Emergent BioSolutions Receives U.S. FDA Approval of Cyfendus™
Emergent BioSolutions Inc. has announced that the U.S. Food and Drug Administration has approved Cyfendus™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
Cyfendus is a component of the U.S. government’s preparedness efforts, working with the U.S Department of Health against anthrax since 2019. It has been demonstrated that by using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response, it can be especially important in response to a large-scale public health emergency involving anthrax.
The FDA approval of Cyfendus is based on data from a series of studies supported by the U.S. government and conducted by Emergent.
The most common adverse reactions reported were tenderness, pain, warmth, itching, swelling, redness, bruising, arm motion limitations, muscle aches, tiredness, headache, and fever. Cyfendus can cause fetal harm when administered to a pregnant individual.
