Disgusting Chemicals in vaccines: MF59

A premonition come true

An adjuvant is a substance added to produce a high antibody response using the smallest amount of viral-containing (antigen) solution possible in the shot. By definition adjuvants are considered to be “pharmacologically active drugs.” They are designed to be inert without inherent activity or toxicity on their own yet they are required to “potently augment effects of the other compounds” in the vaccines.  It is difficult to explain how a substance can be defined as “pharmacologically active” and at the same time, be described as “inert and have no activity or toxicity.”

The first adjuvants were used in 1925 by French researcher G. Ramon. He found that by adding breadcrumbs, agar, tapioca, starch, or oil lecithin to vaccines, he could increase the response to diphtheria and tetanus antitoxins. Although these substances are no longer used, adjuvants are regularly added to vaccines and they are grouped chemically into “classes” based on their mechanisms of action. For example, hyper-tensive drugs are grouped together based on how they work; one can be classified as a “beta-blocker” and another as an “ace-inhibitor,” based in its effect in the body. Adjuvants are similarly grouped based on the type of immune system response they are thought to induce. But therein lies the rub: After more than 75 years of use, the mechanism of actions for most adjuvants is still “incompletely understood.” In other words, what they do to the body is unknown.

For an adjuvant to work it must be attached to a molecule called a “carrier” or a “vehicle.” The combination (adjuvant + carrier) is referred to as an “adjuvant formula,” a supposedly inert compound. The combination of the attenuated virus or bacteria plus the “adjuvant formula” used in a vaccine causes an amazingly complex immunological cascade of events, including the release of dozens of molecules called cytokines that cause inflammation and activation of the immune response.

The nonspecific response induced by the vaccine and its adjuvant wreaks havoc in the normally organized, highly structured immune system. What happens is rather like setting off a tiny explosion under a pile of dry, fall leaves, watching the explosion and then trying to describe the trajectory of the leaves by explaining where they landed. Hardly “inert,” the reaction that occurs after each vaccine, within each individual, is truly a new experiment.

Adjuvants have the potential for causing serious health problems. A partial list of risks that have been associated with adjuvants includes the following:

• Local or acute inflammation, including the formation of painful abscesses, persistent nodules, ulcers or draining lymph nodes;

• Induction of fever, muscle pain, joint pain and headaches—much like the flu;

• Immune suppression;

• Anaphylaxis (shock), hives and vasculitis;

• Systemic toxicity to tissues and organs;

• Induction of autoimmune arthritis, and other autoimmune
  disorders;

• Cross-reactivity with human cells, causing glomerulonephritis (renal failure) and meningoencephalitis (brain swelling);

• Genetic events: carcinogenesis (cancer); teratogenesis (birth defects) and abortogenesis (causing abortions)

Does that sound inert to you?

Choosing an adjuvant for use in humans has been difficult because it must be based on the level of toxicity observed when the adjuvant formulation is injected into animals. Decades of experimentation have shown that “successful predictions about safety, potency, or efficacy in humans for a particular adjuvant cannot be reliably made from [animal] models. Unfortunately, the absolute safety of vaccines containing adjuvants, or any vaccine¸ cannot be guaranteed.” (Emphasis added.)

For decades, vaccine developers have been tinkering with various substances to “trick” the body into producing heightened immune responses. The only adjuvants currently licensed for use in human in North America are aluminum compounds—aluminum sulfate, aluminum hydroxide, and aluminum phosphate—which have been in use since the 1920s. The limiting factor for approval of new adjuvants has been that most are far too toxic for use in humans. However, one adjuvant was approved in 1992. It is an oil-based adjuvant called MF-59, primarily composed of squalene.

On first blush, squalene seems like a good choice for an adjuvant. Manufactured in the liver, squalene is a precursor for cholesterol, the fat that is the essential building block for hormones and part of the surface of all cells. It is also found in a variety of foods, including eggs and olive oil, over-the-counter medications, and health supplements. Squalene can be purchased at health food stores in its more commonly known form, shark liver oil.

In the early 1970s, UCLA Medical Center scientist Carl M. Pearson began experimenting with a variety of edible oils, hoping to discover a safer, less toxic vaccine adjuvant. His assumption was that because these oils were naturally occurring and could be metabolized by the body they would be safe. In his well-chronicled book Vaccine A: The Government Experiment That’s Killing Our Soldiers and Why GIs Are Only The First Victims, award-winning investigative journalist, Gary Matsumoto, gives an excellent explanation of the difference between ingesting an edible compound and injecting one into the body:

“Intuitively, this premise seems somewhat dubious: Your body could metabolize a cheeseburger, for instance, but you couldn’t liquefy it in a blender and inject the resulting slurry [into your arm], and then expect to feel well in the morning.”

The same holds true for squalene in shark oil and other edible oils. Research was conducted throughout the 1980s and 1990s using metabolizable oils hoping to find an adjuvant to use in vaccines that didn’t induce an antibody response. Many different oils were tried before Chiron settled on MF59, an adjuvant comprised of squalene and two emulsifying agents, Tween80 (polysorbate 80) and Span85. Mixed together, these compounds form an oil-in-water emulsion with uniform droplets less than 1 micron in diameter. The description on the patent application for MF59 states:

“Any metabolizable oil, particularly from an animal, fish, or vegetable source, may be used herein. It is essential that the oil be metabolized by the host to which it is administered, otherwise the oil component may cause abscesses, granulomas, or even carcinomas, or (when used in veterinary practice) may make the meat of vaccinated birds and animals unacceptable for human consumption due to the deleterious effect the unmetabolized oil may have on the consumer.” (Emphasis added.)

Scientific data, published in peer reviewed journals, show that injected squalene is not metabolized like a food passing through the intestinal tract. Injected squalene droplets in vaccine research are considered to be “metabolized” when immune cells interact them, transport them through the lymphatic system and form antibodies to them. In other words, squalene molecules are not broken down nor are they excreted from the body; they end up in tissues where toxic reactions can occur.

Injected oils

Svelander, et al. injected dozens of metabolizable oils including squalene into rats and found that all the oils were toxic, inducing arthritis with varying degrees of severity. Based on their ability to cause arthritis, the oils were assigned “arthritis scores,” ranging from (+), considered to be mildly toxic, to (++++), which was “guaranteed to cripple.” Squalene was given with a score of (+++). In addition, all rats injected with squalene developed an MS-like disease that left them crippled, dragging their paralyzed hindquarters across their cages.

Similarly, when molecules of squalene are injected into humans, even at concentrations as small as 10 to 20 parts per billion, the oil can lead to self-destructive immune responses, such as autoimmune arthritis and lupus.

Several mechanisms have been proposed to explain this reaction. Metabolically, squalene stimulates an immune response excessively and nonspecifically. More than two dozen peer-reviewed scientific papers from ten different laboratories throughout the U.S., Europe, Asia, and Australia have been published documenting the development of autoimmune disease in animals subjected to squalene-based adjuvants. A convincing proposal for why this occurs includes the concept of “molecular mimicry” in which an antibody created against the squalene in MF59 can cross react with the body’s squalene on the surface of human cells. The destruction of the body’s own squalene can lead to debilitating autoimmune and central nervous system diseases.

The squalene in MF59 is not the only cause for concern. One of its components, Tween80 (polysorbate 80) is considered to be inert but is far from it. A recent study (December 2005) discovered that Tween80 can cause anaphylaxis, a potentially fatal reaction characterized by a sharp drop in blood pressure, hives, and breathing difficulties. Researchers concluded that the severe reaction was not a typical allergic response characterized by the combination of IgE antibodies and the release of histamines but it was caused by a serious disruption that had occurred within the immune system.[viii] [ix]

MF59 is capable of accelerated activation of the immune system, particularly the innate (in borne) or cell-mediated immune system. Once the immune reaction is “turned on” there is no available “switch” to turn it off. MF59 induces the expression (activation) of at least 891 genes. It is the most potent activator of all adjuvants tested so far.  The long-term results of this activation are unknown and most likely will not be known. Following patients for an extended period of time looking for the development of serious reactions is not what the vaccine industry is interested in studying.

Vaccine clinical trials are interested primarily in two results: 1) the assessment of reactions, usually within five to fourteen days of receiving the vaccine and, 2) the development of an “adequate antibody response.” If the numbers of reactions were “acceptably” low and the antibody level was found to be “acceptably” high the vaccine is considered to be “safe and effective.” But there are problems with this conclusion. For one, it can take longer than 14 days to develop an autoimmune reaction in the body; in fact, it can take months. No long-term studies have been designed to investigate the development of these problems because these studies are expensive and time-consuming. Manufacturers conclude that the number of severe reactions are so small that they are not “statistically significant,” deeming them not worthy of study. And of course the FDA and the IOM have the prerogative of declaring that “no causal relationship exists” even if the studies were undertaken by independent investigators.

The second problem is the definition of “effectiveness” used by clinical investigators. Most clinicians interpret “effective” as “protective.” In other words, if a vaccine is declared effective the person who receives it will be protected from infection. However, in vaccine research, “effectiveness” is defined as the vaccine’s ability to induce an “acceptably high antibody response,” called a titer. The assumption is made that if the titers are elevated, protection is automatically conferred. This assumption has not been proven. In fact the mainstream medical journal Vaccine published an article in 2001, clearly stating, “It is known that, in many instances, antigen-specific antibody titers do not correlate with protection.” (Emphasis added.) This means you can get the vaccine, develop antibodies, and still get the disease the vaccine was designed to protect you from. In addition, you get all the risks that come with the toxic vaccine components.

In spite of the known risks, MF59 was licensed for use in Fluad in Europe in 1997 and in the US in 2016. The adjuvant was chosen over concerns that aluminum did not substantially increase the antibody level in elderly patients who received a flu shot, but when MF59 was added, the antibody response more than doubled. The vaccine was deemed “safe and effective” by the investigators, but the results of the study could be seriously flawed. The clinical trial only involved elderly people in nursing homes; the average age was 71.5 years. If autoimmune problems such as fatigue and joint pain developed in this geriatric population, doctors might not attribute these complaints to anything but old age. If autoimmune problems occur in the general population after vaccination, doctors may well attribute these complaints to “anything but” the vaccine.

The risks are magnified by the fact that MF 59 was not tested to see if it induces hypersensitivity or if it increases the risk of anaphylaxis, allergies, or even cancer. The manufacturers of Fluad admitted to this lack of testing at the original approval meeting. They passed it off by saying,

“We don’t test MF59 separately because it’s not a product.”

• REF: Workshop on Adjuvants and Adjuvanted Preventive and Therapeutic Vaccines for Infectious Disease Indications. Wed. December 3, 2008. DAY 1, pgs 389-392

If the term “MF59” rings a bell, it may be through its association with the anthrax vaccine. Matsumoto’s book is a bone-chilling account of MF59 used in the anthrax vaccine given to tens of thousands of U.S troops going to the Gulf. This squalene-containing, unlicensed, experimental vaccine has been implicated as the cause of Gulf War Syndrome in thousands of military men and women.

The warning given by Matsumoto in his book regarding the widespread use of MF59 is sobering:

“The unethical experiments detailed in [my] book are ongoing, with little prospect of being self-limiting because they have been shielded from scrutiny and public accountability by national security concerns.”

He was referring to anthrax vaccine and the military. However, because squalene-containing adjuvants are going to be a key ingredient in a whole new generation of vaccines intended for mass immunization around the globe, the problems may just be just over the horizon.

The grave reality is that despite denials from the government, the vaccine industry, and the military the highly-recommended book, Vaccine A, was a premonition of the serious health problems to come when MF59 or similar adjuvants are used in vaccines for the general population.