by Brenda Baletti, Ph.D., Childrens Health Defense:
“You can’t make this stuff up,” wrote Meryl Nass, M.D., commenting on the lack of efficacy, toxic ingredients and major side effects associated with Emergent BioSolutions’ new anthrax vaccine that won FDA approval last week.
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“Is this a label or a cartoon?” asked Meryl Nass, M.D., a bioterrorism and anthrax expert who published an analysis of the insert on Substack. “You can’t make this stuff up,” she said.
The insert reports that Cyfendus uses two adjuvants, an aluminum adjuvant and a new synthetic adjuvant — CPG7909. The vaccine also contains a saline solution containing formaldehyde and benzethonium chloride as preservatives.
Aluminum adjuvant is a known cytotoxic and neurotoxic substance used to induce autoimmunity in lab animals.
Peer-reviewed research published in Neuromolecular Medicine linked the aluminum adjuvant in the existing anthrax vaccine to Gulf War Illness (GWI), a cluster of symptoms including muscle aches, joint pain, dizziness, memory lapses, headaches, fatigue, insomnia, emotional disorders, posttraumatic stress reactions, headaches, and memory loss.
Hundreds of thousands of Gulf War veterans suffered with GWI, but so did many troops who were never deployed but who had also been vaccinated against anthrax — which led researchers to study the vaccine as a likely cause of the illness.
According to The BMJ, aluminum adjuvants are associated with numerous adverse effects, including injection site pain and tenderness, persistent lumps, granulomas, contact dermatitis, post-immunization headache, macrophagic myofasciitis and autoimmune/inflammatory syndromes.
Research has also found a strong link between aluminum exposure and asthma, Alzheimer’s disease and autism.
Formaldehyde is a known carcinogen and benzethonium chloride, an ammonium compound often found in detergents, is highly toxic if ingested.
Too few cases worldwide to test for efficacy
The new Cyfendus vaccine is an updated version of Emergent’s BioThrax, also known as Anthrax Vaccine Adsorbed, which the company has been producing since 2002.
Emergent said prior to last week’s approval, it had been delivering Cyfendus to the U.S. Department of Health and Human Services (HHS) since 2019, under pre-emergency use authorization status.
Cyfendus is approved only for use after suspected or confirmed exposure to Bacillus anthracis, also known as anthrax, but it must be administered together with other antibacterial drugs.
The drug is administered by intramuscular injection as a series of two doses, two weeks apart. BioThrax required three doses over four weeks.
Nass told The Defender that if someone has a serious anthrax exposure, they typically die within several days unless treated with antibiotics.
“You can’t be sprayed with anthrax and then get vaccinated and then patiently wait a month to develop immunity. You’d be dead by then,” she wrote.
Nass said FDA’s requirement that the vaccine be given jointly with antibiotics is a tacit admission by the agency that the vaccine “doesn’t work.”
Nass told The Defender there are too few anthrax cases worldwide to study its efficacy in people. She cautioned that animal models have limits in predicting human immune responses, so the vaccine’s effectiveness remains uncertain.
In this case, the insert reports that in logistic regression analysis of testing done in rabbits, the treatment demonstrated a “70% probability of survival” eight weeks after the full dose was administered. That “does not sound promising,” Nass said.
Four clinical studies evaluated Cyfendus’ safety. But according to the insert, three of the studies compared different doses of Cyfendus (studies 1, 2, and 3) and one (study 4) compared Cyfendus and BioThrax.
Observational studies of BioThrax — which has the same ingredients but does not contain the CPG7909 adjuvant — show the vaccine causes birth defects when administered to pregnant women.
According to the insert, “Of the 11 pregnancies (one twin pregnancy), 1 (9.1%) resulted in miscarriage and there were 2 infants (18.2 %) born with major birth defects.”
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