Summary of Corvelva Report — Gardasil 9

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The Corvelva Team

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 Summarized by Deborah Sullivan and Emily Tarsell 

A Summary — Study of the Chemical Composition Profile: Gardasil 9

Frequent serious adverse events following inoculation (AEFI) with HPV vaccines include cardiovascular events, motor neuron disorders, autoimmune disorders, cognitive and mood disorders, neurological disorders, gastrointestinal disorders, miscarriages, menstrual disorders, seizures, headaches, extreme fatigue, skin disorders, sleep disorders, paralysis, encephalitis and even sudden death. Explanations as to what could cause such a wide range of symptoms have varied, but one possibility that has not been explored is suggested here.

There is a neurotoxin which is used in the manufacture of Gardasil, Gardasil 9 ( and presumably also Cervarix) which is not listed as an ingredient in the package insert but it is listed in the patent information. That neurotoxin, phenylmenthylsulfonyl flouride (PMSF) is a nerve agent which inactivates central nervous system functions. It is compelling that the known outcomes from PMSF chronic exposure are very congruent with all of the known outcomes from serious AEFls for HPV vaccines. Could it be that trace amounts of PMSF are in the final product and are at least partly causally related to the serious outcomes?

The process

According to patent information, the process for producing recombinant HPV vaccines (and Hep B) starts with specific segments of nucleic acid DNA to construct viral structural proteins which make up the the viral envelope or capsid but do not contain the whole viral genome. These molecules are then cloned in a yeast (Gardasil) or insect cell (Cervarix) environment. When the desired yields are reached, production is stopped chemically. Then a number of complex stages of harvesting the molecules from the yeast and stages of purification of the virus like particles occur. There are various purification techniques one of which involves the addition of Benzonase to the batch to clean up contaminants. In the final formulation, aluminum adjuvant is added and the purified VLPs are absorbed on the aluminum containing adjuvant.

Some chemicals that are added on multiple occasions in the purification stage of the manufacturing process are PMSF and AEBSF. According to patent information, PMSF is used for the purification of Recombinant L1 and L2 capsid protein, HPV types 16, 18 and 6 while AEBSF is used instead of PMSF in the purification of HPV type 11. Both PMSF and AEBSF are serine protease/ acetylcholinesterases inhibitors.

A protease is a type of enzyme that can have various vital roles in human functioning. Protease inhibitors are molecules that block the activity of a protease. PMSF and AEBSF block certain types of enzymes of the serine hydrolase family which includes acetylcholinesterases. Acetylcholinesterases are enzymes that interrupt motor movement signals across synapses. If this enzyme is blocked, there could be uncontrollable firing of motor signals which possibly manifests as seizures or other motor neuron disorders.

If PMSF is present in the final vaccine product it could explain the significant disturbances in motor-neuron behavior post vaccination that has been reported as well as a host of other serious adverse events which are well documented in the literature.

The questions

The potential for serious negative immune responses in the recipient who might be exposed to PMSF prompted the FDA to warn Merck to demonstrate the removal of PMSF and small, detectable contaminants. Did they do that? Where is the proof? The use of PMSF did not have to be identified in the package insert because it is used in the manufacturing process.

Alternatively, was it intended that the vaccine should contain a trace amount of a serine protease inhibitor? An experiment done in 1916 explored the effect of “Toluene Merck-Pure” on the production of antibodies. They found that during the early stages of antibody production, injections of toluene decreased the output of antibodies. However, when rabbits were injected with toluene while antibody content was high, it caused longer persistence of new antibodies. This raises the question,  did Merck  use an aluminum adjuvant to kick start the antibody response to targeted HPVs but then hope to increase the longevity of the antibodies with the inclusion of a small amount of serine protease inhibitor in subsequent inoculations. Is that why even though a study from Costa Rica showed that one inoculation with Gardasil was as effective as two or three in terms of antibody count, two or three shots continued to be recommended. Was that to extend the longevity of the antibodies via the serine protease inhibitor?

In addition, there are papers which state that protease inhibitors have been known to exhibit anticarcinogenic activity and a paper which identifies a protease inhibitor as a selective inhibitor of the growth of HPV infected tissue. Was a serine protease inhibitor intentionally left in the final product without disclosure?

Why did Merck use AEBSF (4-[2-aminoethyl]-benzenesulfonylfluoride) in the purification of HPV 11 capsid protein rather than PMSF as they had done with HPV 16, 18 and 6? PMSF is unstable in aqueous solution and as already mentioned it is highly toxic. AEBSF is more stable and less toxic but is still a serine protease inhibitor. Is it via binding with the allowed protein contaminants from the HPV 11 capsid protein that a serine protease inhibitor enters the host to extend the persistence of new antibodies? Was it used because AEBSF is more stable and thought to be safer than PMSF in the host? Or might it have been used to lower the burden of PMSF in the recipient if indeed PMSF is in the final product?

If AEBSF is bound with the allowed contaminants from HPV 11 capsid protein or with the yeast fragments or perhaps the aluminum adjuvant to enter the recipient via vaccination to extend the persistence of the targeted HPV antibodies, how would this be accomplished in the HPV vaccine Cervarix which does not contain HPV 11 and which is grown in insect cells rather than yeast?

It is reported that serine protease inhibitors like toluene or PMSF that are inhaled or absorbed through the skin can be eliminated in the body by being metabolized by enzymes in the CYP450 pathway that will convert the toxin into benzyl alcohol for excretion. However it is not clear what happens if one is lacking the specific enzymes needed for excretion or what happens when the toxin or serine protease inhibitor is injected into the bloodstream in humans. A study in rats who were injected with toluene resulted in lack of coordination, clonic twitching, paralysis of the hind legs, abnormal EEG and toluene-induced changes in the sleep-waking rhythms. All of these symptoms are frequently reported as adverse events following HPV vaccine inoculations.

What is the reason that some people suffer serious AEFls while others do not? In addition to differences in possible enzyme deficiencies among recipients and differences in preexisting conditions, HPV vaccines contain different amounts of allowable contaminants and require specific pH values and storage temperature. Does the redacted letter from the FDA to Merck dated April 28, 2008 regarding “significant deviations from current good manufacturing practice…of licensed biological vaccine products…” provide leads to answer some questions?

Where there is smoke, there is fire. Papers and documentation are available in support of the hypothesized undisclosed presence of a acetylcholine/serine protein inhibitor in Gardasil and possibly in other recombinant vaccines. We hope through research and discovery the proposed hypothesis can be thoroughly investigated:

1. Does an analysis of vials of Gardasil, Gardasil 9 show the presence of toluene type toxin?
2. Does discovery regarding the manufacturing process for these vaccines show evidence that the toxins have been completely removed? What is the percent of contaminants and the type of contaminants in the end product? Were there problems with pH or temperature regulation during the processing and distribution of the product?
3. What is revealed in the unredacted minutes to the July 28, 1988 Vaccine Advisory Committee meeting for Hep B vaccine?
4. What is revealed in the unredacted letter from the FDA to Merck dated April 28,2008 regarding deficiencies in the manufacture of biological vaccine products?
5. Does the blood of recipients of HPV vaccines like Gardasil test positive for signs of toluene type poisioning? An interesting study would be to compare the pre and post blood and urine tests for muscarinic acetylcholine and adrenergic receptor antibodies and hippuric acid in consumers who receive HPV vaccines as well as a checklist of pre and post inoculation medical conditions.
6. Obtain access to papers that have disappeared like the paper regarding “Frequent undesired covalent modification of Proteins by the Protease inhibitor AEBSF, Pefabloc.”
7. If research supports the presence of toluene or PMSF type toxins in vials of HPV vaccine and in patients, then further discovery might investigate if the presence of the toxins in the final product was intentional on the part of the manufacturer.

Corvelva — Gardasil Report