Virusul uite-l nu-i!

2021-01-20T12:16:32+02:0020 ianuarie 2021|Textele altora|

Specialista în genetică Alexandra Henrion-Caude avertizează, există pericolul transmiterii genelor editate de vaccinul pfizer către urmași

Tot mai multe informații apar despre vaccinul pe care mass media și autoritățile îl prezintă ca fiind singura soluție pentru ieșirea din criză și întoarcerea la normalitate. Specialista nr. 1 în Franța pe ARN, Alexandra Henrion-Caude, avertizează că există pericolul transmiterii genelor editate de vaccinul Pfizer către urmași:

„Dacă într-adevăr nu ar exista niciun risc de transmitere către descendenți, atunci de ce există pagini întregi în protocoalele Pfizer dedicate faptului că este foarte, foarte important să fii pe contraceptive sau să faci sex cu prezervativ? Ei exprimă foarte clar în protocolul lor că nu ar trebui să riști să rămâi însărcinată… Nu este banal! Deci, cum o putem explica, dacă nu există riscul transmiterii către următoarea generație?”

Ne vaccinăm pentru ce?

Stanford, Cornell și alte cinci laboratoare universitare din California au anunțat nu au găsit virusul Covid-19, care, netrecând testul Koch, este fictiv. Aceste laboratoare plănuiesc să dea în judecată CDC pentru frauda Covid-19.

Rob Oswald, dr. în virologie și imunologie de la Universitatea Cornell:

“Deci, cu ce ne ocupăm acuma este doar o altă tulpină de gripă ca în fiecare an. Covid-19 nu există și este fictiv. Cred că China și globaliștii au orchestrat acest COVID (gripa deghizată în nou virus) prin care ne păcălește pentru a stabili o tiranie globală și o stare de supraveghere totalitară, polițienească si globală, iar acest complot a inclus fraude electorale masive.

“Am un doctorat în virologie și imunologie și sunt un om de știință și de laborator clinic. Am testat 1500 de eșantioane de presupus test C-19 pozitiv colectate în California de Sud. Când eu și echipa mea de laborator am efectuat testele în conformitate cu postulatele și observațiile testului Koch, pe SEM (microscop electronic cu scanare), nu am găsit Covid în aceste 1.500 de probe. Ceea ce am constatat a fost că acele 1.500 de eșantioane erau în mare parte cazuri de gripă A și unele cazuri de gripă B, dar nici un singur caz de Covid și nu am folosit pseudo-testul PCR

Am trimis apoi restul probelor la Stanford, Cornell și câteva laboratoare de la Universitatea din California și au găsit aceleași rezultate ca și noi, FĂRĂ COVID! Au găsit gripa A și B. Am vorbit apoi cu toții la CDC și am solicitat probe viabile de COVID, pe care CDC a spus că nu le poate furniza, deoarece nu avea probe.

Am ajuns la concluzia fermă, prin toate lucrările noastre de cercetare si de laborator, că C-19 este imaginar și fictiv. Gripa a fost numită Covid și majoritatea celor 225.000 de persoane care au murit au fost cauzate de comorbidități precum boli de inimă, cancer, diabet, emfizem etc. Încă nu am găsit un singur eșantion viabil de Covid19 cu care să lucrez.”

5 Comments

  1. 1955m 24 ianuarie 2021 la 10:05 am - Raspunde

    : … _ Important de stiut: …

    -1) _ Cum a fost „prelucrat / sintetizat”, „ARN-ul mesager” ?!!!

    -2) _ In ce consta „mesajul” transmis prin „ARN-ul mesager”, …si, …cum se presupune actiunea de „reparare a ARN-ului autohton afectat / atacat” ?!!!

    = Cu stima. -„Mesia” _ Ioan 2/25; 5/30.

    • 1955m 25 ianuarie 2021 la 6:02 am - Raspunde

      -3) De ce „nu se leaga covidul de copii, …sau, in general de tineri cu varste mici, sub adolescenta ?!!!, …

      P.S. – Cand veti gasi raspunsul la aceasta intrebare, va veti apropia de rezolvarea problemelor „virusologice”, si veti intelege si mai profund care sint „directiile de cercetare, in domeniile genetice”, … [_ Iesirea 4/(1,10),11-16], …”Iesirea, insemnand Trimiterea, in directia Evolutiei* _ Ioan 7/49; _ Osea 4/(2),6,[7-10], …

      {pana atunci „injectati-va cu empirism, la nimereala”, …si, …”bajbaiti in intuneric, ziua in amiaza mare, ca noaptea” _ Iov 5/(12,13),14; 12/25}, …

      pana nu va vor mai supara mustrarile Mele {si nu Ma veti mai cenzura} _ 1 Tesaloniceni 5/(19),2020,2021,[22]; _ Apocalipsa 3/(1,17,18),19; _ Isaia 1/(10-18),19,(20-22); _ Ezechiel 22/(19),20-27: …

      -*27. Capeteniile lui sunt in mijlocul lui ca niste lupi care isi sfasie prada, varsa sange, pierd sufletele, numai ca sa-si potoleasca lacomia de bani.*

      = Cu stima. -„Mesia”.

    • 1955m 25 ianuarie 2021 la 9:17 am - Raspunde

      -4) _ [Q-?]: -*De ce, cei maturi sint mai pre’dispusi la infectare, fata de tinerii nematurizati, Covidul preferand pe cei cu afectiuni mai vechi, …selectand pe cei care mai au si alte afectiuni / mai multe „co’morbiditati” ?!!!*

      = Cu stima. -„Mesia”, …”vorbind in pustiu” _ Ioan 1/23; 3/14,(16),19, …*nu Ma aude nimeni (?!!)* _ Romani’a 10/16,[17],18,(19),2020,2021, …sau, cumva, „viclenia, golania si derbedeismul, implicite in nelegiuire {_ Romani’a 1/28-32; 10/4,(5)}, stau la panda” _ Mica 3/5-7,11; 7/1-4; _ Isaia 9/[1,2,(6)],15-17.

  2. caroline gunderode 20 ianuarie 2021 la 5:14 pm - Raspunde

    adevaratul protocol Pfizer are 134 pagini – nu e cacatul masluit de escroci trimis romanilor pe piata !!!

    https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf

    MERITA AFISEAT SUMARUL : de aici se vede ca ne-vaccinul

    este insuficient testat, adica este un act criminal de testare direct pe oameni fara informarea lor cinstita si fara anamneza caci se face vaccinare in serie !!!!!!!!!!!!!!!!!!!!!!!!!!
    Vor s-o faca cu armata in corturi ! Sau in lagare, pe viitor, amenajate precis pentru refractari .

    C4591001_Clinical_Protocol.pdf (pfe-pfizercom-d8-prod.s3.amazonaws.com)

    SUMARUL PROTOCOLULUI Pfizer , protocol ce are 134 pagini !

    PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 1 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS Study Sponsor: BioNTech Study Conducted By: Pfizer Study Intervention Number: PF-07302048 Study Intervention Name: RNA-Based COVID-19 Vaccines US IND Number: 19736 EudraCT Number: 2020-002641-42 Protocol Number: C4591001 Phase: 1/2/3 Short Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 2 TABLE OF CONTENTS LIST OF TABLES………………………………………………………………………………………………………7 1. PROTOCOL SUMMARY………………………………………………………………………………………..9 1.1. Synopsis ……………………………………………………………………………………………………..9 1.2. Schema ……………………………………………………………………………………………………..16 1.3. Schedule of Activities …………………………………………………………………………………17 1.3.1. Phase 1…………………………………………………………………………………………..17 1.3.2. Phase 2/3………………………………………………………………………………………..22 2. INTRODUCTION …………………………………………………………………………………………………24 2.1. Study Rationale ………………………………………………………………………………………….24 2.2. Background ……………………………………………………………………………………………….24 2.2.1. Clinical Overview……………………………………………………………………………25 2.3. Benefit/Risk Assessment……………………………………………………………………………..25 2.3.1. Risk Assessment ……………………………………………………………………………..27 2.3.2. Benefit Assessment………………………………………………………………………….28 2.3.3. Overall Benefit/Risk Conclusion……………………………………………………….28 3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS …………………………………………………..28 3.1. For Phase 1 ………………………………………………………………………………………………..28 3.2. For Phase 2/3……………………………………………………………………………………………..30 4. STUDY DESIGN…………………………………………………………………………………………………..32 4.1. Overall Design……………………………………………………………………………………………32 4.1.1. Phase 1…………………………………………………………………………………………..33 4.1.2. Phase 2/3………………………………………………………………………………………..34 4.2. Scientific Rationale for Study Design……………………………………………………………34 4.3. Justification for Dose ………………………………………………………………………………….35 4.4. End of Study Definition ………………………………………………………………………………36 5. STUDY POPULATION…………………………………………………………………………………………36 5.1. Inclusion Criteria………………………………………………………………………………………..36 5.2. Exclusion Criteria……………………………………………………………………………………….37 5.3. Lifestyle Considerations………………………………………………………………………………39 5.3.1. Contraception………………………………………………………………………………….39 PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 3 5.4. Screen Failures…………………………………………………………………………………………..40 5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Study Intervention Administration …………………………………………………………………………..40 6. STUDY INTERVENTION……………………………………………………………………………………..41 6.1. Study Intervention(s) Administered ………………………………………………………………41 6.1.1. Administration ………………………………………………………………………………..42 6.2. Preparation/Handling/Storage/Accountability ………………………………………………..42 6.2.1. Preparation and Dispensing ………………………………………………………………43 6.3. Measures to Minimize Bias: Randomization and Blinding……………………………….44 6.3.1. Allocation to Study Intervention ……………………………………………………….44 6.3.2. Blinding of Site Personnel………………………………………………………………..44 6.3.3. Blinding of the Sponsor……………………………………………………………………44 6.3.4. Breaking the Blind…………………………………………………………………………..45 6.4. Study Intervention Compliance…………………………………………………………………….45 6.5. Concomitant Therapy………………………………………………………………………………….45 6.5.1. Prohibited During the Study ……………………………………………………………..46 6.5.2. Permitted During the Study ………………………………………………………………46 6.6. Dose Modification………………………………………………………………………………………47 6.7. Intervention After the End of the Study …………………………………………………………47 7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL…………………………………………………………………47 7.1. Discontinuation of Study Intervention …………………………………………………………..47 7.2. Participant Discontinuation/Withdrawal From the Study …………………………………47 7.2.1. Withdrawal of Consent…………………………………………………………………….48 7.3. Lost to Follow-up ……………………………………………………………………………………….48 8. STUDY ASSESSMENTS AND PROCEDURES………………………………………………………49 8.1. Efficacy and/or Immunogenicity Assessments ……………………………………………….50 8.1.1. Biological Samples………………………………………………………………………….52 8.2. Safety Assessments …………………………………………………………………………………….53 8.2.1. Clinical Safety Laboratory Assessments (Phase 1 Participants Only) …….53 8.2.2. Electronic Diary………………………………………………………………………………54 8.2.2.1. Grading Scales…………………………………………………………………54 PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 4 8.2.2.2. Local Reactions……………………………………………………………….54 8.2.2.3. Systemic Events ………………………………………………………………55 8.2.2.4. Fever………………………………………………………………………………56 8.2.2.5. Antipyretic Medication …………………………………………………….57 8.2.3. Phase 1 Stopping Rules ……………………………………………………………………57 8.2.4. Surveillance of Events That Could Represent Enhanced COVID-19 and Phase 2/3 Stopping Rule …………………………………………………………………58 8.2.5. Randomization and Vaccination After a Stopping Rule Is Met ……………..59 8.2.6. Pregnancy Testing …………………………………………………………………………..59 8.3. Adverse Events and Serious Adverse Events………………………………………………….60 8.3.1. Time Period and Frequency for Collecting AE and SAE Information…….60 8.3.1.1. Reporting SAEs to Pfizer Safety………………………………………..61 8.3.1.2. Recording Nonserious AEs and SAEs on the CRF……………….61 8.3.2. Method of Detecting AEs and SAEs………………………………………………….61 8.3.3. Follow-up of AEs and SAEs……………………………………………………………..61 8.3.4. Regulatory Reporting Requirements for SAEs…………………………………….62 8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure …………………………………………………………………………………………….62 8.3.5.1. Exposure During Pregnancy………………………………………………62 8.3.5.2. Exposure During Breastfeeding …………………………………………64 8.3.5.3. Occupational Exposure …………………………………………………….64 8.3.6. Cardiovascular and Death Events………………………………………………………64 8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs or SAEs……………………………………………………………………65 8.3.8. Adverse Events of Special Interest…………………………………………………….65 8.3.8.1. Lack of Efficacy ………………………………………………………………65 8.3.9. Medical Device Deficiencies…………………………………………………………….65 8.3.10. Medication Errors………………………………………………………………………….65 8.4. Treatment of Overdose………………………………………………………………………………..66 8.5. Pharmacokinetics ……………………………………………………………………………………….67 8.6. Pharmacodynamics……………………………………………………………………………………..67 8.7. Genetics…………………………………………………………………………………………………….67 PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 5 8.8. Biomarkers………………………………………………………………………………………………..67 8.9. Immunogenicity Assessments………………………………………………………………………67 8.10. Health Economics …………………………………………………………………………………….67 8.11. Study Procedures………………………………………………………………………………………67 8.11.1. Phase 1…………………………………………………………………………………………67 8.11.1.1. Screening: (0 to 28 Days Before Visit 1) …………………………..67 8.11.1.2. Visit 1 – Vaccination 1: (Day 1) ………………………………………68 8.11.1.3. Visit 2 – Next-Day Follow-up Visit (Vaccination 1): (1 to 3 Days After Visit 1) ……………………………………………………………71 8.11.1.4. Visit 3 – 1-Week Follow-up Visit (Vaccination 1): (6 to 8 Days After Visit 1) ……………………………………………………………….72 8.11.1.5. Visit 4 – Vaccination 2: (19 to 23 Days After Visit 1) ………..73 8.11.1.6. Visit 5 – 1-Week Follow-up Visit (Vaccination 2): (6 to 8 Days After Visit 4) ……………………………………………………………….75 8.11.1.7. Visit 6 – 2-Week Follow-up Visit (Vaccination 2): (12 to 16 Days After Visit 4) ……………………………………………………………..76 8.11.1.8. Visit 7 – 1-Month Follow-up Visit: (28 to 35 Days After Visit 4)…………………………………………………………………………………..77 8.11.1.9. Visit 8 – 6-Month Follow-up Visit: (175 to 189 Days After Visit 4)…………………………………………………………………………..78 8.11.1.10. Visit 9 – 12-Month Follow-up Visit: (350 to 378 Days After Visit 4)…………………………………………………………………………..79 8.11.1.11. Visit 10 – 24-Month Follow-up Visit: (714 to 742 Days After Visit 4)…………………………………………………………………………..79 8.11.2. Phase 2/3………………………………………………………………………………………80 8.11.2.1. Visit 1 – Vaccination 1: (Day 1) ………………………………………80 8.11.2.2. Visit 2 – Vaccination 2: (19 to 23 Days After Visit 1) ………..82 8.11.2.3. Visit 3 – 1-Month Follow-up Visit (After Vaccination 2): (28 to 35 Days After Visit 2)…………………………………………………….84 8.11.2.4. Visit 4 – 6-Month Follow-up Visit: (175 to 189 Days After Visit 2)…………………………………………………………………………..85 8.11.2.5. Visit 5 – 12-Month Follow-up Visit: (350 to 378 Days After Visit 2)…………………………………………………………………………..85 8.11.2.6. Visit 6 – 24-Month Follow-up Visit: (714 to 742 Days After Visit 2)…………………………………………………………………………..86 PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 6 8.12. Unscheduled Visit for a Grade 3 or Suspected Grade 4 Reaction ……………………86 8.13. COVID-19 Surveillance (All Participants) …………………………………………………..88 8.13.1. Potential COVID-19 Illness Visit: (Optimally Within 3 Days After Potential COVID-19 Illness Onset) ………………………………………………………..88 8.13.2. Potential COVID-19 Convalescent Visit: (28 to 35 Days After Potential COVID-19 Illness Visit)…………………………………………………………90 8.14. Communication and Use of Technology………………………………………………………91 9. STATISTICAL CONSIDERATIONS ……………………………………………………………………..91 9.1. Estimands and Statistical Hypotheses……………………………………………………………91 9.1.1. Estimands……………………………………………………………………………………….91 9.1.2. Statistical Hypotheses………………………………………………………………………92 9.2. Sample Size Determination………………………………………………………………………….92 9.3. Analysis Sets……………………………………………………………………………………………..93 9.4. Statistical Analyses …………………………………………………………………………………….94 9.4.1. Immunogenicity Analyses………………………………………………………………..94 9.4.2. Efficacy Analyses……………………………………………………………………………99 9.4.3. Safety Analyses …………………………………………………………………………….100 9.4.4. Other Analyses………………………………………………………………………………102 9.5. Interim Analyses ………………………………………………………………………………………102 9.5.1. Analysis Timing…………………………………………………………………………….105 9.6. Data Monitoring Committee or Other Independent Oversight Committee………..105 10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS …………………………………………………………………………………………..107 10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations………….107 10.1.1. Regulatory and Ethical Considerations …………………………………………..107 10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP……………………………………………………………..107 10.1.2. Informed Consent Process…………………………………………………………….108 10.1.3. Data Protection ……………………………………………………………………………109 10.1.4. Dissemination of Clinical Study Data …………………………………………….109 10.1.5. Data Quality Assurance ………………………………………………………………..110 10.1.6. Source Documents……………………………………………………………………….112 10.1.7. Study and Site Start and Closure ……………………………………………………112 PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 7 10.1.8. Sponsor’s Qualified Medical Personnel ………………………………………….113 10.2. Appendix 2: Clinical Laboratory Tests………………………………………………………114 10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting …………………………………………………………..116 10.3.1. Definition of AE ………………………………………………………………………….116 10.3.2. Definition of SAE………………………………………………………………………..117 10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs…………………119 10.3.4. Reporting of SAEs……………………………………………………………………….122 10.4. Appendix 4: Contraceptive Guidance ………………………………………………………..123 10.4.1. Male Participant Reproductive Inclusion Criteria …………………………….123 10.4.2. Female Participant Reproductive Inclusion Criteria………………………….123 10.4.3. Woman of Childbearing Potential ………………………………………………….124 10.4.4. Contraception Methods…………………………………………………………………125 10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments……127 10.6. Appendix 6: Abbreviations ………………………………………………………………………129 10.7. Appendix 7: Stopping and Alert Rules for Enhanced COVID-19 ………………….133 10.8. Appendix 8: Criteria for Allowing Inclusion of Participants With Chronic Stable HIV, HCV, or HBV Infection …………………………………………………………….136 11. REFERENCES ………………………………………………………………………………………………….137 LIST OF TABLES Table 1. Local Reaction Grading Scale …………………………………………………………55 Table 2. Systemic Event Grading Scale…………………………………………………………56 Table 3. Scale for Fever………………………………………………………………………………57 Table 4. Probability of Observing at Least 1 AE by Assumed True Event Rates With Different Sample Sizes ………………………………………………….93 Table 5. Interim Analysis Plan and Boundaries for Efficacy and Futility…………103 Table 6. Statistical Design Operating Characteristics: Probability of Success or Failure for Interim Analyses………………………………………………………104 Table 7. Statistical Design Operating Characteristics: Probability of Success for Final Analysis and Overall……………………………………………………….104 Table 8. Laboratory Abnormality Grading Scale ………………………………………….114 PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 8 Table 9. Stopping Rule: Enrollment Is Stopped if the Number of Severe Cases in the Vaccine Group Is Greater Than or Equal to the Prespecified Stopping Rule Value (S)…………………………………………….134 Table 10. Alert Rule: Further Action Is Taken if the Number of Severe Cases in the Vaccine Group Is Greater Than or Equal to the Prespecified Alert Rule Value (A) ……………………………………………………………………135

Lasă un răspuns

Acest sit folosește Akismet pentru a reduce spamul. Află cum sunt procesate datele comentariilor tale.

Go to Top