"Schwere Verstöße und Manipulationen des Studienprotokolls: Wie Pfizer die FDA-Notfallgenehmigung für Kinder erhielt"

Unter die­sem Titel wur­de am 6.7. auf uncut​news​.ch eine Analyse vonYaffa Shir-Raz, PhD, ver­öf­fent­licht (dort ohne Anführungszeichen). Shir-Raz ist Forscherin im Bereich Risikokommunikation und Lehrbeauftragte an der Universität Haifa und dem Interdisciplinary Center Herzliya in Israel.

Sie ver­weist auf die vier Kinder unter den 1.131 "geimpf­ten", für die schwer­wie­gen­de uner­wünsch­te Ereignisse gemel­det wur­den. Drei von ihnen muß­ten wegen schwe­rer Depressionen eini­ge Tage nach der "Impfung" in Krankenhäusern behan­delt wer­den. Wenig beru­hi­gend ist die Erklärung von Pfizer, daß bei den Kindern schon zuvor ent­spre­chen­de Diagnosen bestan­den hat­ten. Sie hät­ten damit selbst nach dem eige­nen Studienprotokoll gar nicht in die Studie auf­ge­nom­men wer­den dür­fen. "Verschlimmernde Suizidgedanken" sei­en bei der Behandlungsart der vor­be­la­ste­ten Kinder ein "aner­kann­tes Risiko", so Pfizer.

Shir-Raz ver­mu­tet wei­ter, daß schwer­wie­gen­de uner­wünsch­te Ereignisse, die nach einem Beobachtungszeitraum von 30 Tagen auf­tre­ten, in der Studie nicht ver­mel­det werden.

Darüber hin­aus inter­pre­tiert sie eine Formulierung im Studienprotokoll so, daß ärzt­li­che Diagnosen nicht berück­sich­tigt wür­den, die außer­halb des Forschungsstandorts gestellt wer­den. Erkenntnisse von Erkrankungen, die in ande­ren Krankenhäusern anfie­len, wür­den so ggf. nicht in die Ergebnisse einfließen.

12 Antworten auf „"Schwere Verstöße und Manipulationen des Studienprotokolls: Wie Pfizer die FDA-Notfallgenehmigung für Kinder erhielt"“

  1. https://​www​.idc​.ac​.il/​e​n​/​p​a​g​e​s​/​f​a​c​u​l​t​y​.​a​s​p​x​?​u​s​e​r​n​a​m​e​=​Y​a​f​f​a​.​S​h​i​r​Raz
    "Ihre Schwerpunkte in Forschung und Lehre lie­gen in den Bereichen Gesundheits- und Risikokommunikation, Gesundheits-PR und per­sua­si­ve Kommunikation. Dabei kon­zen­triert sie sich vor allem auf kon­tro­ver­se Themen, die mit Unsicherheit ver­bun­den sind.
    Sie unter­sucht die Strategien und Taktiken von Pharmaunternehmen zur Bewerbung von Medikamenten und damit die Frage, wie Gesundheitsrisiken im Zusammenhang mit Krankheiten und Medikamenten von die­ser Industrie kom­mu­ni­ziert wer­den und wie Behörden die­se Werbemaßnahmen regulieren.
    Darüber hin­aus kon­zen­triert sich ihre Forschung auf die Gesundheits- und Risikokommunikation wäh­rend Epidemien (EID-Kommunikation), durch­ge­führt im Rahmen der Forschungsprojekte TELL ME und ASSET, die bei­de von der Europäischen Kommission finan­ziert werden.
    Sie ist außer­dem lei­ten­de Gesundheitsjournalistin für das Menta Magazine, Yedioth Aharonot, Israel, und hat sich in den letz­ten 15 Jahren auf inve­sti­ga­ti­ven Journalismus konzentriert."

  2. "Schwere Verstöße und Manipulationen des Studienprotokolls: Wie Pfizer die FDA-Notfallgenehmigung für Kinder erhielt"
    Wer mir jetzt immer noch erzäh­len will, dass dies doch gar nichts mit den Versuchen der 30er Jahre zu tun hat, dem kann ich nicht helfen.
    Für mich ist es ein bewuß­tes Inkaufnehmen von schwe­ren gei­sti­gen und kör­per­li­chen Nebenwirkungen, jetzt sogar auch bei Kindern. Es wird sogar der Tod in Kauf genommen.
    Diesem Gesindel ist alles erlaubt; sie wer­den auch nie­mals zur Rechenschaft gezo­gen und wir wis­sen nicht, was die noch so alles in pet­to haben.
    Das wuß­te man damals auch nicht.

  3. Dr. Robert Malone (Erfinder der mRNA- Methode) zu den uner­forsch­ten Vakzin- Risiken⚠️ und der gro­ben Fahrlässigkeit der Zulassungsbehörden bei der Prüfung der Impfstoffe vor Anwendung in der brei­ten Bevölkerung! https://​alsch​ner​-klar​text​.de/​2​0​2​1​/​0​7​/​0​3​/​d​i​e​-​z​u​l​a​s​s​u​n​g​s​b​e​h​o​e​r​d​e​n​-​h​a​b​e​n​-​k​e​i​n​e​n​-​b​l​a​s​s​e​n​-​s​c​h​i​m​m​er/

    1. die Studien waren immer gefälscht. sie­he Timiflu, von Roche! Negative Ergebnisse wer­den weg­ge­las­sen, um eine Notfall Genehmigung mit kor­rup­te Institutionen zu erhalten

    2. @D.D. vie­len Dank für den Link, UNFASSBAR!! Der Bericht soll­te auf der Titelseite einer gro­ßen Tageszeitung ver­öf­fent­licht wer­den, aber ich schät­ze, dann kön­nen die ein­packen! Warum eigentlich??
      Oder, evtl. kopie­ren und den in die­sem Lande für die Impfung ver­ant­wort­li­chen "POLITIKERN"( ha, ha,) als "denkauf­fri­schen­den" Einschreibebrief sen­den, wenn´s denn ankommt.…

  4. Das "Design" der Studien zwecks erfolg­rei­cher Zulassung wird doch gera­de­zu von den welt­weit ope­rie­ren­den Corona-Regimen impli­zit gefor­dert. Es muss ein "Impfstoff" her. Absprachen zwi­schen der for­schen­den Pharmaindustrie und den welt­weit ope­rie­ren­den Corona-Regierungen exi­stie­ren wohl zwangs­läu­fig. Der impli­zi­te Druck auf regu­la­to­ri­sche Behörden zur Zulassung ist das Resultat. Man hat ja Plandemie. Wann, wenn nicht jetzt kann die­se Technologie gete­stet wer­den ohne finan­zi­el­le Risiken und grö­ße­re ethi­sche Bedenken.

  5. Depressionen? Ende Juni 2021:
    "Ein Mutter aus Ohio spricht über ihre 12-jäh­ri­ge Tochter, die unter extre­men Reaktionen lei­det und fast gestor­ben wäre durch Teilnahme an der Pfizer Coronavirus-Impfstoff-Studie.
    Stephanie De Garay sag­te 'Tucker Carlson Tonight' am Donnerstag, dass nach Auskunft meh­re­re Ärzte, Maddie De Garay nicht durch den Impfstoff schwer krank gewor­den sein könne.
    'Die ein­zi­ge Diagnose, die wir für sie bekom­men haben, ist, dass es Konversionsstörung oder funk­tio­nel­le neu­ro­lo­gi­sche Symptomstörung ist, und sie schie­ben es auf Angst,' sag­te de Garay Tucker Carlson. …"
    https://​www​.fox​news​.com/​m​e​d​i​a​/​o​h​i​o​-​w​o​m​a​n​-​d​a​u​g​h​t​e​r​-​c​o​v​i​d​-​v​a​c​c​i​n​e​-​r​e​a​c​t​i​o​n​-​w​h​e​e​l​c​h​air

  6. 26.10.2021
    FDA
    VRBPAC 

    Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Document

    BNT162b2
    VRBPAC Briefing Document 

    BNT162B2 [COMIRNATY (COVID-19 VACCINE, MRNA)]

    Page 11

    Overall Risk-Benefit Conclusions 

    COVID-19 con­ti­nues to be a serious and poten­ti­al­ly fatal or life-threa­tening infec­tion for child­ren and the­re is a signi­fi­cant unmet medi­cal need in the 5 to <12 years of age population. 

    Two pri­ma­ry doses of the 10 μg BNT162b2 vac­ci­ne given 3 weeks apart in 5 to <12 years of age have shown a favorable safe­ty and tole­r­a­bi­li­ty pro­fi­le, robust immu­ne respon­ses against all vari­ants of con­cern and high VE against sym­pto­ma­tic COVID-19 in a peri­od whe­re the del­ta vari­ant was predominant. 

    The num­ber of par­ti­ci­pan­ts in the cur­rent cli­ni­cal deve­lo­p­ment pro­gram is too small to detect any poten­ti­al risks of myo­car­di­tis asso­cia­ted with vac­ci­na­ti­on. Long-term safe­ty of COVID-19 vac­ci­ne in par­ti­ci­pan­ts 5 to <12 years of age will be stu­di­ed in 5 post-aut­ho­rizati­on safe­ty stu­dies, inclu­ding a 5‑year fol­low-up stu­dy to eva­lua­te long term seque­lae of post-vac­ci­na­ti­on myocarditis/pericarditis.

    https://​www​.fda​.gov/​m​e​d​i​a​/​1​5​3​4​0​9​/​d​o​w​n​l​oad

    · Ceterum cen­seo COVAX del­en­dam esse ·

    1. 17.09.2021 • U.S. Food and Drug Administration • FDA 

      Vaccines and Related Biological Products Advisory Committee – 9/17/2021

      [ VRBPAC Meeting ]

      (Join us for a Vaccines and Related Biological Products Advisory Committee mee­ting to dis­cuss Pfizer-BioNTech’s sup­ple­men­tal Biologics License Application for admi­ni­stra­ti­on of a third dose, or “boo­ster” dose, of the COVID-19 vac­ci­ne, Comirnaty, in indi­vi­du­als 16 years of age and older.) 

      [ h 8:09.40 ] [ Beinahe acht Stunden und zehn Minuten ist hier das VRBPAC Meeting / Advisory Committee Meeting vom 17. September 2021 doku­men­tiert. Ab h 4:20:10 Steve Kirsch. ] 

      h 4:20:28
      Steve Kirsch: 

      « I'm going to focus my remarks today on the ele­phant in the room that nobo­dy likes to talk about—that the vac­ci­nes kill more peo­p­le than they save. Today we focus almost exclu­si­ve­ly on COVID death saves and vac­ci­ne efficacy—because we were led to belie­ve that vac­ci­nes are per­fect­ly safe. But this is sim­ply not true. For exam­p­le the­re are four times as many heart attacks in the tre­at­ment group in the Pfizer six-month tri­al report—that wasn't bad luck. VAERS shows heart attack hap­pen­ed 71 times more often fol­lo­wing the­se vac­ci­nes com­pared to any other vac­ci­ne. In all 20 peo­p­le died, who got the drug, 14 died who got the pla­ce­bo. Few peo­p­le noti­ce that, if the net all-cau­se mor­ta­li­ty from the vac­ci­nes is nega­ti­ve, vac­ci­nes, boo­sters, and man­da­tes are all nonsensical—this is the case today. » 

      « Death rates. This shows that the all-cau­se death light rate and, in three cases, only the VAERS num­bers are sta­tis­ti­cal­ly signi­fi­cant, but the other num­bers are troubling. Even if the vac­ci­nes had 100% pro­tec­tion, it still means we kil­led two peo­p­le to save one life. Four experts did ana­ly­ses using com­ple­te­ly dif­fe­rent Non‑U.S. data sources, and all of them came up with appro­xi­m­ate­ly the same num­ber of excess vac­ci­ne-rela­ted deaths, about 411 deaths per mil­li­on doses. That trans­la­tes into 150,000 peo­p­le have died. Now the real num­bers con­firm that we kill more than we save. And I would love ever­yo­ne to look at the Israel Ministry of health data on the 90 plus-year-olds whe­re we went from a 94.4% vac­ci­na­ted group to 82.9% vac­ci­na­ted in the last four months. In the most opti­mi­stic sce­na­rio, it means that 50% of the vac­ci­na­ted peo­p­le died, and 0% of unvac­ci­na­ted peo­p­le died. Unless you can explain that to the American public—you can­not appro­ve the boosters. » 

      — Steve Kirsch, Executive Director of COVID-19 Early Treatment Fund · CETF 

      https://​www​.you​tube​.com/​w​a​t​c​h​?​v​=​W​F​p​h​7​-​6​t​34M

      Advisory Committee Meeting 

      Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement 

      September 17, 2021 

      https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17–2021-meeting-announcement

      · Ceterum cen­seo COVAX esse delendam ·

  7. 22.10.2020 / 22. Oktober 2020 / October 22, 2020 

    [ VRBPAC-Treffen Nummer 161 ] 

    161st Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting 

    Sheldon Toubman, J.D. New Haven Legal Assistance Association
    Doran Fink, M.D., Ph.D. Food and Drug Administration
    Marion Gruber, Ph.D. Food and Drug Administration
    Arnold Monto, Professor of Public Health and Epidemiology at the University of Michigan School of Public Health
    Robert Johnson * , Ph.D. BARDA
    Hilary Marston ** , M.D., M.P.H. NIAID & NIH 

    MR. TOUBMAN:

    (…) Two que­sti­ons rela­ted for Dr. Fink spe­ci­fi­cal­ly. Two rela­ted to eit­her licen­su­re or EUA, and one spe­ci­fi­cal­ly to EUA. (…) 

    So my que­sti­on is, why would that not requi­re the pri­ma­ry end­point is serious disease? 

    The second que­sti­on (…) we read about the 50 per­cent and it was repea­ted again today. But this mor­ning, Dr. Marston from NIH said—and, you know, Dr. Monto fol­lo­wed up on that, that 60 percent (…) 

    And then my last que­sti­on rela­ted to EUA is, this came up in the public hea­ring as well, two months. (…) expl­ana­ti­on we were told that the docu­ment says that most of the adver­se effects occur in the first six weeks. But they could be lon­ger than that and we’re tal­king about drugs based on unte­sted, or I should say unu­sed plat­forms that have never been the basis for vac­ci­nes.

    So the­re could be adver­se effects we don’t know about. And so isn’t two months a litt­le short? (…)

    fda​.gov/​m​e​d​i​a​/​1​4​3​9​8​2​/​d​o​w​n​l​oad

    ( 161st Meeting )
    ( 161. Treffen ) 

    SUMMARY MINUTES

    (…)

    On October 22, 2020 at 10:00 a.m. Eastern Standard Time (EST), the 161st Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in open ses­si­on to dis­cuss, in gene­ral, the deve­lo­p­ment, aut­ho­rizati­on and/or licen­su­re of vac­ci­nes to pre­vent COVID-19. No spe­ci­fic appli­ca­ti­on was dis­cus­sed at this meeting. 

    Dr. Arnold Monto, the Acting Chair, cal­led the mee­ting to order. The DFO made admi­ni­stra­ti­ve remarks, con­duc­ted roll call and invi­ted the com­mit­tee mem­bers to intro­du­ce them­sel­ves, and read the Conflict of Interest (COI) state­ment into the public record. It was sta­ted that two con­flict of inte­rest wai­vers were issued under 18 U.S. Code 208 in con­nec­tion with the mee­ting and the wai­vers were posted on the FDA web­site for public disclosure. 

    Dr. Marion Gruber of FDA pro­vi­ded an intro­duc­to­ry pre­sen­ta­ti­on tit­led “Development, Authorization & Licensure of Vaccines to Prevent COVID-19.” This was fol­lo­wed by a pre­sen­ta­ti­on by Dr. Cliff McDonald from the Centers for Disease Control and Prevention (CDC) entit­led, „Epidemiology, Virology, and Clinical Features of COVID-19.” Following Dr. McDonald’s pre­sen­ta­ti­on was an over­view pre­sen­ta­ti­on by Dr. Hilary Marston tit­led ‘COVID-19 Vaccine Development: The Role of the NIH.’ Once her pre­sen­ta­ti­on con­clu­ded, Dr. Robert Johnson with BARDA pre­sen­ted ‘COVID-19 Vaccine Development Portfolio.’ 

    After a 10-minu­te break, Dr. Tom Shimabukuro and Dr. Stephanie Schrag with CDC gave a joint pre­sen­ta­ti­on on “CDC plans for Vaccine Safety and Effectiveness moni­to­ring & eva­lua­ti­on during future EUA use and post licen­su­re.” Following their pre­sen­ta­ti­on, Dr. Steven Anderson with the FDA pre­sen­ted on ‘CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness. Then CAPT. Janell Routh from CDC pre­sen­ted on ‘COVID-19 Vaccine Implementation: Operational aspects of COVID-19 vac­ci­ne dis­tri­bu­ti­on and tracking.’ 

    After a 30-minu­te lunch break, the pre­sen­ta­ti­ons con­tin­ued, resum­ing with ‘COVID-19 Vaccine Confidence’ pre­sen­ted by Ms. Susan Winckler and Dr. Wilks, both with the Reagan-Udall Foundation. Dr. Weir with FDA then pre­sen­ted ‘Licensure and Emergency Use Authorization of Vaccines to Prevent COVID-19: Chemistry, Manufacturing, and Controls (CMC) Considerations.’ The last Agency pre­sen­ta­ti­on in the after­noon was by Dr. Doran Fink with FDA tit­led ‘Licensure and Emergency Use Authorization of Vaccines to Prevent COVID-19: Clinical Considerations.’ 

    fda​.gov/​m​e​d​i​a​/​1​4​3​9​8​3​/​d​o​w​n​l​oad

    13.02.2020

    * Robert Johnson 

    Development of Medical Countermeasures for 2019-Novel Coronavirus 

    Robert Johnson, PhD
    Director, Division of Influenza and Emerging Infectious Diseases
    BARDA/ASPR/HHS
    National Vaccine Advisory Committee, 2/13/2020

    Abbreviations / Einige Abkürzungen erklärt 

    BARDA = Biomedical Advanced Research and Development Authority 

    ASPR = Assistant Secretary for Preparedness and Response 

    HHS > The Office of the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS)

    EZ-BAA [ Beispielsatz ] This Easy Broad Agency Announcement (EZ-BAA) sets forth are­as of inte­rest (AOIs) for the Division of Research, Innovation, and Ventures (DRIVe) in the Office of Biomedical Advanced Research and Development Authority (BARDA), issued under para­graph 6.102(d)(2)(i) of the Federal Acquisition Regulation (FAR).

    ENACT
    DRIVe [ Textbeispiel ] BARDA’s Division of Research, Innovation, and Ventures (DRIVe) today expan­ded the Early Notification to Act, Control, and Treat (ENACT) pro­gram to dri­ve dis­rup­ti­ve tech­no­lo­gies nee­ded to save lives in future public health emer­gen­ci­es. To soli­cit poten­ti­al part­ners, DRIVe ope­ned two new are­as of inte­rest (AOI) under the EZ Broad Agency Announcement (EZ-BAA) soli­ci­ta­ti­on: Digital Health Tools for Pandemic Preparedness and Bringing Laboratory Testing to the Home. In 2018, DRIVe explo­red ear­ly detec­tion of respi­ra­to­ry infec­tions with the launch of ENACT, part­ne­ring with inno­va­tors to deve­lop dis­rup­ti­ve tech­no­lo­gies that could detect infec­tion and enable ear­ly inter­ven­ti­on pri­or to sym­ptom onset. These tech­no­lo­gies inclu­ded both bio­phy­si­cal and digi­tal health solu­ti­ons cou­pled with data ana­ly­tics approa­ches to assess ear­ly infec­tion sta­tus of an indi­vi­du­al as well as within a population. 

    medi​cal​coun​ter​me​a​su​res​.gov/​n​e​w​s​r​o​o​m​/​2​0​2​1​/​d​r​i​v​e​a​o​i​14/

    hhs​.gov/​s​i​t​e​s​/​d​e​f​a​u​l​t​/​f​i​l​e​s​/​n​v​a​c​_​f​e​b​2​0​2​0​_​d​a​y​1​_​j​o​h​n​s​o​n​.​pdf

    ** Hilary Marston 

    Dr. Marston was a panelist for the Forum’s dis­cus­sions on The Coronavirus Outbreak. 

    Hilary Marston, MD, MPH is a Medical Officer and Policy Advisor for Global Health focu­sing on emer­ging infec­tious dise­a­se pre­pared­ness and respon­se. In this role, she coor­di­na­tes the National Institute of Allergy and Infectious Diseases’ respon­se to out­breaks inclu­ding Zika in the Americas and Ebola in West Africa and the Democratic Republic of the Congo. Dr. Marston trai­ned in inter­nal medi­ci­ne at Brigham & Women’s Hospital, during which time she work­ed with Partners in Health and the Clinton Health Access Initiative. Before her medi­cal trai­ning, Dr. Marston work­ed for McKinsey & Company and at the Bill & Melinda Gates Foundation as a Program Officer and Special Assistant to the Co-Chair. 

    the​fo​rum​.sph​.har​vard​.edu/​e​x​p​e​r​t​-​p​a​r​t​i​c​i​p​a​n​t​s​/​h​i​l​a​r​y​-​m​a​r​s​t​on/

    24.09.2021
    Harvard T.H. Chan School of Public Health 

    Hilary Marston, MD, MPH ’13 | 2021 Emerging Public Health Professional Award 

    Director for Global COVID Response on the White House COVID-19 Response Team 

    Hilary Marston has devo­ted her care­er to pro­tec­ting public health on a glo­bal sca­le, working as a poli­cy advi­sor in the field of infec­tious dise­a­ses. She joi­n­ed the National Institute of Allergy and Infectious Diseases (NIAID) in 2013, whe­re she was instru­men­tal in deve­lo­ping and orga­ni­zing U.S. respon­ses to the Ebola and Zika outbreaks. 

    In ear­ly 2020, Marston beca­me a key figu­re in the coor­di­na­ti­on of COVID-19 acti­vi­ties for NIAID and the National Institutes of Health. She also made signi­fi­cant con­tri­bu­ti­ons to Operation Warp Speed, the government’s initia­ti­ve to acce­le­ra­te COVID-19 vac­ci­nes, the­ra­peu­tics, and dia­gno­stics. In January 2021, Marston joi­n­ed the U.S. National Security Council as direc­tor for medi­cal and biode­fen­se pre­pared­ness. Since May, she has ser­ved as direc­tor for glo­bal COVID-19 respon­se on the White House COVID-19 Response Team. In this role, she leads the administration’s work in glo­bal dis­tri­bu­ti­on of COVID-19 vac­ci­nes, inclu­ding over­see­ing sha­ring from the dome­stic sup­p­ly and lar­ge-sca­le vac­ci­ne purcha­ses for inter­na­tio­nal donation. 

    you​tube​.com/​w​a​t​c​h​?​v​=​F​2​i​m​i​i​I​F​zKE

    „STOP modRNA“
    „STOP COVAX“

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