Research and Development Authority.

 

The vaccine was developed as a national security measure to protect first responders and potentially exposed personnel in the event of a deliberate act of bioterrorism.  Anthrax vaccine has been administered over an extensive period to military personnel with minimal side effects as BioThrax. Use by the military was suspended in 2003 when it was disclosed that the Food and Drug Administration had not specifically approved the vaccine to prevent inhalational anthrax, the lethal form of infection.

 

Emergent BioSolutions (EBS) manufactures a smallpox (vaccinia) vaccine, Anthrasil™ immune globulin to treat anthrax and a botulism antitoxin of equine origin, Narcan® naloxone nasal spray and Trobigard™ atropine sulfate auto injectors to treat mass organophosphate poisoning with many of these products manufactured under Federal contract to be incorporated into national strategic stockpiles.

 

In 2021, Emergent BioSolutions (EBS) was the subject of investigations following revelations of improper manufacturing practices at a Baltimore plant as revealed by The New York Times leading to the destruction of 15 million doses of Covid-19 vaccine and cessation of production of an additional 24 million doses contracted to Pfizer and Johnson and Johnson.  This resulted in a sharp reduction in the share price of the company during April 2021 from $134 to $68. Manufacturing was suspended and the plant underwent extensive changes with Johnson & Johnson responsible for production of COVID vaccine.