C4591001 show that BNT162b2 at 30 µg was safe and well-tolerated in participants ≥16 years of age. National protocol for COVID-19 mRNA vaccine BNT162b2 (Pfizer/BioNTech) v06.00 is valid from 20 November 2021 to 31 March 2022. Reactogenicity and AEs were . Study C4591001 5.2.1. Study to Evaluate the Safety and Efficacy of a Booster ... Adverse events . Vaccine development. A Phase 1/2/3 Study to Evaluate the Safety, Tolerability ... Pfizer-BioNTech COVID-19 Vaccine VRBPAC Briefing Document . Review of COVID-19 Vaccines Approved in the United States ... From pages 28 & 29 (original emphasis replaced with my own): 2.5.4.1.1.1. History of Changes for Study: NCT04368728. In September, following months of campaigning for greater openness,12 four manufacturers made their full study protocols publicly available.3456 The publications create a rare opportunity for "real time transparency . Moderna(NCT04470427) Pfizer(NCT04368728) Examplesymptomsincluded Cough Sorethroat Coughandfever Coughandheadache inprimaryendpoint* "1.4%forthe October-November timeframe" Placebogroupeventrate 6monthincidenceof0.75% 1.3%ayear "Approximately0.8%" citedinsamplesize calculation Excludesseropositiveat baseline Excludesseropositiveat baseline protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. (C4591001 / NCT04368728) - 15 healthy participants (18-55 or 65-85 years of age) per dose level [12 active vaccine recipients and 3 placebo recipients] - 10 µg, 20 µg, 30 µg, 100 µg - Immunized on Day 1 and a boost dose on Day 21 [No boost for 100µg cohort] Germany Phase 1/2 Study** (BNT162-01 / NCT04380701) - 12 healthy participants (18-55 or Pfizer and BioNTech finalized the Phase 2/3 study protocol in response to feedback from global regulators, including the FDA and the German Paul-Ehrlich-Institut. Pfizer-BioNTech COVID-19 Vaccine VRBPAC Briefing Document . That clinical protocol said vaccinated people can transmit COVID by thei… A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. -Have a physical exam. without important protocol deviations, and follow-up through Nov 14, 2020 : -Have a nasal swab to check for COVID-19. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. You can read it on line. Initially the study Analysis and comparison of the review document submitted by Pfizer to the US Food and Drug Administration, on the basis of which the FDA gave the green light to expand the emergency permit for vaccination also for children aged 12-15 (1), as opposed to the study protocol in children (2, 3), reveal concerning findings, including violations of the protocol established by Pfizer . protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Primary Efficacy Endpoints. Submission of the dossier The applicant BioNTech Manufacturing GmbH submitted on 30 November 2020 an application for July 5, 2021. Study C4591001 is the pivotal (and only) efficacy study. Published 18 December 2020 protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Pfizer and BioNTech finalized the Phase 2/3 study protocol in response to feedback from global regulators, including the FDA and the German Paul-Ehrlich-Institut. - 5.2. Safety over a median of 2 months was similar to that of other viral vaccines. Final Report Submission: October 31, 2023. Pfizer-BioNTech COVID-19 Vaccine . Sponsor Pfizer, Inc., on behalf of Pfizer and BioNTech . Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Ongoing Phase 1, dose-Ongoing Phase 1/2/3 . PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)Protocol C4591001 Page 68• A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception. Contact the medical monitor within 24 hours. Studies C4591001 and BNT16201 started in April 2020 (first participant, first visit). 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, Its address is below. The following article relates to the Pfizer COVID Vaccine Protocol#C4591001: All participants who courageously volunteered to help make a difference during this pandemic have the option to receive the investigational vaccine while continuing to be part of the clinical trial. A study version is represented by a row in the table. High level overview of long-term safety analyses for individuals 16+ years of age 2. Worldwide Research, Development and Medical Confidential 2 1. The Pfizer document is nothing more than a standardized protocol document. High level overview of long-term safety analyses for individuals 16+ years of age 2. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. Ongoing Phase 1, dose-Ongoing Phase 1/2/3 . People asked why I did it, being that there were not much data on . Pfizer submitted a Biologics License Application (BLA 125742.0) on May 18, 2021 to seek licensure of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. Study BNT162-01 Study C4591001 . Pfizer will provide access to individual de-identified participant data and related study documents (e.g. C4591001 Pfizer Clinical Protocol Nov2020 - Free download as PDF File (.pdf), Text File (.txt) or read online for free. Assessment report EMA/707383/2020 Page 8/140 1. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of Sponsor Pfizer, Inc., on behalf of Pfizer and BioNTech . Pfizer will provide access to individual de-identified participant data and related study documents (e.g. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age. The Vaccine Transition Option is a voluntary process that offers all participants 16 . The investigator must report EDP to Pfizer Safety within 24 hours of the investigator's The Phase 2/3 study is an event driven trial that is planned to enroll up to 30,000 participants between 18 and 85 years of age. C4591001 show that BNT162b2 at 30 µg was safe and well-tolerated in participants ≥16 years of age. 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 Even if that were somehow true, spike protein is harmless. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Protocol C4591001 Page 68 • A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception. Pfizer has published the clinical protocol about its COVID vaccine, BioNTech. Study Completion: May 31, 2023. Explicitly, Pfizer's mRNA vaccine protocol design - the most authoritative document we have on the experimental vaccine and the nature of the human experiments being conducted on its behalf - reveals that vaccinees can adversely affect the health, and even reproductive outcomes, of non-vaccinees simply by being in physical proximity. 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 C4591001 COVID-19 BLA Safety and Efficacy Data For ACIP (Data Cutoff 13-Mar-2021) John L. Perez, MD, MBA, MA Vice President, Pfizer Vaccine Clinical Research & Development 30 Aug 2021. Executive Summary. Background information on the procedure 1.1. On October 31, 2020, I enrolled in the phase 3 trial of the Pfizer/BioNTech mRNA vaccine against SARS-CoV-2 (protocol C4591001). Further follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on preterm infants to identify developmental delays). Never has any known research shown that vaccinated people "shed" spike proteins to other people. If you or your child choose to join this study, they will: -Have 2 doses of the vaccine at the clinic. Pfizer-BioNTech COVID-19 Vaccine VRBPAC Briefing Document . The Vaccine Transition Option. Demographic Characteristics, Participants With Protocol Defined Case (Without . Design Study C4591001 is an ongoing, randomized, placebocontrolled, phase- 1/2/3 study being conducted in the US, Argentina, Brazil, Germany, South Africa and Turkey. Latest version (submitted October 20, 2021) on ClinicalTrials.gov. -Complete follow-up visits at months 1,6,12 and 24 (these may be done on the phone) 1. The Phase 2/3 study is an event driven trial that is planned to enroll up to 30,000 participants between 18 and 85 years of age. without important protocol deviations, and follow-up through Nov 14, 2020 : Study C4591001 Safety Overview, Ages 16 Years and Older . PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Final Protocol, 15April 2020 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol TemplatePhase 1 2 3 4 . 2. Select two study versions to compare. Study BNT162-01 Study C4591001 . 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 to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults. Final Protocol Submission: October 7, 2020. Pfizer Clinical Protocol Covid-19 vaccine Pfizer-BioNTech COVID-19 Vaccine . protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Reactogenicity and AEs were . PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Final Protocol, 15April 2020 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol TemplatePhase 1 2 3 4 . The Clinical Overview documents that what would later become evident was already known by the FDA in December: Pfizer did not attempt to evaluate whether these vaccines stopped infection. Additional information regarding the EDP may be requested by the sponsor. Study C4591001 Safety Overview, Ages 16 Years and Older . 6 . PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 In the event of an overdose, the investigator should: 1. (C4591001 / NCT04368728) - 15 healthy participants (18-55 or 65-85 years of age) per dose level [12 active vaccine recipients and 3 placebo recipients] - 10 µg, 20 µg, 30 µg, 100 µg - Immunized on Day 1 and a boost dose on Day 21 [No boost for 100µg cohort] Germany Phase 1/2 Study** (BNT162-01 / NCT04380701) - 12 healthy participants (18-55 or 1. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. -Keep an e-diary for 7 days after each vaccine. Demographic Characteristics, Participants With Protocol Defined Case (Without . -Give blood samples. On November 20, 2020, Pfizer and BioNTech (the Sponsor) submitted an Emergency Use The vaccine development stages include the following steps []: 1) Research and discovery stage: Conceptualization of the research and conduction of laboratory research by scientists occurs at this stage.2) Preclinical phase: Testing in animals and additional research is conducted paving the way towards the clinical phase once safety is assessed. Worldwide Research, Development and Medical Confidential 2 1. ). PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 69. Pfizer submitted a Biologics License Application (BLA 125742/0) on May 18, 2021 to seek licensure of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) for active Adverse events . phase iii - eudract number: 2020-002641-42 sponsor protocol number: c4591001 sponsor: BIONTECH SE (SOCIETAS EUROPAEA), AN DER GOLDGRUBE 12, 55131 MAINZ, GERMANY AND ANY OTHER ONGOING CLINICAL TRIALS OF VACCINE CANDIDATES DESIGNED TO STOP TRANSMISSION OF THE VIRUS FROM THE VACCINE RECIPIENT TO OTHERS AND/OR TO PREVENT COVID-19 OR MITIGATE . C4591001 COVID-19 BLA Safety and Efficacy Data For ACIP (Data Cutoff 13-Mar-2021) John L. Perez, MD, MBA, MA Vice President, Pfizer Vaccine Clinical Research & Development 30 Aug 2021. PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Final Protocol, 15April 2020 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol TemplatePhase 1 2 3 4 . A rare opportunity for public scrutiny of these key trials The ongoing phase III trials for covid-19 vaccines are some of the most consequential randomised trials ever done.