Before You Take the Anthrax Vaccine

Federal court injunction

FDA emergency use authorization

FDA-approved package insert on deaths and chronic illness

DHHS Vaccine Adverse Event Reporting System

FDA letter on additional deaths

DoD National Vaccine Healthcare Center

News articles on deaths and chronic illnesses

INTRODUCTION

 

The Anthrax Vaccine Immunization Program (AVIP) has currently resumed to a mandatory program for all of Centcom and Korean Peninsula. Another lawsuit has been introduced in the federal courts challenging the mandate. The injunction was lifted from the voluntary program when the FDA licensed the anthrax vaccine (biothrax) for inhalation anthrax in December of 2005; it wasn’t until February of 2006 that the Department of Defense could legally mandate the AVIP.

In order to determine MBVP’s mission and intent, it is important to understand where we have already been.

BACKGROUND

 

On October 27, 2004, due to the lawsuit Doe v. Rumsfeld, an injunction was placed on the mandatory AVIP.  At this time, DoD had two options. They could have gone to the president to have service members’ rights to informed consent revoked, or, they could have invoked the Emergency Use Authorization (EUA), through the FDA under Project Bioshield and make the program voluntary. DoD opted for the EUA option.  The logical explanation to this would be that under the EUA, though the anthrax vaccine would still be voluntary, a service member/contractor would not have to be given informed consent, meaning that the risks of the anthrax vaccine could be withheld, unlike when the anthrax mail attacks occurred and informed consent was provided to the postal workers.

DoD was however required by the EUA (PDF), (Text) to advise service members of their right to refuse the anthrax vaccine. DoD acknowledged that only half of eligible service members volunteered to receive the anthrax vaccine. The FDA authorization which allowed for voluntary anthrax immunizations stated:

"...Individuals who refuse anthrax vaccination will not be punished. Refusal may not be grounds for any disciplinary action under the Uniform Code of Military Justice. Refusal may not be grounds for any adverse personnel action. Nor would either military or civilian personnel be considered non-deployable or processed for separation based on refusal of anthrax vaccination. There may be no penalty or loss of entitlement for refusing anthrax vaccination."

BACKGROUND DOCUMENTATION

 

1) Federal court injunction. On April 6, 2005 federal Judge Emmett Sullivan in District Court, Washington D.C., issued an order allowing DoD to conduct voluntary anthrax immunizations - but without informed consent. To view the court order, click here. This was a modification of the permanent injunction Judge Sullivan issued against mandatory DoD anthrax vaccination program on October 27, 2004 because the FDA had never properly licensed the vaccine in accordance with the federal Food Drug and Cosmetic Act.

 

By these court orders and related federal law (10 USC 1107), servicemembers could not be forced or ordered by military authority to receive the anthrax vaccination (or any other experimental vaccine) not fully licensed by the FDA unless the President signed a waiver of your right to informed consent. Neither President Clinton nor President Bush has ever done so.

The Department of Justice is currently appealing Judge Sullivan's injunction on behalf of Defendants DoD, HHS and FDA. Plaintiffs have filed a response in an attempt to keep the anthrax vaccine voluntary. The Washington, DC Circuit Court of Appeals is adjudicating the appeal and it is uncertain how long the court will take to rule.

 

2) FDA emergency use authorization (EUA). After DoD was enjoined from illegally using the anthrax vaccine on October 27, 2004, the Pentagon attempted an end-run around the court order. DoD used a new law -- the 2004 Project Bioshield Act -- to circumvent the permanent injunction. Section 4 of the Bioshield Act modified the federal Food Drug and Cosmetic Act to allow use of "unapproved products" and "approved products for an unapproved use" in response to a declared emergency due to actual or "potential" biological warfare or bioterror threats.

An alternative to using the Bioshield Act to begin a voluntary shot program, DoD could have lawfully continued mandatory anthrax vaccinations simply by going to the President and asking him to sign an executive order waiving service members rights of informed consent. But this would have made the Commander-in-Chief accountable for the deaths and illnesses associated with the anthrax vaccine.  Instead DoD, HHS and FDA used the new Bioshield Act in response to an anthrax "emergency."

So, just two months after the CIA Iraq Survey Group found no weaponized biological warfare agents in Iraq, former Deputy Secretary of Defense Paul Wolfowitz sent a letter on December 10, 2004 to former HHS Secretary Tommy Thompson asserting a threat from anthrax in CENTCOM and Korea.

On January 14, 2005 former HHS Secretary Thompson issued an emergency declaration in response to Wolfowitz anthrax threat assertion.  Thompson then immediately retired from HHS to become CEO of a biodefense company, Logistics Health, Inc.  The declared anthrax "emergency" allowed FDA to issued an "emergency use authorization" allowing voluntary anthrax immunizations without informed consent. This was first published on February 2, 2005, (PDF), (Text) and was subsequently extended on August 3, 2005 (PDF), (Text). (The former assistant to the Secretary of HHS, Jerome Hauer, then went on to become a board of director to Emergent Biosolutions.)

On July 11, 2005 DoD requested FDA to extend the EUA because the FDA and the manufacturer, BioPort, were still unable to meet the regulatory requirements to fully license the anthrax vaccine. Prior to the court injunction, FDA allowed DoD to illegally use the vaccine as a "fully licensed" product for 32 years.

3) FDA-approved package insert. While DoD was required by court order to conduct a voluntary anthrax immunization program, it was not required by the EUA issued pursuant to the Bioshield Act to provide recipients informed consent. This means that readily available, credible information on adverse reactions, including deaths and chronic illnesses associated with the vaccine, were not (and is not) shown to service members who volunteered to take it.

One important source of this information is the FDA-approved package insert that manufacturers are required to issue for any drug or vaccine. DoD was required by the EUA to provide copies of the anthrax vaccine insert to military medical personnel, but not to recipients. If you are considering receiving the anthrax vaccine, ask for a copy and read it. If you are denied a copy of the FDA-approved package insert by military medical personnel please contact MBVP.

The DoD Trifold Brochure which was required by the FDA to be issued to volunteers contained (and currently contains) no information about the chronic autoimmune disorders described in the FDA-approved package insert, and no specific information about the risk of birth defects. This information in the current (Jan 2002) FDA-approved package insert states:

WARNINGS

Preliminary results of a recent unpublished retrospective study of infants born to women in the U.S. military service worldwide in 1998 and 1999 suggest that the vaccine may be linked with an increase in the number of birth defects when given during pregnancy (unpublished data, Department of Defense). Although these data are unconfirmed, pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. Animal reproduction studies have not been conducted with BioThrax.

Post Licensure Adverse Event Surveillance

Data regarding potential adverse events following anthrax vaccination are available from the Vaccine Adverse Event Reporting System (VAERS). The report of an adverse event to VAERS is not proof that a vaccine caused the event. Because of the limitations of spontaneous reporting systems, determining causality for specific types of adverse events, with the exception of injection-site reactions, is often not possible using VAERS data alone. The following four paragraphs describe spontaneous reports of adverse events, without regard to causality.

From 1990 to October 2001, over 2 million doses of BioThrax have been administered in the United States. Through October 2001, VAERS received approximately 1850 spontaneous reports of adverse events. The most frequently reported adverse events were erythema, headache, arthralgia, fatigue, fever, peripheral swelling, pruritus, nausea, injection site edema, pain/tenderness and dizziness. Approximately 6% of the reported events were listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening.

The serious adverse events most frequently reported were in the following body system categories: general disorders and administration site conditions, nervous system disorders, skin and subcutaneous tissue disorders, and musculoskeletal, connective tissue and bone disorders. Anaphylaxis and/or other generalized hypersensitivity reactions, as well as serious local reactions, were reported to occur occasionally following administration of BioThrax. None of these hypersensitivity reactions have been fatal.

Other infrequently reported serious adverse events that have occurred in persons who have received BioThrax have included: cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.

Reports of fatalities included: sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma (1).

4) DHHS Vaccine Adverse Event Reporting System (VAERS). The current version of the FDA-approved package insert was extensively revised in January 2002 to include deaths, pregnancy risks and chronic autoimmune illnesses associated with the BioPort anthrax vaccine. This was a significant revision from the previous (March 1999) version, which contained none of these risks. The changes were made because of the experience gained using the vaccine on military service members from 1998-2001 to include reports submitted to the DHHS Vaccine Adverse Event Reporting System (VAERS).

After seven highly critical Congressional hearings, in October 1999 DoD issued an explicit policy requirement for military healthcare personnel to file VAERS reports whenever a possible adverse event occurs. After two critical Congressional hearings in October 2000, each of the Services issued their own policy guidance again requiring VAERS reports to be filed (see Army memo, Navy memo, Air Force memo). However, since 1999 DoD medical personnel have continued to refuse to submit VAERS reports, even when specifically asked by sick military service members or their dependents/next-of-kin.

Since the inception of the DoD anthrax vaccine immunization program (AVIP), no military medical personnel has ever been punished for failure to file the VAERS reports in accordance with DOD policy. However, during this entire period DoD had used underreporting of adverse reactions to VAERS to attempt to "prove" the safety of anthrax vaccine. In response, in an April 2000 Congressional report on AVIP the House Government Reform Committee observed:

"...Preposterously low adverse report rates generated by DOD point to a program far more concerned with public relations than effective force protection or the practice of medicine." (House Report 106-556, April 2000).

Citing VAERS data provided by NVIC, on June 23, 2005 the Hartford Courant reported (link):

"....in 2003, there were 16,869 federal adverse reaction reports for all vaccines and of those, 1,068 were for the anthrax vaccine. The anthrax vaccine drew more than 6 percent of all vaccine complaints...even though anthrax vaccinations represented less than 1 percent of an estimated 100 million immunizations of all types administered that year....For last year [2004]...there were 15,488 federal adverse reaction reports for all vaccines, and 806 for anthrax, or 5.2 percent of the total."

5) FDA letter on additional deaths. On December 22, 2004 FDA quietly added a letter to the anthrax vaccine regulatory docket acknowledging that the number of deaths related to the anthrax vaccine had increased from six (6) to sixteen (16). The three FDA employees who wrote the letter denied any causal association with anthrax vaccine, but also made willful omissions concerning the circumstances related to the 10 additional deaths.

FDA has not required the manufacturer, BioPort Corp., to revise the FDA-approved package insert to reflect these additional 10 deaths.

FDA has also not required DoD to inform service members who volunteer to take the anthrax vaccine about these 16 deaths. The DoD Trifold Brochure that was required by FDA to be issued to volunteers contained no information about any deaths associated with anthrax vaccine.

FDA and DoD are aware of even more deaths -- beyond the 16 -- associated with the anthrax vaccine but have not acknowledged them. 

 

6) DoD National Vaccine Healthcare Center. After the extensive controversy over the anthrax vaccine in 1999-2000, Congress directed that DoD and CDC set up the National Vaccine Healthcare Center (VHC) to treat those made ill by vaccines. The main VHC is at Walter Reed Army Medical Center, with three satellites operated by the Army, Navy and Air Force.

 

The VHC’s have developed an extensive set of "Clinical Guidelines for Managing Adverse Events after Vaccination" for military healthcare providers to treat adverse reactions. Few military physicians seem to be aware of, or use, the VHC’s or these Clinical Guidelines, even though there are explicit DoD, Army, and Air Force directives to do so.

In 2003-2004, the VHCs diagnosed and treated over 1,200 serious adverse events related to immunization, mostly from anthrax and smallpox vaccines, and also conducted over 139,000 telephone or email consultations in 2003 alone. Despite the demand for the VHC’s services, DoD has threatened the VHC's funding since these centers have developed clear evidence that the anthrax vaccine is associated with chronic autoimmune disease.

7) News articles on deaths and chronic illness. Hundreds of news articles have been published about all aspects of the DoD anthrax vaccine program: policy, law, science, and medicine. Some of these articles -- from a diverse collection of credible media outlets -- contain descriptions of the chronic autoimmune illnesses and deaths associated with the anthrax vaccine. You will find none of these articles on the DoD anthrax vaccine website, although some of them have been carried in the "Early Bird", the Pentagon's daily news digest.

We have provided links to the best of these articles related to the safety of the anthrax vaccine and suggest you read each of them before taking the anthrax vaccine. The articles are listed most-recent first: 

Chronic Illness articles

Secret IDF Anthrax Experiment Participants Develop Illnesses, May 15, 2007

(It is unknown which participant received which country’s vaccine)

 

Secret Shot (Video Clip), May 14, 2007

 

Anthrax Vaccine – The Killer? (Video Clip), April 2007

 

Pentagon Conducting Research into Adverse Events of Anthrax Vaccine, March 27, 2007

 

Mandatory anthrax vaccinations raise concerns, McClatchy Newspapers, Fri, Dec. 22, 2006

 

Vaccine Ruined his Health, Career, Former Airman Claims, December 2006

 

Mother’s Quest for Answers into Sons Death Continues, December 2006

 

Experts Warn of Potential Adverse Health Effects From AVA Anthrax Vaccine, October 2006

 

Poisoning U.S. Troops: Anthrax, Lies and Vaccines, October 2006

 

Jesse Lusian, age 24, died Sep 2nd, complications from anthrax vaccine, September 2006

 

How a Company Cashed in on Anthrax, The Daily Press, December 2005

 

'The Man Had Never Been Sick', The Daily Press, December 2005

 

'Still a Little Unclear What She Died From', The Daily Press, December 2005

 

'They Gave Me An order ... and I Refused', The Daily Press, December 2005

 

'I'll Just Stay on it as Long as I Can ...' The Daily Press, December 2005

 

'We Wish it Didn't Happen at All’, The Daily Press, December 2005

'Young' Men got Lou Gehrig's Disease, The Daily Press, December 2005

 

'I'd Known that Kid ... That Wasn't Him', The Daily Press, December 2005

 

An Incomplete Picture, The Daily Press, December 2005

 

Special Report: Anthrax Puzzle, The Daily Press, December 2005

 

Anthrax Vaccine Costs High, Yet Uncertainties Are Many, Newsday, November 2005

 

Ky. Air Guardsmen Say Anthrax Vaccine Caused Ongoing Health Problems, Wave 3 TV Kentucky, November 2005

 

A Shot in the Dark?, Newsday, November 2005

 

Soldier Falls Ill After Taking Vaccine Shots, Oklahoma News, September 2005

 

Anthrax Vaccine Under Fire, Kansas City Star, July 2005

 

Why Did He Die?, Globe Gazette, June 2005

 

Military Vaccines Trigger Special Treatment for 1,200, Global Security Newswire, May 2005

 

Chicago Attorney Wants Anthrax Vaccines Stopped, NWI Times, April 2005

 

Soldiers Fear the Needle, Village Voice, March 2005

 

Airman: Vaccine Caused Illness, Fayette Observer, January 2005

 

The Needle and the Damage Done - Vaccinating America's Soldiers, Vietnam Veteran Magazine, January 2005

 

CNN TRANSCRIPT, Interview with Rusty Yates, CNN, December 2004

 

Airman Seeks Answers After Heart Transplant, Air Force Times, November 2004

 

Man Claims Anthrax Vaccine Almost Killed Him, First Coast News, November 2004

 

Victims of Vaccine?, Charlotte Observer, September 2004

 

The Shots of War, St. Petersburg Times, September 2004

 

‘That Shot Messed Him Up’, Army Times, August 2004

 

Hunting for a Link Between Anthrax Shots and Illness, Navy Times, March 2004

 

Growing Doubts on Vaccine in Military, Washington Post, March 2004

 

Military Vaccine Flattens GI, CBS News, March 2004

http://www.cbsnews.com/stories/2004/03/01/eveningnews/main603284.shtml

 

Some Await Anthrax Shot Antidote, The Daily News, Jacksonville NC, January 2004

 

Mandatory Anthrax Shots Stir Health Fears, Sap Morale, USA Today, December 2003

http://www.usatoday.com/news/opinion/editorials/2003-12-11-our-view_x.htm

 

Some Troops Blame Mandatory Anthrax Vaccine for Disabilities, The Orlando Sentinel, December 2003

 

Dearly Deported, Salon, December 2003

 

A Shot in the Dark, Salon, December 2003

 

Bitter medicine, “A reaction to vaccinations, including anthrax, probably killed 22-year-old Rachael Lacy”, Salon, December 2003

http://dir.salon.com/story/news/feature/2003/12/10/death/index_np.html

 

Ill airman: ‘Wounded by my Country, Manchester (NH) Union-Leader, October 2003

 

Widow Fears Pentagon 'Lying' on Pneumonia, UPI, August 2003

 

Questions Mount Over Anthrax Shot, CBS Evening News, June 2003

 

Anthrax Vaccine a Deadly Defense?, Northwest Indiana Times, June 2003

 

The Needle and the Damage Done, London Times, November 2002

 

Anthrax Vaccine May Increase Incidence of Birth Defects for Pregnant Women, Wall Street Journal, January 2002

 

The Public May Have a New Urge for Anthrax Vaccinations, But Some Military Vets Contend their Injections Ruined their Lives, The American Lawyer, January 2002

 

Injecting Doubt: Worries About Safety Of Its Anthrax Vaccine Put the Army in a Bind --- Soldiers Ordered Inoculated Against Biological Threat Claim Harsh Side Effects --- The Threat of Court-Martial, The Wall Street Journal, October 2001

 

Amid Anthrax Worries, Many Veterans Decry Military's Vaccination Program, Stars and Stripes, October 2001

 

‘A Prisoner in his own Body’, Air Force Times, August 2001

 

How the Anthrax Vaccine Ruined My Life, Air Force Times, August 2001

 

GI Thinks Anthrax Vaccine is Responsible for Illness, Fayetteville Observer, February 2000

 

Articles on anthrax vaccine 2001-2005, Global Security News, UPI, CBS News

 

Medical Journals

 

An Assessment of the Safety of the Anthrax Vaccine. A letter Report by the Institute of Medicine (IOM). "Conclusions of Human Studies.... There is a paucity of published peer-reviewed literature on the safety of the anthrax vaccine."

http://newton.nap.edu/html/anthrax_vaccine/

 

An overview of adverse events reported by participants in CDC's anthrax vaccine and antimicrobial availability program
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15717323&query_hl=106



Anthrax vaccination and joint related adverse reactions in light of biological warfare scenarios
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12051402&query_hl=2


Anti-Squalene Antibodies Link Gulf War Syndrome to Anthrax Vaccine

"Data published in the February 2000 and August 2002 issues of Experimental and Molecular Pathology strongly suggests that Gulf War Syndrome is caused by a vaccine contaminated with squalene.”

http://www.autoimmune.com/GWSGen.html

 

Antibodies to squalene in recipients of anthrax vaccine
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12127050&query_hl=74


Comments on the Institute of Medicine's 2002 report on the safety of anthrax vaccine
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12353779&query_hl=74


Delayed life-threatening reaction to anthrax vaccine
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11327232&query_hl=74


Gastrointestinal adverse reactions following anthrax vaccination: an analysis of the Vaccine Adverse Events Reporting System (VAERS) database
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15143911


Hypersensitivity pneumonitis following anthrax vaccination
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12171861&query_hl=74


Inflammatory causes of gastroparesis: report of five cases
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12498282&dopt=Abstract


K-State Researchers Find "Significant" Association Between Anthrax Vaccination, Medication and Health Problems of Gulf War Veterans

http://www.mediarelations.ksu.edu/WEB/News/NewsReleases/gulfanthrax50602.html

 

Lymphocytic vasculitis associated with the anthrax vaccine: case report and review of anthrax vaccination
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14585454&dopt=Abstract&itool=iconabstr


Oral pemphigus vulgaris after anthrax vaccine administration: association or
coincidence
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14699385&dopt=Abstract


Stevens-Johnson syndrome after immunization with smallpox, anthrax, and tetanus vaccines
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15357044&query_hl=22

 

 

The Anthrax Vaccine: Is It Safe? Does It Work?

Institute of Medicine. The IOM "committee also concluded that AVA is "reasonably safe".... The committee concluded, however, that a new vaccine, developed according to more modern principles of vaccinology, is urgently needed."

http://www.nap.edu/books/0309083095/html

 

The Anthrax Vaccine: Is it Safe? Does it Work?

 

Comments on the Institute of Medicine's 2002 report on the safety of anthrax vaccine. "Institute of Medicine ignored evidence of several recent research studies from three different nations that have implicated vaccines, often including anthrax vaccine, in the epidemiology of Gulf War Illnesses."

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12353779&dopt=Abstract&itool=iconabstr

 

Treatment of anthrax infection with combination of ciprofloxacin and antibodies to protective antigen of Bacillus anthracis
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14734189&query_hl=22


20th Anniversary Edition of Jordan Report: “The efficacy of AVA for preexposure vaccination against pulmonary anthrax has only been demonstrated in animal models.”