More Big Pharma/Big Government Attacks Coming - Arepanrix: Package Insert & Approval Letter

Article posted with permission from the author, Suzanne Hamner

By now, readers know this writer is a staunch advocate for proper informed consent following the informed consent process. Previously, the injectable vaccine AUDENZ for H5N1 manufactured by Seqirus was reviewed to inform the public about the product. While it was a long read, the package insert for AUDENZ proved there were not enough participants to represent the population, placebo-controlled trials were only conducted in one study, and the one-year follow-up was not long enough to uncover potential serious adverse events relating to development of autoimmune diseases. Understandably, reading package inserts is not particularly “attention-grabbing” and can be quite boring and tedious. However, it is the only way you will receive all the information you need to give proper informed consent, which includes denying taking a product. Because of the volume of data to be covered in the AREPANRIS package insert, it will be covered in two parts.

In this article, the approval letter and package insert for AREPANRIX will be reviewed. The only approval letter for AREPANRIX on the Food and Drug Administration (FDA) website is dated October 18, 2024. This letter references another letter dated April 19, 2024, which requested a supplement to their license regarding packaging to include the proprietary name of AREPANRIX. There should be another letter indicating the initial FDA approval for this vaccine. Without the initial approval letter, there is no additional information to be gleaned besides the package insert.

AREPANRIX, manufactured by GlaxoSmithKline (GSK), is approved for active immunization for the prevention of disease caused by the Influenza A virus H5N1 subtype contained the vaccine for individuals 6 months and older. AREPANRIX comes in two vials that must be mixed before administration: one contains the H5N1 antigen and the other contains the AS03 adjuvant. The AS03 adjuvant will be explained in Part II. For individuals ages 6 months through 17 years, two doses of 0.25 ml are injected intramuscularly 21 days apart. For individuals ages 18 years and older, two doses of 0.5 ml are injected intramuscularly 21 days apart. (Sections 1 through 2.2)

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It is contraindicated in individuals with previous “severe allergic reactions” (anaphylaxis) to any component of the vaccine, which will be disclosed later, egg protein, or a previous influenza vaccine. Providers are advised to have appropriate medical treatment, including epinephrine, and supervision available to monitor for possible hypersensitivity reactions, including anaphylaxis. Those who have suffered Guillian Barre Syndrome within 6 weeks of a prior influenza vaccine are given special consideration for administration of AREPANRIX regarding risks and benefits. (Sections 4 through 5.2)

Syncope is specifically cited in Section 5.3 as a point of precaution.

Syncope (fainting) can occur with administration of injectable vaccines, including AREPANRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. [Tonic-clonic limb movements could indicate a possible seizure]

If you recall, AUDENZ did not list syncope in its warnings and precautions section.

Section 5.4 of the package insert for AREPANRIX states vaccination with this product may not protect all susceptible individuals, specifically citing those who are immunosuppressed through immunosuppressive therapy or those who are immunocompetent.

In all package inserts for vaccines, clinical trial data is contained in Section 6.1. The clinical trial data for AREPANRIX contained in the package insert is a bit more in-depth than AUDENZ. In this trial, child participants were further stratified by age when monitoring for adverse events. For adults ages 18 and older, 4,561 participants from the US and Canada were included: 3,422 received two 0.5 ml doses of AREPANRIX given 21 days apart; 1,139 received two 0.5 ml doses of normal saline placebo. All were followed for 7 days after each injection and one year after the last dose. This was a ratio of 3:1 vaccine vs. placebo.

The adverse events for the seven-day-period following injection were reported as mild or moderate in both the AREPANRIX and placebo groups documented in Table 2, under Section 6.1. What is puzzling is the reports of mild or moderate adverse events in the normal saline placebo group. And, the number of individuals at the column headings had a slight alteration. The AREPANRIX group was documented as having a number of participants as 3,375 – 3,376 while the placebo group was documented as having a number of participants as 1,122 – 1,123. What happened to the others?

For unsolicited adverse events, the package insert reports the following:

The incidences of unsolicited adverse events reported during the 21- day post-vaccination periods for subjects who received AREPANRIX (n = 3,422) or placebo (n = 1,139) were 38.5% and 35.2%, respectively. Events reported in the AREPANRIX group at a rate of 0.5% of subjects and at a rate at least twice that of the placebo group were injection site pruritus (1.8% vs. 0.4%), dizziness (1.4% vs. 0.7%), injection site warmth (1.3% vs. 0.2%), injection site reaction (0.6% vs. 0.2%), and rash (0.6% vs. 0.3%). [Emphasis mine]

Again, why would a normal saline placebo group have any reaction?

Another questionable result occurred in the reporting of serious adverse events (SAEs).

SAEs were reported for 0.5% of recipients of AREPANRIX (n = 3,422) and for 0.3% of placebo recipients (n = 1,139) through Day 42 (21 days following the second dose of vaccine or placebo). During the approximately one-year safety follow-up (Day 364), SAEs were reported for 3.3% of recipients of AREPANRIX and for 4.1% of placebo recipients. [Emphasis Mine.]

The following SAEs reported through Day 182 in subjects who received AREPANRIX are noted due to a temporal association with vaccination or because no alternative plausible causes for the event were identified: cerebral vascular accidents on Day 1 and Day 9 following the second vaccine dose (1 subject), pulmonary embolism (1 subject) on Day 21 following the first vaccine dose, and corneal transplant rejection (1 subject) 18 years post-transplant on Day 103 following the second vaccine dose.

The following additional SAEs reported through Day 364 are noted because they were reported exclusively in subjects who received AREPANRIX and because no alternative plausible causes were identified: convulsion (3 subjects) on Days 35, 252, and 346 and thyroid cancer (3 subjects) on Days 21, 29, and 223.

Why would individuals who received a normal saline placebo have a higher percentage of reporting of SAEs? Moreover, the SAEs for the normal saline placebo group were not reported. What is concerning is the SAEs reported within six months of AREPANRIX injection – one individual experiencing 2 cerebral vascular accidents or stroke (Days 1 and 9); one individual suffering a pulmonary embolism or blood clot that traveled to the lung (Day 21 following the first dose); and one individual suffering a corneal transplant rejection 18 years post-transplant on Day 103 following the second dose. Other SAEs were convulsions in 3 individuals and thyroid cancer in 3 individuals within one year.

This statement was included in the insert regarding the SAES of convulsions and thyroid cancer.

The following additional SAEs reported through Day 364 are noted because they were reported exclusively in subjects who received AREPANRIX and because no alternative plausible causes were identified: convulsion (3 subjects) on Days 35, 252, and 346 and thyroid cancer (3 subjects) on Days 21, 29, and 223. [Emphasis mine]

The insert did not separate out medically-attended adverse events (MAAEs) as did the AUDENZ insert. However, one can deduce that cerebral vascular accidents, a pulmonary embolism, convulsions, and corneal transplant rejection would fall under MAAEs. Likewise, one can deduce that thyroid cancer would also qualify.

The trial revealed 14 new onset potential immune-mediated diseases – one in the placebo group and 13 in the AREPANRIX group – within one year. Those diseases included polymyalgia rheumatica (muscle pain and stiffness), psoriasis, autoimmune hepatitis, celiac disease, cranial nerve IV palsy (affecting eye movement), Crohn’s disease, facial palsy, radiculitis (nerve pain following a specific nerve), rheumatoid arthritis, rheumatoid lung (group of lung problems related to rheumatoid arthritis), temporal arteritis (inflammation, swelling, and narrowing of temporal arteries supplying blood to head, neck, and upper body), and erythema nodosum (symmetrical tender red patches on the shins). The one placebo recipient reported new onset psoriasis.

For adults 18 years and older, the number of participants are not enough to represent the population and the follow-up of one year was not enough to identify autoimmune diseases that could occur after one year. In looking at the SAEs reported within one year, autoimmune diseases are identified.

Our attention is now turned to the clinical trial participants ages 6 months through 17 years. It followed the same pattern of administration of AREPANRIX and placebo as the adult study using the pediatric dosage of 0.25 ml intramuscularly. Participants were followed for the same time frames following vaccination with the product and placebo and for one year after the last dose of either placebo or AREPANRIX. There were 838 participants from the US, Canada, and Thailand in this group: 607 received AREPANRIX while 231 received a saline placebo. This is a 3:1 ratio of vaccine vs. placebo.

Since the pediatric study was stratified by age, the breakdown will include vaccine vs. placebo recipients for each age group. For brevity, this will be simplified as much as possible. Since the uncontrolled crossover study using 155 placebo participants, Part II will begin with it and continue through the rest of the package insert.

In the 6 through 35 months age group, 196 received the vaccine product while 73 received a placebo. From the age group 3 years through 8 years, 197 received AREPANRIX while 76 received a placebo. The 3 years through 8 years group was stratified into 3 through 5 years and 6 years through 8 years. In the 3 through 5 years group, 98 received AREPANRIX, 49 a saline placebo. 99 participants in the 6 through 8 years group received AREPANRIX while 27 received a saline placebo. 210 recipients received ARAPANRIX in the 9 through 7 years age group while 80 in the same age group received a placebo. In all groups, the trial followed a close to 3:1 ratio of vaccine vs. placebo, except for the 3 through 5 years group.

The adverse events reports in the 6 months through 35 months (Table 3, Section 6.1, page 7) were considered mild to moderate in both the AREPANRIX and placebo groups. However, considering the age of the participants in the study, one has to wonder how many in the placebo group were receiving additional vaccines at their “well baby” visits and how many were teething. This information was not included. Yet, the placebo group indicated a higher incidence of “loss of appetite” among the placebo group. Placebos should produce no adverse events in any participant. Localized reactions are expected at an injection site when any needle is inserted into a muscle.

For the 3 through 8 years age group (Table 4, Section 6.1, page 8), again, reported adverse events were considered mild to moderate in both groups where localized events were reported. The 3 through 5 years age group had similar generalized results between the vaccine and placebo group. Again, questions arise as saline placebos should not produce generalized reactions. The surprising result was the incidence of all reports of fever being higher in the placebo group than the vaccine group.

In the 6 through 8 years group (Table 4, Section 6.1, page 8), the adverse event under the category “gastrointestinal” was included, showing a higher percentage in the placebo group versus the vaccine group. Gastrointestinal issues were defined as nausea, vomiting, diarrhea, and/or abdominal pain. The same pattern in this group appears in the 9 through 17 years age category (Table 5, Section 6.1, page 9).

According to the package insert, unsolicited adverse events reports during the monitoring period (21 days post vaccination) were higher in the placebo group (42.0 %) than the AREPANRIX group (39.4 %). For this section, the package insert reveals a placebo group of 231(6 months through 17 years) and an AREPANRIX group of 607 (6 months through 17 years). However, “Events reported in the AREPANRIX group at a rate of 0.5% of subjects and at a rate at least twice that of the placebo group were all injection site reactions combined (1.6% vs. 0.4%), gastroenteritis (1.2% vs. 0.4%), eye infections (1.0% vs. 0.4%), varicella (0.7% vs. 0%), and fatigue (0.5% vs. 0%).”

Beginning with unsolicited adverse events after the stratified age breakdown in the Tables that only covered 7 days, the analysis returns to the larger age group of 6 months through 17 years. If you are not reading carefully, this could be missed.

While serious adverse events (SAEs) were reported in 2 AREPANRIX recipients and 0 placebo recipients through Day 42 (21 days after last doses), the SAE was not identified. Within the one year follow-up (specifically documented as Day 385), 8 AREPANRIX recipients and 4 placebo recipients reported SAEs. Again, those SAEs are not documented. Then, this statement is included: “One SAE of febrile convulsion was reported on Day 11 following the first vaccine dose in a 30-month-old subject who received AREPANRIX; although no fever occurred during the first 7 days post-vaccination, febrile convulsion is noted due to the temporal association with vaccination and because no alternative plausible cause for the event is identified.”

When monitoring for potential immune-mediated diseases, it was reported that one participant receiving AREPANRIS reported alopecia (hair loss) on Day 385 and one placebo participant developed Type I diabetes. It would be beneficial to know which stratified age group these incidences occurred, but that is not reported.

Remember, the Tables that were age-stratified only covered 7 days as were the tables for adults. And, if you recall, pediatric participants were followed for one year, which means adding the 21-day follow-up after the last dose to 365 equaling 386 days. However, in the adult group, adverse events were only reported through Day 364. This is a significant discrepancy. Why the difference? The package insert does not explain this.

The clinical trial data is inadequate for children. There were not enough participants to represent the population for the entire age group or when stratified by age groups. Moreover, the follow-up timeframe was insufficient to discover autoimmune diseases that could occur after one year (identified in the study as Day 385). And, in this writer’s opinion, there appears to be some data gymnastics occurring in the 6 months through 17 years age group: stratifying age groups to report adverse events during the initial 7-day monitoring period then combining all age groups to report SAEs and potential immune-mediated diseases. Curiously missing data for the 6 months to 17 years age group is medically-attended adverse events (MAAEs). Were there any? It would be beneficial to know. Absence of data doesn’t mean absence of event. If there were no MAAEs in this age group, it should be indicated.

In the Part II installment of AREPANRIX, the uncontrolled pediatric study will be covered as well as Section 6.2 to the end of the package insert.

Hopefully, readers are beginning to see some of the issues with pharmaceutical companies conducting clinical trials on their own products and the FDA relying solely on their data for approval. Remember, vaccines are just products – not gods, not a religion, not a “ruler”. But a cult has arisen around these products, not based on solid data, but propaganda and misinformation. It’s time to break through the propaganda and misinformation by viewing it for ourselves.

Article posted with permission from Sons of Liberty Media