Brook Jackson’s complaint is clear: The US drug company failed to address the violations that compromise its clinical trial. Relevant information was withheld, incorrect data submitted in the results. Millions of Americans have been given a Covid vaccine whose effectiveness and safety are in doubt.
This was published in November of the previous year BMJ the disclosure report of an investigative journalist who covers scandalous incidents during phase III – Approval Studies for the Covid-19 vaccine Comirnaty brought to light. Brook Jacksonclinical trials auditor and regional director at Ventavia, the company contracted by vaccine manufacturer Pfizer to conduct said trials, described serious abuses in numerous aspects. After reporting this to their superiors and also to the US Food and Drug Administration FDA brought notice, Jackson was fired.
Prof. Dr. Sucharit Bhakdi, former head of the Institute for Medical Microbiology and Hygiene at the Johannes Gutenberg University in Mainz and recipient of numerous medical awards, commented on the facts as follows:
„The moment it is known that data from a scientific study is falsified, every scientific study is considered to no longer exist. (…) And the consequence of this revelation is plain and simple – and actually has to be, in normal times – that the only evidence for the effectiveness of this vaccine no longer exists. (…) And if the effectiveness is not proven, then the vaccine must not be approved. The whole house of cards would have to collapse immediately.” If this does not happen, it is due to criminal activities: “There can be no other conclusion.”
Read the details at:
“Somebody needs to be held accountable”
Back in January 2021, Jackson filed lawsuits against Pfizer, Ventavia and ICON, another company involved, after which False Claims Act submitted. According to this American federal law hold individuals and organizations accountable and obliged to pay damages by means of civil penalties, provided by fraud and other criminal activities at the expense of the US government could realize unjustified claims.
After the US Department of Justice decided not to intercede for Jackson in the matter, the lawsuit, which has been kept secret until now, was made public. Plaintiff Jackson relies on the lack of support don’t get discouraged and will the case even without help to be followed up by the US government. It is, she told the media, an opportunity she wants to take: “I feel like someone needs to be held accountable.”
Forgeries of the study documents included
Developing a safe and effective vaccine against the new coronavirus, COVID-19, was urgent, Jackson said in the introduction to their complaint at. However, this urgency does not excuse it in clinical trials curtailing procedures, wasting taxpayers’ money, violating federal regulations, and possibly harming the health of Americans. In the race to secure billions in funding and be first to market, held the defendants intentionally crucial information who question the safety and effectiveness of their vaccine. The defendants concealed violations of both their clinical study protocol and federal regulations, including falsification of the study documents.
According to the defendants’ plan millions of Americans received a mislabeled vaccine that may not be as effective as it is portrayed. The approval by the US Food and Drug Administration resulted from a massively flawed clinical study, violated FDA regulations. The defendants profited from the COVID-19 pandemic at the expense of the United States and its citizens by abusing the scientific process.
Ineligible subjects, lack of blinding, etc.
Ventavia’s violations of the study protocol and regulations were like that oftenthat Jackson could watch them almost every day. Among other things, she found:
- invention and counterfeiting of blood collection information, vital signs, signatures and other essential study data
- intake and injection of ineligible study participantsincluding family members of Ventavia employees
- Failure to timely remove data from ineligible patients from the study
- failure to obtain the Temperature control for the vaccine in question
- Failure to follow patients after their injection according to the study protocol
- Oversight failure of investigators
- use of unqualified and untrained personnel as vaccinators and laboratory staff
- omission, the required blinding to get which in this observer-blinded clinical study is crucial for credibility and validity
- Ethics violations such as failure to secure informed consent and awarding unauthorized compensation to patients
- improper injection of the vaccine, for example through too strong Dilute of the vaccine concentrate or use of the wrong size needle
- Failure to ensure that study staff are adequately trained as consistent with good clinical practice
- Security and confidentiality issues, including violations of HIPAA regulations
- other violations of study protocol, FDA regulations, and federal procurement guidelines and their amendments by the DoD
The problems were ignored
Ventavia failed to report the majority of its study protocol and rule violations to Pfizer or the external institutional review board. Problems were only insufficiently documented or hidden in the “notes on the file”, and also not corrected. Icon and Pfizer communicated with each study site to monitor compliance, but failed to track missing information, ignored “red flags” of protocol violations and incorrect data, and failed to remove ineligible participants from the study dataset. As a result, in its rush to be “first,” Pfizer failed to address the violations that are compromising its entire clinical trial – including those raised by the plaintiff. That led to Pfizer essential information before the United States withheld and submitted false data and records in its study results.
Read the below 76-page complaint letter the plaintiff in the original:
Relator Brook Jackson´s Original Complaint for Violations Of The Federal False Claims Act