Embattled Anthrax Vaccine Maker Lands New U.S. Government Contract
Maryland-based Emergent BioSolutions this month signed a new contract with the U.S. Department of Defense (DOD) to supply the U.S. military with its BioThrax anthrax vaccine over at least the next five years, Fierce Pharma reported.
The indefinite-delivery, indefinite-quantity contract, announced Jan. 11 by the company, has a maximum value of $235.8 million. According to Yahoo Finance, “The vaccine is intended for use by all branches of the United States military as pre-exposure prophylaxis (PrEP) for anthrax disease.”
Under the contract, Emergent is guaranteed a $20.1 million purchase, with future orders of an estimated $20 million or more for each of the remaining years of the initial five-year term.
After the initial term, the contract has an option for an additional five-year extension, potentially extending the deal to 2033, according to Fierce Pharma.
BioThrax is the only vaccine approved by the U.S. Food and Drug Administration (FDA) for pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease, Yahoo Finance reported. Another anthrax vaccine in the company’s portfolio, Cyfendus, is used only for post-exposure prophylaxis in adults 18 and over.
According to Yahoo Finance, anthrax is an infectious disease caused by Bacillus anthracis. It occurs naturally in soil, and commonly affects domestic and wild animals.
People can contract anthrax if they come in contact with infected animals or contaminated animal products, through skin contact, ingestion and inhalation, The Defense Post reported. It can cause organ damage, inflammation of the brain and spinal cord, and death.
In a statement, Paul Williams, senior vice president and products head at Emergent, praised the deal.
“As a part of our mission to protect and enhance lives, Emergent is proud to continue supporting and preparing our nation’s service members who have a high risk of exposure to anthrax bacteria by supplying BioThrax vaccine,” he said.
“This new contract award is a testament to the importance of Emergent’s medical countermeasures portfolio, and we look forward to delivering on our commitments to the U.S. DoD,” Williams added.
But some anthrax experts questioned the deal and the safety of the company’s two anthrax vaccines.
Dr. Meryl Nass, a widely recognized bioterrorism and anthrax expert and member of the Children’s Health Defense scientific advisory board, told The Defender that neither vaccine is safe.
“Neither has been shown to be effective against inhalation of anthrax,” she said.
According to Nass, the DOD may say “they needed to maintain a ‘warm manufacturing base’” as a justification for the new contract.
University of Illinois international law professor Francis Boyle, J.D., Ph.D., a bioweapons expert who drafted the Biological Weapons Anti-Terrorism Act of 1989, told The Defender the U.S. government may have proceeded with the contract based on a biological warfare risk it is aware of.
“It does seem to me that the Pentagon is gearing up to fight biological warfare with anthrax. That’s the only reason for that massive contract as I see it,” he said. The U.S. government still maintains stockpiles of Amerithrax, Boyle said, which he described as “super weapons-grade anthrax” that “survives for decades.”
In June 2014, as many as 75 scientists working at Centers for Disease Control and Prevention (CDC) laboratories were treated — and vaccinated — after possible exposure to live anthrax bacteria which, according to The New York Times, “were supposed to have been killed.”
The laboratories were “unequipped to handle” the samples, the Times reported.
“There’s no reason for all these labs to have all this anthrax unless they’re getting ready to use it for biowarfare purposes,” Boyle said.
In October 2022, the Biden administration announced an $88 billion National Biodefense Strategy and Implementation Plan outlining planned responses to future pandemics, public health emergencies and biological threats.
Precedence Research estimates that the global biodefense market size, which totaled $15.5 billion in 2022, will surpass $32.09 billion by 2032, while a 2021 estimate by The Insight Partners stated that the U.S. biodefense market is expected to reach $8.35 billion in 2027, up from $4.11 billion in 2019.
Boyle said that such government programs and spending violate the 1989 act he authored, which “was intended to stop the abuse of DNA genetic engineering and other forms of biological warfare weapons.”
Anthrax vaccines have caused fetal harm, ‘death and disability’
According to Nass, there is no need for an anthrax vaccine because antibiotics can be used as a treatment for exposure.
Nass told The Defender in July 2023 that if someone has a serious anthrax exposure, they typically die within several days if not 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 said at the time, adding that the FDA requirement that the vaccine be given jointly with antibiotics is a tacit admission by the agency that the vaccine “doesn’t work.”
In an October 2020 talk, Nass said that after the 2001 anthrax letter exposures, “thousands of people took antibiotics while only 198 agreed to receive the anthrax vaccine.”
“Not a single person who was exposed to the anthrax letters who took antibiotics for prevention came down with anthrax,” she said at the time.
The FDA’s package insert for BioThrax also indicates several adverse reactions, including arm motion limitation in 63.7% of recipients. Six deaths and 62 serious adverse events were reported in clinical trials for BioThrax.
The insert also notes that Cyfendus, which has the same active ingredient as BioThrax, “can cause fetal harm when administered to a pregnant individual.”
“In an observational study, there were more birth defects in infants born to individuals vaccinated with BioThrax (a licensed anthrax vaccine with the same active ingredient as CYFENDUS) in the first trimester compared to infants born to individuals vaccinated post pregnancy or individuals never vaccinated with BioThrax,” the insert states.
Cyfendus uses two adjuvants, an aluminum adjuvant and a new synthetic adjuvant — CPG7909. And the vaccine 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.
As a result, “Cyfendus can be assumed to have more side effects,” Nass told the Defender.
In July 2023, the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) exercised a $75 million option for the purchase of new doses of Cyfendus. The FDA approved Cyfendus in July. It had previously been available since 2019 under an emergency use authorization (EUA).
Boyle told The Defender that anthrax vaccines were proven during the Gulf War to be deadly.
“I wouldn’t even call them vaccines. I would call them frankenshots,” he said. “The bottom line is that of 500,000 U.S. forces were inoculated with the previous anthrax and Botulism frankenshots, it killed 11,000 and disabled 100,000 members of the U.S. armed forces,” noting figures he cited in his 2005 book, “Biowarfare and Terrorism.”
“And those are lowball figures because the Pentagon still lies about the death and disability from the Gulf War anthrax shots, because they know they committed a Nuremberg crime on their own troops,” Boyle added.
Nass told The Defender in July that she does not believe much has changed with the currently available anthrax vaccines. Referring to Emergent, she said, “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.”
One such example arises from controversies connected to Emergent’s manufacture of the Johnson & Johnson (Janssen) COVID-19 vaccine. In 2021, the company made headlines when it lost a $600 million federal contract after millions of vaccine doses were ruined.
An ingredient mix-up at Emergent’s Baltimore plant may have resulted in the contamination of 15 million doses of Johnson & Johnson’s COVID-19 vaccine, which were discarded, according to an April 2021 FDA report, which also identified a series of other problems at the Baltimore facility.
In May 2021, a U.S. House of Representatives panel investigation revealed taxpayers paid Johnson & Johnson vaccine manufacturer, Emergent BioSolutions, $271 million under vaccine contracts despite “serious deficiencies” at the Baltimore plant.
Nass also told The Defender in July that anthrax vaccines have been tested only on animals, as there are too few anthrax cases worldwide to study its efficacy in people.
Anthrax vaccines may be linked to Gulf War syndrome
A 2002 commentary Nass authored for the American Journal of Public Health also noted a possible connection between anthrax vaccines and Gulf War syndrome.
“The anthrax vaccine was never proven to be safe and effective. It is one cause of Gulf War illnesses, and recent vaccinees report symptoms resembling Gulf War illnesses,” she wrote at the time, adding that “The vaccine’s production has been substandard.”
Peer-reviewed research published in Neuromolecular Medicine in 2007 linked the aluminum adjuvant in the existing anthrax vaccine to Gulf War syndrome, with symptoms including muscle aches, joint pain, dizziness, memory lapses, headaches, fatigue, insomnia, emotional disorders, posttraumatic stress reactions, headaches and memory loss.
It also noted that anthrax adverse reactions were very similar to Gulf War illness symptoms and that many veterans reported the vaccine as the cause of this illness, which they also reported in congressional hearings, according to Nass.
During her October 2020 talk, Nass said, “The vaccines were given to at least 150,000 soldiers,” during the Gulf War, while “about 25% of soldiers sent to the Gulf developed Gulf War syndrome.”
“While it was never proven what caused this, questions were raised about the role of vaccines both in the U.S. and the U.K. Several studies showed that the more vaccines a soldier received, the likelier they were to develop Gulf War Syndrome … but these studies were ignored in the post-Gulf War push to make troops impermeable to biological warfare,” Nass said at the time.
Boyle agreed that there is a connection between the anthrax vaccines and Gulf War syndrome.
Noting that the U.S. military had mandated the vaccine at the time for its service members, he said, “I still get calls today from veterans suffering from Gulf War syndrome and asking me for advice where they can get, because they can’t get proper treatment at the Veterans Administration Hospital because they get lied to. It’s that simple.”
“They really have to go into the private sector to get proper treatment,” Boyle added.
‘Odd relationship’ between Emergent, DOD
Emergent works with the U.S. Department of Health and Human Services, the Defense Advanced Research Projects Agency, 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 CDC, which buys it for the Strategic National Stockpile, and BARDA. Those contracts alone have yielded at least $1 billion for the company.
According to Fierce Pharma, “Emergent has been a long-time supplier of anthrax countermeasures to the U.S. government. Its procurement deals have included a CDC contract worth up to $911 million in 2016 and a $258 million contract modification from the Office of the Assistant Secretary for Preparedness and Response in 2020.”
And according to Yahoo Finance, “Emergent derives a substantial portion of its revenues from sales of its anthrax and smallpox vaccines to the U.S. government, which the latter procures for the strategic national stockpile,” while also selling vaccines to domestic and international non-governmental organizations and foreign governments.
Nass told The Defender, “There has been an odd relationship between this company and the DOD since the company was formed in 1998 as BioPort and was given a full indemnity by the Secretary of the Army the day before the company purchased the Michigan anthrax manufacturing facility.”
“The company has been allowed higher profits and worse quality than other products purchased by the military,” Nass added.
Investigative reporter Whitney Webb previously discovered a direct link between Robert Kadlec, who served as the top bioterror advisor to the Pentagon prior to the 2001 anthrax attacks, and Emergent BioSolutions, the Strategic National Stockpile, the 2001 anthrax attacks and the Dark Winter simulation of an anthrax attack.
Kadlec participated in the June 2001 Dark Winter simulation, helped establish the Strategic National Stockpile and has directly advised Emergent BioSolutions, among other Big Pharma companies.
Emergent was founded in 1998, originally as BioPort, to distribute and produce the anthrax vaccine for the U.S. military, taking over the assets of the state-owned Michigan Biologic Products Institute.
The anthrax vaccine was developed and in limited use in the military since 1970.
Emergent reached its financial zenith early in the pandemic after earning lucrative contracts to produce Johnson & Johnson and AstraZeneca COVID-19 vaccines.
Nass told The Defender in July that in 1997, the 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 subsequently implemented AVIP in 1998.
Reports of adverse reactions and dissent on the part of service members led to congressional hearings and in early 2000, the House Committee on Government Reform recommended halting the mandatory program, although it was not officially halted.
As of 2000, more than 500,000 service members had received at least one dose of the vaccine, which was designed to be administered in six doses.
The plant where the government produced the anthrax vaccine faced a series of regulatory issues and was closed in 1997, according to Nass.
When BioPort acquired the plant from the state-owned Michigan Biologic Products Institute in 1998, it rebuilt it, but it was not FDA-authorized to produce the vaccine. So for a period, the vaccines were unavailable.
Then, starting on Sept. 18, 2001 — a week after the 9/11 attacks — media outlets began reporting that a sophisticated, weaponized and fatal form of anthrax had been sent via mail to numerous news outlets and American politicians. These letters continued to appear over the next six weeks.
Subsequently, the media and figures such as John McCain linked the anthrax to Saddam Hussein in Iraq. In 2008, the FBI accused U.S. Army scientist Bruce Ivins of being responsible for the attacks, although Ivins took his own life before he could be prosecuted. The FBI’s claims are widely doubted and its evidence has been questioned.
The Government Office of Accountability (GAO) and the National Academies of Sciences, Engineering, and Medicines also found that the FBI lacked data to back its claims.
Yet, fears arising from the anthrax letters helped inspire the Patriot Act and led to calls to continue producing the anthrax vaccine and administering it to military service members.
In 2002, shortly after the FDA approved BioPort’s new vaccine plant, the GAO issued a report to Congress on the AVIP, noting a significant number of adverse reactions to the vaccine — more than double the rate reported by the manufacturer — along with a mass exodus of military pilots and other military personnel who refused the mandate.
From 2000 to 2018, the military anthrax mandate was challenged several times in court for lacking FDA approval and licensure, and for lacking proven potency against fatal inhalation of anthrax. During this time, the DOD restricted the anthrax vaccine to a smaller group of “at-risk troops” and halted and resumed the program several times.
Prior to 2001, the DOD concluded that biological agents such as anthrax were not a threat for mass casualties due to the limited number of countries with the expertise and sophistication required to weaponize and disseminate anthrax.
According to an investigation by Webb, the 2001 anthrax attacks also rescued Emergent, then BioPort, from certain financial ruin.
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
January 30, 2024 -
Posted by aletho |
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