WARNING: Influenza Virus Vaccine H5N1 National Stockpile Manufactured By Sanofi Pasteur - Mixing & Matching "Vaccines" In A Deadly Cocktail

Article posted with permission from the author, Suzanne Hamner

If you have been reading the H5N1 package insert series, AUDENZ and AREPANRIX were covered extensively. The analysis indicated there were problems with both of these products that would cause a reasonably prudent person to question taking either of these products. The third product that will be reviewed is described on the Food and Drug Administration (FDA) website page, “Vaccines Licensed for Use in the United States”, as Influenza Virus Vaccine, H5N1 (national stockpile).

First, we will look at the approval letter, which had to be gleaned from the Wayback Machine archive. The letter is dated April 17, 2007, for the product Influenza Virus Vaccine, H5N1 manufactured by Sanofi Pasteur. Of course, we find a very interesting statement in the first paragraph.

You are hereby authorized to introduce or deliver for introduction into interstate commerce, Influenza Virus Vaccine, H5N1, under your existing Department of Health and Human Services U.S. License No. 1725; however, we acknowledge your statement provided in your submission of April 5, 2007, that Sanofi Pasteur Inc. does not intend to license this product for commercial distribution, since it was produced under contract to the U.S. Department of Health and Human Services as part of national pandemic preparedness initiatives. [Emphasis Mine]

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This is the same statement as found with AUDENZ. While AUDENZ and this product are approved, neither have been commercially distributed. Further down in the approval letter, we find this caveat.

We note that you have submitted samples and Batch Release Protocols for Influenza Virus Vaccine, H5N1, bulk Lots U2148, U2149, and U2150. For any other bulk lots that you may have produced or will produce in the future, please submit final bulk samples of the product together with lot release protocols in the proper format showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER). [Emphasis Mine]

For future reference, it is known samples have been submitted in bulk lots to the government along with “batch release protocols”. If you go to the CBER-Regulated Products with Supporting Documents, and enter “influenza” in the search box, it will return 3 pages of products. The Influenza Virus Vaccine, H5N1 (national stockpile) product manufactured by Sanofi Pasteur is not listed. Yet, this product has an approval letter. However, the Influenza Virus Vaccine, H5N1(for national stockpile) product manufactured by ID Biomedical Corporation of Quebec is listed, along with AUDENZ and AREPANRIX. The product by ID Biomedical Corporation of Quebec will be covered in the next installment.

For simplicity, we will call the product being discussed SP H5N1 national stockpile or the “national stockpile”.

The package insert for SP H5N1 national stockpile indicates it is an inactivated monovalent (containing one antigen) influenza virus vaccine, indicated for active immunization of persons 18 through 64 years of age. It is to be administered in a two-dose regimen of 1 ml (90 µg or mcg) 28 days apart. The product is supplied in 5 ml multi-dose vials. (Sections 1, 2, and 3)

There are no contraindications listed in Section 4.

Section 5 warns against hypersensitivity because the product contains chicken and egg proteins. There is also a warning concerning individuals who have had previous life-threatening reactions to influenza vaccines. Life-threatening reactions would equate to anaphylaxis. This product carries the same warning on Guillain Barre Syndrome as AUDENZ and AREPANRIX in Section 5.2.

If Guillan-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Influenza Virus Vaccine, H5N1, should be based on careful consideration of the potential benefits and risks.

As with the other products, Section 5.3 indicates that administration of SP H5N1 national stockpile to immunocompromised individuals or those receiving immunosuppressive therapies, may have a reduced immune response.

The clinical trial data contained in Section 6.1 indicates a placebo-controlled study with 103 participants ages 18 through 64 receiving the two-dose regimen of SP H5N1 national stockpile 28 days apart and 48 participants (no age range given) receiving a saline placebo. No indication of whether the placebo group received another injection 28 days after the first placebo injection.

According to Table 1 contained in Section 6.1, participants were assessed for reactions for seven days after each vaccination.

Prior to Table 1 indicating the adverse events and percentages in the placebo and SP H5N1 national stockpile groups, this statement is found.

Four serious adverse events (SAEs), all considered unrelated to vaccine, occurred after vaccination including one death and three other SAEs (one each: menorrhagia, cerebrovascular event, and breast cancer). [Emphasis Mine]

One death after vaccination was considered “unrelated to vaccine” as well as one cerebrovascular event, which could be a stroke, was considered unrelated as well. Menorrhagia, heavy menstrual bleeding, could be a reason to see a medical provider, particularly if it is abnormal for the individual and leads to anemia which can be life-threatening.

One has to question the higher percentage reports in the placebo group of headache, malaise, and myalgia versus the SP H5N1 national stockpile group. And, if you look closely at Table 1, there are noticeable discrepancies. For the vaccine group, it is documented that 101 participants received a 7.5 mcg dose of SP H5N1 national stockpile vaccine, 101 participants received a 15 mcg dose of SP H5N1 national stockpile vaccine, 98 participants received a 45 mcg dose of the national stockpile vaccine, and 103 participants received 90 mcg of the national stockpile vaccine. In the text under 6.1, it clearly states:

A total number of 103 subjects (mean age: 39.4 years; age range 18 through 64 years; 53.4 % female, race: 81.6% White, 10.7% Black or African American, and 7.8% Asian) received an intramuscular injection of an investigational vaccine formulation of A/Vietnam/1203/2004 (H5N1, clade 1) containing 90 μg hemagglutinin and no preservative, followed by another injection of the same dose approximately 28 days later. Forty-eight (48) subjects received 0.5 mL intramuscular injection of saline placebo. [Emphasis Mine]

So, there was a total of 103 subjects who were to receive 90 mcg of the national stockpile followed by another injection of the same dose about 28 days later. From where did the other participants come since they were not listed in the text? One has to look at Section 14 to discover that information.

A prospective, randomized, double-blinded, placebo-controlled, dose-ranging, Phase 1-2 study was conducted in 452 healthy subjects 18 through 64 years of age (mean age: 40.5 years; 46.5% female, race: 80.8% White, 8.4% Black or African American, and 11.5% Asian). Vaccine doses contained 7.5 µg, 15 µg, 45 µg, or 90 µg no preservative hemagglutinin of the strain A/Vietnam/1203/2004 (H5N1, clade 1). For the 90 µg dosage, a total of 103 subjects received a dose on day 1 given as a 1.0 mL intramuscular injection, followed by another injection of the 90 µg dosage approximately 28 days later. Forty-eight (48) subjects received 0.5 mL intramuscular injections of saline placebo on the same schedule. [Emphasis Mine – this is the group mentioned in the text]

Section 14 explains the reason for conducting the tests on different dosages was to assess safety in collection solicited and unsolicited adverse events and assess immunogenicity through titers.

At this point, the number of participants are not robust enough to reflect the general population and the length of time of follow-up of 7 days is grossly insufficient to determine serious adverse events (SAEs), adverse events of special interest (AESI), medically attended adverse events (MAAEs), potential immune-mediated disease or autoimmune diseases.

Another puzzling part of this package insert is Section 6.2 – Adverse Events Associated with Influenza Vaccines. There are no reports of SAEs, MAAEs, potential immune-mediated diseases or autoimmune diseases specific to the national stockpile. There wouldn’t be because follow-up only consisted of 7 days after each administration of the national stockpile.

Anaphylaxis has been reported after administration of influenza vaccines. Although Influenza Virus Vaccine, H5N1, 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 WARNINGS AND PRECAUTIONS (5.1)]

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.

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.

There is no data involving administration of SP H5N1 national stockpile at the same time as other vaccines (concomitant). However, the insert states if the national stockpile is to be given at the same time as other vaccines, the vaccine should be administered using another injection site. The insert stated the national stockpile should not be mixed with any other vaccine in the same syringe or vial.

It was rather surprising and puzzling what the insert stated about giving the vaccine to pregnant women in Section 8. Despite there being no animal reproductive studies to determine safety in pregnant women or to know if fetal harm would occur or reproductive capability would be affected, the recommendation was to give the national stockpile to pregnant women only if clearly needed. Not only is that surprising and puzzling. It seems irresponsible, foolish, and negligent.

There is no study to indicate if SP H5N1 national stockpile is excreted in breast milk. No study for pediatric use has been done and neither have studies been done in the 65 and older age group. There were no studies conducted to determine carcinogenesis, mutagenesis, or impairment of fertility.

Section 11 contains the ingredients of the national stockpile.

Influenza Virus Vaccine, H5N1, is a clear and slightly opalescent suspension formulated to contain 90 µg hemagglutinin (HA) per 1.0 mL dose of the influenza virus strain A/Vietnam/1203/2004 (H5N1, clade 1). Porcine gelatin (500 μg/dose) is added as a stabilizer. Thimerosal, a mercury derivative, is added as a preservative. Each 1.0 mL dose is formulated to contain not more than 98.2 µg thimerosal (approximately 50 µg mercury/dose). Each dose may also contain residual amounts of formaldehyde (not more than 200 μg), Polyethylene Glycol p-Isooctylphenyl Ether (not more than 0.05%), and sucrose (not more than 2.0%).

If this isn’t enough to get you scratching your head, information found in Section 12 just might.

Antibody against one influenza virus type or subtype confers little or no protection against viruses from other types or subtypes. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virological basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year’s influenza vaccine. [Emphasis Mine – antigenic drift was reported all over the news as CONvid-1984 variants requiring updated boosters]

Global surveillance of influenza identifies yearly antigenic variants. An influenza pandemic occurs when humans have little or no immunity to an influenza virus strain and this virus strain is rapidly transmitted from human to human. Antigenic variants of H5N1 viruses have been in circulation in the avian species globally, with rare transmission to humans. However, these avian H5N1 viruses may acquire mutations that facilitate transmission among humans. [Emphasis Mine]

Remember, this was approved in 2007. Section 12 sounds eerily familiar to what has been said about the current “bird flu”. If you will remember during the CONvid-1984 planned scam-demic, “vaccine” boosters were created for variants the original product no longer “protected against” – otherwise known as antigenic drift. SP H5N1 national stockpile, AUDENZ, and AREPANRIX are waiting in the wings for use – already approved. The other potential candidate waiting for use will be covered in the next installment.

If you believe viruses exist, variants of viruses occur, and you can vaccinate against them, it would behoove you to learn to read, decipher, and analyze package inserts. You will not be able to get informed consent any other way.

Article posted with permission from Sons of Liberty Media