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THREAD: As FDA hearing on emergency use authorization for COVID vaccines takes place in DC this a.m., I will summarize the 3 installments of my #COVIDGATE series on corruption of vaccine clinical trials. We must not simply think and do as we're told. /1 https://twitter.com/tomselliott/status/1327358666845118464
#COVIDGATE Part One unpacks Moderna & Pfizer's clinical trial-by-press-release strategy of conditioning Americans to parrot the "more than 90%" or "94.5% effective" soundbites without understanding what the trials actually measured.
https://www.unz.com/mmalkin/covidgate-the-corruption-of-clinical-trials-part-one/
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https://www.unz.com/mmalkin/covidgate-the-corruption-of-clinical-trials-part-one/
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Pfizer enrolled 43,538, of whom 94 (about .2 of 1%) were identified as having COVID. Moderna included 30,000+, of whom 95 (about .3 of 1%) categorized as having COVID. In other words: Vaccine tested on those at incredibly low risk, not only vaccinated but also unvaccinated. /3
BMJ notes none of the trials “are designed to detect reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.” /4 https://www.bmj.com/content/371/bmj.m4037
Moderna’s chief medical officer told BMJ its trial lacks adequate statistical power to assess severe outcomes. COVID hospital admissions/deaths “are simply too uncommon...for an effective vaccine to demonstrate statistically significant differences in a trial of 30k people. /5
"The same is true of ability to save lives or prevent transmission: the trials are not designed to find out.” Bottom line: COVID-19 is too rare & too benign to permit analysis of exactly the kind of serious health outcomes that most Americans believe the vaccine will “cure.” /6
#BigPharma propagandists on both the Left & Right who tell you the vaccine prevents transmission of the virus, when the trial protocols measure no such thing, are straight up lying to you. TAKE NOTE of who is lying.
https://twitter.com/benshapiro/status/1336340323228737536 /7
https://twitter.com/benshapiro/status/1336340323228737536 /7
BMJ also noted “lab confirmed infections even w/only mild symptoms qualify as meeting primary endpoint definition." Mere cough & positive PCR test qualify as positive COVID cases in Moderna/Pfizer. "Efficacy" based on a measly 150-160 such “events” regardless of severity. /8
Big Pharma can't say how long alleged protection of COVID-19 vaccines will last.
Can’t tell you about synergistic effects with other vaccines.
Can't tell you about long-term side effects.
Don't forget: Vax-makers are IMMUNE from liability!
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https://www.law.cornell.edu/uscode/text/42/300aa-22
Can’t tell you about synergistic effects with other vaccines.
Can't tell you about long-term side effects.
Don't forget: Vax-makers are IMMUNE from liability!
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https://www.law.cornell.edu/uscode/text/42/300aa-22
Vaccinating billions to prevent a disease w/99% survival rate for people under 70, all based on clinical trial efficacy analysis of less than 200 COVID-19 cases involving patients w/coughs & unreliable PCR tests, is not triumph of science. It’s corruption of science. /10
Let's move on to #COVIDGATE PART 2: Clinical Trials and Crusader Bias. The "gold standard" of randomized, placebo-controlled, double-blind trials has been undermined by zealots & blabbermouths enrolled in the COVID vaccine research experiments. /11 https://www.unz.com/mmalkin/covidgate-part-two-clinical-trials-and-crusader-bias/
Unlike any other modern clinical trial, COVID vaxx trials attracted legion of crusaders w/pro-vaxx bias. Many of them are advocacy media who turned volunteer stints into splashy, self-aggrandizing op-eds. Like this one from leftist @MollyJongFast :
https://www.nytimes.com/2020/09/17/opinion/coronavirus-vaccine-trials.html /12
https://www.nytimes.com/2020/09/17/opinion/coronavirus-vaccine-trials.html /12
Or this one from WaPo's @WalterIsaacson proclaiming the COVID vaccine a "miracle of genetic medicine." https://www.newsbreak.com/news/2099089119836/i-was-part-of-a-trial-for-pfizers-covid-19-vaccine-its-a-miracle-for-genetic-medicine
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I tallied at least a dozen such pieces downplaying vax side effects & promoting universal jabs. Jong-Fast wrote that a doctor involved in her trial divulged to her that “people had so few symptoms they thought they were in placebo arm of study.” That's unethical disclosure. /14
Randomized, placebo-controlled & double-blind means each person has equal chance of receiving vaccine or placebo. Double-blind means neither volunteers nor trial investigators know which group received which shots (although administrators of shots know who’s getting what).
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Blinding prevents patients’ beliefs about treatment from influencing study outcome & prevents investigators from revealing clues about which treatment subjects receive. But crusader bias demonstrated by media enrollees & other general public volunteers taints the trials.
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I obtained screenshots of social media posts from
dozens of self-identified Moderna & Pfizer trial volunteers unblinding themselves while experiments ongoing.
I've submitted 20 to FDA as part of public comment process on EUA & offered to share all of them w/ agency.
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dozens of self-identified Moderna & Pfizer trial volunteers unblinding themselves while experiments ongoing.
I've submitted 20 to FDA as part of public comment process on EUA & offered to share all of them w/ agency.
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Volunteers discussed/posted antibody test results, shared symptoms & plotted how to drop out of trials and enroll in new ones if they suspected they didn’t get the vaccine.
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One woman told a Facebook group that her shot during Pfizer vaccine trial “was covered in a bunch of tape, but the part I could see was dark.” A man responded by posting a picture of his vial, partially covered in tape with a dark liquid visible. /19
Another volunteer, J.D.T., posted on Facebook that “someone working at study site” told him “the placebo and the vaccine are different colors.” This a brazen breach of protocol and ethics. Anyone who purports to be for "sound science" should be alarmed. /20
2 trial volunteers discussed being able to guess if they got vaccine based on whether administrator rushed into room to inject them. “The vaccine has to remain at a certain temp so once ready, it has to go. Pays to ask a lot of questions,” 1 advised the other. /21
Look at this @US_FDA - Pathologist enrolled in @moderna_tx vax trial posted on Facebook that she got tested during trial, advised others where to get tested & offered to give other trial volunteers antibody test from her private lab! Double-blind protection obliterated. /22
When 1 volunteer expressed concern antibody testing was “kind of ‘cheating'” & “against rules of the study,” another argued “My trial site said go for it. There is nothing in the legal documentation that says you cannot.” Another gave in to peer pressure & got tested.
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SCIENCE: Systematic review of meta-analyses looked at avg bias associated w/reported methodological aspects of RCTs: Lack of/unclear double blinding was associated w/23% exaggeration of intervention effect estimates in trials w/ subjective outcomes. /24 https://catalogofbias.org/biases/lack-of-blinding/
Now: #COVIDGATE PART 3: Attack on Informed Consent. It matters more than ever because we are entering most coercive era of medical tyranny in human history. Can you really offer voluntary & thorough consent at “warp speed” with a gun to your head? /25 https://www.unz.com/mmalkin/covidgate-part-3-attack-on-informed-consen
In case you need a primer on the history of informed consent requirements in the U.S., here's an overview. Our right to self-determination cannot be protected if doctors fail to disclose all risks of treatments. Same holds true in medical research.
https://dash.harvard.edu/bitstream/handle/1/8852197/Wandler.pdf?sequence=1
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https://dash.harvard.edu/bitstream/handle/1/8852197/Wandler.pdf?sequence=1
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The unthinking surrender of our autonomy to global pandemic blackmailers who will pre-condition travel, work, education & LIFE itself on COVID vaccination is horrific. The circumventing of parental authority over minors is even more evil==> /27 https://wamu.org/story/20/12/07/d-c-activists-push-bowser-to-veto-a-bill-that-would-allow-minors-to-consent-to-vaccines/
You probably didn't hear about it, but responsible experts warn us that *adult* COVID vaccine trial volunteers were inadequately told of risks that the shots “could worsen disease." And we expect minors to be able to offer "informed consent?!"
https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795
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https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795
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SCIENCE: COVID-19 vaccine protocol review in Intl Journal of Clinical Practice determined that “antibody-dependent enhancement”- which could worsen COVID-19 - “was obscured” by vaccine manufacturers“ & should have been prominently & independently disclosed to volunteers.
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T. Cardozo of NYU Langone Health & R. Veazey of Tulane U. Medical School wrote that vax-makers' downplaying of antibody-dependent enhancement risk, buried “last or next to last” in clinical trial consent forms, “obviate(ed) truly informed consent.”
/30 https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795
/30 https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795
Burying adverse effects in fine print is SOP for #BigPharma. It’s exactly what they’ll do w/package inserts for the shots, too. Speaking of which, have you seen FDA’s draft list of “adverse event outcomes” for COVID-19 vaccines? Get informed.
https://www.fda.gov/media/143557/download
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https://www.fda.gov/media/143557/download
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Public health-industrial complex is pushing hard to sabotage parental authority over children. AMA pimping "model legislation" to give kids under 12 "ability to consent for their own vaccines," while *ADULTS* have nowhere near truly INFORMED CONSENT! /32
https://ama-assn.org/system/files/2019-05/a19-yps-resolution-01.pdf
https://ama-assn.org/system/files/2019-05/a19-yps-resolution-01.pdf
REMINDER: National Vaccine Injury Compensation Program’s payouts to vaccine-injured total more than $4.4 billion since 1989. Here are petition & compensation data. Will minors get a chance to review before granting "informed consent!?"
https://www.hrsa.gov/vaccine-compensation/data/index.html
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https://www.hrsa.gov/vaccine-compensation/data/index.html
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Let's talk more about adverse outcomes. Crusader volunteers are downplaying side effects or telling people they need to suck it up for the greater good, like this nurse volunteer in the Pfizer trials making the media rounds... https://www.businessinsider.com/nurse-got-covid-vaccine-side-effects-bad-but-worth-it-2020-12
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Pfizer/Moderna volunteers took to Facebook to gossip about side effects, incl high fever, being “unable to lift anything," vertigo, high BP, arm pain for weeks, feeling “beaten with a baseball bat” & hours-long vomiting. "I'd be worried about elderly/weak people," one mused.
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One side effect you may have read about is allergic reactions, which vax-makers couldn't bury. Pfizer/BioNTech warned COVID shots shouldn't be given to people w/history of allergies after 2 UK health care workers suffered symptoms following jabs.
https://www.cnn.com/2020/12/09/health/covid-vaccine-allergies-health-workers-uk-intl-gbr/index.html
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https://www.cnn.com/2020/12/09/health/covid-vaccine-allergies-health-workers-uk-intl-gbr/index.html
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Another adverse outcome that broke in the news: 4 volunteers in Pfizer trial who developed Bell's Palsy.
Attached: Relevant chart from FDA website: 4 BP cases among vaccinated vs. 0 cases in placebo group. Mere 10 serious COVID-19 cases overall.
https://www.wionews.com/world/four-trial-volunteers-who-got-pfizers-covid-19-vaccine-developed-bells-palsy-348547
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Attached: Relevant chart from FDA website: 4 BP cases among vaccinated vs. 0 cases in placebo group. Mere 10 serious COVID-19 cases overall.
https://www.wionews.com/world/four-trial-volunteers-who-got-pfizers-covid-19-vaccine-developed-bells-palsy-348547
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I urge every American to read 2 petitions by Wodarg, @MichaelYeadon3, et al to European & US FDA officials calling for suspension of all COVID-19 clinical trials. They raise red flags re. unreliable PCR tests & risks of ADE, allergies & infertility.
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi4mPzag8LtAhXAURUIHXrdB4s4ChAWMAV6BAgMEAI&url=https%3A%2F%2Fwww.wodarg.com%2Fapp%2Fdownload%2F9033912514%2FWodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_signed_with_Exhibits_geschwa%25CC%2588rzt.pdf%3Ft%3D1606870652&usg=AOvVaw3uUxCRJSd-1Rta-57kC9OX
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https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi4mPzag8LtAhXAURUIHXrdB4s4ChAWMAV6BAgMEAI&url=https%3A%2F%2Fwww.wodarg.com%2Fapp%2Fdownload%2F9033912514%2FWodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_signed_with_Exhibits_geschwa%25CC%2588rzt.pdf%3Ft%3D1606870652&usg=AOvVaw3uUxCRJSd-1Rta-57kC9OX
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Petitioners warn about 2 additives in Pfizer vaccine: polyethylene glycol (against which 70% of people produce antibodies that could provoke “allergic, potentially deadly reactions”) & mNeonGreen (bioluminescent derived from marine invertebrate “of unknown antigenicity”). /39
Women, pay attention! @MichaelYeadon3 et al also warn of potential fertility-specific risks involving antibodies against “spike proteins” that could disrupt development of placenta. "Unclear" what if any warnings vax-makers have given.
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https://2020news.de/en/dr-wodarg-and-dr-yeadon-request-a-stop-of-all-corona-vaccination-studies-and-call-for-co-signing-the-petition/
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https://2020news.de/en/dr-wodarg-and-dr-yeadon-request-a-stop-of-all-corona-vaccination-studies-and-call-for-co-signing-the-petition/
mRNA vaccines are totally untested in general population. Mainstream scientists & others are asking serious questions about whether they will INCREASE long-term risk of autoimmune disease. The discussion is widespread on social media despite censors.
https://twitter.com/search?q=autoimmune%20mrna%20spike%20protein&src=typed_query&f=live
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https://twitter.com/search?q=autoimmune%20mrna%20spike%20protein&src=typed_query&f=live
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For those with allergies who want more info on polyethylene glycol in COVID vaccines, see here: "treating patients who have acquired anti-PEG antibodies...results in...low drug efficacy, hypersensitivity &...life-threatening side effects."
==> https://www.mdpi.com/2073-4360/12/2/298/htm /42
==> https://www.mdpi.com/2073-4360/12/2/298/htm /42
The @ChildrensHD sent multiple letters to HHS/FDA re PEG additive in COVID vaccines. Govt brushed them off.
"Extrapolated to the U.S. population of 330 million, 16.6 million may have antibody levels associated w/adverse effects."
https://childrenshealthdefense.org/defender/pfizer-covid-vaccine-allergic-reactions/ /43
"Extrapolated to the U.S. population of 330 million, 16.6 million may have antibody levels associated w/adverse effects."
https://childrenshealthdefense.org/defender/pfizer-covid-vaccine-allergic-reactions/ /43
For those who want more info on antibody-dependent enhancement (ADE), see this thread. There's disagreement on how big, if any, a problem it is/will be. Bottom line: NOBODY KNOWS because long-term clinical trial data is lacking. #InformedConsent
https://twitter.com/eclecticbiotech/status/1248224087639539712
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https://twitter.com/eclecticbiotech/status/1248224087639539712
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Experts treat "positive results from PCR-based tests for COVID-19 as if they are completely reliable...In fact, however, false positives occur in PCR tests for COVID-19 often enough to be a significant problem."
https://www.icd10monitor.com/false-positives-in-pcr-tests-for-covid-19
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https://www.icd10monitor.com/false-positives-in-pcr-tests-for-covid-19
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Related: Deep dive into PCR test protocol for detection of COVID and challenge/retraction paper issued by team of dissident scientists.
/46 https://twitter.com/patricksavalle/status/1333171959832711168
/46 https://twitter.com/patricksavalle/status/1333171959832711168
To simplify: A test with a low false positive rate can result in more false positives than true positives if the disease being tested (like COVID-19) is rare. If you don't know why, read up on the false positive paradox: https://puzzlewocky.com/paradoxes/the-false-positive-paradox/
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MUST WATCH Former Pfizer top researcher @MichaelYeadon3 : "Cease mass testing of the mostly well population immediately...for God's sake don't increase number of tests. It's a pathology all its own which must be stamped out by right-thinking people."
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Do your own homework. Here are links to the Pfizer and Moderna clinical trial protocols. How can you give #InformedConsent if you DON'T inform yourselves?
https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf
https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
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https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf
https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
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As of 3:30pm Eastern, the FDA hearing on emergency use authorization of Pfizer COVID vaccine that started this morning at 9am is still ongoing. Q&A happening. Vote scheduled after discussion. Watch now:
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Now that this #COVIDGATE thread has broken the 50-tweet mark, I'll be doing a livestream shortly to review all the info as FDA takes a break and hurtles toward a vote at warp speed for Pfizer COVID vaccine. Stand by. /51
Here's my COVIDGATE clinical trial corruption livestream. FDA has just now approved emergency use authorization for Pfizer vaccine. Now it's up to you to do your own homework. Informed consent is meaningless unless you are TRULY, THOROUGHLY INFORMED. /52 https://twitter.com/michellemalkin/status/1337140442773667840
FDA vote breakdown. Interesting: It was NOT unanimous.
Via @highwiretalk - 17 ‘yes’ votes, 4 ‘no’ votes & 1 abstention. https://twitter.com/HighWireTalk/status/1337167309501296640
Via @highwiretalk - 17 ‘yes’ votes, 4 ‘no’ votes & 1 abstention. https://twitter.com/HighWireTalk/status/1337167309501296640
