What they’re not telling you about Pfizer and Moderna mRNA-1273 and PEG

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I have already written about Pfizer’s vaccine containing Polyethelene glycol after the ex Vice President of Pfizer Dr Michael Yeadon objected to it’s use. Pfizer’s vaccine has been given approval. Now Moderna has also been given so called emergency approval- side stepping any long term testing. But Moderna’s shot also contains PEG.{PEG2000 DMG]

mRNA-1273 Vaccine

The mRNA-1273 vaccine was codeveloped by researchers at the NIAID Vaccine Research Center and Moderna in Cambridge, Massachusetts. This vaccine encodes a stabilized version of the SARS-CoV-2 full-length spike glycoprotein trimer, S-2P, which has been modified to include two proline substitutions at the top of the central helix in the S2 subunit. The mRNA is encapsulated in lipid nanoparticles at a concentration of 0.5 mg per milliliter and diluted with normal saline to achieve the final target vaccine concentrations. Source

Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG. Source

 Company product pages showing this compound

PEG2000 IN MODERNA mRNA 1273 Vaccine

Must be kept at -20ºC


A paper from Dec 13, 2016

Polyethylene glycol as a cause of anaphylaxis

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Abstract

Background

Polyethylene glycols (PEGs) or macrogols are polyether compounds and are widely used as additives in pharmaceuticals, cosmetics, and food.

Case report

We report on a Caucasian patient experiencing recurrent severe allergic reactions to several drugs. An extensive diagnostic workup including skin prick tests, intradermal tests (IDT) and a double-blind oral challenge was performed to identify the trigger of anaphylaxis. In the present case hypersensitivity to the additive polyethylene glycol was confirmed by an IDT suggesting an Immunoglobulin E-dependent mechanism as a cause of the reaction.

Conclusion

Potential life-threatening hypersensitivity reactions to hidden molecules like macrogol may be underdiagnosed. Cases of immediate-type PEG hypersensitivity were reported with increasing frequency. The awareness regarding the allergenic potential of PEG should be raised and a proper product labelling is crucial to prevent PEG mediated hypersensitivity.

Background

Polyethylene glycol (PEG) or macrogol is a polyether compound. It is widely used as an additive in pharmaceuticals, cosmetics and food [1]. Different types of macrogol exist according to their molecular weight from 300 g/mol to 10,000,000 g/mol [2]. Anaphylactic reactions to macrogol are rarely reported. However, in recent years more reports appeared in the literature with macrogol induced hypersensitivities due to drugs, personal hygiene products, dental products, lozenges and lubricants [3, 4]. Here we report on a female with a history of three immediate type reactions triggered by macrogol 3350.

Another paper on the causal link between PEG(which is in Moderna and Pfizer’s vaccines) and Anaphylaxis

Abstract

Background

Polyethylene glycols (PEGs) and their derivatives are non-ionic polymers of ethylene oxide commercially available with numerous synonyms, such as macrogol, oxyethylene polymer, and laureth-9. Although these polymers are usually safe, mild to life-threatening immediate-type hypersensitivity reactions have been reported. Nevertheless, awareness about their allergic potential is minimal due to the non-standardization of their nomenclature.
Since its development, PEG polymers held a reputation for safety, nevertheless from mild to life-threatening immediate-type hypersensitivity reactions have been reported, with clinical manifestations ranging from generalized urticaria to anaphylactic shock [2,3,4,5]. Awareness about the allergenic potential of these polymers is minimal due to the non-standardization of their nomenclature, inadequate labelling of products containing PEGs,and the lack of suspicion as the agents responsible of such reactions. In fact, no studies have examined the prevalence of type 1 PEGs hypersensitivity, so its incidence may have been underestimated.

Case presentation

We present the case of a 29-years-old woman with history of atopic eczema and contact dermatitis by nickel sulfate, subclinical sensitization to mites and cypress, and cholinergic urticaria. She developed several local and systemic type I hypersensitivity reactions including a severe anaphylactic reaction to different pharmacologic and cosmetic products whose excipients included PEGs.
Two years before consultation, the patient developed generalized urticaria, dizziness, and dyspnea 30 min after using a skin antiseptic (Betadine® solution: iodopovidone and laureth-9(PEG) as excipient). Symptoms improved after treatment with dexchlorpheniramine and methylprednisolone. Six months later, 30 min after swallowing 30 ml of a cough syrup (GripaNait®: paracetamol, dextromethorphan, and doxylamine as active ingredients and several excipients, including macrogol 6000-[PEG]), she developed generalized pruritus, dyspnea, severe dizziness, seizures, loss of consciousness, and respiratory arrest, requiring urgent treatment with adrenaline, plasma expanders, and parenteral corticosteroids. In the last 7 years she developed itchy maculopapular rashes in contact with some moisturizing skin creams containing PEG-75 and PEG-100. In May 2017, she reported generalized urticaria after applying soap to a tattooed area and wheals after applying a moisturizing creams on intact skin. In November 2017, she experienced swelling of the gums and tongue after using a toothpaste for which she did not need treatment. SOURCE: https://aacijournal.biomedcentral.com/articles/10.1186/s13223-019-0327-4
Obviously this 29 year old was a very sensitive person with allergies and PEG really troubles her. But Wodarg and Yeadon do warn that up to 70% of people will be allergic to PEG. The side effects she had were life threatening!
Pruritus: Itchy skin is an uncomfortable, irritating sensation that makes you want to scratch. Also known as pruritus (proo-RIE-tus), Depending on the cause of your itchy skin, it may appear normal, red, rough or bumpy. Repeated scratching can cause raised thick areas of skin that might bleed or become infected. -Source- https://www.mayoclinic.org/diseases-conditions/itchy-skin/symptoms-causes/syc-20355006
Dyspnea– shortness of breath – caused by “A severe allergic reaction known as anaphylaxis” https://www.webmd.com/lung/shortness-breath-dyspnea#1

Discussion and conclusion of the tests on PEG causing allergic reactions

As in 2 of 37 patients of Wanande trial [2], we didn’t find specific IgE against ethylene oxide [2]. However, our results give limited information on the safety of ethylene oxide for patients sensitized to PEG. IgE test was negative, but we cannot rule out a potential reaction in vivo. Nevertheless, the lesser reactivity observed when assaying PEGs of decreasing molecular weight, may indicate that monomeric ethylene oxide could be devoid of allergenicity by itself, unless conjugated to a complex carrier molecule (i.e. a hapten-carrier mechanism).

My comments on the conclusion

They cannot rule out a potential reaction in vivo(within the body and cells).Moderna uses PEG2000 DMG-This woman would definitely react badly to it. The Molecular weight of the PEG in these vaccines is 2000…compared to those in skin creams containing PEG-75 and PEG-100 making them potentially more of a risk. “UNLESS conjugated to a complex molecule”….which is what is done with the PEG in the vaccines!


A similar product as in the vaccine causes these side effects. Sounds like the same side effects for a vaccine to me.

Methoxy polyethylene glycol-epoetin beta injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • vomiting
  • constipation
  • runny nose, sneezing, and congestion
  • headache
  • muscle spasms
  • back pain
  • stomach pain
  • fever, cough, or chills
  • pain in legs or hands

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • rash
  • hives
  • itching
  • skin blisters or peeling skin
  • swelling of the face, throat, tongue, lips, or eyes
  • wheezing
  • difficulty breathing or swallowing
  • seizures

Methoxy polyethylene glycol-epoetin beta injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
Using methoxy polyethylene glycol-epoetin beta injection may increase the risk that blood clots will form in or move to the legs and lungs.

PEG can also cause SEVERE ANEMIA in certain people

“tell your doctor if you have or have had high blood pressure and if you have ever had pure red cell aplasia (PRCA; a type of severe anemia that may develop after treatment with an ESA such as darbepoetin alfa injection, epoetin alfa injection, or methoxy polyethylene glycol-epoetin beta. Your doctor may tell you not to use methoxy polyethylene glycol-epoetin beta injection.

PEG can also be dangerous for the unborn

“tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using methoxy polyethylene glycol-epoetin beta injection, call your doctor.”

Before using [PEG] methoxy polyethylene glycol-epoetin beta injection,–ie Before taking the Moderna and Pfizer vaccine!!

  • tell your doctor and pharmacist if you are allergic to methoxy polyethylene glycol-epoetin beta, any other medications, or any of the ingredients in methoxy polyethylene glycol-epoetin beta injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

QUESTION? How do you know if you are allergic to PEG UNTIL YOU TAKE IT ???

Wodarg and Yeadon state that 70% of people will develop antibodies against PEG–ie they are allergic to it.
SOURCE https://medlineplus.gov/druginfo/meds/a619007.html


Moderna’s Clinical Tests acceptance criteria

Think about each of these criteria which excludes people from taking the shot. Why would they NOT want any of these people?

Criteria
Inclusion Criteria:
A subject must meet all of the following criteria to be eligible to participate in this study:

  1. Provides written informed consent prior to initiation of any study procedures.
  2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
  3. Agrees to the collection of venous blood per protocol.
  4. Male or non-pregnant female, >/= to 18 years of age at time of enrollment.
  5. Body Mass Index (BMI) 18.0-35.0 kg/m^2, inclusive (< 56 years of age), at screening; BMI 18.0-30.0 kg/m^2, inclusive (>/= 56 years of age), at screening.
  6. Women of childbearing potential* must agree to use or have practiced true abstinence** or use at least one acceptable primary form of contraception.***, **** Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship).
    • Not of childbearing potential – post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement).
      • True abstinence is 100% of time no sexual intercourse (male’s penis enters the female’s vagina). (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
        • Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject’s first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products.
          • Must use at least one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination.
  7. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination.
  8. Male subjects of childbearing potential*: use of condoms to ensure effective contraception with a female partner of childbearing potential from first vaccination until 60 days after the last vaccination.*Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy.
  9. Male subjects agree to refrain from sperm donation from the time of first vaccination until 60 days after the last vaccination.
  10. In good health.**As determined by medical history and physical examination to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of subjects. Chronic medical diagnoses/conditions should be stable for the last 60 days (no hospitalizations, emergency room (ER), or urgent care for condition or need for supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 60 days before enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the participating site principal investigator (PI) or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to study vaccination.
  11. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
  12. Pulse no greater than 100 beats per minute.
  13. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
  14. Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb), platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine (Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), Lipase, prothrombin time (PT), and partial thromboplastin time (PTT)) are within acceptable normal reference ranges at the clinical laboratory being used.
  15. Must agree to have samples stored for secondary research.
  16. Agrees to adhere to Lifestyle Considerations throughout study duration.
  17. Must agree to refrain from donating blood or plasma during the study (outside of this study).

Leukapheresis Inclusion Criteria:
A subject must meet all of the following criteria to be eligible for leukapheresis:

  1. Written informed consent for leukapheresis is provided.
  2. Weight >/= 110 pounds.
  3. Screening laboratory evaluations are within acceptable ranges at the site where the leukapheresis procedure will be performed.
  4. Negative urine or serum pregnancy test within 48 hours of the leukapheresis procedure for women of childbearing potential.
  5. Adequate bilateral antecubital venous access.
  6. No use of blood thinners, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) at least 5 days before the leukapheresis procedure.
  7. Enrolled in cohorts 2, 3, 5, 10, or 11, and possibly cohort 6, if enrolled, and completed the two-dose vaccination series.

Exclusion Criteria:
A subject who meets any of the following criteria will be excluded from participation in this study:

  1. Positive pregnancy test either at screening or just prior to each vaccine administration.
  2. Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
  3. Has any medical disease or condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation.**Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject’s successful completion of this trial.
  4. Presence of self-reported or medically documented significant medical or psychiatric condition(s).**Significant medical or psychiatric conditions include but are not limited to: Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), history of myocarditis or pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia.Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson’s disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer’s disease).
    Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
    An autoimmune disease, including hypothyroidism without a defined non-autoimmune cause, localized or history of psoriasis.
    An immunodeficiency of any cause. Chronic kidney disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2.
  5. Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination.*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
  6. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
  7. Has participated in another investigational study involving any investigational product* within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.*study drug, biologic or device
  8. Currently enrolled in or plans to participate in another clinical trial with an investigational agent* that will be received during the study-reporting period.***Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.**13 months after the first vaccination.
  9. Has previously participated in an investigational study involving lipid nanoparticles (LNPs) (a component of the investigational vaccine assessed in this trial).
  10. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
  11. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.**Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
  12. Anticipating the need for immunosuppressive treatment within the next 6 months.
  13. Received immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
  14. Has any blood dyscrasias or significant disorder of coagulation.
  15. Has any chronic liver disease, including fatty liver.
  16. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration.
  17. Has a positive test result for drugs of abuse at screening or before the first vaccine administration. If cannabis is the only detected drug, inclusion is permitted.
  18. Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region).
  19. Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination.
  20. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination.
  21. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
  22. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
  23. History of COVID-19 diagnosis.
  24. On current treatment with investigational agents for prophylaxis of COVID-19.
  25. Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the investigator or necessary to manage a chronic condition.
  26. Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska) from enrollment through 28 days after the second vaccination.
  27. Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care.
  28. Non-ambulatory.
  29. For subjects >/= 56 years of age, history of chronic smoking within the prior year.
  30. For subjects >/= 56 years of age, current smoking or vaping.
  31. For subjects >/= 56 years of age, individuals currently working with high risk of exposure to SARS-CoV-2 (e.g., active health care workers with direct patient contact, emergency response personnel).

SOURCE: https://clinicaltrials.gov/ct2/show/NCT04283461
LASTLY HERE IS AN ACTUAL INSTRUCTION PAPER FOR THE MODERNA VACCINE
Here I have copied and pasted the side effects

What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue; dizziness or weakness) fast heart beat trouble breathing
Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):
chills
fever
headache
joint pain
muscle pain
nausea pain,
redness, or irritation at site where injected
swollen lymph nodes in the same arm
tiredness
This list may not describe all possible side effects. Call your doctor for medical advice about side effects.

The title of the paper is

Synthetic messenger RNA (mRNA) of SARS-CoV-2, SM-102,Cholesterol, 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PEG2000-DMG Suspension for injection

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
any allergies
bleeding disorder
fever or infection
immune system problems
recent or upcoming vaccine including previous COVID-19 vaccine
an unusual or allergic reaction to COVID-19 vaccine, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding.
Good luck with this folks….and as the paper says “SARS COVID-19 VACCINE is a vaccine used to reduce the risk of getting COVID-19. This vaccine does not treat COVID-19. There is no FDA-approved vaccine to prevent COVID-19.The FDA has authorized the emergency use of this vaccine during the COVID-19 pandemic”
Get vaccinated even though there are all these risks, and it doesn’t even stop you getting the virus. So what does it do?
Read my posts on mNeonGreen and the Global Reset
http://awakeandsee.com/blog/2020/12/21/the-global-reset-link-to-vaccines/
http://awakeandsee.com/blog/2020/12/25/pfizer-mnanogreen-makes-you-trackable-in-real-time/