Anthrax Vaccine Awarded U.S. FDA Approval

Emergent BioSolutions Inc. today announced that the U.S. Food and Drug Administration (FDA) approved CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted) (AV7909) for post-exposure prophylaxis (PEP) of disease following suspected or confirmed exposure to Bacillus anthracis in adults when administered in conjunction with recommended antibacterial drugs.

The efficacy of the CYFENDUS™ vaccine for PEP is based solely on studies in animal models of inhalational anthrax.

Emergent's anthrax franchise includes the BioThrax® vaccine, which will continue to serve a critical purpose, as well as two treatments, Anthrasil®, a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.

Dr. Kelly Warfield, Emergent's senior vice president, science and development, commented in a press release on July 20, 2023, "The 20-year journey from early development to approval is a major milestone that attests to Emergent's scientific and technical prowess and partnering capabilities."

"We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority and early support from the Defense Advanced Research Projects Agency and the National Institute of Allergy and Infectious Diseases.

CYFENDUS vaccine is comprised of Anthrax Vaccine Adsorbed and an additional adjuvant. It has been demonstrated that using an additional adjuvant, two doses administered over 14 days elicit protective levels of an immune response, which can be especially important in response to a large-scale public health emergency involving anthrax.

In December 2018, the CYFENDUS vaccine was the subject of a pre-emergency use authorization package submitted to the FDA. The following year, the U.S. government procured this product for national preparedness efforts.