The FDA's new label (2002) on the anthrax vaccine admits to a systemic averse reaction rate of between 5% and 35% - whereas previously, the DoD claimed it was a mere .02%. Since then, the GAO (Government Accounting Office, a watch-dog agency) has come out with a new report estimating the systemic adverse reaction rate is probably as high as 85%. In addition, it is known that women have twice the adverse reaction rate as men. The GAO also issued a 2001 report that of the Guard and Reserve units forced to take the vaccine, fully 25% of the pilots resigned or obtained transfers out of their units rather than take the vaccine and jeopardize their civilian flying careers.

The anthrax vaccine was never originally licensed for use against aerosolized anthrax, and thus was used on our troops illegally up until December, 2003. Just eight days after the Dec. 22, 2003 decision by federal Judge Emmett Sullivan's that orders to take the vaccine were illegal, the FDA issued a ruling that it was both legal and safe - based on animal data. 

The anthrax vaccine was originally licensed based on data from a different vaccine. The only safety/efficacy study ever done on human beings was done on that different vaccine. The FDA and DoD have also previously admitted that efficacy based on animal studies against inhalation is problematic because no proven correlate of immunity between animals and humans exists for anthrax infection. The anthrax vaccine protocol originally called for 3 shots only; the change to a series of 6 shots with annual boosters was done with no foundation in research or fact. The label was actually changed to reflect the protocol then in practice; the protocol was not dictated by instructions on the label.

BioPort, the original manufacturer of the vaccine, changed its filtering and fermenting equipment in 1991 without notifying the FDA. The result was a 100-fold increase in the potency of the vaccine. It was used anyway. BioPort also produced non-sterile and contaminated vaccine and changed expiration dates on labels of some of the vaccine lots to portray false expiration dates. BioPort's was issued a new contract with the government to produce more anthrax vaccine in the week between Judge Sullivan's ruling and the FDA declaration that the vaccine is legal. Strangely enough, although the government has awarded contracts to several other companies to produce a new and better anthrax vaccine (see "Vaccines in Development" on this web site), as of Oct. 16, 2006, the same old BioPort brew is going to again be mandated for the troops.

A Kansas State University Study has definitely pointed to the anthrax vaccine as one of the major components of Gulf War Syndrome. An adjuvant, or vaccine booster, called squalene is present in an unknown number of lots of the anthrax vaccine. Though its presence was long denied by the DoD, FDA testing eventually proved its presence in at least five lots, possibly more. The use. of squalene as an adjuvant for human beings is illegal in both the U.S. and Great Britain. It is known to be a primary cause of severe arthritis and other debilitating conditions when injected. Micoplasma is also present in the vaccine. Mycoplasma are the smallest of free-living organisms, and can reproduce outside of living cells. They can cause chronic inflammatory diseases of the respiratory system, urogenital tract, and joints. The most common human illnesses caused by mycoplasma are due to infection with M. pneumoniae, which is responsible for 10-20% of all pneumonias. This type of pneumonia is also called atypical pneumonia, walking pneumonia, or community-acquired pneumonia. Infection moves easily among people in close contact because it is spread primarily when infected droplets circulate in the air (that is, become aerosolized), usually due to coughing, spitting, or sneezing. (Source: Gale Encyclopedia of Medicine online)

SMALLPOX -
Smallpox, one of the deadliest diseases to hit mankind, was eradicated by 1977. Many credit the smallpox vaccine, yet the vaccine itself is known to be dangerously reactive. Again, there is a debate as to how much of a threat smallpox may be, when used as a biological weapon - and just who may have the capabilities of using it.

The Department of Defense now makes the smallpox vaccine another mandatory vaccine for our troops facing certain deployments. And yet...

1. the old vaccine was never subjected to controlled clinical trials
2. the new vaccine will not have to be proven effective in humans
3. standards for safety will be lowered to fast-track production
4. vaccine manufacturers, as well as healthcare providers -- physicians -- will be protected from liability for any vaccine-induced injuries or deaths, which are likely to occur

Vaccines under development for our military troops:

Avian (Bird Flu) Flu Vaccine 
Bird flu is an infection caused by avian (bird) influenza (flu) viruses. These flu viruses occur naturally among birds. Wild birds worldwide carry the viruses in their intestines, but usually do not get sick from them. However, bird flu is very contagious among birds and can make some domesticated birds, including chickens, ducks, and turkeys, very sick and kill them. Bird flu viruses do not usually infect humans, but several cases of human infection with bird flu viruses have occurred since 1997; Avant and GlaxoSmithKline Pharmaceutical companies are working on a vaccine to prevent bioterrorist Bird Flu nifection.

Ebola Vaccine
The Ebola virus is one of the few viruses capable of causing hemorrhagic fever, a severe, often-fatal disease in humans characterised by high fever and massive internal bleeding. Other hemorrhagic fevers include Marburg and Lassa. One of the most lethal of all viral diseases, Ebola causes death in 50% to 80% of all cases. Ebola outbreaks occur regularly in tropical Africa, affecting both human and great ape populations. Since the Ebola virus was first recognized, approximately 2,000 cases with over 1,200 deaths have been reported. Ebola usually appears in sporadic outbreaks, and spreads within a health-care setting. Because of the high disease-related mortality rates and lack of any vaccine or therapy, the Ebola virus is on the Centers for Disease Control (CDC), National Institute of Allergy and Infectious Diseases (NIAID) and U.S. Department of Defense Category "A" list of bioterror agents, together with smallpox and anthrax.

Vical Incorporated announced in February 2006 that an Ebola vaccine candidate administered using Vical's proprietary DNA delivery technology was safe and well tolerated, and produced both antibody and T-cell Ebola-specific responses in all healthy volunteers who received the full 3 doses of vaccine. The Phase 1, randomized, placebo-controlled, dose-escalation study, the first human trial for any Ebola vaccine, was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and conducted at the NIH Clinical Center. The data were presented at the American Society for Microbiology (ASM) 2006 Biodefense Research Meeting in Washington, D.C., by Julie E. Martin, D.O., a trial investigator and research scientist at NIAID's Dale and Betty Bumpers Vaccine Research Center (VRC), which developed the vaccine. In June 2007, it was announced that U.S. scientists have found a topical respiratory tract vaccine, tested for the first time in primates, might protect against the Ebola virus. That virus produces a highly contagious form of severe hemorrhagic fever with a high mortality rate in humans. It's also considered to be a high risk for use as a biological weapon. Now researchers from the National Institutes of Health have discovered existing intranasal vaccines might prove vital in preventative therapies.

Encephalitis Vaccine
"Encephalitis" means "inflammation of the brain," but it usually refers to brain inflammation caused by a virus. This severe and potentially life-threatening disease is rare. The illness occurs in two forms, a primary form and a secondary form. The primary form of the disease is more serious, while the secondary form is more common. But because of the milder nature of secondary encephalitis, doctors actually see more cases of primary encephalitis. Discussion of a vaccine to prevent Encephalitis is underway.

Lassa Fever Vaccine
A team of U.S. and Canadian scientists has developed a vaccine against Lassa fever that fully protects nonhuman primates from experimental infection with lethal doses of Lassa virus. The research, published in the online and print editions of the journal PLoS Medicine, could eventually lead to development of a vaccine for human use. Currently there is no preventive measure available to halt the spread of Lassa fever, other than rodent control in affected areas. The disease is transmitted to humans from rodents that carry the virus. Lassa fever is common in parts of West Africa where it causes a significant amount of death and disability among the population. Recently, Lassa fever has been imported by travelers to the United States and Europe. The Lassa virus that causes the disease is considered a potential agent of bioterrorism. Principal investigators Thomas Geisbert of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and Heinz Feldmann and Steven Jones of the Public Health Agency of Canada (PHAC) developed the vaccine using a non-pathogenic form of vesicular stomatitis virus, or VSV, as a carrier--into which they inserted genetic material from the deadly Lassa virus.

Malaria Vaccine
Malaria continues to claim an estimated 2 to 3 million lives annually and to account for untold morbidity in the approximately 300 to 500 million people infected annually. Four species of protozoan parasites cause malaria in humans: Plasmodium falciparum, P. vivax, P. malariae, and P. ovale. P. falciparum is responsible for the majority of deaths and most of the severe forms of disease, including cerebral malaria. At-risk groups include those in whom immunity has not yet developed (travelers, young children in endemic areas, etc.) and those in whom immunity has diminished (pregnant women, and people from endemic areas who have ceased to be routinely exposed to infection). Malaria is often cited as a substantial impediment to economic and social development in endemic regions. Malaria is considered a re-emerging disease, due largely to the spread of drug-resistant parasite strains, decay of health-care infrastructure and difficulties in implementing and maintaining vector control programs in many developing countries. Malaria is reported frequently in U.S. travelers and military or other personnel deployed in endemic areas. While nowhere near the levels reported in the U.S. through the 1940's, malaria transmission still occurs sporadically in this country due to the persistence of mosquitoes capable of transmitting the parasite. Each year there are over 1,000 cases of imported malaria reported in the U.S. As a result of the spread of drug-resistant parasites and insecticide-resistant mosquitoes, in many respects there are now fewer tools to control malaria than existed even 20 years ago. Because of malaria's growing global burden, its control is essential. Historically, vaccines have been one of the most cost-effective and easily administered means of controlling infectious diseases, yet no licensed vaccines exist for malaria. Accumulating basic and clinical research suggest that effective vaccines for malaria can be developed and could significantly reduce morbidity and mortality, and potentially reduce the spread of infection. GenVec, Inc. entered into a collaborative research and development agreement (CRADA) with the US Military Malaria Vaccine Program at the Walter Reed Army Institute of Research (WRAIR)

Plague Vaccine
Plague vaccine is an active immunizing agent used to prevent infection by plague bacteria. It works by causing your body to produce its own protection (antibodies) against the disease. Plague is a serious disease that can cause death. It is caused by a germ called Yersinia pestis, and is spread most often by infected rodents and by the bites of infected fleas. Plague may also be spread by close person-to-person contact with infected persons (such as occurs with persons living in the same household) who may carry plague bacteria in their nose and throat. Some infected persons do not appear to be sick, but they can still spread the germ to others. If you are traveling to plague-infected areas of Africa, Asia, Latin America, or the western third of the United States, plague vaccine may help prevent plague infection. However, plague vaccine does not provide 100% protection. Therefore, it is very important to avoid contact with domestic and wild animals that may be infected, even if you have received the vaccine. To reduce your chance of getting plague from the bites of infected fleas, use insect repellent on exposed parts of your body, such as legs and ankles. Also apply DEET or another insecticide to clothes and outer bedding according to manufacturers' directions. Plague vaccine is to be administered only by or under the supervision of a doctor.

Ricin is a poison that can be made from the waste left over from processing castor beans. It can be in the form of a powder, a mist, or a pellet, or it can be dissolved in water or weak acid. It is a stable substance. For example, it is not affected much by extreme conditions such as very hot or very cold temperatures. Where ricin is found and how it is used Castor beans are processed throughout the world to make castor oil. Ricin is part of the waste mash produced when castor oil is made. Ricin has some potential medical uses, such as bone marrow transplants and cancer treatment (to kill cancer cells). How you could be exposed to ricin It would take a deliberate act to make ricin and use it to poison people. Accidental exposure to ricin is highly unlikely. BioPharma, Inc.'s patent related to its ricin toxin vaccine was approved in 2006. This patent includes methods of use and composition claims for RiVax (TM), its lead biodefense product. BioPharma, Inc. is studying RiVax, a recombinant subunit vaccine against ricin toxin intended to protect against exposure to ricin that might result from purposeful release of toxin in an aerosolized form or as a poisonous contaminant in food or water. The results of interim analysis in the formal stability program demonstrate that the immunogen component of RiVax(TM), a recombinant derivative of ricin A chain, is stable under storage conditions for at least one year without loss of its natural configuration or the appearance of any detectable degradation products. A vaccine for ricin is considered by many the best way to prospectively protect c