MF59 and Squalene

MF59 is an adjuvant which is a chemical used to increase the immune system’s response to an antigen.

 

 

MF59:

 

MF59^TM is a sub-micron oil-in-water emulsion of a squalene, polyoxyethylene sorbitan monooleate (Tween^TM 80) and sorbitan trioleate.  Squalene is a natural organic compound originally obtained from shark liver oil and a biochemical precursor to steroids. The MF59 adjuvant was developed by Chiron Corp., a company acquired by Novartis.  MF59 is approved in Europe and is found in several vaccines, such as an influenza vaccine manufactured by Novartis.  It has also been licensed to other companies and is being actively tested in vaccine trials.

 

 Chiron Announces Promising Data from Clinical Study of Adjuvanted Avian Influenza Vaccine; Results Confirm Previous Clinical Studies: Chiron’s MF59 Adjuvant Significantly Enhances Immune Response

 

 

Safety of MF59™ adjuvant

 

 

Researchers Try to Boost Supply of Flu Vaccine

 

…We are in possession of one of the key ingredients of a potential solution to the pandemic threat,” said Howard Pien, president of Chiron Corp. The California biotech firm has an adjuvant, an emulsion called MF59 whose main constituent is shark-liver oil. It is already in use in a flu vaccine in Europe.

“We believe that the adjuvant may become the holy grail of vaccines,” Chrystyna Bedrij, an analyst with Griffin Securities, wrote in November in a review of avian flu-related business.

 

Vaccines with the MF59 adjuvant do not stimulate antibody responses against squalene. (Research Center, Novartis Vaccines, Via Fiorentina 1, 53100 Siena, Italy.)

Squalene is a naturally occurring oil which has been used in the development of vaccine adjuvants, such as the oil-in-water emulsion MF59. In past years, by use of noncontrolled and nonvalidated assays, a claim was made that antisqualene antibodies were detectable in the sera of individuals with the so-called Gulf War syndrome. Using a validated enzyme-linked immunosorbent assay for the quantitation of immunoglobulin G (IgG) and IgM antibodies against squalene, we demonstrated that antisqualene antibodies are frequently detectable at very low titers in the sera of subjects who were never immunized with vaccines containing squalene. More importantly, vaccination with a subunit influenza vaccine with the MF59 adjuvant neither induced antisqualene antibodies nor enhanced preexisting antisqualene antibody titers. In conclusion, antisqualene antibodies are not increased by immunization with vaccines with the MF59 adjuvant. These data extend the safety profile of the MF59 emulsion adjuvant.

 

 FLU SHOTS AND THE NEW ADJUVANTS: BEWARE! By Dr. Sherri Tenpenny

…When molecules of squalene enter the body through an injection, even at concentrations as small as 10 to 20 parts per billion, it can lead to self-destructive immune responses, such as autoimmune arthritis and lupus.[9]

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.[10] 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 sometimes 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; it was caused by a serious disruption that had occurred within the immune system.[11]

Vaccine manufacturer, Chiron, is already using MF59 in its European influenza vaccine for seniors called Fluad™. It remains to be seen if Chiron will gain approval for using this adjuvant-containing vaccine in the U.S…

 

Vaccine A:  THE COVERT GOVERNMENT EXPERIMENT  THAT’S KILLING OUR SOLDIERS and Why GIs Are Only the First Victims

 

1.   Many new vaccines feature recombinant DNA. One piece of a deadly germ is inserted or spliced into other organisms, creating bio-engineered microbial molecules. To prompt the body to create antibodies to these recombinants, scientists have created deadly oil-based vaccine additives called adjuvants. Oil-based adjuvants cause extreme inflammation and animals injected with them always develop painful, incurable auto-immune diseases like multiple sclerosis, rheumatoid arthritis or systemic lupus.

 

2.   Since Gulf War I, the military has been secretly putting an oil-based adjuvant called SQUALENE into certain experimental lots of military vaccines. Just like lab animals, thousands of soldiers given SQUALENE- laced vaccines have developed disabling auto-immune diseases. Independent researchers have found SQUALENE antibodies in these sick soldiers. In 2005, the military admitted that 1,200 military personnel who received anthrax vaccine before going to Iraq recently developed serious illnesses, including memory loss and chronic fatigue.

 

3.  The military and federal health agencies have long kept their SQUALENE experiments on U.S. military troops secret because they know that oil-based adjuvants wreak havoc with immune function, causing the body to attack itself. Matsumoto documents how federal and military officials have often been caught lying about the SQUALENE in military vaccines.

 

4.  Matsumoto warns that the National Institutes of Health has funded production of new vaccines for flu, human papilloma virus, malaria, HIV and herpes that also contain SQUALENE. The federal government has been running human clinical tests on these new commercial vaccines and test subjects have not been properly informed of the grave health dangers. Researchers have even found SQUALENE in some of the older vaccines containing tetanus and diphtheria toxoids. Should we wonder why auto-immune diseases like fibromyalgia and chronic fatigue are now rampant?

 

5.    The Bush administration is funding development of new bio-warfare vaccines that will also contain oil- based SQUALENE adjuvants like MF59 or MPL. Because federal officials know that these vaccines may cause disability or death, legislation to protect vaccine makers from lawsuits is expected to be passed by Congress before the end of 2005.* If you become chronically ill from these vaccines, tough luck!

 

 

Antibodies to Squalene in Recipients of Anthrax Vaccine

 

We previously reported that antibodies to squalene, an experimental vaccine adjuvant, are present in persons with symptoms consistent with Gulf War Syndrome (GWS) (P. B. Asa et al., Exp. Mol. Pathol 68, 196–197, 2000). The United States Department of Defense initiated the Anthrax Vaccine Immunization Program (AVIP) in 1997 to immunize 2.4 million military personnel. Because adverse reactions in vaccinated personnel were similar to symptoms of GWS, we tested AVIP participants for anti-squalene antibodies (ASA). In a pilot study, 6 of 6 vaccine recipients with GWS-like symptoms were positive for ASA. In a larger blinded study, only 32% (8/25) of AVIP personnel compared to 15.7% (3/19) of controls were positive (P _ 0.05). Further analysis revealed that ASA were associated with specific lots of vaccine. The incidence of ASA in personnel in the blinded study receiving these lots was 47% (8/17) compared to an incidence of 0% (0/8; P _ 0.025) of the AVIP participants receiving other lots of vaccine. Analysis of additional personnel revealed that in all but one case (19/20; 95%), ASA were restricted to personnel immunized with lots of vaccine known to contain squalene. Except for one symptomatic individual, positive clinical findings in 17 ASA-negative personnel were restricted to 4 individuals receiving vaccine from lots containing squalene. ASA were not present prior to vaccination in preimmunization sera available from 4 AVIP personnel. Three of these individuals became ASA positive after vaccination. These results suggest that the production of ASA in GWS patients is linked to the presence of squalene in certain lots of anthrax vaccine. © 2002 Elsevier Science (USA).

  

The Endogenous Adjuvant Squalene Can Induce a Chronic T-Cell-Mediated Arthritis in Rats

 

…Our demonstration that an autoadjuvant can trigger chronic, immune-mediated joint-specific inflammation may give clues to the pathogenesis of rheumatoid arthritis, and it raises new questions concerning the role of endogenous molecules with adjuvant properties in chronic inflammatory diseases.