FDA approves Cyfendus anthrax vaccine for post-exposure prophylaxis of disease.- Emergent BioSolutions.

The efficacy of Cyfendus vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

“The approval of Cyfendus vaccine is symbolic of Emergent's longstanding partnership with the U.S. government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development. “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 years long collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID). Congratulations to the Emergent team and all our partners for advancing this product to approval.”

Cyfendus vaccine is comprised of Anthrax Vaccine Adsorbed (AVA) and an additional adjuvant. It has been demonstrated that by using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response, which can be especially important in response to a large-scale public health emergency involving anthrax. In December 2018, Cyfendus vaccine was the subject of a pre-emergency use authorization package submitted to the FDA. The following year, the U.S. government began procuring this product for national preparedness efforts.