On July 20th, CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909 became the latest U.S. Food and Drug Administration (FDA) approval, licensure or clearance of a medical countermeasure developed with BARDA support.

This recent FDA licensure is a critical step in BARDA’s overarching strategy, outlined in the 2022-2026 Strategic Plan, to ensure preparedness against known and emerging national security threats. This program is the latest step in BARDA’s longstanding preparedness efforts and advances its ability to protect people from the consequences of deliberate or naturally occurring biological threats.

BARDA provides industry partners with expertise, oversight, and guidance on quality and regulatory processes to help them navigate the complex pathway from product development to approval. By supporting development toward FDA approval of lifesaving medical countermeasures, BARDA helps enable accessibility and availability of those products during public health emergencies. BARDA and Emergent BioSolutions initially partnered in 2008 to develop the investigational vaccine candidate AV7909.

CYFENDUS is a two-dose vaccine that can be used for post-exposure prophylaxis (doses administered after exposure to prevent illness), along with antibiotics, during an emergency involving anthrax.

For post-exposure prophylaxis, CYFENDUS improves upon the licensed anthrax vaccine, BioThrax (Anthrax Vaccine Adsorbed), by using an adjuvant, CPG7909, to stimulate a rapid immune response against B. anthracis. Unlike BioThrax, which is a licensed three-dose post-exposure prophylaxis vaccine administered over 28 days, Cyfendus requires only two doses over 14 days to provide protection. This approach enables people to complete the vaccine dose schedule faster and enables a more rapid onset to protection.

Anthrax is an infectious disease caused by Gram-positive, rod-shaped, spore-forming bacteria known as Bacillus anthracis that can cause severe illness and death. The bacteria occur naturally in soil and commonly affect domestic and wild animals around the world. People can get sick with anthrax if they come in contact with infected animals or contaminated animal products, or during an accidental or intentional exposure, such as a bioterrorism incident.

Anthrax remains a serious bioterrorism threat due to the ease of production and delivery of aerosolized spores that can cause high morbidity and mortality through gastrointestinal, cutaneous, inhalational (pulmonary), or injection routes. Although clinical manifestations of the disease differ by route, inhalation anthrax is the most lethal. BARDA is pursuing a comprehensive strategy to address the threat of inhalation anthrax; this strategy calls for investing in the advanced research, development, and procurement of vaccines, therapeutics, and diagnostics.

In a public health emergency involving anthrax, a rapid vaccination campaign will be crucial to saving lives, protecting health security, and minimizing the public health impacts and economic disruption. The success of the program demonstrates the value of public-private partnerships to enhance preparedness and response.

In 2016, BARDA and Emergent BioSolutions extended their partnership to support clinical development and manufacture of the AV7909 vaccine candidate, including a Phase III trial to demonstrate safety and efficacy, working toward the goal of eventual FDA licensure. In April 2022 Emergent submitted the Biologics License Application (BLA) to the FDA for review, leading to this 2023 licensure.

BARDA is honored to be a part of endeavors that help make the world a healthier, safer place. With novel medicines, diagnostics and vaccines, we can save lives, protect the American people and enhance global health security.

Visit our FDA Approvals Page to learn more about our support aiding our partners in achieving the other approvals.