This thread is about the possibility of severe long term consequences from an adjuvant which will form part of a proposed pandemic vaccine.
part 1 of this thread is here
bump
Part of the story of MF59 involves the possibility that the US military have been doing trials of various vaccine components, including MF59, on servicemen and women. Matsumoto in his book ‘Vaccine A’ believed that this kind of research was not limited to anthrax but had been going on for years with different kinds of vaccines. If this is indeed true, then the following paper is highly significant:
Objectives: To report a series of five patients who developed systemic lupus erythematosus (SLE) after immunization and review the literature on vaccineassociated connective tissue diseases and the theoretical mechanisms that could explain such an association.
Methods: Uncontrolled retrospective analysis of cases identified sporadically over 7 years at three centers.
Results: In our series of 5 patients, symptoms of SLE developed within 2 to 3 weeks after secondary immunization. All patients met American College of Rheumatology (ACR) criteria for the diagnosis of SLE. In most patients, symptoms have been persistent.
Conclusion: Although a coincidental association between vaccination and the onset of SLE cannot be excluded, the temporal relationship with the development of symptoms makes it immunologically plausible that vaccination triggered systemic autoimmunity in these rare cases. We propose that epidemiological studies be performed to examine this potential association in more detail to quantitate the risk and identify possible genetic risk factors.
The five cases of systemic lupus…drum rolls…. were ALL military personnel.
And 2 out of those 5 were men.
Now what are the chances that this is all a coincidence?
BTW for those who didn’t quite get the point, it is this:
Systemic lupus is extremely rare among men. 2 out of 5 is definitely an oddity which should immediately alert one to a unique causative agent.
Systemic lupus occurring shortly after any vaccination is also extremely rare.
IF there was a causal relationship between those vaccinations given to these service personnel and the onset of lupus, it would NOT be due to the other components of the vaccines, which are the same as those commercial ones used for civilians, but possibly to other additives that are not in commercial vaccines. In other words, experimental additives, such as adjuvants.
Such as MF59.
Thank you, anon_22, for this. I just finished reading part 1 of the thread and am floored.
First I have to say I am as far from a medical professional as you can get (a mom and a CPA). Your summary was quite comprehendable and educational. I thank you for that.
I have to say the rose colored glasses I have worn most of life continue to be blasted to bits as I weave my way through almost 1 year of reading fluwiki. I continue to glean priceless and sometimes completely overwhelming information here. Tonight was one of those moments. I will hold onto what you have shared in this thread. I have no idea how I will ever decide whether or not to accept an H5N1 vaccine for my young children. I only pray that fluwiki and people like you will be available at the time to guide us. Otherwise, I may be lost and just follow the herd to the vaccination center. I shiver at the thought.
bump for info on systemic lupus.
This is from the General Vaccination Discussion Thread
Leo7 – at 03:14 Anon 22:
Gary Matsumoto has written that the GSK bird flu vaccine contains monophosphory lipid A which is the same ingredient combined with squalene he originally wrote about for TRI Max in Gulf war vets. The GSK doesn’t have the squalene but as you know the lipid mentioned above has a list of problems on it’s own.
GM says the danger remains as a cross reaction that initinates autoimmunity. I was surprised because when I first tried to research the proprietary ingredient all I could reference was it was from tree bark. So there, lets X that one off our master list.
Some here might protest, but hey there’s a man offering over 20,000 for anyone, orignally he just asked doctors, to drink the ingredients added to vaccines and so far no takers. If you won’t go drink the concoction don’t complain about the GSK vaccine going off our master list. Let me know if anyone here would like to drink the concoction and I’ll share the website with you.
Sadly, the vaccine A controversy continues….
Did you write to Matsumoto? Yes, I knew that the GSK has that kind of formulation, but didn’t have time to look it up again, thanks. I am not too concerned about GSK because it will take so long for their adjuvant to get licensed that but MF59 is currently still the frontrunner for pandemic vaccine formulation, and that scares me.
The (false) rationale behind the proponents that such formulations are safe includes how these substances are used in cosmetics, present in small quantities in our body, are ‘natural’, and so on.
It’s the same thing as saying just because you can drink milk, you can inject it.
This document at the FDA site Accelerating the development & availability of vaccines for a pandemic or other emerging threats: present and future quotes results from MF59-adjuvanted H5N1 vaccine. It is the only vaccine quoted, which worries the h*** out of me. They are nearing the finishing line, and lots of lives are at stake.
If we let them, they will make this vaccine and give it to millions and millions of people, and if Gary Matsumoto is right, Gulf War Syndrome will just be a rehearsal for more nightmares.
Please contact your representatives to raise your concerns about this particular adjuvant. Currently it is not FDA approved, but since it is approved in the EU, the FDA would have good justification to license it for Emergency use under the ‘Emergency Use Authorization’
Emergency Use Authorization (EUA):
Sec. of HHS can declare emergency after Sec. of Defense, Homeland Security, or HHS determines an emergency (or potential for one) exists, affecting national security
Sec. of HHS (FDA) can authorize use of product:
Science teacher, Sarah, Nightowl, CAPmom, and whoever else has an interest in advocacy, please read this thread and help raise the awareness to this issue.
This is beyond the general ‘possible long term consequences of vaccination’. This is a specific chemical that has had a very troubled history which is now a component of one of the most likely pandemic vaccine candidates. Please research this and ask tough questions! Thanks!
for attention
http://www.sciencedaily.com/releases/2006/09/060925143523.htm
Bird Flu Vaccine Additive May Stretch Supply
Researchers have achieved an effective immune response to an avian influenza vaccine with doses as low as one-quarter of the norm when they added a chemical mixture known as MF59. The research is published in the November 1 issue of Clinical Infectious Diseases, now available online.
MF 59 is an adjuvant—a substance that increases the immune system’s ability to respond to a stimulus. For this research, the investigators used inactivated H9N2 influenza vaccines—not the H5N1 virus currently feared as a potential pandemic strain. However, the study does suggest that if the feared pandemic comes to be, adjuvants might be used to extend the vaccine supply. Furthermore, the authors note, H9N2 is itself a pandemic threat.
http://www.scharp.org/public/redbook/protocol/apxa2.htm
The adjuvant emulsion, MTP-PE/MF59, contains a muramyl tripeptide (MTP) linked covalently with dipalmitoyl phosphatidylethanolamine (PE) and MF59, a microfluidized oil-in-water emulsion. This emulsion, the adjuvant for the HIV-1 SF-2 rgp120, consists of 0.5% polysorbate 80 (Tween 80, polyoxyethylene sorbitan mono-oleate) and 0.5% sorbitan trioleate (Span 85, Arlacel 85) in a citrate buffer. Squalene (5%), a metabolizable lipid, constitutes the oil phase. For most studies, the preparation contains MF59 without MTP-PE.
http://www.who.int/vaccine_safety/topics/adjuvants/squalene/Jun_2006/en/index.html
Squalene alone is not an adjuvant, but emulsions of squalene with surfactants enhance the immune response when added to antigens. MF59, a proprietary adjuvant containing squalene, is included in a seasonal subunit influenza vaccine licensed by the Italian regulatory authority in 1997 and subsequently by several other countries. The vaccine contains about 10 mg of squalene per dose. Over 22 million doses have been distributed since that time. Reported rates of adverse events and local reactogenicity are not in excess of those that would be expected with other inactivated seasonal flu vaccines, suggesting that squalene in this vaccine poses no significant risk. This vaccine has been administered primarily to individuals aged 65 years and older, for whom the vaccine was licensed.
http://www.gulfwarvets.com/additive.htm
Trace amounts of the additive squalene have been found in the anthrax vaccine used to protect U.S. service members from the biological warfare agent, federal health officials have found.
The finding contradicts repeated assertions by the Pentagon that squalene is not present in the vaccine.
The federal Food and Drug Administration said its results were based on tests of five lots of the vaccine. The agency did not make clear whether those lots containing squalene were used to inoculate troops during the Persian Gulf War, those receiving the vaccine since a mandatory inoculation program began in 1998, or both.
The FDA also did not address potential health problems with the vaccine; agency spokeswoman Lenore Gelb declined to comment.
Squalene is found in the human liver, some vegetable oils and shark oil; as an additive to a vaccine, it is used to foster a faster, stronger or longer protective reaction, according to a 1999 U.S. Government Accounting Office report. It is not approved by the FDA for use in the anthrax vaccine.
Squalene’s safety was called into question when a 1999 Tulane University study of blood samples taken from sick gulf war veterans detected the presence of antibodies linked to the additive. Some of the samples were taken from soldiers who did not take part in the war; but all presumably received the vaccine.
Previously, Congress’ watchdog agency, the General Accounting Office, had reported that gulf war veterans were complaining of mysterious, undiagnosed illnesses similar to patients with auto-immune disorders. A Tennessee immunologist, Dr. Pamela B. Asa, concluded those illnesses were caused by exposure to additives in vaccines, the GAO said.
James Turner, a Pentagon spokesman, said Wednesday that officials in his department were not prepared to comment on the FDA’s finding.
Sorbitan Laurate and Sorbitan Trioleate were cocarcinogens in one mouse study …
http://home.att.net/~dstormmom/metcalf.htm
Congressman Jack Metcalf has issued a report culminating a three year investigation into the conduct of the DOD (Department of Defense) with regard to the possibility that squalene, a substance in vaccine adjuvant formulations not approved by the FDA, was used in inoculations given to Gulf War era service personnel. According to the GAO (General Accounting Office), scientists have expressed safety concerns regarding the use of novel adjuvant formulations in vaccines, including squalene.
The report reveals that the FDA has found trace amounts of scalene in the anthrax vaccine. The amounts recorded are enough to “boost immune response,” according to immunology professor Dr. Dorothy Lewis of Baylor University. Therefore, the report concludes that immediate action should be taken to halt the current AVIP (Anthrax Vaccination Immunization Program). It further states that an aggressive investigation must be undertaken to determine the source of the squalene, and the potential health consequences to those who have been vaccinated, both during and after the Gulf War.
The report also documents at length DOD “stonewalling” attempts to resolve this issue, which GAO investigators characterized as “a pattern of deception.” The GAO stated the DOD denied conducting extensive squalene testing before the Gulf War, then admitted it after being confronted with the public record. The GAO revealed that DOD officials deliberating deployment of the anthrax vaccine expressed a “willingness to jump out and, use everything:” in discussing experimental vaccines containing adjuvants not approved by the FDA.
GAO also found Peter Collis, DOD official who headed vaccine efforts, refused to cooperate with them. The report states that the DOD has refused to act in good faith upon the GAO recommendation to replicate the findings of a test developed by renowned virologist Dr. Robert Gary of Tulane University, although DOD admitted they could easily do so. The work of theTulane researchers has been peer-reviewed in a scientific publication of high standing.
Finally, the report states that “Congress should take immediate action to review the findings of the GAO and the Armed Services Epidemiological Board, and provide independent oversight for the immediate implementation of their recommendations. “The board called on the DOD to engage in close cooperation with the Tulane researchers.
http://www.chiroweb.com/archives/18/24/06.html
In a follow-up study published earlier this year, a Tennessee immunologist confirmed the findings of the Tulane study and concluded that the mysterious illnesses suffered by Gulf War veterans could have been caused by exposure to additives in vaccines.2 This conclusion was vehemently contested by Pentagon officials, who maintained that squalene was never used in the making of the anthrax vaccine, and that even it were present, it would not cause soldiers to become sick.
As early as this March, the FDA began releasing preliminary information stating that low levels of squalene had indeed been detected in some anthrax vaccines. In a written statement delivered during congressional hearings into the safety of the anthrax vaccine on March 20, the FDA said that test results showed “squalene content was determined to be in a level of low parts-per-billion and was comparable to levels determined in three other lots of the anthrax vaccine.”3
On September 28, the FDA released another report showing that trace amounts of squalene were found in five lots of the anthrax vaccine. The FDA did not make clear whether the lots that contained squalene were the same lots used to inoculate troops during the Gulf War, or whether they are being used in the current anthrax vaccination program. A spokesperson for the FDA also declined to comment on any potential health problems associated with the vaccine.
As late as this October, however, the DoD was still insisting that squalene “is not in the anthrax vaccine” and that the substance “has not been used in vaccines … for a considerable period of time.”3
http://darwin.nap.edu/books/030907178X/html/309.html
Squalene has attracted the interest of arthritis researchers because of its ability to activate the immune system nonspecifically. It was one of the constituents used in the 1970s to create the first animal models of multiple sclerosis, known as experimental allergic encephalomyelitis (EAE) (Beck et al., 1976). Squalene is one of several adjuvants (such as incomplete Freund’s adjuvant) found to induce arthritis in susceptible rat strains and has been used in the generation of animal models of arthritis (Whitehouse et al., 1974; Lorentzen, 1999). The effect is so pronounced that researchers have coined the term “squalene-induced arthritis.” After a single intraarticular injection of 50 μL squalene into Lewis (Yoshino, 1996) and Dark Agouti rats (Yoshino and Yoshino, 1994), animals experienced moderate joint inflammation by day 6, followed by more severe chronic arthritis by day 21. The inflammation was marked by joint swelling and infiltration of CD5+ and + T cells. Similarly, intradermal injection of 200 mL squalene into Dark Agouti rats produced arthritis (Lorentzen, 1999). Although the mechanisms are not fully understood, the inflammation is blocked by agents that suppress T cells (Yoshino, 1996; Sverdrup et al., 1998) . Animal studies do not report whether injection of squalene produces antisqualene antibodies.
In summary, there is limited published information about squalene toxicity. The human relevance of what has been published is unclear because of species differences in absorption. Squalene has been found to produce arthritis and neuropathology under select conditions in animals; the relevance to humans of these toxicity findings is uncertain.
Finally, the 0.5% Polysorbate 80 is also nasty stuff.
http://www.medscape.com/viewarticle/544332
Docetaxel Injection (Taxotere) Linked to Risk for Severe Hypersensitivity Reactions
On June 7, the FDA approved safety labeling revisions for docetaxel injection concentrate (Taxotere, made by Sanofi-Aventis US) to warn of the risk for hypersensitivity reactions associated with its use, particularly during the first and second infusions.
Severe hypersensitivity reactions have been reported in patients who received the recommended 3-day dexamethasone premedication regimen (16 mg/day starting 1 day prior to docetaxel administration). The reactions were characterized by generalized rash/erythema, hypotension, and/or bronchospasm; fatal anaphylaxis occurred very rarely.
Such reactions require immediate discontinuation of the infusion and initiation of appropriate therapy. Patients who experience severe hypersensitivity reactions should not be rechallenged with docetaxel. [b]Use of the drug is also contraindicated in patients with a history of reactions to other drugs formulated with polysorbate 80.
I saw the MF-59 article yesterday and thought it was very misleading - didn’t address side effects.
Annon-22, our friend who participated in the vaccine trial has been told she probably has systemic lupus erythematosus (SLE), as you told her. She hasn’t been hanging around here lately, but I talked to her this week.
tjclaw1, I know. I got her emails, and a lot of information which I haven’t had time to read through yet cos I was on the road. I hope she finds at least some resolutions soon about where all this takes her. We should stay on email about this.
anon_22, sorry, this is the first time I have read this thread and did not see your comment on 9/02. I have a big yikes! after having read this. Do you have ideas on who we should send letters to? Can we still try to stop this? This is such a disaster waiting to happen.
A22,
If we can do anything to help, feel free to contact me.
Are there any further developments on the adjuvents included in the most recent H5N1 vaccine trials?
Science Teacher,
The only thing that I see is that MF59 is not FDA approved. In the normal scheme of things, there are many hurdles to approval. However, in the context of an impending pandemic, then the FDA or HHS (see my post at 10:48 for details) has the power to waive some of the normal requirements as long as they have some data to show that “Known & potential benefits outweigh known & potential risks”, which they can very well do using data from Europe.
Now in Europe they have been vaccinating elderly people only, so I don’t know that they have huge volumes of safety data for younger age groups. But in the context of emergency use, they could very easily fudge that as long as those charged with oversight (?Congressional committees) accept their arguments and do not have any information to the contrary.
Now, if there is a pandemic tomorrow, and the ONLY thing that has the remotest chance of saving some lives is this vaccine with MF59, then there might be a case for its consideration. But since we are seeing viable new products or approaches like the HA recombinant vaccine, which seeing as it is made by a very small company aka not enough lobby voices on the Hill, there may be a case for actively approaching politicians and bringing the problem to their awareness.
The story of BARDA is a good warning, that most Congressmen do not read and do not understand what they vote on. And that those with the most voice on the Hill will get what they want. I’m not American. Go figure.
Science Teacher at 18:20,
I’m convinced that due to the very high dosages required and the very low seroconversion rates on most of the H5N1 vaccine trials that the squalene / MF59 broth is the best method that the manufacturers have to move their program to the next step.
I personally see the mix as a high-risk toxin. I also believe that if you are going to be standing in line for an H5N1 vaccine, the most likely adjuvents will be extremely powerful, hence extremely high-risk.
This might be relevant here Biodefense bill passes House
The House passed the Biodefense and Pandemic Vaccine and Drug Development Act of 2006 today, which would establish the Biomedical Advanced Research and Development Authority (BARDA) in the Department of Health and Human Services. BARDA will develop advanced countermeasures to pandemic viruses and defenses against biological attacks.
The bill provides $160 million in funding for BARDA in 2007 and 2008 and calls for the authority to streamline development of drugs designed to counter pandemics or biological attacks.
NS1, Seems we will all be caught between a rock and a hard place.
Anon_22, BARDA may cut through the red tape, but we will hear a lot less about the adjuvents. They will be able to bypass the FDA.
I plan to write Ted Kennedy and state our concerns about MF-59 and some other congressmen as well. I hope others will do the same.
Closed to maintain Forum speed.