As reported by Fierce Pharma, Emergent BioSolutions has secured a full approval from the FDA for use of anthrax vaccine Cyfendus after supplying the shot for years. Prior to this, Emergent has provided the Department of Health and Human Services with its AV7909 anthrax vaccine for emergency preparedness since 2019.
The FDA's full approval encompasses the anthrax vaccine's use for adults 18 to 65 in conjunction with antibacterial drugs after suspected or confirmed exposure to the potentially fatal bacteria. According to the regulator, two doses in 14 days deliver a protective level of immune response.
Cyfendus has only been tested in animal models of inhalation anthrax. However, Emergent said a Phase 2 clinical study has shown its non-interference with antibacterial drugs. A Phase 3 trial that measured its lot consistency, immunogenicity and safety following a two-dose schedule yielded successful results. (Related: FDA uses ‘animal’ rule to approve anthrax vaccine for humans… You’re just an experimental animal to the vaccine industry.)
But the product's package insert revealed the dangerous ingredients in every vial of Cyfendus. The insert disclosed that the anthrax shot uses two adjuvants, one with aluminum and the new synthetic adjuvant CPG7909. It also contains a saline solution containing formaldehyde and benzethonium chloride as preservatives.
Commonly used as an adjuvant in vaccines, aluminum is a known cytotoxin and neurotoxin. Formaldehyde has been branded as "carcinogenic to humans" by the World Health Organization's International Agency for Research on Cancer (IARC) based on sufficient evidence it can cause nasopharyngeal cancer and leukemia.
Meanwhile, benzethonium chloride – an ammonium compound often found in detergents – has been found to be irritating and harmful to mucous membranes at concentrations as low as one percent. Higher concentrations of this chemical are highly toxic if ingested.
Dr. Meryl Nass, an expert on bioterrorism and anthrax, expressed skepticism about whether Cyfendus offers any new substantive health benefit. She told the Defender, the newsletter of health freedom group Children's Health Defense: "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."
She expounded on her skepticism in a Substack article, noting that the FDA itself has admitted it does not work. Nass said the vaccine requires antibiotics alongside it, "and it is the antibiotics that actually kill anthrax after an acute exposure."
"You can't be sprayed with anthrax, get vaccinated and then patiently wait a month to develop immunity – you'd be dead by then. Plus, if you lived – you would, of course, show immunity by a month because you were just exposed to anthrax."
Nass also cited that BioThrax, the predecessor of Cyfendus, "caused birth defects." An observational study on the anthrax shot found that "there were more birth defects in infants born to individuals vaccinated with BioThrax in the first trimester, compared to individuals vaccinated post pregnancy or individuals never vaccinated."
"This shot [Cyfendus] is the old anthrax shot with a novel adjuvant added – so it cannot possibly be safer than the bad old vaccine," the expert continued. She also mentioned the "horrendous" effects of the injection – with 84 percent of trial participants experiencing a systemic reaction and 64 percent having limited use of the arm the vaccine was injected in.
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