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# FDA OKs Emergent’s Anthrax Vaccine
- URL: https://www.fdaweb.com/fda-oks-emergents-anthrax-vaccine/
- Published: 2023-07-21T12:00:00.000Z
- Updated: 2026-09-14T18:45:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154929

FDA has approved an Emergent BioSolutions BLA for Cyfendus (anthrax vaccine adsorbed, adjuvanted) for post-exposure prophylaxis of disease following suspected or confirmed exposure to *Bacillus anthracis* in people aged 18 through 65 years. Approval was based on data in animal models of inhalational anthrax, the company says, adding that the vaccine is a component of the U.S. government’s anthrax preparedness efforts. Emergent says additional data relied upon came from:

- a pivotal Phase 3 clinical study that evaluated the lot consistency, immunogenicity, and safety of the vaccine following a two-dose schedule administered intramuscularly in healthy adults,
- a Phase 2 study that evaluated non-interference between the vaccine and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease, and
- non-clinical studies that assessed protective efficacy of the vaccine against lethal challenge with anthrax spores and helped identify neutralizing antibody levels associated with protection against disease.