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Anthrax Chronology

1500 B.C. God smote the Egyptians with the ten plagues, the fifth of which, dever, gives anthrax to livestock and the sixth, shachean, to humans.

1600s Black Bane kills 60,000 cattle in Europe, later called anthrax from the Greek for burning coal.

1876 German physician Robert Koch identifies the bacterium bacillus anthracis as the cause of anthrax, the first microorganism linked directly to a disease.

1881 Louis Pasteur develops first vaccine to immunize livestock from anthrax using weakened bacterium.

1915 Norwegian police thwart first attempt to use anthrax as a weapon when they arrest a German agent carrying two vials of the bacteria intended to infect reindeer carrying supplies to allied forces in Europe.

1937 Japanese immunologist Ishii Shiro conducts experiments with anthrax on Chinese prisoners in Harbin.

1942 England conducts experiments with anthrax at Gruinard Island off the coast of Scotland poisoning the soil.

1943 United States develops anthrax weapons.

1943 President Roosevelt appoints George W. Merck, the president of Merck Sharp and Dome, to lead the secret government program to develop biological weapons at Fort Detrick in Fredrick, Maryland.

1945 Anthrax outbreak kills one million sheep in Iran

1950's George Wright develops original cutaneous anthrax vaccine which is first produced by Merck Sharp & Dohme.

1950s Government erects building 470 at Fort Detrick, an eight story factory for making anthrax.

1960 United States Army begins Operation Whitecoat testing weopanized anthrax and the anthrax vaccine on Seventh Day Adventists.

1960 Dr. Phillip S. Brachman, Dr. Herman Gold, Dr. Stanley Plotkin, Dr. F. Robert Fekevy, Milton Werrin, and Dr. Norman Ingraham conduct efficacy study for cutaneous anthrax vaccine.

1962 In a report titled "Field Evaluation of Human Anthrax Vaccine," Merck researchers report the vaccine was still highly effective for cutaneous anthrax, though the case study focused only on local and systematic reactions and not long term adverse effects.

1969 In a speech at Fort Detrick, Richard Nixon orders the end of the United States' offensive biological weapons program, stating: "The human race already carries in its hands too many seeds of its own destruction.

1970 U.S. Food and Drug Administration approves anthrax vaccine.

1970 The United States Public Health Service issues the AVA license to the state-owned facility operated by the Michigan Department of Public Health for protection against cutaneous anthrax only.

1970-1990 Only a limited number of individuals receive the AVA as reported by Dr. Kwai Chan's General Accounting Office Report to Congress.

1972 The United States, Soviet Union and more than 100 other nations sign the Biological and Toxin Weapons Convention outlawing the development or stockpiling of biological weapons.

1972 Government establishes United States Army Medical Research Institute of Infectious Diseases, based at Fort Detrick, to develop and research defenses to biological weapons.

1973 FDA publishes standards for making, using and storing anthrax vaccine at 21 CFR Section 620.20.

1978-80 More than 6,000 are infected and as many as 100 killed by human anthrax epidemic in Zimbabwe.

1979 Approximately 68 people die at a Soviet Union military facility in Sverdlovsk when weaponized aerosolized anthrax is accidentally released.

Mid 1980's After the efficacy of the AVA is demonstrated for cutaneous anthrax, the FDA approves the AVA for two limited markets: 1) individuals who may come in contact with animal products or high-risk persons such as veterinarians and others handling potentially infected animals; and 2) individuals engaged in diagnostic or investigational activities using anthrax.

1982 Soviets build the Scientific Experimental and Production Base in Stepnogorsk to manufacture lethal strain of anthrax.

1985 The Division of Biologic Standards, now the Food and Drug Administration, begins licensing vaccines.

1985 The DoD issues a Request for Proposal soliciting the development of a new anthrax vaccine. The Request for Proposal states that there is no vaccine in current use that would safely and effectively protect military personnel against exposure to anthrax.

1985 The FDA publishes a Proposed Rule for a specific product review of the AVA, stating that the vaccine's "efficacy against inhalation anthrax is not well documented."

1988 Iraq begins its biological weapons program as its war with Iran winds down ultimately producing 1000s of gallons of anthrax.

1989 Assistant Secretary of Defense Robert B. Barker writes in a letter to Senator John Glenn that "current vaccines, particularly the anthrax vaccine do not readily lend themselves to use in mass troop immunizations for a variety of reasons�a higher than desirable rate of reactogenicity and, in some cases, lack of strong efficacy against infection by the aerosol route of exposure."

1990 On August 2, 1990, Iraq invades Kuwait.

1990 Army doctors Col. Takafuji and Col. Phillip K. Russell describe the AVA as a "limited use vaccine" and an "unlicensed experimental vaccine" in an article "Military Immunizations," in Infectious Disease Clinics of North America.

1990 The State of Michigan changes the name of the original facility to the Michigan Biologic Products Institute ("MBPI") in order to make the move from state owned and operated to private ownership.

1990 Despite the absence of any proof of safety or efficacy of the AVA, about 150,000 U.S. troops and personnel receive at lease one dose of the AVA during Operations Desert Shield and Desert Storm, purportedly for the purpose of protection against inhalation anthrax if it were used as biological weapons by Iraq.

1990 MBPI changes both the fermenters and the filters used in manufacturing the AVA without notifying the FDA causing a hundred fold increase in the protective antigen levels in vaccine lots.

1990-93 Anthrax is released in Tokyo by the terrorist group Aum Shinrikyo.

1991 Despite the absence of any proof of safety or efficacy of the AVA, about 150,000 of 500,000 U.S. troops and personnel receive at lease one dose of the AVA during Operations Desert Shield and Desert Storm, purportedly for the purpose of protection against inhalation anthrax if it were used as biological weapons by Iraq.

1991 On February 28, 1991, Iraq surrenders; as condition of surrender, UNSCOM inspect Iraqi facilities confirming huge stockpile of weaponized anthrax.

1991 MBPI and the U.S. Army enter into an agreement for the manufacture of the AVA.

1991 In preparation for the Gulf War, U.S. troops receive anthrax vaccine; hundreds later complain of a variety of autoimmune problems given the name "Gulf War Syndrome" and believed by many to be adverse reactions from the vaccine.

1991-2000 Hundreds of Gulf War Veterans complain of a variety of autoimmune problems given the name AGulf War Syndrome@ and believed by many to be adverse reactions to the vaccine.

1991 The U.S. Army, an agency of the DoD, awards MBPI the Commander's Award for Public Service for their supply of the AVA during the Gulf War.

1993 In June 1993, Pentagon creates joint program office for biological defense.

1993 MBPI fails an FDA inspection of its facilities.

1993 The Pentagon's deliberative process of mass vaccination of military personnel with the AVA begins with the development and implementation of DoD's Directive 6205.3, DoD Immunization Program for Biological Warfare Defense.

1993 Ronda Wilson joins the U.S. Army.

1993 AUM Shinrikyo members fail in their attempt to spray anthrax from aerosol device on roof in downtown Tokyo; 2 years later, they release saran gas in Tokyo subway killing 12.

1994 On November 26, 1994, William Perry Deputy Secretary of Defense signs order committing to program ordering troops to be given AVA.

1994 Senate report reveals the sale of Anthrax to Irag during its war with Iran with approval by the U.S. Department of Commerce.

1994 Senate Report 103-97 calls the AVA "investigational."

1995 The FDA issues a warning letter to MBPI requiring it to remedy the violations at its facility.

1995 The Department of the Army contracts with the Science Applications International Corporation ("SAIC") to develop a plan to obtain FDA approval for a license amendment for the AVA in order to add inhalation anthrax exposure to the product license and to enable BioPort to list on the product license that the AVA was effective against inhalation anthrax.

1995 The Army Joint Program Office for Biological Defense notes there was insufficient data to demonstrate protection against inhalation anthrax.

1995 Sandra Larson joins the U.S. Army.

1996 The DoD seeks and receives permission from the FDA to begin vaccinations of all military personnel without obtaining a new licensed indication for the AVA.

1996 As part of the Army/SAIC plan, MBPI submits an IND application in order to modify the product's license to add an indication for inhalation anthrax.

1997 MBPI executes another U.S. Army contract in order to maintain the AVA stockpile.

1997 The FDA sends MBPI a Notice of Intention to Revoke because no real changes had been made to the facility.

1997 MBPI fails another FDA inspection.

1997 Secretary of Defense William Cohen announces the Anthrax Vaccination Immunization Program (AVIP) for all U.S. military personnel.

1997 Internal FDA memo describes use of DoD's use of the AVA as experimental requiring informed consent.

1997-2003 All military personnel, including new recruits, begin receiving the six-shot series of the anthrax vaccination in the following inoculation program: 1) Phase 1: Forces assigned now or rotating to high threat areas in Southwest Asia and Korea; 2) Phase 2: Early deploying forces into high threat areas; 3) Phase 3: Remainder of the force and new recruits; and 4) Phase 4: To Continue the Program, annual booster shots.

1998 Anthrax vaccination plan for all military service members is approved by U.S. Secretary of Defense William Cohen.

1998 The FDA issues a report finding that the manufacturing process for Anthrax was not validated and listed 11 pages of quality control failures for anthrax vaccine production, including reuse of expired vaccine, grossly inadequate testing and use of lots that failed testing.

1998 An FDA Inspection report dated February 28th reports that Lot Number FAVO44, filled on January 7th had an "invalid" potency test on December 8, 1997. Also, Lot No. FAVO31 was partially formulated from sublots contaminated with microorganisms.

1998 Army Secretary Togo West, Jr. takes steps to approve a request to indemnify BioPort against all liability arising from "the unusually hazardous risks associated with potentially severe adverse reactions and the potential lack of efficacy of the AVA." The indemnification concerns, according to Secretary West, were a result of the limited use of the vaccine on too small a scale to permit accurate assessments of types and severities of adverse reactions and, insufficient experience in mass immunization programs to evaluate the efficacy of the vaccine.

1998 BioPort jointly purchases the state owned MBPI with former MBPI lab directors for approximately $24 million.

1998 FDA suspends AVA shipments from BioPort because of questions about the facility's quality control.

1998 Sandra Larson leaves for a year tour of duty at Camp Stanley, South Korea. Sandra Larson receives her first of six AVA injections in the 18-month anthrax series on September 16. The Lot Number for this first AVA injection is FAVO17. On September 30, October 13 and April 6, 1999 Sandra Larson receives her next three AVA injections from Lot Number FAVO17.

1998 Ronda Wilson receives her first AVA injection from Lot Number FAVO36.

1999 Ronda Wilson receives her second AVA injection and immediately thereafter she experiences numerous other symptoms including: unrelenting nausea, stomach pain and seizure-like spasms.

1999 After Ronda Wilson receives her third AVA injection with Lot Number 041 she has significant memory loss and her bowel, small intestine, colon and heart are all damaged.

1999 Sandra Larson receives her fifth AVA injection from Lot Number FAVO 44.

1999 Sandra Larson is relieved of her duties in South Korea and her new orders require her to relocate to Fort Rile, Kansas.

1999 BioPort is still unable to ship the AVA and at BioPort's request the DoD restructures BioPort's contract, providing BioPort with $24.1 million dollars in relief, reducing the number of doses demanded to 4.6 million and agreed to raise the price per dose to $10.64.

1999 Dr. Kathryn Zoon writes to Dr. Sue Bailey, Assistant Secretary of Defense Health Affairs, reiterating her position that the AVIP follow the FDA approved schedule.

1999 BioPort's manufacturing plant is found to have about 30 deficiencies in safety, sterility and consistency.

2000 Office of the Inspector General, DoD, issues an audit report D-2000-105, reporting that over $2 million in taxpayer funds advanced to BioPort were not spent on improvements to vaccine production but spent on office remodeling, furniture for the CEO, parking lot re-paving, unwarranted travel expenses, unsubstantiated consulting costs, and an unrelated medical program. Additionally, senior managers planned on rewarding themselves $1.2 million in bonuses and a retired employee is collecting $10,000/month in severance and consulting fees.

2000 The Full Committee on Government Reform adopts the Subcommittee report recommending suspension of the AVIP.

2000 425,976 service members receive 1,620,793 doses of AVA.

2000 The DoD curtails the anthrax program because of vaccine shortages at Bioport forcing some soldiers to actually suspend vaccination mid-process. Still, BioPort is awarded a new contract which provides for $2-$2.5 million per month to cover costs related to getting the company to pass FDA approval of renovated anthrax production facilities.

2000 BioPort voluntarily recalls the AVA because wrong expiration dates were put on the labels; at the same time, BioPort's scientists seek royalties for their part in changing the anthrax vaccination process.

2000 Sandra Larson receives her sixth and final injection of the AVA from Lot Number FAVO 31 on March 12 2000. Sandra Larson's blood capillaries are bursting and she is experiencing heavy vaginal bleeding. On April 8th she is admitted to the hospital and on April 10th Sandra Larson is put into the intensive care unit at Kansas Medical Center and is diagnosed with aplastic anemia, where her bone marrow had stopped producing blood cells.

2000 On May 2nd, Sandra Larson is supposed to be transferred to Ft. Lewis in order to be treated at Madigan Army Medical Center; however the plane that is transferring her has to make an emergency landing at Travis Air Force Base in California.

2000 On June 12th, breathing through a ventilator, Sandra Larson goes into a coma. On June 14th, as result of the inoculation of the AVA, Sandra Larson dies.

2000 Richard Dunn, a BioPort employee required to take the AVA as a condition of his employment, dies from an adverse reaction to the vaccine.

2001 Ronda Wilson is discharged from the U.S. Army.

2001 In the weeks after the September 11 terrorist attacks on the Pentagon and World Trade Center, letters containing anthrax spores are mailed to American Media in Miami, NBC, ABC, the New York Times, the New York Post and Governor Pataki's office in New York City, and to Senator Daschle's office in Washington D.C. One man dies after inhaling anthrax at the offices of American Media, three postal workers die in Washington D.C., and more than a dozen others are infected with cutaneous anthrax. Some call for the anthrax vaccine to be available for postal workers and the general public.