The Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services has awarded a $75 million option to Emergent BioSolutions’ existing contract for the acquisition of newly licensed anthrax vaccine CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted).
Previously known as AV7909, CYFENDUS vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact.
“CYFENDUS vaccine is a critical component of Emergent’s anthrax medical countermeasures franchise, and supports the U.S. government’s anthrax preparedness strategy,” said Paul Williams, senior vice president, products head at Emergent. “This procurement helps ensure the nation has sufficient anthrax vaccine and aligns with Emergent’s longstanding commitment to strengthen public health preparedness.”
In 2016, BARDA and Emergent extended their partnership to support clinical development and manufacturing efforts for the AV7909 vaccine, including a Phase 3 trial to demonstrate safety and efficacy, working toward the goal of eventual FDA licensure.
A pre-Emergency Use Authorization (EUA) package was submitted in December 2018, and the first pre-EUA doses of AV7909 were delivered to the U.S. government in 2019. In April 2022, Emergent submitted the Biologics License Application to the FDA for review, leading to approval and licensure in July 2023. This latest contract option supplements previous contract procurements and supports the U.S. biodefense preparedness efforts.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority.