Emergent secures FDA nod for anthrax vaccine Cyfendus after supplying the shot for 4 years

Under a pre-emergency use authorization, Emergent BioSolutons has provided the Department of Health and Human Services with its AV7909 anthrax vaccine for emergency preparedness since 2019.

Four years later, Emergent has won a full approval from the FDA for its use in adults 18 to 65 in conjunction with antibacterial drugs, after suspected or confirmed exposure to the potentially fatal bacteria.

Branded as Cyfendus, the vaccine includes anthrax vaccine adsorbed (AVA) and an adjuvant. Two doses provided over 14 days delivers a protective level of immune response.

With news of the thumbs up, Emergent’s share price had increased by 8% from close on Thursday.

Emergent has had a difficult few years, reaching its height early in the pandemic after earning lucrative contracts to produce COVID-19 vaccines. But the CDMO had numerous missteps in producing the shots and saw the value of its shares fall from $133 to $7.

Last month, CEO Robert Kramer, who had much to do with Emergent's rise, stepped down.

Cyfendus has only been tested on animals. But it was successful in a phase 3 trial that measured its lot consistency, immunogenicity and safety following a two-dose schedule administered intramuscularly, Emergent said.

A phase 2 study also has shown its non-interference with antibacterial drugs.

Cyfendus is Emergent’s follow-up to its previous anthrax vaccine BioThrax. Under a five-year deal worth $1.25 billion, the company supplied 44.7 million doses to the Strategic National Stockpile between 2011 and 2016. Another five-year deal followed in which Emergent signed up to provide 29.4 million doses.

In addition to the two vaccines, Emergent has two treatments for anthrax in its portfolio—Anthrasil, a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody.