The U.S. Food and Drug Administration (FDA) on Thursday approved an anthrax vaccine for adults ages 18-65, according to Emergent BioSolutions, the vaccine’s maker.
The vaccine, Cyfendus, is approved for use after suspected or confirmed exposure to Bacillus anthracis, also known as anthrax, but must be administered together with other antibacterial drugs, Reuters reported.
Emergent said it had been delivering Cyfendus to the U.S. Department of Health and Human Services (HHS) since 2019, under pre-emergency use authorization status.
The efficacy of Cyfendus for post-exposure prophylaxis was tested only on animals.
Dr. Meryl Nass, bioterrorism and anthrax expert, told The Defender she is skeptical about whether the vaccine offers any new substantive health benefit.
“Given the history of the company’s many failures, and the lack of proper safety or efficacy testing of prior anthrax vaccines, one can only expect problems,” Nass said.
“The fact that there is no label available, there is no information on how it was tested, what placebo was used, et cetera — that all adds to the consternation and concern people should have about the value of this product,” Nass added.
Emergent said the drug has been in development for 20 years in collaboration with the Defense Advanced Research Projects Agency (DARPA), the Biomedical Advanced Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID), formerly headed by Dr. Anthony Fauci.
Paul Williams, senior vice president at Emergent, said anthrax “remains a high-priority national security threat.”
Cyfendus is comprised of Emergent’s anthrax vaccine adsorbed (AVA), marketed as Biothrax, plus an additional adjuvant, the name of which the company did not disclose.
Cyfendus is administered in two doses over 14 days to elicit an immune response that the company said: “can be especially important in response to a large-scale public health emergency involving anthrax.”
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