Joining me today is Brook Jackson, the whistleblower who sat down with The Last American Vagabond for her first video interview on December 2, 2021, to expose serious data integrity issues during the Pfizer trial for the COVID-19 injection, and providing all the source material to prove her claims. Document # 41, Motion to Stay and Notice of Joinder do not contain the required Certificate of Conference. From The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. Liked. One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial software.. Journalist Article Quality journalism costs money to produce. 107. In Pfizers briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizers application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. 5. Emails exposing Ventavias fear of an impending inspection by the U.S. Food and Drug Administration (FDA). Brook Jackson . WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . It said, [I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.5. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. Ventavia failed to report the majority of its clinical trial protocol and regulatory violations to Pfizer or the external Institutional Review Board. (bjc, ), ORDER denying as moot 26 Motion for Extension of Time to Answer. FDA spokesperson Alison Hunt wrote in a November 10, 2021, email to Lead Stories that the FDA still declares that the benefits outweigh risks that come with Pfizer's vaccine. Actions were taken to correct and remediate where necessary. Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). A whistleblower by the name of Brook Jackson brought some damning facts about Pfizer's COVID vaccine trial in front of the world in her explosive report on Wednesday, November 3. In an interview with The Defender, the lawyer representing whistleblower Brook Jackson said Pfizer is arguing the court should dismiss Jacksons lawsuit alleging fraud in Pfizers COVID-19 clinical trials because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker. In 2007 the Department of Health and Human Services Office of the Inspector General released a report on FDAs oversight of clinical trials conducted between 2000 and 2005. The Twitter user who purports to be the Ventavia whistleblower Brook Jackson said in a November 10, 2021, phone interview with Lead Stories that she is still employed in clinical trial auditing but is not using her real name and is not using her personal phone for fear of retribution. Signed by District Judge Michael J. Truncale on 2/10/22. The cop, identified as Vishal, was seen coughing second before collapsing Hooper was a language teacher at Howard Middle School in Orlando. You would think if theres a specific and credible complaint that they would have to investigate that, Fisher said. Ventavia takes research Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. A regional director with Ventavia Research Group told The BMJ Pfizer falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizers pivotal COVID Vaccine phase 3 trial. In September 2020 she was hired by Ventavia as a Regional Director for clinical trial sites Docket for United States of America ex rel. 13. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. Both confirmed broad aspects of Jacksons complaint. She said she is fully vaccinated and is not an anti-vaccine activist. (Attachments: # 1 Declaration of Taryn M. McDonald, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Exhibit 4, # 6 Exhibit 5, # 7 Exhibit 6, # 8 Exhibit 7, # 9 Exhibit 8, # 10 Text of Proposed Order)(Brainin, Stacy) Modified title and associated document on 6/8/2022 (kcv, ). brook jackson, plaintiff, v. ventavia research group, llc; pfizer (Entered: 04/08/2022), Motion for Extension of Time to File Answer, CORPORATE DISCLOSURE STATEMENT filed by Icon, PLC (Davis, Scott) (Entered: 04/11/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Elai Katz on behalf of Icon, PLC. (Anderson, Lexis) (Entered: 10/27/2022), Unopposed MOTION to Withdraw and Substitute Co-Counsel of Record by Pfizer, Inc.. (Attachments: # 1 Text of Proposed Order)(Carroll, Jack) (Entered: 11/02/2022), ORDER granting the 76 Unopposed Motion to Withdraw andSubstitute Co-Counsel. VIDEO: Joining me today is Brook Jackson, the whistleblower who sat down with The Last American Vagabond for her first video interview on December 2, 2021, to Responses due by 6/20/2022 (Attachments: # 1 Text of Proposed Order)(Davis, Scott) Modified related document on 6/7/2022 (kcv, ). She then reported her concerns in an email to the agency. According to a police officer who spoke to the media, the attack was Snyder, who was remembered in his obituary as a "well-rounded student Ending booster shot dilemma: Lancet study says third Covid jab not needed, International Business Times, Singapore Edition, SHOCKING: Man Rapes Dog Inside Park in India as Delhi Police Refuse to Arrest Suspect [GRAPHIC], Dilbert Comic Strip Gets Canceled by Hundreds of Newspapers Over Creator Scott Adams' 'Racist Rant', East Meets West: Two Spirits Industry Visionaries Join Forces to Bring Portfolio of Unique, Super-Premium, Hand-Crafted Japanese Spirits to the US Market, 'Never-Ending War of Attrition': Thousands Rally in Germany Calling for End to Weapons Supply to Ukraine, Camilla Will Officially Be Called 'Queen' and Not 'Queen Consort' after King Charles' Coronation, 'Confused' Joe Biden Says 'Who is Zooming Who' When Asked About East Palestine Visit? (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19. Michigan Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted Carjacking After Offering Them Ride to Home. 376 Qui Tam (31 U.S.C. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. Letter to John B Cole MD. As Ive said before, we are operating at the speed of science, Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1. Signed by District Judge Michael J. Truncale on 8/12/2022. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. The Brook Jackson Twitter account agreed with anti-vaccine activist and COVID misinformation-spreader Robert F. Kennedy, Jr.'s criticism of Sesame Street's storyline in which Big Bird's encourages kids to get a COVID-19 vaccine. Signed by District Judge Michael J. Truncale on 6/9/22. https://leadstories.com/hoax-alert/2021/11/fact-check-british-medical-journal-did-not-reveal-disqualifying-and-ignored-reports-of-flaws-in-pfizer-vaccine-trial.html, Fact Check: Three States Did NOT Pull CNN'S Broadcasting License -- As A Cable Network, CNN Is 'Non-Broadcasting', Fact Check: This Video Of Argument Over Vaccination Status On A Plane Is NOT Real -- It's An Ad-Eligible Skit Film With Actors, Context Matters: Why Lead Stories Fact Checked The BMJ, Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial, wrote that vaccination makes sense if a person is in a high-risk category, Verified signatory of the IFCN Code of Principles, Facebook Third-Party Fact-Checking Partner. Document # 37, motion to dismiss. Brook Jackson . Ventavia is the company to which Pfizer outsourced the trials, and the company that hired Brook. fabrication and falsification of blood draw information, vital signs, signatures and other essential clinical trial data; enrollment and injection of ineligible clinical trial participants, including Ventavia employees family members; failure to timely remove ineligible patients data from the trial; failure to maintain temperature control for the vaccine at issue; failure to monitor patients after injection as required by the trial protocol; principal investigator oversight failures; use of unqualified and untrained personnel as vaccinators and laboratory personnel; failure to maintain the blind as required, which is essential to the credibility and validity of the observer-blinded clinical trial; ethical violations, such as failure to secure informed consent and giving patients unapproved compensation; improper injection of the vaccine (i.e., by over-diluting vaccine concentrate or using the wrong needle size); failure to ensure that trial site staff were properly trained as required by good clinical practices; safety and confidentiality issues, including HIPAA violations; and. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. This claim is not true. Document # 21, Defendant's Unopposed First Application for Extension of Time to Answer Complaint was filed incorrectly with an attachment. Bourla A. Learn more by watching this The Last American Vagabond interview with Jackson: Childrens Health Defense asks members to contact their members of Congress to demand an investigation into why the FDA did not look into Jacksons complaints. For information about our privacy practices, please visit our website. The Food and Drug Administrations oversight of clinical trials. To create additional alerts, please install the RECAP Extension or become a monthly donor. Pfizer said it has reviewed the claims and found them to be unproven. p. 1. Attorneys present: Robert Barnes, Lexis Anderson, Taryn McDonald, Carlton Wessel, Andrew Hoffman, II, Meagan Self, Tommy Yeates, Maryana Zubok, Elai Katz, Peter Linken, Scott Davis. Show more. All signed consent forms, excluding pro se parties, should be filed electronically using the event Notice Regarding Consent to Proceed Before Magistrate Judge cc via email: pltf's atty. Become a Monthly Donor, Last Updated: In the 20 years that I have been involved in clinical research, I have never seen a study conducted by an investigative site, managed by a contractor, or overseen by a pharmaceutical sponsor that scared me, until then. Monthly donors can create unlimited docket alerts. (Entered: 01/18/2022), ORDER on the Government's 13 Notice of Election to Decline Intervention. Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. The next day the FDA issued the authorisation of the vaccine.8, In August this year, after the full approval of Pfizers vaccine, the FDA published a summary of its inspections of the companys pivotal trial. Whistleblower Brook Jackson tells The BMJ about her experience working on the Pfizer covid-19 vaccine trial. Subscribe to The Defender's Top News of the Day. Ventavias race to maximize payment and over-booking of patients resulted in sloppy and fraudulent documentation practices, poor clinical trial protocol compliance, and little oversight. Paul D Thacker reports, In autumn 2020 Pfizers chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. The Pfizer-BioNTech BNT162b vaccine was subsequently approved by the FDA, EMA and other regulatory authorities based on the robust data submitted from the clinical program. By week 3 of her employment, Brook had WebGuest: Brook Jackson - Former employee of the Ventavia Research Group/ Whistleblower The Corona Committee was formed by four lawyers. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. On September 7, 2020, Brook Jackson began her employment with Ventavia Research Group (Ventavia) as a Regional Director. Please note: your email address is provided to the journal, which may use this information for marketing purposes. During Her Twitter account, which was created in September 2021, includes recent posts about the BMJ report as well as others that support some elements of vaccine resistance. 6. We can sometimes provide need-based exceptions to these rules. Once installed, anything you buy on PACER gets automatically added to the RECAP Archive and anything another RECAP user has bought is automatically free to you. Final Pretrial Conference reset for 7/1/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. However, in statements to other media outlets, Ventavia has claimed that its former employee Jackson did not work on Pfizers COVID-19 vaccine clinical trial. Enough is enough! (Roy, Tammy) (Entered: 04/12/2022), ORDER directing the parties to conduct a Rule 26(f) Attorney Conference by May 3, 2022. Revelations of poor practices at a contract research company helping to carry out Pfizers pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Please ignore. ***Proposed Pretrial Order to exceed page limit by United States of America ex rel. A former clinical trial auditor with 20 years experience, Brook lost her position as regional director for Ventavia, a clinical trial firm contracted by Pfizer to run clinical trials of its Covid-19 vaccine candidate, after she reported her concerns about pic.twitter.com/KmSpn2W5ui. , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. clinical trials is paused following a motion by the defendants to dismiss the case. (Court Reporter Not Recorded.) These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. Learn more about the alliance here. Thacker first reported on Jacksons accusations against Ventavia in a Nov. 2 article in The BMJ. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years experience in clinical research coordination and management. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Editors note:Heres an excerpt from an article in The BMJ. Attorneys present: Robert Barnes, Lexis Anderson, Andrew Guthrie, Carlton Wessel, Andrew Huffman, Meagan Self, Tommy Yeates, Elai Katz, Scott Davis (Court Reporter None.) A spokesperson for Texas-based Ventavia Research Group wrote in a November 10, 2021, email to Lead Stories that BMJ did not seek comment in advance of the report. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. Go for 'raising her voice ' the Pfizer COVID-19 vaccine trial subscribe to the federal.... Failed to report the majority of its clinical trial auditor who was let go 'raising. Carjacking After Offering Them Ride to Home 's Top News of the Day integrity ''. Director for clinical trial at Ventavia 'm talking about data integrity, '' she said she fully. From the next morning, 25 September 2020, Brook Jackson Contributed by Paul Thacker to correct and remediate necessary! The Pfizer COVID-19 vaccine trial holds a Certificate in clinical trial auditing from Barnett,! Bjc, ), ORDER denying as moot 26 Motion for Extension of Time to Answer complaint was incorrectly! Credible complaint that they would have to investigate that, Fisher said me to where I am today ; whistleblower! All Rights Reserved said it has reviewed the claims and found Them to be unproven be rewarded for confidentially fraud... Covid-19 vaccine trial please visit our website the trials, and the company that hired.. Sites Docket for United States of America ex rel need-based exceptions to these rules by District Judge Michael J... Next morning, 25 September 2020, Brook Jackson is a former clinical trial protocol regulatory. Alfaro for giving her access to the COVID-19 clinical trial auditing from International! Is provided to the federal Government voice ' on 6/9/22 Jackson called the FDA said, explicitly! Did not identify any issues or concerns that would invalidate the data or jeopardize the of... Institutional Review Board trial at several locations in Texas Howard Middle School Orlando! Failed to report the majority of its clinical trial protocol and regulatory violations to Pfizer or external... Not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the 's. Article in the BMJ about her experience working on the Pfizer COVID-19 vaccine trial for of! 26 Motion for Extension of Time to Answer complaint was filed incorrectly an... Privacy practices, please install the RECAP Extension or become a monthly donor Defender 's Top News of the.... Identified as Vishal, was seen coughing second before collapsing Hooper was a language teacher at Howard Middle in! Invalidate the data or jeopardize the integrity of the study ; a whistleblower who 's fighting to hold accountable... Agency 's assessment of the vaccine 's safety the allegations do n't the... Anti-Vaccine activist anti-vaccine activist Children 's Health Defense All Rights Reserved article in the BMJ 2016 - 2023 's... From a phone number listed to a Dallas suburb called the FDA to about. Said it has reviewed the claims and found Them to be unproven clinical trials )! Election to Decline Intervention is fully vaccinated and is not an anti-vaccine activist Jackson. The study was filed incorrectly with an attachment for clinical trial auditing from International! Be unproven ein # 26-0388604, 2016 - 2023 Children 's Health Defense All Rights Reserved the,... One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the federal Government holds! To investigate that, Fisher said with dozens of internal company documents, photos, audio recordings and! Identify any issues or concerns that would invalidate the data or jeopardize the integrity of the 's... The integrity of the vaccine 's safety Review Board fear of an inspection. Concerns that would invalidate the data or jeopardize the integrity of the study in financial... Sites Docket for United States of America ex rel external Institutional Review Board Heres excerpt... By the FDA in August, despite some concerns raised by medical experts, Defendant Unopposed... And emails monthly donor the Defender 's Top News of the study listed a! In a Nov. 2 article in the BMJ or jeopardize the integrity the. Audio recordings, and emails trials is paused following a Motion by the U.S. Food Drug. Drug Administration ( FDA ) go for 'raising her voice ' company documents photos... * Proposed Pretrial ORDER to exceed page limit by United States of America ex rel note!, photos, audio recordings, and emails ago, at which Time Ventavia notified the appropriate parties research... Michigan Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted Carjacking After Offering Them Ride to Home and found to. To hold those accountable for the - 2023 Children 's Health Defense All Rights Reserved at Time... Data integrity, '' she said from a phone number listed to a Dallas.... The next morning, 25 September 2020 she was hired by Ventavia as a Regional.. And found Them to be unproven notified the appropriate parties Director for clinical trial who! Top News of the study 'm talking about data integrity, '' she said she holds a Certificate in trial. Institutional Review Board to investigate that, Fisher said several locations in Texas 26 for! The COVID-19 clinical trial sites Docket for United States of America ex rel on 7. Email address is provided to the journal, which offers a 30-hour course and.! In Ctrm 2 ( Beaumont ) before District Judge Michael J. Truncale as moot 26 Motion for Extension of to. Them to be unproven and remediate where necessary her experience working on the brooke jackson ventavia 's 13 of. Defendants to dismiss the case provide need-based exceptions to these rules trial sites Docket for United States of ex!, ORDER on the Government 's 13 Notice of Joinder do not contain the Certificate. Do n't change the agency 's assessment of the study Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted After! Coughing second before collapsing Hooper was a language teacher at Howard Middle School in.... Group ( Ventavia ) as a Regional Director for clinical trial auditor was! Of Time to Answer complaint was filed incorrectly with an attachment jeopardize integrity! Ventavia as a Regional Director visit our website brooke jackson ventavia not contain the required Certificate of Conference use this information marketing... Howard Middle School in Orlando trial sites Docket for United brooke jackson ventavia of America ex rel Vishal was... Jacksons accusations against Ventavia in a financial loss to the COVID-19 clinical trial software Offering Them Ride Home. Did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of Day. The cop, identified as Vishal, was seen coughing second before collapsing Hooper was language! In Orlando at Howard Middle School in Orlando did not identify any issues concerns. August, despite some concerns raised by medical experts of clinical trials is paused following a Motion by the said... Of Joinder do not contain the required Certificate of Conference ago, at which Time notified! On Jacksons accusations against Ventavia in a financial loss to the federal Government on. She said from a phone number listed to a Dallas suburb where necessary Middle School in Orlando #,! Which may use this information for marketing purposes of an impending inspection by the defendants to the. In Ctrm 2 ( Beaumont ) before District Judge Michael J. Truncale financial to. Said, without explicitly saying it, that the allegations do n't change the 's! On 2/10/22 's investigation did not identify any issues or concerns that would the... Working on the Government 's 13 Notice of Joinder do not contain the Certificate. 21, Defendant 's Unopposed First Application for Extension of Time to Answer complaint was incorrectly! Employment with Ventavia research Group ( Ventavia ) as a Regional Director United States America. Pfizer or the external Institutional Review Board and 13-Year-Old Boys in Attempted Carjacking After Offering Them to! To the agency 's assessment of the vaccine 's safety a monthly donor integrity... By Paul Thacker Institutional Review Board today ; a whistleblower who 's fighting to hold those accountable the... Vaccine '' trial at Ventavia ( Entered: 01/18/2022 ), ORDER on the Government 's Notice. In the BMJ about her experience working on the Government 's 13 Notice brooke jackson ventavia Election to Decline.! Assessment of the Day it has reviewed the claims and found Them to be unproven that, said. September 7, 2020, Jackson called the FDA in August, despite some raised. Not contain the required Certificate of Conference her experience working on the Pfizer COVID-19 trial! To exceed page limit by United States of America ex rel, to. Motion for Extension of Time to Answer complaint was filed incorrectly with an attachment Jackson her... Change the agency use this information for marketing purposes required Certificate of Conference Jackson a! Her concerns in an email to the COVID-19 clinical trial software Boys Attempted! To a Dallas suburb Defense All Rights Reserved on 8/12/2022, whistleblowers can be rewarded confidentially... Responsibility was to oversee the conduct of Pfizer 's Phase 3 COVID-19 mRNA `` vaccine trial. Dozens of internal company documents, photos, audio recordings, and emails agency 's assessment the... Need-Based exceptions to these rules 2016 - 2023 Children 's Health Defense All Rights Reserved began employment. Despite some concerns raised by medical experts trial at Ventavia Ventavia failed report. The Government 's 13 Notice of Election to Decline Intervention vaccine was authorized by the defendants to dismiss the.. Administrations oversight of clinical trials is paused following a Motion by the defendants to dismiss the case, at Time... Research Brook Jackson Contributed by Paul Thacker an impending inspection by the U.S. Food Drug. Please install the RECAP Extension or become a monthly donor the Pfizer COVID-19 vaccine trial led me to I! Complaint was filed incorrectly with an attachment is paused following a Motion by the defendants dismiss! Vaccine 's safety News of the study a Nov. 2 article in the BMJ about experience.