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Emergent BioSolutions’ new anthrax vaccine contains dangerous toxins and may cause severe side effects, according to the product’s package insert.
The U.S. Food and Drug Administration (FDA), which approved the vaccine last week, posted the package insert late Friday.
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.
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.
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
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.
“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 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.”
The vaccine also caused other major side effects. 65% of subjects had limited use of their arm after the shot. 84% of subjects had a systemic reaction, and 8% refused a second shot.
According to the insert, none of the six reported deaths or serious adverse events that happened in the clinical trial “were determined to be related to the administration of Cyfendus.”
In the approval letter, the FDA told Emergent it did not refer the application to the FDA’s Vaccines and Related Biological Products Advisory Committee, which typically evaluates data concerning the safety, effectiveness, and appropriate use of vaccines, because FDA’s review of the application, “did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”
But Brian Hooker, Ph.D., P.E., chief scientific officer for Children’s Health Defense, told The Defender he found the approval of the drug very concerning.
“The anthrax vaccine used in the military has been a horrible failure with links to GWI and other neurological sequelae. It will be interesting to see where this goes with ACIP [Advisory Committee on Immunization Practices]. My fear is that they’ll recommend it broadly for adults [after anthrax exposure], which would be a huge mistake.”
Ties to military
Emergent was founded in 1998 as BioPort, a private for-profit government contractor to distribute and produce the anthrax vaccine for the U.S. military, taking over the assets of the state-owned Michigan Biologic Products Institute.
It purchased the existing stockpile of anthrax vaccine and the vaccine production plant when the U.S. Department of Defense (DOD) made the vaccine compulsory as part of the Anthrax Vaccine Immunization Program (AVIP) for all 2.5 million military service members — including active duty and reserve personnel and civilian contractors.
The DOD has been administering the vaccine to service members since the 1970s.
After the 2001 anthrax scare, the company restarted production of the anthrax vaccine.
The company works with HHS, the Defense Advanced Research Projects Agency, the Biomedical Advanced Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases, to develop “countermeasures,” such as vaccines and therapeutics, for “public health threats.”
Primary purchasers for its anthrax vaccine are the Centers for Disease Control and Prevention, which buys it for the Strategic National Stockpile, and BARDA. Those contracts alone have yielded at least $1 billion for the company.
Its other products include its Narcan brand of naloxone, an opioid antagonist that can reverse opioid overdoses.
Emergent also briefly produced the COVID-19 vaccine for Johnson & Johnson and AstraZeneca, but its plant was shut down in 2021 when it was revealed the company hid likely contamination problems at the plant from FDA inspectors.
It eventually had to destroy 400 million vaccine doses — which led its share price to fall from $133 to $7. The company has been traded publicly since 2006.
Emergent’s stock price, which crashed to $7 per share after its COVID-19 vaccine production debacle, rose 30% after it announced FDA approval of Cyfendus last week.