WebBrook Jackson, known as the COVID-19 Whistleblower, is under scrutiny over her allegations against her former employer, Ventavia Research Group (VRG), and Pfizer, The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November. She added that during her time at Ventavia the company expected a federal audit but that this never came. Added link to BMJ's open letter and our response. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. Ventavia ultimately enrolled about 1,500 clinical trial patients. 9, 2022, 7:32 a.m. According to Jackson, Ventavia "falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer's pivotal phase III trial. Issues were improperly documented or hidden away in notes to the file, and not corrected. (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, ). (jmv, ), RESPONSE in Opposition re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support filed by United States of America ex rel. An Interview With Ventavia and Pfizer-BioNTech COVID Vaccine Trial Whistleblower Brook Jackson 71 10 comments Sonia Elijah Author at Trial Site News | Investigative journalist and broadcaster Mar. As interpreted by the Supreme Court, if the government continued paying a contractor despite the contractors fraudulent activity, the fraud was not considered material to the contract. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. After the explosive whistleblower report came out, shares of BioNTech, the German company that co-developed the vaccine with Pfizer, took a drastic 20% plunge on Friday, November 5. Miss a day, miss a lot. (Attachments: # 1 Text of Proposed Order)(kcv, ) Modified on 2/11/2022 (kcv, ). Were going to get some kind of letter of information at least, when the FDA gets here . Skip to "One photo showed needles discarded in a plastic biohazard bag instead of a container box. 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. RFK, Jr. & Robert DeNiro Press Conference, Subscribe to The Defender's Top News of the Day, DOE Finds COVID Likely Emerged From Wuhan Lab, Sparks Congressional Investigation, CDC Advisers Tout RSV Vaccines as FDA Admits Shots Linked to Rare Immune Disorder in Older Adults, EPA Still Hasnt Studied How Pesticides Disrupt Human Hormones 27 Years After Congress Demanded It. *** MOTION to Stay re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support and Notice of Joinder in Pfizers Motion to Stay Discovery by Icon, PLC. "Ventavia fired her later the same day." CROs work on a fee-for-service basis, and they have grown like Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards to prevent future harm. And sometimes oversight occurs too late. (Entered: 03/18/2022), CORPORATE DISCLOSURE STATEMENT filed by Pfizer, Inc. (Yeates, Tommy) (Entered: 03/18/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint is granted pursuant to Local Rule CV-12 for Pfizer, Inc. to 4/22/2022. Pfizer is a federal contractor because it signed, with the U.S. government to provide COVID-19 vaccines and. Another showed vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially unblinding participants," the BMJ article stated. Both confirmed broad aspects of Jacksons complaint. Final Pretrial Conference reset for 7/1/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. Signed by District Judge Michael J. Truncale on 10/14/22. Ventavia executives later questioned Jackson for taking the photos. 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. She then emailed a complaint to the US Food and Drug ", Ventavia spokesperson Lauren Foreman discredited Jackson's claims. The regional director for Ventavia, Jackson was fired immediately after she On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Ventavia responded by denying Jackson had worked on the Pfizer trials. Signed by District Judge Michael J. Truncale on 12/15/22. You would think if theres a specific and credible complaint that they would have to investigate that, Fisher said. 376 Qui Tam (31 U.S.C. Spotted something? (Anderson, Lexis) (Entered: 03/22/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Icon, PLC. Ventavia was compensated by Pfizer mainly on a per-patient basisup to a weekly limitand rushed to enroll as many clinical trial participants as possible per week. Subscribe to The Defender's Top News of the Day. A clinical trial delegation log listing Jackson as a participant. (Entered: 06/07/2022), NOTICE of Hearing: Status Conference set for 6/9/2022 at 11:30 AM via TELEPHONE CONFERENCE (Beaumont) before District Judge Michael J. Truncale. We use Mailchimp as our marketing platform. In an interview with The Defender, Jacksons lawyer said Pfizer argued the lawsuit, which was filed under the False Claims Act, should be dismissed because the U.S. government knew of the wrongdoings in the clinical trials but continued to do business with the vaccine maker. know it, an executive stated. 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Icon, PLC served on 3/16/2022, answer due 4/6/2022. (kcv, ) (Entered: 12/09/2022), Minute Entry for proceedings held before District Judge Michael J. Truncale: Telephone Status Conference held on 12/13/2022. BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60. (Entered: 08/22/2022), ***FILED IN ERROR. The report further stated that Jackson "provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails," some of which depict "poor laboratory management" by the firm. Pfizer remained responsible for managing and quality checking all data for the entire clinical trial, per the trials protocol. . The Food and Drug Administrations oversight of clinical trials. (Anderson, Lexis) (Additional attachment(s) added on 8/23/2022: # 1 Text of Proposed Order) (kcv, ). Ventavia fired her later the same day. Brook began her employment with Ventavia on September 8, 2020 as a Regional Director on the Phase 3 trial of the Pfizer Covid-19 vaccine, supervising two of Ventavia's three clinical trial sites. If you are unable to import citations, please contact The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDAs vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7. (Entered: 03/18/2022), Unopposed Application for Extension of Time to Answer Complaint, Application Granted for Extension of Time to Answer Complaint, ***FILED IN ERROR. Login for free View subscription options Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. 30 Days Granted for Deadline Extension. Claim: Covid-19: Researcher blows the whistle on data integrity issues in Pfizers vaccine trial (Lockhart, Michael) (Entered: 10/04/2022), MOTION for Leave to File Response to Statement of Interest by United States of America ex rel. p. 1. (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. Brook Jackson . In September 2020 she was hired by Ventavia as a Regional Director for clinical trial sites It just seemed like something a little different from normalthe things that were allowed and expected.. (Entered: 05/17/2022), NOTICE by Ventavia Research Group, LLC re 41 MOTION to Stay re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support and Notice of Joinder in Pfizers Motion to Stay Discovery, 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support - Notice of Joinder in Pfizer and Icon's Motions to Stay Discovery (Brainin, Stacy) (Entered: 05/17/2022), STATUS REPORT Joint Report of Attorney Conference by Pfizer, Inc.. (Attachments: # 1 Exhibit A - Proposed Scheduling Order, # 2 Exhibit B, # 3 Exhibit C)(Wessel, Carlton) Modified Exhibit description on 5/18/2022 (kcv, ). "My story is not about whether the vaccine is efficacious. Brook Jackson whistleblower lawsuit allegations against Ventavia Pfizer and Icon, Defendants admit fraud by filing that fraud is not material to the contract. ***Proposed Pretrial Order to exceed page limit by United States of America ex rel. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or Defendant Ventavia Research Group, LLC (Ventavia) was contracted by Pfizer to provide three Phase 3 test sites for the vaccine trial in Houston, Fort Worth, and Keller, Texas. Telephonic Status Conference set for 12/13/2022 at 05:00 PM before District Judge Michael J. Truncale. Docket for United States of America ex rel. ( Davis, Scott) Modified title on 4/11/2022 (kcv, ). . More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. Examples included two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted. This is notable because Ventavia has said she was not part of that team. Ventavia spokeswoman Lauren Foreman said in a statement that the company is investigating the allegations made by Jackson. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. (Mendenhall, Warner) (Entered: 11/29/2022), REPLY to Response to Motion re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by Pfizer, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E)(Wessel, Carlton) (Entered: 12/01/2022), DECLARATION of Meagan D. Self in Support of 81 REPLY to Response to Motion re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by Pfizer, Inc.. (Wessel, Carlton) Modified title and associated document on 12/2/2022 (kcv, ). Learn more about Mailchimp's privacy practices here. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction (kcv, ) (Entered: 07/29/2022), Order on Motion for Extension of Time to File Response/Reply, ORDER denying as moot 50 Motion to Dismiss. 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. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction Date: November 11, 2021 Delivery: Personal Service I write on behalf of Brook Jackson, my client, to demand an immediate retraction and public correction of a false statement made by Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or 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. (bjc, ) (Entered: 05/05/2022), Order on Motion for Extension of Time to Answer, MOTION to Stay Motion to Stay Discovery and Memorandum in Support by Pfizer, Inc.. (Attachments: # 1 Exhibit, # 2 Text of Proposed Order)(Self, Meagan) (Entered: 05/17/2022), ***FILED IN ERROR. Brook Jackson, a trained clinical trial auditor with more than 15 years experience in clinical research coordination and management, worked for Ventavia Research Group of Texas for two weeks in September, 2020 and was fired the day she raised her concerns to the U.S. Food and Drug Administration (FDA). Brook Jackson. Ventavia is the company to which Pfizer outsourced the trials, and the company that hired Brook. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. Signed by District Judge Michael J. Truncale on 6/9/22. p. 1. brook jackson, plaintiff, v. ventavia research group, llc; pfizer No, that's not true: Pfizer and the FDA were made aware of the allegations about the contractor in 2020. Ventavia managed 3 of 153 sites at which the trial was carried out. Under National Institutes of Health standards, a "double-blind" clinical trial is one in which neither the patient nor the person giving the medicine knows if the patient is getting a placebo or the actual drug. The allegations were investigated and determined to be unsubstantiated. Install RECAP Yet according to investigative journalist Paul D. Thacker, despite the new documented proof, Ventavia Research Group the Texas-based company Pfizer hired to conduct the pivotal trial has so far refused to retract statements the company made to the media alleging Jackson had no direct involvement. We know that its significant., Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. The claims were made in a November 2, 2021, article on the BMJ blog titled "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial" (archived here), which opened: Users on social media only saw this title, description and thumbnail: Revelations of poor practices at a contract research company helping to carry out Pfizer's pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. (Katz, Elai) (Entered: 04/12/2022), Notice of Attorney Appearance - Pro Hac Vice, NOTICE of Attorney Appearance - Pro Hac Vice by Peter Linken on behalf of Icon, PLC. Retweeted. Provenance and peer review: commissioned; externally peer reviewed. Like many, I had confidence and trust in a regulatory process and in the federal agencies in place to protect public health. 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. Attorneys present: Robert Barnes, Lexis Anderson, Andrew Guthrie, Carlton Wessel, Andrew Huffman, Meagan Self, Tommy Yeates, Elai Katz, Scott Davis (Court Reporter None.) Our response is here, we stand by our reporting. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. Signed by District Judge Michael J. Truncale on 10/19/22. (kcv, ), In accordance with the provisions of 28 USC Section 636(c), you are hereby notified that a U.S. Magistrate Judge of this district court is available to conduct any or all proceedings in this case including a jury or non-jury trial and to order the entry of a final judgment. Reply. Let us know!. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. 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