More Big Pharma/Big Government Attacks Coming – Arepanrix: Package Insert & Approval Letter Pt 2

Article published with permission from the author, Suzanne Hamner

In this package insert series for all H5N1 vaccines listed on the Food and Drug Administration (FDA) website page “Vaccines Licensed for Use in the United States”, this installment covers Part II of the package insert for AREPANRIX, beginning with the uncontrolled cross-over study conducted on 155 undefined age placebo recipients.

By now, readers should be getting familiar with where to look in the package inserts and approval letters for information that will guide you toward making proper informed consent. It may take a few days of study to truly disseminate and process the information, which is to be expected when unfamiliar with reading these inserts. When faced with making an immediate decision by a provider on vaccines, you can defer receipt of the product until you can thoroughly review the package insert. You can return to the provider to ask questions. At that point, you decide whether the information received warrants taking the product or refusing to take the product.

Remember, the approval letter for AREPANRIX on the FDA website only addressed a label change. The original approval letter is not found on the FDA website. A clinical trial for GlaxoSmithKline’s H1N1 biologic injection (vaccine) was found at clinicaltrials.gov for Arepanrix^TM. A reference that could be found for an H5N1 biologic manufactured by GlaxoSmithKline was found at bionity.com, which was a product in 2007.

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“Adjuvanted vaccines appear to hold the greatest promise for solving the grave supply-demand imbalance in pandemic influenza vaccine development. They come with obstacles—immunologic, regulatory, and commercial—but they also have generated more excitement than any other type of vaccine thus far. [In August 2007], scientists working with a GlaxoSmithKline formula published a trial of a two-dose regimen of an inactivated split-virus vaccine adjuvanted with a proprietary oil-in-water emulsion; …”

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. Let’s continue our look at AREPANRIX.

Surprisingly, an uncontrolled cross-over study was completed where 155 placebo participants received a two-dose regimen of AREPANRIX. No age groups were defined. Two individuals reported SAEs (undisclosed), which were considered “unrelated” to vaccination, during the one-year follow-up (Day 385), with no reports of any potential immune-mediated diseases.

This is very limited data considering the data produced in adults and children previously covered in Part I. Again, we see data gymnastics where follow-up occurred through Day 385 in the uncontrolled cross-over whereas it was Day 364 in 18 years and older group and Day 385 in the 6 months through 17 years age group. Moreover, there is not enough data to even make a critical analysis of serious adverse events (SAEs) or medically attended adverse events (MAAEs). The question arises, “What was the point of doing this?” Naturally, researchers conducting this study would report the undisclosed SAEs were “unrelated” to the vaccine.

If this wasn’t enough, another study was conducted on 6 months through 9 years age group for additional safety with AS03-adjuvanted H1N1 influenza vaccine, consisting of 6,145 participants from 8 unidentified countries outside the US. The participants were randomized 1:1:1 to receive the following: “one dose of a non-US licensed influenza A (H1N1) virus vaccine adjuvanted with AS03 (manufactured by GlaxoSmithKline), two doses of the same vaccine administered 21 days apart, or two doses of a non-US licensed, unadjuvanted influenza A (H1N1) virus vaccine (manufactured by GlaxoSmithKline) administered 21 days apart.” [Emphasis Mine]

Notice carefully, these “vaccines” were unlicensed in the united States, meaning unapproved. In the clinical trial information at clinicaltrial.gov, there were trials that appeared to have been conducted in Germany, Philippines, Taiwan, Thailand, Belgium, Estonia, France, and Australia that were completed. Some had no means of looking at results. But, the trials that did were quickly reviewed. It would be difficult to say if these trials were the source of the above information because the ages did not correspond to what was reported.

AS03 is GlaxoSmithKline’s formulation of squalene. How do we know this? Ingredients for AREPANRIX are contained in Section 11 of the package insert. AS03 comes in a separate vial that must be added to the vial containing the H5N1 antigen.

While the package insert reported similar percentages of SAEs in the adjuvanted groups and the unadjuvanted (without AS03) groups through Day 385, no SAEs were documented in the unadjuvanted group. However, the SAEs for the adjuvanted group was documented.

SAE rates in subjects who received the adjuvanted vaccine (one or two doses) and the unadjuvanted vaccine were similar (0.4 % in these groups through Day 42, and 3.5% and 3.3% in these groups, respectively, through Day 385). The following SAEs reported through Day 385 in subjects who received the adjuvanted vaccine are noted because no alternative plausible causes for the event were identified or due to the temporal association with vaccination. One death was reported within 42 days of any vaccination: a 6-month-old with a prior episode of pneumonia developed symptoms described as pneumonia and asthma exacerbation beginning on Day 7 following the first dose of the adjuvanted vaccine and died of sepsis on Day 19. The following non-fatal SAEs were reported through Day 385: hepatitis and nasopharyngitis on Day 5 following vaccination (1 subject), appendicitis on Days 8 or 9 following vaccination (3 subjects), and papillary thyroid cancer on Day 84 following vaccination (1 subject).

Remember, the adjuvanted product contained squalene. There were three groups in this trial receiving non- US licensed products with only one group receiving an unadjuvanted (without squalene) product AND the product was an H1N1 antigen. So, the only perceived reason to do this trial was to test AS03 – GSKs squalene adjuvant. Yet, there was no placebo control group. There was no indication of these products were licensed outside of the united States in the package insert.

Documentation on potential immune-mediated diseases indicates both the adjuvanted and unadjuvanted groups reported new onsets.

Based on a pre-specified list of events, 7 subjects (0.2%) in the adjuvanted arms (n = 4,096) reported new-onset potential immune-mediated diseases through Day 385; four subjects (0.2%) in the unadjuvanted arms (n = 2,049) reported such 11 events. Events reported following administration of the adjuvanted vaccine were alopecia areata (2 subjects), glomerulonephritis (2 subjects), hypothyroidism (2 subjects), and idiopathic thrombocytopenic purpura (1 subject). Events reported following administration of the unadjuvanted vaccine were glomerulonephritis (2 subjects), Guillain-Barré syndrome (1 subject), and erythema multiforme (1 subject).

Notice for the unadjuvanted arm, four participants reported 11 events but the data does not contain the timeframe as the adjuvanted participants. Only four events were documented for the unadjuvanted four subjects despite the indication that 11 events were reported. Some of these conditions are quite serious – Guillain Barre Syndrome, glomerulonephritis, and idiopathic thrombocytopenic purpura. Remember these trials were conducted on children.

In Section 6.2 covering post-marketing experience, there is no information for AREPANRIX. The information in this section is in reference to other influenza vaccines manufactured by GSK containing AS03 (squalene) administered during 2009.

There is no postmarketing experience following administration of AREPANRIX.

Other influenza vaccines containing AS03 adjuvant, Influenza vaccine (A/California/7/2009 H1N1), manufactured by GlaxoSmithKline in Quebec, Canada and Influenza vaccine (A/California/7/2009 H1N1), manufactured by GlaxoSmithKline in Dresden, Germany, were administered outside the United States during the Influenza A 2009 (H1N1) pandemic. [Emphasis Mine]

So, the “spontaneously reported events” for that time period for those vaccines were documented for AREPANRIX. The events included: anaphylaxis, allergic reactions, febrile convulsions, Guillain Barre Syndrome, narcolepsy (will be covered in detail), somnolence, paresthesia, angioedema, generalized skin reactions, urticaria (hives), and injection site reactions to include inflammation, mass, necrosis (dead or dying tissue), and ulcer.

In Section 6.2, there is an entire section devoted to narcolepsy. This data was collected for the products used in 2009. It indicated that “published studies reported a 2.9- to 14.2-fold increase in the risk of narcolepsy, with or without cataplexy, among vaccinated children and adolescents (younger than 20 years), and a 2.2- to 5.5- fold increase among vaccinated adults aged 20 years and older, compared with individuals of the same age group who did not receive this H1N1 vaccine.”

Approximately 3 to 8 additional cases of narcolepsy per 100,000 vaccinated children/adolescents and approximately 1 additional case per 100,000 vaccinated adults were estimated to occur based on data from some of these studies. No increase in the risk of narcolepsy was reported in some studies. The relevance of these findings on narcolepsy to the United States population or to AREPANRIX is unknown. [Emphasis Mine]

Apparently, these findings cannot translate to AREPANRIX because the antigen used was H1N1 plus the AS03 adjuvant. Basically, one can say there is no way to truly determine what adverse events will occur with the administration of AREPANRIX. Without any post-marketing experience, one can factually state this product has not been on the commercial market.

There is no data available to evaluate the administration of AREPANRIX concomitant with other vaccines. No data on administration of this product to pregnant women. It is unknown whether AREPANRIX is excreted in breast milk. Safety and efficacy have not been determined in children younger than 6 months. The insert does state that immunosuppressive therapies (irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and high corticoid steroid administration) may reduce the immune response to AREPANRIX.

Section 11 of the package insert gives a description of AREPANRIX, which is basically the ingredients of the product.

Each 0.5-mL adult dose contains 3.75 mcg hemagglutinin (HA) of the influenza virus strain A/Indonesia/05/2005 (H5N1); 5 mcg thimerosal, a mercury derivative, as a preservative (<2.5 mcg mercury); and AS03 (10.69 mg squalene, 11.86 mg DL-a-tocopherol, and 4. 86 mg polysorbate 80). Each 0.5 ml adult dose may also contain residual amounts ovalbumin (≤0.083mcg), formaldehyde (≤12.5 mcg), and sodium deoxycholate (≤3.75mcg) from the manufacturing process. [Emphasis Mine]

Each 0.25-mL pediatric dose contains 1.9 mcg hemagglutinin (HA) of the influenza virus strain A/Indonesia/05/2005 (H5N1), and half of the amounts of the other components in the adult dose (listed above).

No studies have been performed to indicate whether AREPANRIX is carcinogenic, mutagenic, or impairs fertility.

The remainder of the package insert covers immunological evaluation – how well the product produces immunity. For the purposes of this review, it will not be covered.

In taking the entire information provided in Part I for AREPANRIX and Part II for AREPANRIX, it would be safe to surmise the numbers of trial participants were not robust enough to represent the population; the reporting of SAEs exhibited some data gymnastics; it contained questionable adverse events with placebos; it inappropriately used H1N1 vaccines to produce post-marketing experience for the H5N1 product; and, the length of follow-up time of one year is insufficient to determine immune-mediated disease frequency in the long term.

The next installment will cover the H5N1 product without a trade name that is designated “national stockpile”.

It is up to you to exercise your right to proper informed consent for yourself, your children, and your family members when it comes to pharmaceutical products. Look at the package inserts for these products to verify what has been presented here. It could save a life in the long run.

Article posted with permission from Sons of Liberty Media