They're Gearing Up To Do It To You Again! Bird Flu "Vaccine" Audenz Package Insert & Approval Letter Review: "It Will Be Produced & Distributed Under Contract To The U.S....

Article posted with permission from the author, Suzanne Hamner

In yesterday’s article, “Dr. Lena Wen Pushes Fear Over H5N1 Bird Flu” at Sons of Liberty Media, readers were informed there are four vaccine products currently approved for H5N1 “bird flu” – two with the trade names AUDENZ and AREPANRIX. Wen is pushing for the Biden administration to “authorize” a bird flu vaccine for the low-risk, no human-to-human transmission illness. However, as reported, two vaccine products exist that are approved and will be covered in two parts. Today, we’ll take a look at the AUDENZ package insert to discover some facts about the product. The other three will be covered in subsequent articles.

AUDENZ received approval from the Food and Drug Administration (FDA) on January 31, 2020, for use in individuals 6 months of age and older. In the approval letter, several statements stand out. First, “For use in persons 6 months through 17 years of age, we have approved your BLA according to the regulations for accelerated approval, 21 CFR 601.41.” The next interesting statement is astounding – “However, we acknowledge the statement in your submission of January 29, 2020, that Seqirus, Inc. does not intend to market this product for commercial distribution in the U.S. since it will be produced and distributed under contract to the U.S. Government as part of national pandemic preparedness initiatives.” [Emphasis mine.] The last statement that truly catches the eye is this; “Furthermore, if Influenza A (H5N1) Monovalent Vaccine, Adjuvanted is used in another country and additional safety and effectiveness data are obtained, you will provide these data to the FDA.”

As we can see, AUDENZ was produced and distributed under contract to the US government as part of the national pandemic preparedness initiatives, meaning under the PREP Act and OTA contracts that were used during the CONvid-1984 bioweapon development. Sasha Latypova and Katherine Watt exposed this PREP Act OTA contracts with CONvid-1984. This should give anyone contemplating taking an injection for “bird flu” pause.

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In a separate summary basis letter dated January 31, 2020, a description of the product is found on page 3.

Audenz consists of an inactivated, subunit monovalent influenza virus antigen produced in Madin Darby Canine Kidney (MDCK) cells and an oil-in-water emulsion adjuvant (MF59C.1 adjuvant). The antigen is manufactured in Holly Springs, North Carolina (N.C.) according to the Flucelvax seasonal influenza virus vaccine process licensed in the United States (U.S.). The MF59C.1 adjuvant is manufactured in Holly Springs, N.C. MF59C.1 adjuvant is also present in the seasonal influenza vaccine, Fluad, which has been approved for use in individuals 65 years of age and older in the U.S. since 2015. The final drug product consists of combined antigen and adjuvant that is filled into a 1.0 mL syringe at the Holly Springs, N.C. facility. The dosing regimen in persons ≥ 6 months is two doses of 7.5 µg H5N1 hemagglutinin (HA) MF59 adjuvant (total volume of 0.5 mL per single dose) administered intramuscularly (IM) 21 days apart. [Emphasis mine]

Audenz is an injectable emulsion for intramuscular use supplied in a 1.0 mL single-dose pre-filled syringe. Each 0.5 mL dose contains:

• 7.5 micrograms (µg) hemagglutinin (HA) of influenza – subtype (A/H5N1)

• 9.75 mg squalene – prepared from shark liver oil (page 8) [Emphasis Mine]

• 1.175 mg sorbitan trioleate

• 1.175 mg polysorbate 80

• 0.66 mg sodium citrate dihydrate

• 0.0425 mg citric acid monohydrate

On page four of the summary basis letter, it states:

The Biomedical Advanced Development and Research Authority (BARDA) of the U.S. Department of Health and Human Services (DHHS) contracted Novartis Vaccines (transitioned to Seqirus, Inc., November 2015) to develop and submit for licensure a cell culture-derived H5N1 influenza virus vaccine with antigen-sparing potential for inclusion in the U.S. National Stockpile. The clinical development of this MF59-adjuvanted cell culture-derived H5N1 influenza virus vaccine was conducted under IND 13536, which was submitted on October 24, 2007. Fast Track designation was granted in December 2015. [Emphasis Mine]

Subsequent approval letters for certain updates were issued on October 29, 2021 (labeling and multi-dose preservative formulation), November 17, 2021 (clinical trial results in the 6 months to 17 years age group), and April 24, 2024 (update to package insert sections 2.2 and 16).

According to the package insert for AUDENZ, the product comes in two forms: 0.5 ml single dose syringe and 5 ml multi-dose vial containing 10 doses of 0.5 ml. Individuals are to receive two doses (0.5ml) 21 days apart of the “inactivated vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine”. The only contraindication for AUDENZ is anaphylaxis or severe allergic reaction to any component of the vaccine or previous influenza vaccine.

Section 5 of the package inserts states that appropriate medical treatment and supervision should be available to manage severe allergic reactions. In addition, Section 5 specifically mentions Guillian Barre Syndrome (GBS). Because of the elevated risk of Guillian Barre syndrome (GBS) associated with the 1976 Swine flu vaccine, it is recommended that special consideration be given to individuals who experienced GBS within 6 weeks of receiving a prior influenza vaccine – the potential benefits and risks are to be weighed carefully. The same section also states “Vaccination with AUDENZ may not protect all individuals” specifically citing immunocompromised individuals.

The clinical trial experience contained in Section 6.1 outlined four participant groups: 18 through 64 years of age; 65 years of age and older; 6 months through 5 years of age; and 6 years through 17 years of age. The clinical trial for 18 years of age and older is rather convoluted, but simplicity will be used to show the number of individuals in the trial was insufficient; there was not a placebo-controlled trial until study 3; and the length of monitoring time was insufficient to determine auto-immune disease development in these groups.

The number of individuals in the trial is reported as follows for Study 1 and 2.

The safety population includes 3,579 subjects who received at least one dose of AUDENZ. Of these, 1,683 were adults 18 through 64 years of age and 1,896 were adults 65 years of age and older.

In Study 1 and 2, there were only 3,579 subjects with 1,683 being 18 through 64 years of age and 1, 896 being over 65 years of age. Later in the package insert, it is stated that no participant in Study 1 and 2 received a placebo. Participants were given 2 0.5ml doses of AUDENZ 21 days apart. Solicited local and systemic adverse events were collected for 7 days and unsolicited adverse events were collected for 21 days after each injection. Participants were followed for one year for additional serious adverse events, adverse events of special interest – potential immune-mediated conditions (autoimmune disease), new onset of chronic diseases, and medically-attended adverse events.

As we can see the number of participants was insufficient to be representative of the population. Moreover, there was not a placebo-control group. One year is insufficient to determine the development of autoimmune disease caused by the vaccine since it can take 3 to 5 years or more for autoimmune disease to emerge.

Study 3 contained 3,191 subjects – 1,596 18 through 64 years of age and 1,595 65 years of age and older. Subjects were randomized 3 to 1 to receive 2 doses of AUDENZ, following the same schedule as studies 1 and 2 or placebo. It was reported that 2,395 participants received at least one dose of AUDENZ and 796 received a saline placebo.

Table 1 in Section 6.1 indicates there were 1,163 participants in the 18 through 64 years of age who received AUDENZ and 387 who received a placebo. For the 65 years and older age group, 1,189 received AUDENZ and 397 received a placebo. Table 1 and 2 in Section 6.1 indicates the common non-serious adverse events for each age group further separated by whether receiving AUDENZ or placebo.

Study 3 was also lacking in two of the areas identified – insufficient participants to be representative of the population and lack of long-term follow-up.

The reporting of Serious Adverse Events (SAEs) reported in the AUDENZ group and placebo groups produced puzzling results.

In Study 3, fatal and non-fatal SAEs reported in the 12 months following vaccinations among adults 18 through 64 years of age occurred in 2.9% of subjects who received AUDENZ and 3.3% of subjects who received placebo. SAE rates among adults 65 years of age and older were 10.5% in subjects administered AUDENZ and 15.3% in subjects who received placebo. Fatal SAEs included 11 (0.5%) AUDENZ recipients and 1 (0.1%) placebo recipients. No SAEs were assessed as being related to AUDENZ. [Emphasis Mine]

Studies 1 and 2 did not have a placebo or active comparator control for comparison of safety. Four deaths occurred in Study 1 (subjects 18 through 64 years) and two in Study 2 (subjects ≥ 65 years), none assessed as related to AUDENZ. In the 12 months following vaccinations, SAEs (fatal and non-fatal) occurred in a total of n=28 (3%) of all subjects in Study 1. SAEs occurred in a total of n=96 (7%) subjects in Study 2. In both Studies 1 and 2, all SAEs appeared unrelated to study treatment. [Emphasis Mine]

A placebo control of injectable saline was used. Saline produces NO type of adverse event since the body contains saline normally expressed as 9% normal saline. Why would the placebo group have more serious adverse events than the AUDENZ group in both age group participants? This should signal there is an issue. Moreover, it is claimed no SAEs were assessed as being related to AUDENZ.

Since Studies 1 and 2 did not have a placebo group, it is puzzling why the trial would report the SAEs were unrelated to AUDENZ or study treatment when four deaths occurred in the 18 through 64 years group (Study 1) and two deaths occurred in the 65 years and older group (Study 2). During the 12-month follow-up, a total of 28 individuals (3%) experienced SAEs in Study 1 and 96 individuals (7%) experienced SAEs in Study 2.

For Adverse Events of Special Interest (AESIs), all studies were combined to assess AESIs in the groups. Again, the results were puzzling.

The percentages of subjects with an AESI at any time after vaccination was 0.2% among adults 18 through 64 years of age and 0.4% among adults 65 years of age and older who received AUDENZ. In the placebo group, 1.8% of adults 65 years and older reported AESIs while there were no AESIs reported for adults 18 through 64 years. No AESIs were assessed as related to AUDENZ. [Emphasis Mine]

For new onset chronic diseases (NOCDs) and medically-attended adverse events, all studies were combined again. “In Studies 1, 2 and 3 combined, NOCDs (9.7% vs 9.2%) and MAAEs (47.1% vs 46.0%) occurred with similar frequencies between AUDENZ and placebo recipients, respectively, with larger proportions of these events occurring in subjects ≥ 65 years.” With what is known about saline placebos, this should disturb anyone who reads this information.

In Study 4, involving children 6 months through 17 years of age, 160 participants were ages 6 months through 5 years and 163 participants were ages 6 years through 17 years. These groups followed the same protocol as the Study 1 and 2 groups – 2 0.5 ml doses 21 days apart following for adverse events 7 days after each dose. SAEs, AESIs, NOCDs, and MAAEs were monitored for one year after the last vaccination. No placebo control group exists for these age groups.

According to the package insert, solicited events were mild to moderate and so were unsolicited adverse events. However, 8 children in the 6 months through 17 years age group or 2% experienced serious adverse events but those SAEs were not identified and determined to be “events typical for a pediatric population and were assessed as unrelated to study vaccine.” There were no deaths reported.

No AUDENZ recipients reported NOCDs during the study. MAAEs were reported by 34% of all subjects and were typical of events that occur in a pediatric population. The most common MAAEs were categorized as infections and infestations (reported by 26% of subjects).

Are you seeing a disturbing pattern here in these clinical trials?

There is no postmarketing experience for AUDENZ; however, a list of adverse events is presented as experienced by participants receiving influenza vaccines containing the same MF59® adjuvant or sharing the same manufacturing platform. These include lymphadenopathy, angioedema, anaphylaxis, Bell’s palsy, convulsions, febrile convulsions, demyelination (loss of nerve covering) encephalitis (brain swelling), Guillian Barre Syndrome, syncope (dizziness), paresthesias (tingling in extremities), urticaria (hives), pruritic (itching), non-specific rash, and muscular weakness.

There is no data available to determine whether it is safe or not to administer AUDENZ concomitant (at the same time) with other vaccines. No data on pregnant women. It is unknown whether AUDENZ is excreted in breast milk.

Section 11 of the package insert contains the description of AUDENZ. Pay close attention to the emphasized content.

AUDENZ, a sterile injectable emulsion for intramuscular use, is an inactivated, monovalent, subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line (cancerous cells). These cells were adapted to grow freely in suspension in culture medium. The virus is inactivated with ß-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. The influenza antigen contained in AUDENZ is manufactured according to the same process as that used to produce the antigens contained in FLUCELVAX® and FLUCELVAX® QUADRIVALENT, which are unadjuvanted seasonal influenza vaccines licensed for use in the United States. [Emphasis Mine]

AUDENZ is a milky-white emulsion. Each 0.5 mL dose is formulated to contain 7.5 mcg of hemagglutinin (HA) of the influenza virus strain A/turkey/Turkey/1/2005 NIBRG-23, a reverse genetics-derived reference strain supplied by the National Institute for Biological Standards and Control (NIBSC), and MF59C.1 adjuvant (MF59), a squalene-based oil-in-water emulsion (9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate, 0.66 mg sodium citrate dihydrate and 0.04 mg citric acid monohydrate), at pH 6.5-7.7. [Emphasis Mine]

Each dose of AUDENZ can contain MDCK cell protein and MDCK cell DNA. A single 0.5 ml dose of AUDENZ contains 25 mcg of mercury since the multi-dose vial contains thimerosal, a mercury derivative.

Based on the review of the package insert and the FDA approval letters, would you put this product into your body or the body of your child? For this writer, the answer would be no. When obtaining any medical product, this information should be given in the informed consent process. If you are not receiving this information, you are not being afforded the right to proper informed consent.

While this review is long, it is provided to help teach you where to look in the package inserts, the approval letters, and other information contained on the FDA website. By learning where to look and what to look for, you can easily navigate and discern the information for yourself. With the medical-industrial complex culture today, it is going to be up to each individual to get informed – the medical providers are not going to do it.

Article posted with permission from Sons of Liberty Media