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H1N1 Vaccine
October 2nd 2009 -
I am quite certain that you have been receiving many messages about the H1N1 virus and the vaccination campaign.  I have reviewed the information that is currently available and have come to the following conclusions.
 
A great deal of misinformation about the H1N1 vaccines is being circulated:

The introduction of the novel H1N1 influenza virus has had what I believe to be the desired intent – with a twist. As I explained in an earlier communication it is a near certainty that the current pandemic flu virus was manufactured in a laboratory and released into the human population. It beggars the imagination to think that genetic material from so many different sources could spontaneously arise in nature without a logical sequence of observed mutations.

I believe that the intent of creating and releasing the virus was to create fear in the general population. This it has done. The fear, however, is not of dying from the disease, which has proven to be milder than most seasonal flu illnesses. The fear is of the measures that have been instituted to respond to the perceived threat.

Never before in my lifetime have I witnessed the degree of fear and distrust of governmental and medical authorities that is present today. I have been sent messages warning that state troopers are about to set up roadblocks where motorists and their passengers will be forced to accept a deadly injection and the application of a permanent RFID bracelet or be immediately loaded on buses and taken to internment camps. I have been advised that the H1N1 virus and particularly the H1N1 vaccine were created to wipe out a significant portion of the world’s population and sterilize infants so that they are unable to produce children in the future. I have seen reports that nanochips, which will give governmental authorities total control over individuals, have been placed in H1N1 vaccine syringes.

While I am not an advocate of flu immunizations, I do not find any basis in fact for the rather fantastic claims that are being made. My greatest concern, based upon widely circulated reports, was that H1N1 vaccines would contain squalene-based adjuvants. I am pleased to report that I have reviewed all of the vaccines that have been approved for use in the United States to date and found none that contain squalene or aluminum adjuvants. It is my understanding that Novartis and GSK have developed vaccines containing squalene, but they are currently being delivered only to Europe, not the U.S. Some U.S. trials are said to have used squalene adjuvants, but they are not in the products currently being distributed.

The FDA could issue an emergency order and license squalene-containing vaccines at any time, but they are unlikely to do so for at least two reasons. First, studies have demonstrated that the non-adjuvanted versions effectively trigger an immune response, making the use of an adjuvant unnecessary. Second, the demand for the vaccine is far below what is currently stockpiled, so a large number of people will need to be convinced that taking the vaccine is in their best interest. This task would become far more difficult were an adjuvanted version of the vaccine to be authorized.

Multidose vials of the vaccine include mercury in the form of thimerosol, but individual packaged doses do not. If you should decide to immunize an infant or child I recommend that you insist upon the use of a single-dose preparation.

I believe there are still reasons to be concerned about the safety of any flu vaccine, including the H1N1.  These are detailed below.

H1N1 Vaccine prescribing information has been released. The following statements were taken from Sandovi-Pasteur’s Fluzone data sheet, but those of other manufacturers contain the same or similar wording. The statements are not very reassuring for pregnant women who have been made the #1 priority for immunization:
  • "Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed."
  • "It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this vaccine is administered to a nursing woman."
  • "The multi-dose presentation of Influenza A (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury."
  • "Neither Fluzone vaccine nor Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility."

Other side-effects that are listed, but with the usual disclaimer that because they arose outside of a controlled study their relationship to the vaccine is uncertain:
"The following additional events have been reported during post-approval use of Fluzone vaccine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

  • Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
  • Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
  • Nervous System Disorders: GBS, convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
  • Vascular Disorders: Vasculitis, vasodilation/flushing
  • Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis
  • Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
  • General Disorders and Administration Site Conditions: Fever, pain, pruritis, asthenia/fatigue, pain in extremities, chest pain
  • Anaphylaxis has been reported after administration of influenza vaccines. Although Influenza A (H1N1) 2009 Monovalent Vaccine contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. [See Contraindications (4)]
  • The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated.
  • Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.
  • Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.

Additional challenges are present with the nasal version (Flumist):
The nasal version (Flumist) is a live version of the virus. This is true for both the H1N1 and the standard seasonal flu. FluMist was approved for use in 2003 as a live “cold adapted” vaccine. It is administered intranasally and targeted to people 2 – 49 years of age.

It has a long list of people in whom it is not approved for use including

  • People less than 2 years of age
  • People 50 years of age and over
  • People with a medical condition that places them at high risk for complications from influenza
  • Chronic heart or lung disease, such as asthma or reactive airways disease
  • People with medical conditions such as diabetes or kidney failure
  • People with illnesses that weaken the immune system
  • Children <5 years old with a history of recurrent wheezing
  • Children or adolescents receiving aspirin
  • People with a history of Guillain-Barré syndrome, a rare disorder of the nervous system
  • Pregnant women
  • People who have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components.

While the official position is that Flumist does not cause influenza in those vaccinated it does often cause fever, runny nose, nasal congestion, cough, chills, tiredness & weakness, sore throat, headache, nausea, vomiting, and diarrhea. (Apparently those symptoms are not "the flu" because they are caused by the vaccine, not exposure to the virus in the environment.)
Flumist has also been reported to cause anaphylaxis, facial swelling, urticaria, Guillan-Barre syndrome, Bell's palsy, and nosebleeds.

Viral transmission (spread to other people) has been reported at a rate of 2.4%, which is probably a low estimate. Shedding of the virus can last for at least 3 weeks, during which time the recipient is warned to stay away from individuals with compromised immunity.

Conclusion: The H1N1 vaccines licensed for administration in the United States as of October 1, 2009 do not contain squalene or aluminum based adjuvants. Concerns remain, however, since the vaccines were rushed into production without the degree of testing and oversight that is normally required. There is no reason to believe that H1N1 vaccines will be safer than other seasonal influenza vaccines.

Dr. Dale

 
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