Anthrax vaccine

Anthrax vaccine. Anthrax is a highly infectious disease caused by a bacterium. Bacillus anthracis spores resist destruction and may be present in the soil for decades, occasionally infecting grazing animals. Human infection occurs by three routes; cutaneous, gastrointestinal and pulmonary. Skin contact with infected animals or the hide, hair or bones of an infected animal may lead to skin infection or cutaneous anthrax; accounting for 95% of all cases. Eating undercooked or raw infected meat can cause gastrointestinal anthrax. Breathing in airborne spores may lead to pulmonary or inhalation anthrax. While untreated cutaneous anthrax has a mortality rate of approximately 20%; inhalation anthrax has a very high (80 to 90%) mortality rate. During the first phase of inhalation anthrax (one to five days after exposure), the patient experiences influenza-like symptoms such as a cough, malaise, fatigue and mild fever. Though symptoms may subside within a few days, they are rapidly followed by a second more severe onset of respiratory distress and fever; likely followed by septic shock and death within a day. Antibiotics are used to treat cutaneous anthrax. Therapy is of limited benefit for pulmonary anthrax, except when given immediately after exposure.

Overview
On April 14, 1966, the Center for Disease Control (CDC) submitted an Investigational New Drug application (IND) for the anthrax vaccine to the Division of Biologics Standards; then part of the National Institutes of Health (NIH) and later transferred to Food and Drug Administration (FDA). The method of preparing this vaccine was similar, but not identical, to the vaccine used in the Brachman et al. controlled field study, conducted in the 1950's.

Both vaccines were based on the immunity induced by the protective antigen (PA). Textile employees and laboratory workers who were vaccinated by the two different methods demonstrated similar peak immune responses (antibody concentration) after the initial three doses. A number of investigational vaccines used by the CDC under this IND were manufactured by the Michigan Department of Public Health (MDPH). Data submitted to the Division of Biologic Standards described the CDC's experience with approximately 16,000 doses of anthrax vaccine from four lots manufactured at MDPH. These MDPH lots were administered to approximately 7,000 study participants. For the four MDPH lots used for vaccinations, local reactions at the immunization site were between 3 and 36% of the initial series and 3 to 33% of the booster; depending on the lot. 3 to 20% reported mild reactions. 1 to 3% reported moderate reactions and less than 1% reported severe reactions. Systemic reactions were reported in four cases during the five-year reporting period. They included fever, chills, nausea and body aches and were reported as transient.

The Division of Biologics Standards determined that data submitted by CDC supported vaccine licensure. In November of 1970, a product license was issued to MDPH to manufacture the anthrax vaccine. Immunization was recommended for persons coming into potential contact with Bacillus anthracis spores or potentially infected animals. The vaccine is administered subcutaneously or under the skin. After the initial dose of .5 ml, doses of .5 ml are administered at two weeks, four weeks, six months, 12 months and 18 months; with yearly boosters. According to an April 1999 Department of Health and Human Services (HHS) report by Kathryn C. Zoon, PhD, there were approximately 130 reported cases of anthrax infection per year at beginning of the 20th century:


 * "In the past decade, there have been years with no reported cases of human anthrax infection in the United States. ...Elsewhere in the world, human anthrax cases continue to be reported, especially in countries with predominately agricultural economies."

The report does not indicate figures for anthrax cases "elsewhere in the world". However, 100 years ago, approximately 35% of Americans were farmers; as opposed to less than 2% today. Also, the majority of American farm animals no longer free graze. See also meat & dairy industry.

Emergent BioSolutions (BioPort)
In November of 1970, the FDA granted an anthrax vaccine license to MDPH (later BioPort Corporation), though neither had conducted a controlled field trial. The data presented in support of the vaccine:


 * Was of a completely different strain of vaccine made by Merck, Sharp, & Dohme.
 * The manufacturing process changed when MDPH took over.
 * The vaccine ingredients were changed.
 * The vaccine was licensed based on the testing of an entirely different vaccine.

Emergent BioSolutions (formerly BioPort Corporation) in Lansing, Michigan is the only manufacturer licensed by FDA to manufacture anthrax vaccine. Originally, the facility was operated by the MDPH. In 1996, the facility became known as the Michigan Biologics Products Institute (MBPI), an entity controlled by the government of Michigan.

In September of 1998, Bioport took over the formerly public MBPI, created in 1996 with a two-year lifespan. Less than a month later, the company gained a $29 million contract with the Department of Defense (DoD) to "manufacture, test, bottle and store the anthrax vaccine."

Lobbying for national immunizations
In 2002, the U.S.' sole manufacturer of the anthrax vaccine launched a lobbying blitz, urging lawmakers to back a national immunization for civilians. BioPort went to Capitol Hill with a report predicting a deadly wave of anthrax attacks; due to the ease of engineering antibiotic-resistant strains.

DoD & Bioport
Regulations allowed the DoD to "provide extraordinary relief" to BioPort Corporation during late FY 1999, in spite of "significant risks." Between 1998 and 2002, the DoD pumped over $130 million into the company, in hopes of stockpiling enough anthrax vaccines for all 2.4 million U.S. soldiers and reservists. The Pentagon continued paying BioPort even after the company repeated failed FDA inspections and was prohibited from shipping any vaccine.

Mandatory experimental vaccinations & related deaths
In 2003, six soldiers filed suit against the government for experimenting on them with the BioPort anthrax vaccine. According to the charges, the vaccine was considered experimental; therefore its mandatory administration was illegal. On Dec. 22, 2003, the US District Court for the District of Columbia ordered the military to stop experimenting on soldiers for dangerous anthrax vaccines. In 2003, army sergeant Rachel Lacey died of complications from the vaccine, according to an autopsy report from the Mayo Clinic. Despite strong evidence that the vaccine was causing pneumonia-like symptoms in military personnel, the Pentagon denied the possibility. Instead, they blamed cigarette smoking as the leading factor. The vaccination is a series of 6 shots over 18 months.

Staff Sgt. Neal B. Erickson Sr. didn't smoke, yet had pneumonia-like symptoms 10 days after his fourth anthrax shot. He required hospitalization 10 days after his next shot; where he tested negative for viruses. The Pentagon referred to the illnesses as a “mysterious pneumonia cluster”. According to Sgt Erickson, there were at least four other cases in his squadron, as well as another hospitalization. There were at least one hundred similar cases as well as multiple deaths; many of which were not investigated.

Thousands of Gulf War I veterans were poisoned by depleted uranium and the same BioPort vaccine under George H.W. Bush and later under Bill Clinton. In October of 2003, 80.3 million tax dollars were spent in ordering VaxGen Inc. to develop an experimental anthrax vaccine. An additional $71.3 million was contracted to Avecia for 3 million doses of a new anthrax vaccine. Within weeks of a court decision to cease mandatory vaccinations, the FDA approved BioPort's vaccine as "“safe and effective”. Judge Emmit Sullivan, who ruled that soldiers should not be used in experimental vaccination programs, issued a subsequent order allowing the Pentagon to resume mandatory vaccinations; a “temporary boost” for BioPort.  Just days before his ruling, the Pentagon ordered a $29.7 million order of anthrax vaccine from BioPort, part of a $245.6 million contract, in anticipation of the reversal.

PR & lobbying a shot in the arm
According to Bob Evans in a December of 2005 article in the Newport News Daily Press, the only licensed U.S. anthrax vaccine maker, BioPort, turned government contracts into "a gold mine ...with help from the "right lobbyists and public relations professionals." In 2002, following questions about vaccine safety and its financial practices, BioPort nearly quadrupled spending on lobbyists (from $30,000 to $110,000) and hired Ruder Finn and Fleishman-Hillard, "high-powered public relations firms staffed by many former government officials." The company began "sponsoring 'public education seminars' and studies."

In September 2002, a report released by "bioterrorism experts" encouraged the government "to purchase millions of doses of BioPort's product." According to Evans, the report was written by either BioPort or its public relations agent. BioSolutions pays $40,000 a year to maintain a website that advertises that it is sponsored by the Partnership for Anthrax Vaccination Education and touts the company's product. In 2005, BioPort won a $122.7 million dollar contract with the HHS.

Vaccines & pharmaceuticals
A vocal minority of high-level doctors and medical experts believe that vaccines have not been proven to prevent disease and in fact, weaken the immune system. In some cases, they cause the disease they are meant to prevent, known as provocation disease. Vaccine manufacturers identify and magnify an ‘epidemic' diseases, whip up a panic and devise and administer just before an epidemic starts to wane naturally. For example, polio, small pox and many other diseases were in a steep decline long before the implementation of immunization programs.

A landmark article published in the Journal of the American Medical Association (JAMA) on April 15, 1998 entitled, "Incidence of Adverse Drug Reactions in Hospitalized Patients", evaluated serious and fatal adverse drug reactions (ADR)s in U.S. hospitals. The study revealed that in 1994, ADRs accounted for 2,216,000 serious events and 106,000 hospital deaths. According to a 2003 comprehensive study of medical peer-review journals and government health statistics, there are an additional 199,000 fatal ADR outpatient deaths in the U.S. annually. , According to the study, there are approximately 783,936 iatrogenic (medically induced) deaths every year in the U.S. Furthermore, the actual figure is estimated to be much higher, as only a fraction (between 5% and 20%) of iatrogenic acts are ever reported.

Researchers from Harvard and Boston Universities concluded that medical measures (drugs and vaccines) accounted for between 1 and 3.5% of the total decline in mortality rate since 1900. Scores of animals were killed in the quest to find cures for tuberculosis, scarlet fever, small pox and diphtheria. Dr. Edward Kass of Harvard Medical School asserts that the primary credit for the virtual eradication of these diseases must go to improvements in public health, sanitation and general standard of living. See also pharmaceutical industry.

SourceWatch articles

 * bioterrorism
 * Centers for Disease Control
 * Department of Defense
 * DynPort
 * Emergent BioSolutions (formerly BioPort Corporation)
 * Food and Drug Administration
 * Meat & Dairy industry
 * Pharmaceutical industry
 * Project BioSense
 * Project BioShield
 * Project BioWatch
 * weapons of mass destruction suspected terrorists

External resources

 * Hearing Before the Military Personnel Subcommittee of the Committee on Armed Services, DoD Anthrax Vaccine Immunization Program (AVIP), 106th Congress, 2nd session, July 2000, Speaker Index.
 * Anthrax and the Vaccine, PBS Online NewsHour, October 1999
 * Anthrax Vaccine Immunization Program (AVIP) Production, AVIP government web site. Contains background and status of BioPort operations (Q & A format), accessed December 2009