When will sharing news like this be a federal offense? Leading COVID Vaccine Candidates Plagued by Safety Concerns > > Unproven technologies, unsafe ingredients and inadequate testing — > fortunately, current law prohibits mandating unlicensed vaccines approved > for “emergency use.” > > By > > Alix Mayer <https://childrenshealthdefense.org/author/alix-mayer>, > <https://childrenshealthdefense.org/author/alix-mayer> > > Link copied > > > https://childrenshealthdefense.org/defender/covid-vaccine-candidates-safety-concerns/?utm_source=salsa&eType=EmailBlastContent&eId=eb801843-26cf-4ada-b215-12aa92ce761a > > “It works!” trumpeted the normally stoic Nature journal > <https://www.nature.com/articles/d41586-020-03166-8> about Pfizer’s early > release results > <https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against> > in > a Phase III trial of its vaccine for COVID-19 > <https://childrenshealthdefense.org/defender/covid-19-vaccine-news/>. > Pfizer > <https://childrenshealthdefense.org/defender/pfizer-covid-vaccine-questions-safety> > stated > the vaccine was 90% effective when trial participants were exposed to SARS > CoV-2, the virus said to cause COVID-19 symptoms. > > Not so fast. Pfizer’s study protocol > <https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol_0.pdf> > states > cases count even if a trial participant has a positive test and only one > symptom — like a cough, chills or diarrhea — that could easily be caused by > one of 1,400 human pathogens <https://www.nature.com/articles/nrmicro2644>, > including 200 viruses > <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3427559/> known to infect > humans. Except for Hepatitis A, B, C and HIV, the study protocol is silent > on testing for other infectious causes of the participant’s symptoms. > > In other words, the study suffers from confirmation bias. A cough and a > positive test equals COVID, even when an “alternative possible diagnosis > <https://www.bmj.com/content/bmj/369/bmj.m1808.full.pdf>” could be the > real cause of the symptoms. Absence of evidence is not evidence of absence. > > Pfizer, partnering with BioNTech, uses new messenger RNA (mRNA) technology > in their vaccine, and will apply for a coveted Emergency Use Authorization > <https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization> > from > the U.S. Food and Drug Administration (FDA), likely before the end of > November. Pfizer’s announcement comes after 94 trial participants — of more > than 43,000 — tested positive for SARS CoV-2. Pfizer has not released data > on whether the cases were mild, moderate or severe. > > Early results may sound encouraging to some, but experts like Eric Topol, > director of the Scripps Research Translational Institute, indicated > <https://www.nature.com/articles/d41586-020-03166-8> “the vaccine may not > turn out to be as effective once the trial is complete and all the data has > been analysed [sic],” however “its effectiveness is likely to stay well > above 50%.” Pfizer’s study protocol > <https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol_0.pdf> > (p. > 103) states “success at the final analysis” will achieve a minimum 30% > efficacy, with greater than 98% certainty. We hope the vaccine is not 30 to > 90% effective against mild illness. > > Will the Pfizer vaccine work, and is it safe? Questions remain. Any > vaccine, including all COVID-19 > <https://childrenshealthdefense.org/defender_category/big-pharma>vaccines, > must be proven both safe and effective before being administered to > high-risk groups or to the global population. > > A successful vaccine must prevent severe illness, hospitalizations or > death, without serious adverse events that outweigh these benefits. It > cannot just claim to prevent mild cases that would resolve on their own. It > must also prevent person-to-person transmission. The trial data must be > sufficiently powered to answer these questions, not just for the healthy, > but for high-risk groups such as the elderly and those with underlying > conditions. > > Any initial protection from COVID-19 symptoms should also endure, and not > wane after a few weeks or a few months. Questions remain about these valid > criteria as applied to COVID-19 vaccine candidates. Recent publications in > leading medical journals indicate that the answers to safety and efficacy > questions may be less than assuring. > > As most of the world still suffers under lockdowns, many wonder if these > magic keys dangled to unlock us — the vaccines being developed for COVID-19 > — will avert more injuries and deaths than those caused by COVID-19 illness. > > *Illegal to mandate vaccines under Emergency Use Authorization* > > Any COVID vaccine(s) approved for emergency use should be voluntary, since > the vaccine(s) are considered investigational and are held to a much lower > standard for both efficacy and safety. For example, compared to the > non-emergency approval process to get full licensure, an emergency approval > allows for a vaccine that “may” be effective, compared to the non-emergency > approval process where a vaccine must demonstrate “substantial” > effectiveness. > > Emergency Use Authorization > <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities> > (EUA) > law is clear: States are barred from mandating a vaccine approved for > emergency usage. (See Section VI. Preemption > <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities>.) > It also should be illegal for private businesses, airlines or your employer > to mandate a vaccination while it is approved under an EUA. > > The New York Bar Association somehow missed > <https://childrenshealthdefense.org/defender/new-york-state-bar-association-covid-vaccine/> > this > materially important barrier to mandates. Their attorneys published a > position statement urging states to make COVID vaccination mandatory > <https://www.precisionvaccinations.com/new-york-lawyers-recommend-mandatory-covid-19-vaccinations>, > allowing only a medical exemption. It appears that these lawyers either > have supernatural foresight that COVID vaccines will be granted full > licensure sometime in the future, or they have great hubris thinking they > can override EUA law. > > Only if the FDA were to grant full licensure, which normally takes years, > would the states > <https://childrenshealthdefense.org/news/new-england-journal-of-medicine-mandate-covid-vaccines/> > or > businesses be allowed to consider vaccine mandates. The PREP Act > <https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx> exempts > COVID vaccine manufacturers from liability, even if the vaccine(s) harm > recipients, so the idea of mandates is particularly frightening. > > *Settling for a ‘new normal’* > > Public health authorities tantalize us with the idea of a “new normal” > after a vaccine for COVID-19 is widely available. The term implies, and has > been widely interpreted to mean, that for society to return to normal, the > vaccine would prevent person-to-person transmission so everything could > “open up.” > > As appealing as this may sound to those harmed by lockdowns, only 42% of > Americans now say they would get a COVID vaccine, according to the latest > YouGov poll > <https://today.yougov.com/topics/politics/articles-reports/2020/10/26/willingness-be-vaccinated-rises-poll>. > Even among this sanguine minority, two-thirds harbor concerns about COVID > vaccine safety. If public health authorities want high uptake of the > vaccine, they need to push manufacturers to provide transparent trial > information to address concerns, as the vaccine will have to be voluntary > if any EUAs are granted. > > In June, vaccine industry spokesperson Dr. Peter Hotez said > <https://www.latimes.com/science/story/2020-07-30/warp-speed-coronavirus-vaccine-fda>, > “Ideally, you want an antiviral vaccine to do two things. … First, reduce > the likelihood you will get severely ill and go to the hospital, and two, > prevent infection and therefore interrupt disease transmission.” > > However, last week, Dr. Anthony Fauci, director of the National Institute > of Allergy and Infectious Diseases (NIAID) and White House coronavirus > spokesperson, moved the goalpost > <https://finance.yahoo.com/news/fauci-vaccines-will-only-prevent-symptoms-not-block-the-virus-195051568.html> > and > admitted the goal of COVID vaccines is to provide personal protection only, > not to prevent death, or person-to-person transmission. Fauci said he and > his colleagues would “settle for … the primary endpoint to prevent > clinically recognizable disease.” > > “Settle for” could be used when someone cannot afford the house they want, > or when their favorite pizza topping is not available, so someone settles > for cheese pizza instead of pepperoni. It is hard to imagine the words > “settle for” would ever be uttered in reference to a vaccine, let alone by > the guy leading the COVID vaccine program for the U.S. > > Settling for a vaccine that does not meet the initially lofty promises > will not make more people voluntarily line up to get it. > > *Flawed trial design * > > As conceded by Fauci, there are indeed some concerning issues with the > trial design, spelled out <https://www.bmj.com/content/371/bmj.m4037>nicely > by Dr. Peter Doshi in the British Medical Journal. Doshi focuses on the two > biggest issues. First, none of the leading vaccine candidate trials is > designed to test if the vaccine can reduce severe COVID-19 symptoms, > defined as: hospital admissions, ICU or death. And, second, the trials are > not designed to test if the vaccine can interrupt transmission. > > If neither of these conditions is met, the vaccine in essence performs > like a therapeutic drug, except a vaccine would be taken prophylactically, > even by the perfectly healthy, and more than likely carries a higher risk > of injury than a therapeutic drug. If this were to be true, then > therapeutic drugs would be superior to any COVID vaccine. > > *Preventing severe symptoms?* > > Regarding the new Pfizer trial results, Paul Offit, director of the > Vaccine Education Center at Children’s Hospital of Philadelphia, said: “I > want to know the spectrum of disease that the vaccine prevents. You’d like > to see at least a handful of cases of severe disease in the placebo group.” > > Though Pfizer stated > <https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against> > “the > study also will evaluate the potential for the vaccine candidate to … > [prevent] against severe COVID-19 disease,” Pfizer’s press release did not > indicate if the cases described in the company’s Phase III early release > results were mild or severe. “In all the ongoing phase III trials for which > details have been released, laboratory confirmed infections even with only > mild symptoms qualify as meeting the primary endpoint definition,” wrote > Doshi. > > Phase III trials include a challenge test, where those who are vaccinated > and those in the placebo group are followed to see if they end up testing > positive for COVID-19, referred to as events or cases. “Final efficacy > analyses are planned after just 150 to 160 ‘events,’” stated Doshi, > “regardless of severity of the illness.” He went on to say that “hospital > admissions and deaths from COVID-19 are simply too uncommon in the > population being studied for an effective vaccine to demonstrate > statistically significant differences in a trial of 30,000 people.” > > The entire point of clinical trials is to demonstrate statistical > significance so the FDA can make an informed decision on whether or not to > approve the vaccine. The present clinical trials do not provide reliable > data on whether these vaccines prevent hospitalizations and deaths. > > *No blocking of transmission* > > Plans to roll out vaccines to the 7.5 billion people in the world based on > about 160 clinical trial participants per vaccine candidate not only lacks > statistical power; most would consider it reckless. > > Regarding the Pfizer results, Mt. Sinai virologist and trial participant > Florian > Krammer indicated <https://www.bmj.com/content/371/bmj.m4037> “a > transmission-blocking vaccine could accelerate the end of the pandemic. > However, it will be difficult to determine if the Pfizer vaccine, or others > in late-stage trials, can achieve this.” Moderna Chief Medical Officer > Tal Zaks concurs <https://www.bmj.com/content/371/bmj.m4037>, stating > “our trial will not demonstrate prevention of transmission, because … you > have to swab people twice a week for very long periods, and that becomes > operationally untenable,” citing the need for a five-to-ten times longer > trial length and even higher costs. > > Since these COVID-19 vaccines will not be approved for full licensure > based on their ability to stop the spread of COVID-19 or prevent > hospitalization or death, we may face never-ending lockdowns. If the > present COVID-19 vaccine clinical trials eventually lead to full licensure, > yet do not statistically significantly establish prevention of > person-to-person transmission, they should not be used to justify mandated > <https://childrenshealthdefense.org/news/new-england-journal-of-medicine-mandate-covid-vaccines/> > vaccinations > in order to board a plane > <http://www.bbc.com/travel/story/20200831-coronavirus-will-you-need-an-immunity-passport-to-travel> > , go to work > <https://www.reuters.com/article/us-health-coronavirus-tech/back-to-work-not-without-a-check-in-app-immunity-passport-idUSKBN24701B> > , attend a concert > <https://www.billboard.com/articles/business/touring/9481166/ticketmaster-vaccine-check-concerts-plan>or > eat at a restaurant. > > *Lack of study power in groups most affected by COVID-19* > > After Phase I trials, manufacturer studies are recruiting the elderly, > minorities and those with underlying health conditions into larger studies > with more than 30,000 subjects. However, though Pfizer stated > <https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against> > that > “approximately 42% of global participants and 30% of U.S. participants have > racially and ethnically diverse backgrounds,” there are concerns the trials > are not sufficiently powered to evaluate vaccine effectiveness in these > groups. > > The 160-event challenge tests will not be broken down by sub-population, > leaving little actionable data on these vulnerable groups. Additionally, > Pfizer has not disclosed how many elderly are enrolled in its trial. “I > can’t see how anybody — the DSMB [Data Safety Monitoring Board > <https://www.nidcr.nih.gov/research/human-subjects-research/toolkit-and-education-materials/interventional-studies/data-and-safety-monitoring-board-guidelines>] > or the FDA Vaccine Advisory Committee, or FDA decision-makers — would ever > allow a vaccine to be recommended for that group [age 65 and older] without > having adequate data,” said Offit > <https://www.medscape.com/viewarticle/936937#vp_7>. > > *Adverse events and concerning vaccine ingredients* > > So exactly what has been revealed thus far by the COVID-19 vaccine trials? > Below are the issues with trial design, paused trials, adverse events, and > questions about fast-tracking a new mRNA technology, among many other > questions and issues. > > Here are the five companies hoping the FDA will grant an Emergency Use > Authorization > <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities>: > Moderna, Pfizer/BioNTech, Johnson & Johnson, Astra-Zeneca/Oxford, and > GlaxoSmithKline. All receive funding from Operation Warp Speed > <https://childrenshealthdefense.org/news/operation-warp-speed-cia-linked-contractor-covid-vaccine/> > to > compress development time into a few months. Normally, vaccines take years > to go through proper safety testing. > > Significantly, with about two dozen vaccines in active use today, at least 66 > formally tested and approved vaccines > <https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/discontinued-vac.pdf> > in > the U.S. have been discontinued. Many — like RotaShield (rotavirus), > Lymerix, and the DTP shot — were removed due to safety issues. Given the > highly compressed development time, the adverse events experienced by trial > participants and the possibility of vaccine mandates under full licensure, > the public must demand transparency and open access to trial data. > > *Paused trials* > > Johnson & Johnson > <https://www.jnj.com/our-company/johnson-johnson-prepares-to-resume-phase-3-ensemble-trial-of-its-janssen-covid-19-vaccine-candidate-in-the-us> > was > the latest vaccine maker to pause its COVID-19 vaccine trial due to a > severe adverse event in a vaccine recipient. At the Oct. 30 Advisory > Committee on Immunization Practices (ACIP) meeting > <https://www.cdc.gov/vaccines/acip/meetings/slides-2020-10.html>, Johnson > & Johnson’s Dr. Jerald Sadoff was pressed by no fewer than six ACIP members > to reveal the illness, but refused, citing confidentiality. > > Meanwhile, Astra-Zeneca/Oxford > <https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9> > also > had to pause their trial after trial participants developed neurological > conditions > <https://covid19vaccinetrial.co.uk/files/cov002pisages18-55yearsv11011sept2020pdf> > like transverse myelitis and multiple sclerosis > <https://www.nature.com/articles/d41586-020-02706-6> and due to a death > <https://www.washingtonpost.com/world/the_americas/coronavirus-oxford-astrazeneca-vaccine-trial-death/2020/10/21/3f5bedac-13c0-11eb-ad6f-36c93e6e94fb_story.html>, > reportedly in the placebo group, which received meningitis vaccines instead > of true saline placebos. > > In Moderna’s Phase I trial > <https://www.nejm.org/doi/full/10.1056/NEJMoa2022483>, at least one > participant had to drop out due to urticaria > <https://www.drugs.com/cg/urticaria.html>, a common allergic drug > reaction that can cause a life-threatening anaphylaxis, but the drugmaker > did not pause its trial. Pfizer/BioNTech > <https://www.bloomberg.com/news/articles/2020-10-14/pfizer-biontech-covid-vaccine-trial-remains-on-track-ceo-says> > has > stated it will not pause its trial despite “side effects that have emerged.” > > On Oct. 23, the FDA cleared > <https://www.wsj.com/articles/covid-19-vaccine-trial-from-astrazeneca-oxford-can-resume-in-u-s-11603476923> > both > Johnson & Johnson and Astra-Zeneca to resume their trials, stating they > could not definitively link the severe adverse events or death to the COVID > vaccines. Given the small number of people in the trials, severe adverse > events in just a few participants could translate into thousands, if not > millions of injuries if the entire world population were vaccinated. > > *Questionable efficacy* > > Among the leading COVID vaccine candidates, Moderna > <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7377258/>, Pfizer/BioNTech > <https://www.nejm.org/doi/10.1056/NEJMoa2027906?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed> > , Astra-Zeneca > <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext>/Oxford > and Johnson & Johnson > <https://www.medrxiv.org/content/10.1101/2020.09.23.20199604v1> (J&J) > have all published data from early human trials. (Links to published > studies within the text above, and also cited after the article.) > > While all four report 90% to 100% of participants developed antibodies > after two doses (single dose for J&J), all four also report a high rate of > adverse events. Note that antibodies are merely presumed to be effective, > when levels are comparable to antibodies in people who recovered naturally > from COVID. > > We will not know if the vaccines prevent or reduce symptoms, like the > early release results from the Pfizer trial, until complete challenge test > results are back. In the challenge test, the vaccinated and those who got a > placebo injection remain blinded, that is, they do not know which group > they are in. If a participant experiences COVID-like symptoms, he or she > will get a “nasal swab” test. Cases will be counted when a participant > tests positive for SARS CoV-2, the virus that is thought to cause COVID-19 > symptoms, via a polymerase chain reaction test. The vaccinated group will > then be compared to the placebo group. > > *High systemic adverse events* > > One hundred percent of those injected with two doses of Moderna > <https://www.nejm.org/doi/full/10.1056/NEJMoa2022483>’s mRNA vaccine (100 > mcg) experienced systemic adverse events, while 50% of those aged 18-55 in > Pfizer’s > trial > <https://www.nejm.org/doi/10.1056/NEJMoa2027906?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed> > had > systemic adverse events. > > In Astra-Zeneca/Oxford’s > <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext> > trial, > it took only one dose to cause more than 50% of participants to experience > adverse events. In J&J’s > <https://www.medrxiv.org/content/10.1101/2020.09.23.20199604v1> trial, a > single dose caused almost two-thirds of those under 55 to have systemic > adverse events, compared to about a third of those over 65. > > Systemic adverse events experienced by participants in all trials include > chills, fever, muscle pain and headache, which participants claim last > about 24 hours. One man with chills chattered his teeth so badly that he broke > a tooth > <https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html> > . > > *mRNA: unproven new vaccine technology* > > Historically, vaccines are made from an infectious organism — either a > virus or a bacterium — that is grown in a cell culture, like egg or > aborted fetal cells such as MRC-5 > <https://en.wikipedia.org/wiki/List_of_vaccine_ingredients>. > > Vaccine antigens are prepared in four ways: 1) live, but weakened by > attenuation <https://en.wikipedia.org/wiki/Attenuated_vaccine>, like the > measles, mumps, rubella vaccine (MMR); 2) inactivated > <https://en.wikipedia.org/wiki/Inactivated_vaccine> with a poison such as > formaldehyde, like the flu shot; 3) using part of an organism — a subunit > <https://en.wikipedia.org/wiki/Protein_subunit#Subunit_vaccines>, > recombinant, polysaccharide or a conjugate vaccine, like Hepatitis B or the > shingles vaccine; or 4) using a toxoid > <https://en.wikipedia.org/wiki/Tetanus_vaccine> (toxin) made by a germ, > like a tetanus shot. > > In all cases, the resulting vaccine provokes the recipient’s B-cells to > make antibodies to that organism. Subunit and toxoid vaccines tend not to > work without an adjuvant > <https://en.wikipedia.org/wiki/Immunologic_adjuvant> like aluminum, which > causes a more robust immune response. > > In a technological departure from the four basic vaccine types, both > Moderna and Pfizer/BioNTech are testing mRNA vaccines, a technology > <https://www.modernatx.com/mrna-technology/science-and-fundamentals-mrna-technology> > that > does not appear to rely at all on biological products. mRNA instructs our > cells to take action. In the case of the COVID vaccine, the lab works with > synthetic mRNA intended to instruct the body’s cellular machinery to make > some of the SARS CoV-2 proteins, but not the entire SARS CoV-2 virus. Then > the immune system is expected to make antibodies against those parts of the > virus. Basically, mRNA vaccines are intended to biohack — through genetic > modification — a human being to produce parts of a virus. > > Vaccines are classified as biologics > <https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers>, > not drugs, because traditional vaccines have always been derived from > biological materials. It is questionable that an mRNA vaccine using > synthetic RNA — which appears to have nothing biological in it — could > still maintain this classification as a biologic. It is really an injected > drug, and obviously a huge departure from traditional biologically based > vaccine technology. This should give us pause, given the fast-tracked > schedule is even more inappropriate for an entirely new vaccine technology. > > *Autoimmune syndromes caused by vaccination: pathogenic priming and > antibody-dependent enhancement* > > The handful of animal trials performed by the manufacturers — J&J (primate > <https://www.nature.com/articles/s41586-020-2607-z_reference.pdf>), > Moderna (mouse <https://www.nature.com/articles/s41586-020-2622-0> & > primate <https://www.nejm.org/doi/full/10.1056/NEJMoa2024671>), Pfizer ( > mouse <https://www.biorxiv.org/content/10.1101/2020.11.03.366641v1.full> > & primate <https://www.biorxiv.org/content/10.1101/2020.09.08.280818v1>) > and AstraZeneca/Oxford (primate > <https://www.nature.com/articles/s41586-020-2608-y>) — focused on overall > tolerability of the vaccines, clearance of pathogens from the upper and > lower respiratory tract, and probed for which dose level might be > immunogenic and safe. > > The animal trials are being conducted alongside — not before — human > trials, and have yet to release results regarding the possibility of > pathogenic > priming <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7142689/>, which > could lead to enhanced COVID-19 disease in individuals vaccinated against > the SARS-CoV-2 virus, and potentially cause autoimmunity against many human > proteins, including critical proteins in our immune systems. > > As far as is known, none of the vaccines has eliminated unsafe epitopes — > the part of SARS-CoV-2 proteins that match human proteins. If the immune > system produces antibodies to these epitopes, they could attack “self,” the > hallmark of autoimmune disease. > > We may have to wait for results from Phase III COVID vaccine trials for > information on another untoward autoimmune condition, antibody-dependent > enhancement <https://en.wikipedia.org/wiki/Antibody-dependent_enhancement> > (ADE). > In ADE, vaccines may cause idiopathic antibodies that act like a Trojan > horse for wild viruses, allowing the target virus to enter cells and > replicate. The opposite of protecting someone from an infection, ADE causes > the vaccinated person to get a worse case of the disease, and possibly > suffer organ damage. > > A recent review <https://pubmed.ncbi.nlm.nih.gov/33077678/> of ADE, also > termed immune enhancement, noted current trials are not designed to find > ADE, concluding that “rigorous clinical trial design and postlicensure > [sic] surveillance should provide a reliable strategy to identify adverse > events, including the potential for enhanced severity of COVID-19 disease, > after vaccination.” > > ADE has been demonstrated in studies on SARS CoV in: humans > <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4018502/>, ferrets > <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC525089/> (liver damage) and > non-human > primates <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478436/> (acute > lung damage), among a much larger body of literature. > > It is not known what percent of the population may suffer pathogenic > priming or antibody-dependent enhancement after vaccination with a COVID > vaccine. Estimates of Americans who already have an autoimmune disease > range from 14.7 million to 23.5 million > <https://www.autoimmuneregistry.org/autoimmune-statistics>. They are > likely more susceptible to pathogenic priming and ADE. > > *Other concerning ingredients* > > Aside from Moderna and Pfizer/BioNTech, the other leading vaccine > manufacturers are using recombinant vaccine technology, producing a genomic > chimera with properties intended to both activate the immune system and > generate antibodies to the SARS CoV-2 spike protein. > > Astra-Zeneca/Oxford is using a chimp virus > <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext> > — > an adenovirus — that can be the cause of the common cold, combined with the > spike protein from SARS CoV-2. There are long-standing concerns about > primate viruses in vaccines ever since the polio vaccine administered from > 1955 to 1963 was linked with cancer. The polio vaccine was cultured in > primate kidney cells infected with simian virus 40 (SV40). > <https://pubmed.ncbi.nlm.nih.gov/25057632/> > > Johnson & Johnson is using a human adenovirus combined with the spike > protein <https://www.medrxiv.org/content/10.1101/2020.09.23.20199604v1>. > GlaxoSmithKline/Sanofi is using a recombinant antigen based on their flu > vaccine technology > <https://www.precisionvaccinations.com/vaccines/sanofi-gsk-sars-cov-2-vaccine> > . > > Veteran vaccine researchers have also raised a warning flag > <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32156-5/fulltext>about > COVID-19 vaccine candidates that use adenoviruses that could result in an > increased susceptibility to HIV infections based on previous findings. In a > Lancet report > in October > <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32156-5/fulltext>, > researchers utilizing adenovector COVID vaccine technology acknowledged the > “controversial” possibility of their vector increasing the risk of HIV > infection, and said they would watch for it in the vaccine candidate trials. > > There are some other concerning ingredients to watch closely. In the > Moderna and Pfizer mRNA vaccines, polyethylene glycol (PEG) > <https://en.wikipedia.org/wiki/Polyethylene_glycol> is found in the fatty > lipid nanoparticle <https://www.immunohorizons.org/content/3/7/282> coating > around the mRNA. Seventy percent of people make antibodies to PEG > <https://childrenshealthdefense.org/news/a-dangerous-inactive-ingredient/> and > most do not know it, creating a concerning situation where many could have > allergic, potentially deadly, reactions to a PEG-containing vaccine. PEG > antibodies may also reduce vaccine effectiveness. > > Pfizer is inserting an ingredient derived from a marine invertebrate, > mNeonGreen <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3811051/>, into > its vaccine. The ingredient has bioluminescent qualities, making it > attractive for medical imaging purposes, but it is unclear why an injected > vaccine would need to have the equivalent of a visual day-glow marker. > mNeonGreen has unknown antigenicity. > > Finally, the GlaxoSmithKline vaccine will have a well-characterized toxic > ingredient, AS03 > <https://childrenshealthdefense.org/news/a-generation-asleep-narcolepsy-in-teens-and-young-adults/>, > an adjuvant used in the H1N1 vaccine that was linked with narcolepsy and > cataplexy. It contains squalene > <https://childrenshealthdefense.org/news/deja-vu-gsk-recycles-its-problematic-adjuvant-into-covid-19-vaccines/> > which > is harvested from shark livers > <https://www.sharkallies.com/shark-free-products/could-squalene-end-up-in-a-covid-19-vaccine>, > and is linked with Gulf War Syndrome. AS03 also contains polysorbate 80, > which disrupts the normally protective blood-brain barrier > <https://www.sciencedirect.com/science/article/pii/0378517389902664>, and > tocopherol > <https://www.sciencedirect.com/science/article/pii/S0168365919306066>, a > form of Vitamin E, as an emulsifier. > > *Meningitis vaccine ‘fauxcebo’* > > While Pfizer and GSK are using saline placebos in their trials, > Astra-Zeneca/Oxford is using a meningitis vaccine as its “placebo,” which > some term a “fauxcebo.” The meningitis vaccine causes significant levels of > adverse events, and may have even caused the reported death in the > Astra-Zeneca/Oxford trial. > > Comparing a COVID-19 vaccine to a meningitis vaccine as a placebo may have > comparable levels of adverse events, allowing the manufacturers to > misleadingly assert their COVID-19 vaccines had no more adverse events than > the meningitis placebo. If they actually compared their vaccines to a > saline placebo, the COVID-19 vaccine would likely have more adverse events. > > In their study protocol > <https://covid19vaccinetrial.co.uk/files/cov002pisages18-55yearsv11011sept2020pdf>, > Astra-Zeneca/Oxford stated the “use of saline as a placebo would risk > unblinding participants, as those who had notable reactions would know they > were in the ChAdOx1 nCoV-19 vaccine group.” Astra-Zeneca/Oxford does have one > saline placebo trial planned in South Africa > <https://clinicaltrials.gov/ct2/show/NCT04444674?term=NCT04444674&draw=2&rank=1>, > so there will be safety data compared to a real placebo when that trial is > completed in a few years. > > *Tylenol in some study groups* > > Finally, another oddity in the Astra-Zeneca/Oxford trial is the use in > some study groups of acetaminophen, also known as Tylenol or paracetamol. > The vaccine maker explained that it wanted to use the highest vaccine dose > possible, so a higher percentage of people would develop immunity after the > first dose. Per their Phase I study > <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext>, > “a single higher [vaccine] dose was chosen to provide the highest chance of > rapid induction of neutralizing antibody. In the context of a pandemic wave > where a single higher, but more reactogenic dose might be more likely to > rapidly induce protective immunity, the use of prophylactic paracetamol > appears to increase tolerability and would reduce confusion with COVID-19 > symptoms that might be caused by short-lived vaccine-related symptoms > without compromising immunogenicity.” > > Acetaminophen is made from coal tar > <https://www.worldofmolecules.com/drugs/tylenol.htm>, and even though > it’s been in use since the late 1800s, science is still unsure of its > mechanism of action. Side effects are well known, however. It depletes > glutathione, the body’s most abundant antioxidant made in the liver. It is > a questionable practice to administer this over-the-counter drug with > vaccines, as the body needs abundant glutathione to detoxify vaccine > ingredients. > > *BARDA funding and potential approval right around the corner* > > All five of the leading vaccine manufacturers have received money from the > Department of Health and Human Services’ Biomedical Advanced Research and > Development Authority (BARDA > <https://www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx?filter=vaccine>), > in amounts ranging from $1.2 to $3 billion to accelerate trials under > Operation > Warp Speed > <https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html>. > Manufacturers are all committed to producing 100 – 300 million initial > doses of their vaccines, with contracts to produce millions or billions > more doses. > > As enthusiasm for a COVID-19 vaccine wanes, it appears the clinical trials > will not inspire more confidence. Since everyone eagerly awaits the “new > normal” and some think a vaccine is the key to end lockdowns, enthusiasm > remains for even a sub-optimal vaccine. If suboptimal means a high rate of > serious injury, the vaccine makers still have a long road ahead to prove > the vaccines do not cause more death and injury than the symptoms of > COVID-19. > > Confidence is certainly not boosted when new mRNA vaccine technologies are > being tested at Warp Speed > <https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html> > led > by former GSK executive > <https://www.thedailybeast.com/the-sketchy-past-of-moncef-slaoui-trumps-coronavirus-vaccine-czar?ref=home> > Moncef Slaoui > <https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html>, > who helped conceal Avandia’s severe cardiac adverse events — a clear case > of the fox guarding the henhouse. > > Trading COVID disabilities and deaths for vaccine injuries and deaths is > not an option. Even if manufacturers can show the serious injury rate is > less than 1%, if the 7.5 billion people in the world were all vaccinated, > millions could be permanently injured or die from the vaccine. Though > mandates are prohibited under an Emergency Use Authorization, it will not > be too much longer until manufacturers seek full licensure. > > However, even under full licensure, if the vaccine doesn’t prevent spread, > there is no case to be made for vaccine mandates. Individuals should always > have the choice of whether or not to vaccinate themselves or their minor > children, after being fully informed of both risks and benefits. As always, > Children’s > Health Defense <https://childrenshealthdefense.org/> awaits a safe and > effective vaccine, and opposes all mandated medicines. > > *Contributors to this article include: James Lyons-Weiler, Ph.D > <https://jameslyonsweiler.com/>. and Greg Glaser, General Counsel for > Physicians for Informed Consent*. > ---
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