Previously known as AV7909, the Cyfendus vaccine is comprised of Anthrax Vaccine Adsorbed (AVA) and an additional adjuvant, indicated for administration in individuals aged 18 to 65 years, in conjunction with recommended antibacterial drugs
Emergent gets FDA nod for Cyfendus anthrax vaccine. (Credit: Willfried Wende from Pixabay)
Emergent BioSolutions has received the US Food and Drug Administration (FDA) approval for Cyfendus (anthrax vaccine adsorbed, adjuvanted) for post-exposure prophylaxis use.
Previously known as AV7909, the Cyfendus vaccine is comprised of Anthrax Vaccine Adsorbed (AVA) and an additional adjuvant.
It is indicated for administration in individuals aged 18 to 65 years, who were suspected or confirmed exposure to Bacillus anthracis, in conjunction with recommended antibacterial drugs.
In December 2018, the US-based biopharmaceutical company submitted a package to the US FDA, seeking pre-emergency use authorisation of the Cyfendus vaccine.
The following year, the US government started procuring the vaccine, as part of the national preparedness efforts.
Emergent science and development senior vice president Kelly Warfield said: “The approval of CYFENDUS vaccine is symbolic of Emergent’s longstanding partnership with the US 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).”
The FDA approval of the Cyfendus vaccine is based on data from a series of studies conducted by Emergent, with support from the US government.
The studies include a Phase 3 clinical trial evaluating the consistency, immunogenicity, and safety of the vaccine following a two-dose schedule administered intramuscularly in healthy adults.
A Phase 2 study evaluated the non-interference between the vaccine and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease.
Also, non-clinical studies assessed the protective efficacy of the vaccine against the lethal challenge of anthrax spores and identified neutralising antibody levels against the disease.
In addition to Cyfendus, Emergent also develops anthrax vaccines, including the BioThrax vaccine, along with two antibody therapeutics, Anthrasil and raxibacumab.
Emergent products business senior vice president Paul Williams said: “Cyfendus vaccine is a component of the US government’s preparedness efforts against anthrax, which remains a high-priority national security threat due to its ability to be easily disseminated, lethality, and potential for major public health impact.
“The approval of the Cyfendus vaccine demonstrates what effective public-private partnerships can achieve for national security. Emergent will continue to work closely with the US government to transition this product to post-approval procurement while ensuring an uninterrupted supply of this important vaccine.”