Emergent BioSolutions has announced receipt of the US Food and Drug Administration’s (FDA) approval for CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted), for post-exposure prophylaxis of disease after suspected or confirmed exposure to Bacillus anthracis in persons aged 18 through 65 years when administered along with recommended antibacterial drugs.
Earlier known as AV7909, CYFENDUS vaccine’s efficacy for post-exposure prophylaxis is only based on studies in animal models of inhalational anthrax.
Emergent senior vice president, science and development Dr. Kelly Warfield said: “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.
“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 (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 consists of Anthrax Vaccine Adsorbed (AVA) and a further adjuvant.
It is shown that by using a further adjuvant, two doses administered over 14 days demonstrate protective levels of immune response, and this can be particularly significant in response to a public health emergency involving anthrax.
CYFENDUS vaccine was the subject of a pre-emergency use authorisation package submitted to the US FDA in December 2018.
In 2019, the US government commenced procuring this product for national preparedness efforts.
Besides the CYFENDUS vaccine, Emergent’s anthrax franchise includes the BioThrax vaccine, which will continue to cater to a critical purpose, as well as two treatments — Anthrasil [Anthrax Immune Globulin Intravenous (human)], a polyclonal antibody therapeutic; and raxibacumab, a monoclonal antibody therapeutic.
The approval given by the FDA for CYFENDUS vaccine is based on data from a series of studies supported by the US government and conducted by Emergent.