Another Bioweapon Set To Be Released: Influenza AH5N1 Virus Monovalent Vaccine Adjuvant

Hopefully, readers are getting some open eyes regarding the H5N1 influenza vaccines and learning to discern these package inserts to assist in making choices based on informed consent. This is the last in the H5N1 influenza vaccine package insert series. Readers will be interested to know that the easiest one was saved for last, which will be explained why. In this package insert review, the Influenza A (H5N1) Virus Monovalent Vaccines, adjuvanted manufactured by ID Biomedical Corporation of Quebec will be covered along with approval letters that could be located. Read carefully and pay close attention to the referenced sources.

Let’s begin with what is found on the Food and Drug Administration (FDA) website for Influenza A (H5N1)Virus Monovalent Vaccine, adjuvanted manufactured by ID Biomedical Corporation of Quebec. Under Supporting Documents, there are 5 links there. Two will be covered because the first three are the same document and the fourth one is a download containing 86 documents that did not provide an initial approval letter.

The approval letter that could be found is contained in “Supporting Documents older than three years – Q Pan”. This indicates this product has a name that is not found on the FDA website Vaccines Licensed For Use in the United States. The approval letter was sent to ID Biomedical Corporation of Quebec on September 9, 2016, located in King of Prussia, PA. According to the letter, this was an approval to extend the age range coverage for the product to 6 months to <18 years, while requesting final labeling content. From this, it can be hypothesized an approval for this product was completed prior to the date of this approval letter for different age groups.

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We find more information for this product in the document “Statistical-Clinical Review – Influenza A (H5N1) Virus Monovalent Vaccine, adjuvanted”. On page 3 of the document, this is found in the “Executive Summary”.

GlaxoSmithKline Biologicals (GSK) submitted BLA supplement STN 125419/39 to seek a pediatric indication for their Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (referred to as Q-Pan H5N1), in children 6 months to <18 years of age for prevention of disease caused by the influenza A virus H5N1 subtype. The application was supported by study Q-Pan 021, a randomized, placebo-controlled study to evaluate the immunogenicity and safety of Q-Pan H5N1. In addition, study Q-Pan 035 in children 6 months to <10 years was submitted to provide additional supportive safety data comparing adjuvanted to unadjuvanted Q-Pan H1N1 vaccine.

It appears GlaxoSmithKline is associated with ID Biomedical Corporation of Quebec. This is proven in this document. “The vaccine is administered as a two-dose regimen, 21 days apart, via intramuscular injection. It is manufactured by ID Biomedical Corporation of Quebec (IDB), a subsidiary of GlaxoSmithKline Biologicals (GSK). The egg-based manufacturing process is also used for IDB’s seasonal influenza vaccine, FluLaval, which was approved by FDA in 2006.” Notice the first and third paragraphs of this document.

On November 22, 2013, FDA licensed (approved) the second vaccine for use in the United States for the prevention of H5N1 influenza, commonly referred to as avian influenza or “bird flu.” The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is the first adjuvanted influenza vaccine approved by FDA and is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine. [Emphasis Mine]

…

The vaccine will not be commercially available. It has been purchased by the federal government for inclusion within the U.S. government’s National Stockpile for distribution by public health officials if needed. It could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from person-to-person resulting in the rapid spread of disease across the globe. Vaccines are critical to help counter the spread of influenza disease during a pandemic. [Emphasis Mine]

No information could be found if this product was produced as part of the national pandemic preparedness initiative. However, since it has been included for the US government’s national stockpile, it can be hypothesized it is possible based on the approval for Sanofi Pasteur’s Influenza A H5N1 product.

GlaxoSmithKline manufactures AREPANRIX, which if you refer to the approval letter for that product, the addressee at the top of the letter, third line, states, “GlaxoSmithKline Biologics”. Moreover, the location for routing the AREPANRIX approval letter is Rockville, Maryland.

The attention now turns to the package insert for Influenza A (H5N1) Virus Monovalent Vaccine, adjuvanted. Here is where things will become easy for readers. This package insert for this product is the same as the product AREPANRIX.

The question may arise where did Q Pan originate? Q Pan was the pediatric version of this product for ages 6 months to <18 years. It was formally known as indicated previously as Q Pan H5N1. Because the AREPANRIX package insert and the package insert for Influenza A (H5N1) Virus Monovalent Vaccine, adjuvanted are the same, it is safe to hypothesize this product package insert was updated for adults 18 years and older. If you look at the very top of the package insert for AREPANRIX, you will find the initial US approval as 2013 – the same year as Influenza A (H5N1) Virus Monovalent Vaccine, adjuvanted.

This is what was indicated in the AREPANRIX Part II article.

Further research at clinicaltrials.gov produced numerous results for an H5N1 product manufactured by GlaxoSmithKline. The most recent study NCT01910519 was completed in 2019. This was a study conducted at Emory University in Atlanta, GA. And, a “safety and tolerability” study was completed in 2020, which appears to cover some of the adult group. The full study on this biologic on 18 years and older is contained in study NCT00719043, completed in 2018. The clinical trial date for the age group 6 months through 17 years was reported in study NCT01310413, which ended in 2021. This study appears to match the data on the 6-months through 17-years age group. Therefore, one can hypothesize this was the trial for AREPANRIX. Readers can review this data at their leisure.

It can also be hypothesized the FDA approval for the H5N1 AREPANRIX occurred either in 2022 or 2023. Without the original approval letter, there is no way to determine if this product was produced under contract to the US government as part of national pandemic preparedness initiatives. We also do not know if this is available or not for the commercial market.

We know now the original approval for both this product and AREPANRIX occurred in 2013. These additional trials on AREPANRIX could have been done for updates to its original approval and package insert, which would also then update Influenza A (H5N1) Virus Monovalent Vaccine, adjuvanted product because they are the same identical product. We know the safety and tolerability studies were included in the package inserts for both products. So, the additional approval letters could have been to update the package insert when the trials were completed. The last approval letter indicated a change to labeling, which is the only one on the FDA website for AREPANRIX.

When the FDA updates its website, many times information, such as prior approval letters, is often lost as we have seen with AREPANRIX. Even with this product, some of the information was gleaned at the FDA website that used the Wayback Machine internet archive. FDA does not make it easy to find information that would be pertinent to answer some questions. Whether this is intentional or not cannot be determined. This additional information was only able to be found through researching Influenza A (H5N1) Virus Monovalent Vaccine, adjuvanted (this product).

In reality, there are only three approved products for H5N1 (bird flu). Two of the products are the same with one designated for national stockpile – Influenza A (H5N1) Virus Monovalent Vaccine, adjuvanted. The other approved products are AUDENZ and Sanofi Pasteur’s product. It appears GlaxoSmithKline produced one product for commercial distribution (AREPANRIX) and provided an unnamed version for the national stockpile – they are the same product. We know that because of the ingredients contained in Section 11. When compared to AREPANRIX, it is the same. And so is all the other information.

Using the articles on AREPANRIX Part I and Part II at The Sons of Liberty Media website, carefully review the package insert for Influenza A (H5N1) Virus Monovalent Vaccine, adjuvanted, to see it for yourself.

We have learned there are four approved products for H5N1 (bird flu). Two are for national stockpile – one clearly indicated it was produced under the national pandemic preparedness initiative. AUDENZ was developed under the national pandemic preparedness initiative and not for commercial distribution – yet. And, AREPANRIX, which is the same as Influenza A (H5N1) Virus Monovalent Vaccine adjuvanted, for possible commercial distribution. While these products may not currently be commercially marketed, these products are available and approved to use with the declaration of a “national emergency” for “bird flu” or a pandemic (planned scam-demic) of “bird flu”. All were developed and manufactured after the 2005 PREP Act.

The main takeaway is buyer beware. None of these products had a robust number of participants to adequately reflect the population nor did these products have a follow-up period long enough to discover development of autoimmune disease. One of the products had some data gymnastics that proved questionable. Moreover, some of the ingredients in these products should produce great pause when contemplating receiving these products.

As a bonus, the documentary “Shots: Eugenics to Pandemics”, found on Tubi, is included to provide more information to ponder.

https://tubitv.com/movies/672129/shots-eugenics-to-pandemics

You should be equipped to review any package insert for any vaccine product in order to make an informed consent decision. You should direct any questions about these products to your medical provider.

All of this is based on the “science” of viruses exist, have been isolated, can “drift” into variants, cause “pandemics”, and can be prevented with vaccines. It is up to the reader to decide if that “science” is factual or not.

Article posted with permission from Sons of Liberty Media