Anthrax vaccine risks

Congressional Hearings on Anthrax vaccine

Amid anthrax worries, many veterans decry military's vaccination program

Civilians who want the anthrax vaccine but can’t get access may be surprised that a growing coalition of concerned citizens — mostly military — is decrying its use.

Many objecting to the vaccine are military veterans who say they have been severely injured by it. Others were court-martialed for refusing the inoculation. Some say the inoculation is riskier than treating anthrax infection with antibiotics.

Anthrax Vaccine: Controversy Over Safety and Efficacy

The anthrax vaccine in use remains unproven in its ability to stop a lethal dose of weaponized Bacillus anthracis spores, and there are questions about its safety. According to the U.S. Army Medical Research Institute for Infectious Disease (USAMRIID) at Fort Detrick, MD, the anthrax vaccine used by the military was determined to be safe, and adverse reactions were found to occur only at the rate of one per 50,000 doses (less than 0.002%). This has now been revised to a rate of 0.02-0.2% or higher. Moreover, in recent testimony by one of us [M.N.] to the National Academy of Sciences the safety of the anthrax vaccine and the rates of adverse reactions were questioned. Using Dover AFB as an example, the rate of chronic health problems after receiving the anthrax vaccine may be as high as 7%. The difference is that the official rates are for acute reactions only. The Department of Defense (DoD) claims that the rate for vaccine chronic reactions is zero.

A major part of the problem in assessing vaccine safety is in how vaccine adverse effects are reported. Many people who suffer from adverse anthrax vaccine effects are reluctant to step forward to seek medical care, because they have seen their colleagues' concerns dismissed as due to depression or stress. They also fear that they could lose their ability to perform their duties, as a number of the pilots and airmen at Dover AFB are now on DNIF (duties not including flying) status because of undiagnosed illnesses that began after they received their anthrax vaccinations. Lt. Colonel Randy Randolf, director of the U.S. Army’s vaccination program, counters that all vaccines, the anthrax vaccine included, can produce adverse effects, such as soreness, redness, itching, swelling, and lumps at the injection site. He has stated that about 30% of men and 60% of women report these local reactions, but they usually last only a short time. Lt. Col. Randolf further describes that beyond the injection site, from 5% up to 35% of people have noticed muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise, or related symptoms. It is commonly thought that these symptoms go away after a few days, and apparently there has been no completed studies of long-term side effects of anthrax vaccine using active surveillance. Although the DoD began such a study at Tripler Army Medical Center, Honolulu in September, 1998, they have yet to release any preliminary data on long-term problems that developed after anthrax vaccination.

The difference between what military and civilian physicians conclude about adverse reactions and the anthrax vaccine seems to be based on whether you accept that vaccines can cause chronic illnesses beyond the initial reporting period of vaccine adverse effects. The high incidence of unusual chronic health problems at Dover AFB include systemic signs and symptoms, such as vomiting, diarrhea, polyarthralgias, fever, splenic tenderness, cognitive problems, polymyalgias, weakness and numbness, and these problems can occur well after the usual reporting period for vaccine adverse effects. Patients with preexisting autoimmune illnesses such as rheumatoid arthritis, lupus, multiple sclerosis, among others, are probably more likely to suffer a serious adverse reaction, as are those with neurologic disease, such as those who had polio in childhood. Stevens Johnson Syndrome, a severe allergic reaction in which there is loss of epidermis (skin) and the lining of the GI tract, was found in some patients as well as more classic allergic signs and symptoms. Even more serious, many anthrax vaccine recipients report seizures with complete loss of consciousness. Respiratory distress and a variety of pulmonary illnesses have also been reported. Because these types of reactions have rarely been identified with other vaccines and because few of those reporting illness have been subjected to an exhaustive medical evaluation, including sophisticated immunological testing, the mechanisms by which anthrax vaccine may be causing illnesses have not been elucidated. Furthermore, the entire stockpile of anthrax vaccine is owned by the DoD, and none has yet been made available for thorough, independent testing.

The Anthrax Vaccine: Source

One of the most difficult problems in dealing with anthrax vaccine safety is obtaining specific information on the anthrax vaccine and how it was determined to be safe. Most military vaccines in the U.S. are from ‘sole-source’ manufacturers. In the case of FDA-approved vaccines, a number of strict production and safety requirements must be fulfilled, and evidence for effectiveness in humans must be presented to the FDA before approval for production and sale is granted. However, in the case of the anthrax vaccine there seem to be missing elements in this safety net.

The sole producer of the anthrax vaccine was originally Michigan Biologic Products, Inc., a state-owned corporation that obtained U.S. Government approval for the anthrax vaccine at a time when FDA approval was not required. The anthrax vaccine was approved by the Bureau of Biologics at NIH in 1970, two years before efficacy data and approval were required by the FDA. In the case of the anthrax vaccine, long-term safety data were not supplied with the license application, and none has yet been supplied to the FDA. As it turns out, the Bacillus anthracis vaccine now being produced may be different or the procedure for vaccine preparation modified from the original vaccine approved by NIH. The usual requirement is that any new product or modification in preparation must be examined and approved by the FDA, but the FDA has apparently not examined or approved every modification made to the current vaccine for anthrax.

The original license and the facility producing the anthrax vaccine was owned by Michigan Biologic Products, Inc. of the Michigan State Department of Health. The new owner of both is a company called Bioport, Inc., owned by a group of investors lead by Admiral William Crowe, Jr., former head of the Joint Chiefs of Staff, DoD, and Faud El-Hibri, a German citizen of Lebanese descent who has since obtained American citizenship. The facility was sold to Admiral Crowe’s investor group after the DoD decided to vaccinate all of its servicemen and servicewomen against anthrax. Recently Bioport ran into financial problems and negotiated a series of changes in its DoD contract that increases by three-fold the per dose price of the anthrax vaccine supplied to the military. This and other problems have resulted in a congressional investigation into the financial relationship between DoD and the new owners of Bioport, which may constitute a conflict of interest.

Anthrax Vaccine Causes Gulf War Syndrome

A study of Kansas Gulf War veterans was published in 2000 (4).  This study also found that deployment vaccines were related to GWS: 34% of Gulf War veterans met the definition for GWS, while only 4% of non-deployed, non-vaccinated Gulf-era veterans met the definition.  However, 12% of Kansas Gulf-era veterans who were vaccinated in preparation for deployment, but then were not sent to the Gulf, also met the GWS definition.  The paper concluded, "Vaccines used during the war may be a contributing factor." 

Anthrax Vaccine Plagues Dover AFB

Anthrax vaccine report shows spikes in potency

Amid pressure to vaccinate civilians at risk for anthrax, evidence has emerged that unauthorized changes in the vaccine manufacturing process before the Gulf War may have radically boosted the potency of the controversial shots.

Veterans groups and armed services personnel have complained that the anthrax vaccine is unsafe, and they say the new evidence lends credence to their view.

Researchers at the Army's biological warfare defense lab found as much as a 100-fold increase in the concentration of the anthrax vaccine's active ingredient in batches produced after a switch to new filters in 1990.

BioPort faces lawsuit over vaccine

According to the lawsuit, Larson began receiving her six injections in late 1998 and "almost immediately ... began having adverse reactions to the vaccine, including exhaustion and fatigue, skin rashes and numbness and pain in her hands."

When these symptoms did not dissipate, she was admitted to a military hospital, where she later lapsed into a coma and died, the complaint said.

Wilson, a helicopter pilot, also began having adverse reactions "almost immediately" after receiving her inoculations in late 1998, including rapid weight loss and an inability to eat solid foods, the lawsuit alleged. 

How the Anthrax Vaccine Ruined My Life

Thomas J. Colosimo joined the Air Force nearly 11 years ago dreaming of seeing the world and building a strong future for himself. Now, he wonders if he has a future at all.

After taking the anthrax vaccine, Tom Colosimo’s health — and spirit — quickly started to deteriorate.

Still just 29 years old, his once-powerful physique is so withered and frail he must walk with a cane. His boyish looks are marred by bruises and scars, the result of the falls he takes when he unexpectedly passes out. It’s gotten so bad he’s resorted to wearing a hockey helmet around the house.

Life for Colosimo consists of sitting and eating. He sleeps poorly, lives in dread of moments when he slips into delirium, he stumbles over words, his body fails him daily. He has become, he says, a prisoner in his own body.

But unlike sufferers of the mysterious Gulf War illness, whose doctors can’t pinpoint a specific cause for their maladies, Colosimo has medical problems linked to the anthrax vaccine, as publicly acknowledged by Marine Corps Maj. Gen. Randy West, senior adviser to the deputy secretary of defense for chemical and biological protection.

Illegal Vaccine Link to Gulf War Syndrome

The illness known as Gulf war syndrome looks likely to have been caused by an illegal vaccine "booster" given by the Ministry of Defence to protect soldiers against biological weapons, according to the results of a new series of tests.

Scientists in the United States found that symptoms of the illness were the same for service personnel who received the injections whether or not they served in the Gulf.

The common factor for the 275,000 British and US veterans who are ill appears to be a substance called squalene, allegedly used in injections to add to their potency. Such an action would have been illegal. Squalene is not licensed for use on either side of the Atlantic because of potential side effects.

Patients Survey at Dover AFB Indicates Anthrax Vaccine Ills

A list of questions along with a cover letter was sent to the home addresses of 265 squadron members, according to the survey authors. The only members excluded were the administrative workers who had not yet been vaccinated.

Of the 265 surveys sent out, 139 (55 per cent) were returned. The subjects were asked: "From the time you received your first anthrax vaccination, have you started to experience any of the following symptoms?" The numbers following the symptoms are affirmative responses.

·  Ringing in the ears--12

·  Significant hearing loss--3

·  Skin rashes not near injection site--17

·  Itchy skin--21

·  Numbness/loss of sensation in body parts--16

·  Joint and/or muscle pain including arthritis--57

·  Loss of energy/constant tiredness--41

·  Recurring headaches--26

·  Difficulty sleeping--24

·  Nausea, loss of appetite or abdominal pain--9

·  Severe hair loss--8

·  Vertigo--8

·  Balance problems/light-headedness--15

·  Short-term memory loss--34

·  Reduced concentration--36

·  Chills and fever immediately following vaccine--11

·  Other--24

A Soldier's Nightmare

The company that makes the anthrax vaccine says it could protect you from death, from getting the inhaled, fatal form of the anthrax disease. However, WGN uncovered information that shows the vaccine is not without problems.

A woman and her fellow servicemen, who received the vaccine, say they are now living a soldier's nightmare.

"When the joint pain is acting up severely and also the migraines where you just go sit in a dark room and cry," says Robin Hawes.

Three strong, healthy Michigan Air National Guard members who volunteered for duty in the Persian Gulf never made it overseas.

"Imagine having the flu the worst that you could have it and that visits you every week," says Tom Starkweather.

"I felt really fatigued, I was in bed constantly. I couldn't get up. I was tired all the time," says David Churchhill.

Shortly after receiving four of the six required anthrax vaccine shots in 1998 and 1999, the military confirms, nine out of 12 members of the 110th Air Fighter Wing got sick.

(Most of the information on anthrax adverse reactions is not in the medical literature.  However, to see what I've found so far, please click here:)