(The Defender) 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.”
Nass said that during the 2001 anthrax scare, where politicians and media organizations across the country received anthrax in the mail, five people died — but “everyone who got antibiotics early did not come down with anthrax and none of them died.”
“So,” Nass said, “antibiotics worked.” Nass emphasized that after exposure to anthrax, one needs treatment immediately — not over the longer period of time it takes for a vaccine to work.
“The fact that it’s required to be given with antibiotics,” Nass said, “which is what you should have when exposed to anthrax, raises the question: What additional benefit are you gonna get from this vaccine? I don’t know.”
Emergent’s stock shares gained 16.2% in pre-market trading after it announced the FDA approval.
Benchmark analyst Robert Wasserman said the approval provides “greater assurance” the company will reach its projected 2023 earnings of $260-$280 million, Bloomberg Law reported.
The price spike comes on the heels of “a difficult few years,” financially for the company, FiercePharma reported.
The company, founded in 1998 as government contractor BioPort to distribute and produce the anthrax vaccine for the U.S. military, reached its financial zenith early in the pandemic after earning lucrative contracts to produce Johnson & Johnson and AstraZeneca COVID-19 vaccines.
But a congressional report in 2021 revealed the company hid likely contamination problems at the plant from FDA inspectors and eventually had to destroy 400 million vaccine doses — which led its share price to fall from $133 to $7.
History of the anthrax vaccine
The anthrax vaccine was developed and in limited use in the military since 1970.
