What is PfizerGate?

[Mis à jour le 5 novembre 2021 à 15h18] On Tuesday, November 2, 2021, revelations published in the British medical journal British Medical Journal (BMJ) pointed out potential failures, data falsification and security concerns within Ventavia Research Group, one of the sites chosen by the laboratory Pfizer to conduct its clinical trials of the anti-Covid Comirnaty® vaccine. The case, widely covered by the media and shared on social networks like Twitter, has been dubbed the PfizerGate. What is the starting point? Who is Brook Jackson, the whistleblower? What does she denounce in relation to the clinical trials carried out? What evidence is provided? Understand the origin of the scandal.

What is the origin of PfizerGate?

To ensure the efficacy and safety of a vaccine, clinical trials are mandatory on tens of thousands of people volunteers, generally divided into two groups (the first group receives the vaccine, the second group receives a placebo, that is to say a product with no effect). No vaccine can be marketed, and therefore administered, without the performance and positive results of clinical trials. Divided into several phases, the clinical trials are regulated and subject to the authorization of the health authorities (European Medicines Agency (EMA) for Europe and National Medicines Agency (ANSM) for France) and the favorable opinion of a Committee for the Protection of Persons (CPP) . THE’Phase 3 clinical trial of Pfizer’s Comirnaty® vaccine started on July 27, 2020 and the results were published in December in the New England Journal of Medicine. It then had 44,000 participants (46,000 today with the addition of the 12-15 age group). Pfizer was responsible for the design and conduct of the trial, data collection, data analysis, data interpretation and final manuscript writing. BioNTech was the trial sponsor. The test was carried out on 153 sites around the world including 130 in the United States. Among these sites dedicated to medical research, the American company born in 2013, Ventavia Research Group brought together around 1,000 participants at 3 sites (or around 2.23% of participants in total). the testimony of a person working on this site would raise “serious questions about data integrity and regulatory oversight“, reveals the BMJ.

► Starting point of the case: in September 2020, Regional Director Brook Jackson of Ventavia Research Group told BMJ that the company would have falsified data, removed the anonymity of patients, employee of “insufficiently trained vaccinators” and “took a long time” monitor adverse events reported in the Pfizer pivotal phase III trial (the last one before marketing). The staff performing the quality checks were said to have been overwhelmed by the number of problems they found.

► September 25, 2020, after informing Ventavia on several occasions of these problems, the regional director allegedly sent a complaint by email to the United States Food and Drug Administration (FDA), responsible for protecting public health by ensuring safety, l ” drug efficacy and safety, before be fired the same day by Ventavia.

► A few hours later, Brook Jackson received a response from the FDA “thanking her for her concerns and advising her that the FDA could not comment on any investigation that may result“.

► The 10 December 2020, in Pfizer’s backgrounder submitted to an FDA advisory committee meeting to discuss Pfizer’s vaccine marketing authorization application, the company made no mention of any problems with the Pfizer website. Ventavia.

► The 11 december 2020, the FDA has granted authorization for Pfizer’s vaccine in the United States.

Who is the whistleblower?

The whistleblower for the PfizerGate scandal is Brook Jackson, former regional director of Ventavia, one of the Pfizer contractors in charge. clinical trials of the Covid-19 vaccine. During the two weeks she was employed at Ventavia in September 2020, the manager repeatedly informed her superiors poor laboratory management, patient safety issues and data integrity issues. She was fired on September 25, 2020 by Ventavia “for the first time in a 20-year research career“, she specifies to the BMJ.

What does the whistleblower criticize?

In his September 25 email to the FDA, Brook Jackson listed a dozen questionable practices that she allegedly witnessed while working at Ventavia, including:

• Participants placed in a hallway after the injection and not supervised by clinical staff
• Lack of timely follow-up of patients with adverse events
• Unreported protocol deviations
• Vaccines not stored at appropriate temperatures
• Mislabelled laboratory samples
• Lack of staff to swab all trial participants who reported symptoms.

In addition, two former Ventavia employees, testifying anonymously, are said to have confirmed Brook Jackson’s statements. One of them reportedly reported a “messy” work environment. After the dismissal of Brook Jackson, problems would have persisted at Ventavia, according to the same employee.

What evidence does the whistleblower provide?

Ventavia not having reacted to these revelations, Brook Jackson wanted to collect evidence. In total, Brook Jackson would have provided the BMJ dozens of internal company documents, photos, audio recordings and emails. Among the documents collected:

► A photo showing needles thrown in a “biohazard” plastic bag instead of being placed in a specially dedicated sharps box.

► Another photo showing vaccine packaging materials with participant identification numbers the test written on it and left in the open, which potentially lifted the anonymity of the participants.

► A recording of a meeting that took place at the end of September 2020 between Brook Jackson and two directors, in which a Ventavia executive could be heard explaining that the company was unable to quantify the types and number of errors they found when reviewing test documents for quality control.

► An email sent by ICON, the contract research organization with which Pfizer partnered with the trial, showing that Ventavia allegedly failed to follow up on data entry queries. More than 100 requests concerning in particular two serious post-vaccine reactions would have been left in abeyance for several days.

For the moment, the health authorities, Ventavia and Pfizer have not yet reacted to these revelations.

Source: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial, BMJ, November 2, 2021.