In less than a year after Food and Drug Administration (FDA) approval, the two “vaccines” for Respiratory Syncytial Virus (RSV) are under investigation for a link between the “vaccines” and Guillain-Barre Syndrome. Guillain-Barre Syndrome is a rare illness in which a person’s immune system attacks and damages nerve cells causing muscle weakness and ascending paralysis. While most cases of Guillain-Barre Syndrome resolve, leaving no damage from the syndrome, some individuals are left with permanent nerve damage and other instances are fatal. According to medical literature, Guillain-Barre Syndrome can occur after a “virus”, but some cases have been linked to vaccinations.
The two culprits under investigation are Pfizer’s Abrysvo and GlaxoSmithKline’s (GSK) Abrexvy. So far, officials are investigating twenty reports of Guillain-Barre Syndrome after RSV injections.
Last year, the CDC signed off on a recommendation made by the advisory panel, aimed at Americans age 60 and older. It was for a single dose of RSV vaccine. There were two options, one made by Pfizer and the other by GSK.
The CDC said that patients should talk to their doctors about the vaccines and then decide whether to get it.
Officials were aware that instances of Guillain-Barre had been identified in clinical trials done before the shots were approved for sale, and that different systems were watching for signs of problems.
At a meeting of the expert panel on Thursday, CDC officials presented an analysis of the reports taken in by those systems.
About two-thirds of the cases occurred in people who got a version of the vaccine made by Pfizer, called Abrysvo. But officials are also doing follow-up tracking in people who got Arexvy, made by GSK.
About two cases of Guillain-Barre might be seen in every 1 million people who receive a vaccine, health officials estimate. A CDC analysis found that the GSK rate was lower than that, but 4.6 cases per million were reported in recipients of the Pfizer shot.
Data from the U.S. Food and Drug Administration also showed an above-expected number of Guillain-Barre cases being reported in RSV vaccine recipients, with more among Pfizer shot recipients.
“Taken together, these data suggest a potential increased risk” in RSV vaccine recipients 60 and older that must be explored, said Dr. Tom Shimabukuro, a CDC vaccine safety monitoring official.
Officials from GSK and Pfizer made brief statements during the meeting, noting that sorting out a safety signal is complicated.
“Pfizer is committed to the continuous monitoring and evaluation of the safety of Abrysvo” and is conducting four safety studies to look into the possibility of vaccine-related GBS, said Reema Mehta, a Pfizer vice president.
CDC officials also presented estimates that the vaccines have prevented thousands of hospitalizations and hundreds of deaths from RSV, and that current data indicates the benefits of vaccination outweigh the possible risks.
Being that individuals who choose to receive either Abrysvo by Pfizer or Arexvy by GSK will not be given proper informed consent per the process outlined in “Informed Consent: An Unalienable Right”, a review of the package insert housed at the FDA website for both products will be presented.
First, a look at Pfizer’s Abrysvo. According to the FDA website, there are two package inserts for the product. This produced some confusion which was cleared in the FDA September 12, 2023, Summary Basis for Regulatory Action letter.
Per the letter:
Pfizer Inc. (Pfizer) submitted a new Biologics License Application (BLA) 125768 for licensure of their Respiratory Syncytial Virus (RSV) vaccine on December 21, 2022, for a new indication. The proprietary name of the vaccine is ABRYSVO. At the time of submission of STN 125768, ABRYSVO was under review under a separate BLA (STN 125769) for a different indication, under which it was subsequently approved for the indication of active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older on May 31, 2023. The new indication under STN 125768 is for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age. Upon approval, BLA STN 125768 will be administratively closed, and future regulatory activity conducted under BLA STN 125769.
Therefore, BLA STN 125769 will be reviewed. The FDA letter will be referenced again when discussing the placebo used for Abrysvo.
On page 6 of the package insert, Section 6.1, maternal participants were followed for “localized reactions and systemic events using electronic diaries for seven days, adverse events for one month, and obstetrical complications, serious adverse events, and adverse events of special interest for the duration of the study”. Infants born in year 1 were to be followed for 24 months, and infants born in year 2 were to be followed for 12 months. For all infants born during the study, serious adverse events were monitored for one year and half the infants for two years.
One cannot say the timeframe is long enough to determine any long-term effects. In reviewing the charts of BLA STN125769, one can see the “placebo” group had very close percentages to the “vaccinated” group. What placebo was used?
In the September 12, 2023, FDA letter, the “placebo” used “contains 0.11 mg tromethamine, 1.04 mg tromethamine hydrochloride, 11.3 mg sucrose, 22.5 mg mannitol, 0.08 mg polysorbate 80, and 1.1 mg sodium chloride per 0.5 mL.” How do we know this? Section 14.1 of the package insert (page 16) states, “Participants were randomized (1:1) to receive ABRYSVO (0.5 mL dose) or placebo (0.5 mL dose containing the same buffer ingredients in the same quantities as in a single dose of ABRYSVO [see Description (11)]).” In Section 11 (page 15) of the Abysvo package insert, the buffer ingredients are listed. The ingredients are the same as the September 12, 2023, FDA letter.
Tromethamine is a proton acceptor used for the prevention and correction of metabolic acidosis. Why is this included in the buffer ingredients for any vaccine? According to Drugs.com, Tromethamine is an FDA pregnancy Category C drug – “ Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.” The FDA recommends Tromethamine to be used in pregnancy ONLY if clearly needed. Why is this drug included in a vaccine and used as a placebo in pregnant women? Moreover, there is no controlled data for the use of the medication in human pregnancy. According to The Cleveland Clinic, this drug is for intravenous (into the vein) administration by personnel in a hospital or clinical setting.
Another questionable ingredient in the placebo as well as the vaccine is Mannitol. Mannitol is a diuretic that helps you make more urine and lose salts and excess water from your body. It has many adverse events. Some include congestive heart failure, low blood pressure, chest pain, convulsions (seizures), high blood pressure, acidosis, fluid/electrolyte imbalances, etc. In pregnancy and lactation, “use mannitol with caution during pregnancy if the benefits outweigh the risks”. For more information on Mannitol, see Medscape. According to the varied references reviewed, Mannitol is mainly administered intravenously in the hospital or clinical setting.
The use of these two ingredients does not constitute a placebo. Therefore, one can say the Pfizer Abrysvo vaccine was never tested using a true placebo – an inert ingredient, such as a saline solution, that will not harm the individual.
The sixty and older age group were followed for only 25 months.
Section 11 of the Abrysvo package insert contains this little tidbit. “The RSV preF A and RSV preF B recombinant proteins are expressed in genetically engineered Chinese Hamster Ovary cell lines grown in suspension culture using chemically-defined media, without antibiotics or animal-derived components.” [Emphasis Mine] Even after the “purification process”, can we be sure that no contamination from the Chinese Hamster Ovary “cell lines” (usually indicative of immortalized cell lines, aka cancer) are contained in the finished “product”?
Now, the attention turns to GSK’s Arexvy. The same sections of the package insert will be evaluated for Arexvy as was used in Pfizer’s Abrysvo.
In Section 6.1 (page 3), it is indicated that GSK used a saline solution for a placebo, meaning one study used an inert solution. However, GSK conducted two non-placebo-controlled studies but did not indicate what the “non-placebo” contained. Keep in mind that Arexvy is only for use in individuals over 60 years old.
Participants were followed in the study for six months. During the first 30 days, adverse events were monitored using paper diary cards. An ongoing Study 1, phase 3, observer-blind clinical trial will follow participants for up to 36 months, according to Section 14 (page 9) of the package insert. Just as with Abrysvo, this is not long enough to determine long-term effects.
In the non-placebo-controlled studies, one participant in Study 2 developed Guillain-Barre Syndrome nine days after vaccination with Arexvy and two participants in Study 3 developed acute disseminated encephalomyelitis 7 and 22 days respectively after vaccination. One participant died; the other case was non-fatal. According to GSK’s document, those participants received Arexvy concomitantly with FLUARIX QUADRIVALENT.
FLUARIX QUADRIVALENT was not clinically trialed against a placebo – an inert solution.
The Arexvy trial reported that “adverse events leading to death were reported for “49 participants (0.4%) who received AREXVY (n = 12,467) and 58 participants (0.5%) who received placebo (n = 12,499). Based on available information, there is no evidence of causal relationship to AREXVY. Causes of death among participants were consistent with those generally reported in adult and elderly populations.” If there were reported “adverse events leading to death”, how can it be said there is no evidence of causal relationship? Moreover, ten participants who received Arexvy had incidences of atrial fibrillation, a potentially fatal heart arrhythmia, compared to four participants in the placebo group. Per the package insert, GSK maintains “The currently available information on the atrial fibrillation is insufficient to determine a causal relationship to the vaccine.” Shouldn’t this be evaluated instead of issuing a canned “insufficient” statement?
In the package insert of GSK’s Arexvy, Section 11 (page 8) contains the information related to the process by which Arexvy is produced.
The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal-derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized. [Emphasis Mine]
The AS01E adjuvant is composed of 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota and QS-21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in a phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection.
After reconstitution, each 0.5-mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS-21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol.
This appears to be a similar production process as Abrysvo. What is concerning besides the possibility of contamination from Chinese Hamster Ovary cells is the production of 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella Minnesota. Salmonella Minnesota is a subspecies of Salmonella enterica. Salmonella is a leading cause of foodborne illness. It is a rod-shaped gram-negative anaerobic bacterium. The Salmonella enterica serotype Minnesota was first isolated from a turkey farm in Minnesota in 1936. “In poultry production, Salmonella is disseminated into the flocks and farm environments via the avian feces. Other animals may become infected through contaminated poultry litter or close contact with an infected bird. High Salmonella bacterial content in the enteric tract of broilers and layers can result in the contamination of chicken meat, eggs, and other poultry products in slaughterhouses.” The Minnesota serotype “has been detected in different sources, including the natural environment, plants, animal-producing farms, and foods. Poultry products seem to be an important source of human infection with this bacterial foodborne pathogen. In addition, bacteriological analyses have demonstrated that S. Minnesota isolates are resistant to antibiotics, including extended-spectrum cephalosporins.”
Why would a pharmaceutical company use an antibiotic-resistant bacteria to produce a component of an adjuvant used in a vaccine? Does the purification process remove all “contamination” of Salmonella enterica serotype Minnesota?
Another concern is QS-21, a saponin purified from plant extract Quillaja saponaria Molina. According to WebMD, “Quillaia (Quillaja saponaria) is a large evergreen tree found in Peru and Chile. Chemicals in the tree bark called saponins act as natural detergents.” However, there is not enough information to determine proper dosing. According to Drugs.com and WebMD, quillaja is permitted by the FDA for use as a natural flavoring or in conjunction with other flavors and is considered “safe” in small amounts. Both sites refer to this natural component as being ingested orally or used topically. Drugs.com indicated that natural saponin has some antiviral activity, anticancer properties, and potential cholesterol-lowering effects. When it comes to using it as an “immunization adjuvant”, “QS-21 saponin fraction from Q. saponaria has been studied extensively …. Although saponins enhance antibody response and cytotoxic T-cell responses, their use in clinical practice is hindered by dose-limiting local and systemic toxicity, chemical instability in solutions with a pH of 7.4 or higher and in warmer temperatures, and limited availability from natural sources.”
Why is GSK using Q. Saponaria as part of its adjuvant when its use in clinical practice has been hindered by dose-limiting local and systemic toxicity?
Would you want to know this information when a doctor or healthcare provider recommends an RSV “vaccine”?
Considering the manufacturing process of these products is proprietary information, one cannot be certain that harmful impurities were removed. What has been described in both of these RSV vaccines indicates the possibility exists impurities are contained in these inoculations that could cause harmful effects. Could the appearance of Guillain-Barre Syndrome in individuals who received either Abrysvo or Arexvy be caused by contaminants or other “ingredients” in the adjuvant? Unfortunately, it will not be considered by either the FDA or the Centers for Disease Control (CDC).
Both the CDC and the FDA consider the benefits of “vaccines” to outweigh the risks without one single study to determine safety and efficacy. Plus, it is left to the pharmaceutical companies to investigate themselves, which will never bring about any causal relationship to any adverse event.
It cannot be stressed enough that it is up to the individual to demand their right to informed consent utilizing the informed consent process. Even though this information is readily available in package inserts and on the FDA website, you can be assured the doctor, healthcare provider, or the one administering the injection, has not read it or investigated it. Proper informed consent cannot be obtained from the individual receiving a medical intervention if the one responsible for obtaining informed consent has not reviewed the information contained in the package inserts, does not offer an opportunity for questions, and only presents the individual with a “yes or no” option to agree to a medical intervention. Moreover, the right to refuse is part of proper informed consent at any point, but especially if one is not afforded any information on the intervention.
