FDA approves Emergent BioSolutions anthrax vaccine

July 24, 2023

The U.S. FDA has approved Emergent BioSolutions' anthrax vaccine for for post-exposure prophylaxis use in adults aged 18 through 65, the medical countermeasure specialist announced late last week.

The vaccine, previously known as AV7909 now branded Cyfendus, has been approved for use following suspected or confirmed exposure to Bacillus anthracis — the bacteria that causes anthrax — when administered in conjunction with recommended antibacterial drugs. 

Cyfendus was developed through a 2016 $1.5 billion development and procurement contract with BARDA. In July 2019 BARDA exercised its first contract option to procure doses of the vaccine, which had been granted pre-Emergency Use Authorization status by the FDA, for delivery into the Strategic National Stockpile over 12 months. 

Now, Emergent says it will continue to work with the U.S. government to transition to post-approval procurement.

Emergent has been undergoing a strategic prioritization of its medical countermeasure products, including several anthrax products, its smallpox vaccines and opioid overdose reversal medicine Narcan. To that end, the company sold its travel health business for $380 million to Bavarian Nordic earlier this year.