Monday, February 20, 2023

COVID Vaccine Allergies: What We Know So Far

“Excipients” are likely responsible for allergic reactions to COVID-19 vaccines, according to a 2022 review article published in the Journal of the National Medical Association. At least one dose of the COVID-19 vaccine has been administered to 69.5% of the global total population, as of Feb 16, 2023, and over 750,000 doses continue to be administered each day. Vaccine reactions are on the rise, although hypersensitivity reactions are rarely observed. In 2020, TrialSite reported that an ingredient in the COVID-19 vaccine made by Pfizer and BioNTech may have caused severe allergic reactions in at least eight people within two weeks.

Excipients are ingredients added to drugs or vaccines for the purposes of long-term stabilization, protection, and more. They include everything other than the active pharmaceutical ingredient and are ideally inert.

Hypersensitivity is a situation in which the immune system overreacts or reacts abnormally to an antigen. In a lifetime, a person can experience a wide range of allergic reactions. Many of these responses end spontaneously, but some might cause catastrophic consequences, although this is rare. An allergic reaction can be triggered by any material introduced into the body, whether through inhalation, topical application, oral ingestion, or vaccination.

To investigate the allergic effects of globally administered COVID-19 vaccines, Haq et al. gathered findings from 72 articles by using 11 keywords such as "SARS-CoV-2," "COVID-19," and "hypersensitivity". They also examined different types of hypersensitivity reactions, allergic reactions to different COVID-19 vaccines, clinical aspects, and prevention of vaccine-induced hypersensitivity reactions.

Highlights of Hypersensitivity Reactions

Various kinds of hypersensitivities can occur. These different reactions can be classified into four main types:

Type I is an IgE antibody-mediated hypersensitivity that can occur within minutes to a few hours following allergen exposure through a vaccination, wasp, or toxin. This allergen can cause the release of biochemical messengers such as histamine, prostaglandins, and leukotrienes, leading to anaphylactic shock, which can be fatal.

Type II is mediated by IgE or lgM antibodies. This type of allergy causes cell malfunction and cell death. It's responsible for most autoimmune disorders, such as lupus or Goodpasture syndrome that cause antibodies to damage the organs such as kidneys and lungs.

Type III causes a complex reaction of immune complements. Immune complexes, consisting of accumulated antigen and antibody molecules, mediate inappropriate immune reactions. These immune reactions cause damage to vessels skin, and joints.

Type IV, or delayed-type hypersensitivity, is a cell-mediated immune response that occurs after allergen exposure. This response takes place over the course of several days and is triggered by T cells rather than antibodies. T cells that have been sensitized in advance trigger an immunological response that eventually causes dermatitis.

Those who have a history of allergic reactions are more likely to experience anaphylactic reactions to COVID-19 vaccinations. These reactions often take place less than 30 minutes after immunization and are caused by an acute IgE-mediated mechanism.

What Causes Vaccine Hypersensitivity?

The cause of a vaccine-induced hypersensitivity reaction is frequently difficult to pinpoint. Allergies are caused by the excipients added to preserve the drug's density, uptake, or solvability. However, these compounds can produce a variety of detrimental reactions, from dermatitis to hypotensive shock. Unfortunately, vaccinations must contain excipients to sustain vaccine potency, generate a robust immune response, and prevent contamination.

Vaccines that contain egg protein, gelatin, virus-inactivating proteins, mercury-based protective agents, or specific antibiotics such as neomycin can cause common type 1 hypersensitivity. Researchers also point out that the polyethylene glycol (PEG) molecule present in vaccines, including COVID-19 vaccines, could activate the complement system.

PEGs are polyester-based chemicals that are widely utilized as additives in medicine, cosmetics, and the food industry. PEG allergy is uncommon, although it is becoming more common and can be serious. PEGs are utilized for the stabilization of biomedicine formulas, however, conjugating PEGs with other compounds found in vaccines, such as proteins, might boost their immunogenic response.

Different Excipients in Different Vaccines

There are various types of COVID-19 vaccines that use different mechanisms. However, Haq et al. reviewed vaccines by Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), AstraZeneca, Johnson & Johnson (Ad26.COV2.S), and Sinopharm (BBIBP-CorV). They found the following:

The mRNA COVID-19 vaccines, by Pfizer-BioNTech and Moderna, contain many excipients. Both Pfizer-BioNTech and Moderna COVID-19 vaccines contain mRNA and excipients such as potassium chloride, monobasic potassium phosphate, sodium chloride (salt), dibasic sodium phosphate, and sucrose (type of sugar). Minerals such as potassium, chloride, and phosphate are commonly found in foods and medicines. All these chemicals are usually used in vaccines to deliver the vaccine in a liquid solution and also to preserve stability and pH values.

New mRNA vaccines, unlike previously existing vaccines, deliver mRNA to your body using multiple lipid nanoparticles to protect the mRNA and contribute to the formation of immunity. These mRNA vaccines also contain PEG molecules, which were previously mentioned as an allergen.

Oxford/Astra Zeneca and Johnson & Johnson's vaccines insert the COVID-19 S-protein gene into the chimpanzee, gorilla, and human adenovirus vectors. These vectors are used to transport viral genes into a human cell to make it lose its ability to replicate. Excipients like polysorbate 80 or Tween 80 can be found in AstraZeneca's and Johnson & Johnson’s COVID-19 vaccines. The chemical structure of polysorbate 80 is similar to that of PEGs and these can also cause allergic reactions.Most individuals who experience allergic reactions do so as a result of these excipients.

Sinopharm is a more traditional vaccine that is generated from the inactivated COVID-19 virus. Thimerosal and aluminum are used as adjuvants in this type of vaccine in addition to the active ingredient. Thimerosal is a mercury-based antiviral agent that is added to vaccines to kill viruses and bacteria. Aluminum hydroxide or aluminum phosphate is used to boost the immune system. Thimerosal and aluminum are metals and are considered contaminants. However, whether they induce allergies or not is still debatable.

Detection and Prevention of COVID-19 Vaccine Hypersensitivity
Almost all vaccination components may cause allergic reactions in susceptible individuals. Allergies can be caused by living or non-living main ingredients, protective agents, additives, or antibiotics. Pfizer and Moderna's COVID-19 vaccines do not have latex rubber stoppers or cultured proteins made from eggs, yeast, or gelatin, which can cause hypersensitivity. Almost all COVID-19 vaccinations, however, can induce IgE-mediated Type-I hypersensitivity. Although vaccine protective agents and additives can produce particular reactions by boosting the effects of a strong immune system and the vaccination's protection, the vaccine's capacity to trigger reactions is frequently unpredictable.

These reactions can be triggered by vaccine-induced allergies as well as by vasovagal syndrome, which is caused by an inability to regulate blood pressure. Vasovagal syndrome might cause nausea, blurred vision, and a feeling of lightheadedness. Furthermore, anxiety, fear, and tension can promote vasovagal activity and be misinterpreted as an allergic reaction. Tremors, palpitations, dizziness, and breathing problems caused by anxiety may appear to be allergic reactions.

Screening for hypersensitivity reactions before the COVID-19 vaccination is not mandatory. However, it is recommended by the American College of Allergy, Asthma, and Immunology (ACAAI). Many health professionals also advise monitoring allergic reactions for 30 minutes after the first dose of the COVID-19 vaccine. If a severe reaction occurs after the first vaccination, it is recommended not to take a second dose without consulting a medical professional. Allergy sufferers should take precautions and have a clear understanding of their allergic sensitivities.


Vaccine Activist Group Sues to Get VAERS Analyses: “Incredible Level of Harm”?

In a February 17 legal update, the Informed Consent Action Network (ICAN), a nonprofit activist group considered “anti-vax” by the mainstream but one of the most active groups forcing information disclosures from the U.S. government in association with the COVID-19 countermeasure response reports on the status of two lawsuits seeking disclosure of legally required VAERS analyses.

Although considered “anti-vaxers,” ICAN’s efforts may well lead to increased transparency which will benefit the public. They note that on June 30, 2022, they submitted about 20 Freedom of Information Act (FOIA) requests to both the FDA and the CDC seeking analyses they were required to do based on VAERS’ Standard Operating Procedures (SOP) for SARS-CoV-2. To date, ICAN has filed two lawsuits over three of the FOIA, and they allege that they have already uncovered damning data: “They reflect that the CDC’s own pre-determined analysis of VAERS data showed COVID-19 vaccines were causing an incredible level of harm.” CDC’s response is that a separate FDA analysis demonstrates that the CDC’s identification of widespread injuries is “not concerning.” Yet FDA is still fighting to keep its data out of the public realm.

FDA Denies Possession of Records

One key request sought all, “reports of possible concern based on [] data mining results” that FDA had been required to share CDC according to the SOP. After a denial by FDA and its appeal process, ICAN sued FDA on January 13, 2023. A separate request sought records relating to “Empirical Bayesian data mining” which is mandated by the SOP. Asserting that these records are “opinions, recommendations, and policy discussions,” FDA denied the request. Eventually, ICAN filed yet another suit on January 25, 2023. Per the SOP, Propositional Reporting Ratio (PRR) analyses were to be done, “to identify AEs [adverse events] that are disproportionately reported relative to other AEs.” To ICAN’s surprise, FDA responded that it did not have any records that would be covered by the request.

House of Cards?

Yet a letter from CDC Director Dr. Rochelle Walensky to Senator Ron Johnson said otherwise by stating that, “CDC performed PRR analysis between March 2022 through July 31, 2022, to corroborate the results of EB data mining.” And after ICAN sued for PRR-related materials, the Epoch Times reported that, strangely, the outlet did get the PRR analyses from CDC based on its own FOIA—and this is data that ICAN had been told did not even exist. According to ICAN, “the analyses show alarming safety signals.” Dr. Walensky’s letter to Sen. Johnson included that, “Notably, results from PRR analysis were generally consistent with EB [Empirical Bayesian] data mining [conducted by the FDA]….” ICAN supposes that the Bayesian data mining records are being withheld as they likely support the “shocking” PRR data. So, CDC is relying on FDA information to claim that its own PRR data is not of concern, yet the latter agency won’t release this information. To quote ICAN, “If FDA’s Empirical Bayesian analysis also shows the same level of harm, then the entire CDC/FDA house of cards regarding COVID-19 vaccine safety will come crashing down.”




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