H1N1 vaccine by Pandemrix® poses risk to people with known hypersensitivity

Posted on Nov 04, 2009 by Susie Collins in Blog, News, Susie Collins

Environmental physicians in Germany say H1N1 vaccine by Pandemrix® is unsuitable for patients with chronic multi-system illnesses.

CSN: Chemical Sensitivity Network reports the German Professional Association of Environmental Medicine advises against the H1N1 vaccine by Pandemrix® for people with chronic multi-system illnesses.

Press release of the German Professional Association of Environmental Medicine (Deutscher Berufsverband der Umweltmediziner – DBU).

From 26. October 2009.

Swine flu [H1N1] vaccine is unsuitable for patients with chronic multi-system illnesses. Pandemrix® poses substantial health risk with respect to mass immunization programs due to the lack of proof of safety. Because of the producer’s release from liability by the German Federal Government (BRD), the risk of adverse reactions and/or permanent damage due to the vaccine rests with the patient.

The German Professional Association of Environmental Medicine (DBU) has, in spite of press releases from the BRD, the Paul-Ehrlich-Institute, as well as the vaccine producer’s assurances of safety, serious concerns relating to Pandemrix® (GlaxoSmithKline), the only vaccine which has been approved for mass vaccination by the BRD.

The DBU discusses at this point neither the medical use of immunization in general nor the necessity of such measures in the, up until now, mild course of the swine flu pandemic.

Our criticism is directed only against the pandemic vaccine Pandemrix®.

  • There exists considerable doubt as to the effectiveness of the vaccine: during the licensing phase, the vaccine tested had a 40% higher portion of virus antigen (5. 25µg) than the vaccine (3.75µg) now being delivered. An unequivocal consensus has not been reached as to whether the vaccination should be given once or twice a season.
  • There exists considerable doubt concerning the safety of the adjuvanted active amplifier since it is being used for the first time. The vaccine contains 27.4mg AS03, an emulsion of polysorbate, squalene and tocopherol. Sufficient studies are lacking, because in the test phase, only the development of antibody titers was determined as a surrogate criterion, and not any potential adverse reactions.
  • The producer as well as government agencies have concealed the fact that squalene, if used subcutaneously or intramuscularly is an inflammatory immune activation immunogen, unlike when ingested. (Squalene is, among other things, for example, naturally contained in olive oil.)
  • Autoimmune diseases can be provoked by squalene; already existing ones can be activated. Squalene has been connected with the emergence of Guillan-Barré Syndrome (GBS) and is now considered a trigger for Gulf War Syndrome (GWS). In animal studies squalene brought on rheumatoid arthritis.
  • Squalene from food sources is mainly incorporated into membranes in the body. The production of squaline antibodies resulting from an immunization sets off chronic inflammation of the membranes, which explains diseases such as Gulf War Syndrome and also degenerative neurological diseases such as Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Chronic Inflammatory Demyelinating Polyneuropathy and Guillan-Barré Syndrome.
  • The delivery of vaccine in multiple dose ampules is obsolete. In single dose ampules the mercury used for preservation, as in thimerosal – which is included in Pandemrix – would be unnecessary. Also, mercury has been proven to set off autoimmune diseases.
  • Since the vaccine has not been tested on either young children or pregnant women (Ethics Commission objection), the call to give preference in the first phase of vaccination to precisely this particularly endangered segment of the population represents an improper and totally unjustifiable field test.
  • The vaccine poses a higher risk than the swine flu itself for patients with environmental illness and for patients with compromised immune systems (e.g. AIDS).
  • The vaccine producer GlaxoSmithKline (GSK), according to the contract with the BRD, is largely exempt from liability. In case of damage from the vaccination, the affected vaccinee would have to sue the government and therefore the country of Germany, usually a futile exercise.
  • To avoid the trap of liability, the doctor giving the vaccination must meticulously inform the patient of all risks concerning the vaccination and the vaccine. It is recommended to give this information in the presence of an assistant and to have it be confirmed by the patient’s signature. The explanation should also include the liability features. Also the indication that other, lower risk vaccines are available in Europe and that due to a faulty decision by the German government, they are currently not available to the German population. This information should definitely be included in the explanation.

For general and environmental health considerations the DBU urgently advises against carrying out a vaccination with Pandemrix®.

Dr.med. Hans-Peter Donate for the board of the German Professional Association of Environmental Medicine (DBU)

Translation by CSN – Chemical Sensitivity Network.

For more information on Pandemrix®, here is the manufacturer’s summary of product characteristics. Here is a quick look at one section on possible side effects:

Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).

Editor’s Note: Content on this blog is provided for informational purposes only and is not intended as a substitute for the advice provided by your physician or other healthcare professional. You should not use this information for diagnosing or treating a health problem or disease, or prescribing any medication or other treatment.

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8 Responses to “H1N1 vaccine by Pandemrix® poses risk to people with known hypersensitivity”

  1. CatherineWO

    04. Nov, 2009

    Is this the vaccine being distributed in the U.S.? If not, does the U.S. vaccine contain the same ingredients? I don’t ask for myself, because I quit getting any vaccines several years ago when I had a bad reaction. But I have family members who jump at every vaccine that comes along and I would like to give them accurate information about what is being used in the U.S. They won’t listen to me but they will listen to good science.

    Reply to this comment
  2. The choice whether to get the H1N1 shot or not is a tough one. My daughter, 27 years old and 17 weeks pregnant didn’t get it in time before she ended up in bed for days on end with the illness.

    Though she suffered, I feel selfishly happy that she didn’t get the shot. With no confirmed knowledge of the aftereffects of the vaccine, it’s difficult to know what to expect for the fetus. Years ago the medication that was given to women to reduce the nausea during pregnancy turned out to be a disaster for the children who ended up deformed, and worse.

    I think for now I’ll just hide in my cave and leave it be.

    Good Health To You
    Cavewoman-Franny Armstrong-ParaNovelGirl

    Reply to this comment
  3. Susie Collins

    04. Nov, 2009

    Aloha Catherine,

    I appreciate your asking for clarification on the use of Pandemrix® in the U.S. My understanding is that this particular H1N1 vaccine is not being used in the U.S. because of the adjuvant or additive. It is that adjuvant which is of concern to those warning against the use of Pandemrix®. http://abcnews.go.com/Health/wireStory?id=8937059

    Here is the reasoning given by the European Medicines Agency for allowing it into the European market http://www.emea.europa.eu/influenza/vaccines/pandemrix/pandemrix.html

    Here is the response by Glaxo, the manufacturer of Pandemrix®,to the decision of the European Medicines Agency http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10089.htm

    But there are a lot of concerns about Pandemrix® in the countries where it’s allowed http://clareswinney.wordpress.com/2009/10/23/german-medical-association-warns-against-giving-pandemrix-to-young-children-pregnant-women/

    Hope that clarifies things a bit better.

    Aloha,
    Susie

    Reply to this comment
  4. Anne

    13. Nov, 2009

    What about the Sanofi Pasteur H1N1 single dose injected vaccine available in the US, which has no mercury and no adjuncts, but does have Gelatin 0.5 mL dose and residual amounts of formaldehyde (not more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and sucrose (not more than 2.0%)?

    I sort of feel that I may be in a damned if I do, damned if I don’t position. Both my roommate and myself have to be in crowded public places frequently, so it will be hard to limit exposure. I have untreatable asthma due to my MCS and am allergic to most antibiotics, so getting swine flu could be problematic, as could the shot, because of the chemical composition.

    Any suggestions? What is the MCS community advocating regarding for the US vaccines?

    Reply to this comment
  5. Susie Collins

    13. Nov, 2009

    Aloha Anne, I can only speak for myself. I do not get an annual flu shot and I am not getting the H1N1 vaccine in any form.

    Reply to this comment
  6. Rod White

    14. Nov, 2009

    This looks interesting – only problem is that I can’t find any mention of the DBU (or the Deutscher Berufsverband der Umweltmediziner) on a Google search – apart from links to this site and others quoting the same source.

    I find it difficult to believe that an organisation such as the DBU has no internet presence – more information about the source please!

    Reply to this comment
  7. Susie Collins

    14. Nov, 2009

    Rod, very first link that comes for me on Google search for Deutscher Berufsverband der Umweltmediziner is this, their main site: http://www.dbu-online.de/

    Reply to this comment
  8. Susie Collins

    14. Nov, 2009

    Rod, here is the original press release from the the German Professional Association of Environmental Medicine (Deutscher Berufsverband der Umweltmediziner – DBU) http://www.dbu-online.de/fileadmin/news/Pressemitteilung_dbu_Impfstoff_Pnademrix.pdf

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