Revelations that raise questions. An article published Tuesday, November 2 in the British Medical Journal (BMJ), a British scientific journal, triggered a rain of criticism on the pharmaceutical group Pfizer. The main source of the article: a former employee of Ventavia, a subcontractor of Pfizer, which accuses the laboratory of negligence in following the scientific protocol. Charges that have revived criticism of anti-vaccines via the hasthag #Pfizergate on social networks.
But if the charges published in the BMJ are serious, certain elements suggest that they should be approached with caution. Franceinfo deciphers this information into four questions.
1What are the revelations made in the “British Medical Journal”?
The article published in the British Medical Journal, the’one of the most widely read scientific medical journals in the world, revealed multiple negligence in the fall of 2020, on the sites of the Texan group Ventavia, specialist in clinical trials and subcontractor of Pfizer. According to Brook Jackson, who presents himself in this article as a whistleblower, the rush to conduct clinical trials on the anti-Covid vaccine has led to multiple negligence which calls into question the integrity of the data collected and compromised patient safety.
She claims to have noted shortcomings concerning the surveillance of vaccinated subjects and the monitoring of adverse events, as well as unreported protocol deviations. She also explains that vaccines were stored at inappropriate temperatures and that laboratory samples were mislabelled. Among the latter, she accuses Ventavia in particular of having, through its inconsistencies in labeling, compromised the double-blind allocation of the vaccine. This procedure, which consists of injecting the product, placebo or vaccine, without the doctor or the patient knowing what is being injected, is essential for evaluating the effectiveness of a treatment compared to a placebo.
Charges that worry Thibault Fiolet, epidemiologist at Inserm. “The blind is an important part of clinical trials, he stressed to Franceinfo. Because it makes it possible to limit classification or measurement biases linked to the subjectivity of the doctor or the patient. “
Brook Jackson claims to have warned Ventavia of the negligence observed on its sites on multiple occasions. According to her, nothing was done afterwards. She would then have warned the Food and Drug Administration (FDA), the United States Food and Drug Administration, before being fired the same day.
According to another employee of the company Ventavia, quoted in the article of British Medical Journal, Pfizer was reportedly made aware of the multiple negligence at the sites operated by Ventavia shortly after Brook Jackson’s dismissal. An audit would then have been conducted by Pfizer following this information. The subcontracting of three other clinical trials concerning the anti-Covid vaccine was however entrusted to Ventavia: the vaccination of children and young adults, that of pregnant women as well as the tests on a third dose.
2Who is behind these accusations?
The main source behind these accusations is a former Ventavia employee. Brook Jackson is the former regional manager of a clinical trial site at the company. According to the article of British Medical Journal, she was employed for two weeks in this clinical research company, before being fired. It was she who provided the British Medical Journal documents, photos and recordings showing irregularities at the sites subcontracted by Pfizer to Ventavia. Documents that do not appear in the signed article Paul D. Thacker.
The latter is an American journalist specializing in science, medicine and the environment. However, he is accused of having contributed to the dissemination of false information concerning GMOs, according to theAmerican Council on Science and Health (in English) and 5G, reminds The Parisian. In his article published in the BMJ, Paul D. Thaker puts forward the accusations of Brook Jackson without opposing him of contradictory version. Neither Ventavia, Pfizer, nor the FDA are cited in the article to respond to the charges against them.
3What proportion of trials is affected?
Clinical trials of the anti-Covid vaccine developed by Pfizer have been conducted at 153 sites around the world, mainly in the United States, but also in Germany, Turkey, South Africa, Brazil and Argentina. Of these 153 sites, three were subcontracted to the Texan company Ventavia. These three sites included just over 1,000 participants, or 2.3% of the total 44,000 participants in clinical trials.
According to Thibault Fiolet, the small proportion of sites and participants concerned does not call into question the results of the effectiveness of the Pfizer vaccine tests. However, he is worried about the instrumentalization of these revelations by conspiracy theories, as has been the case in recent days with the #Pfizergate which circulates on social networks. “This type of practice, if it is proven, is to be condemned because it casts doubt on the practices of other centers”, he emphasizes.
“However, this does not call into question the efficacy of the vaccines, which has been demonstrated under real conditions in multiple countries and by multiple research teams independent of each other.”
Thibault Fiolet, epidemiologistto franceinfo
Indeed, even if the vaccine effectiveness decreases over time with regard to infections, the efficacy of vaccination is a consensus in the scientific community. Side effects are also monitored very closely and no noticeable side effects have been reported other than rare cases of myocarditis and pericarditis.
4Can these accusations have consequences?
Following the publication of the article by Paul D. Thacker in the British Medical Journal, the #Pfizergate was carried on Twitter trend by Internet users opposed to vaccination. In a video also posted on Twitter, Florian Philippot predicts a “global scandal” and calls on the Minister of Health, Olivier Véran, to ask him for an immediate suspension of vaccination everywhere in France, as a precautionary principle.
The Pfizer press office declined to comment on the publication of the article in British Medical Journal but nevertheless specifies that “research is being carried out internally”. For its part, the company Ventavia announced “to investigate the allegations of Brook Jackson, as reported in the article by P. Thacker in the British Medical Journal“, report Release (article subscribers). Contacted by AFP, the FDA refrained from commenting on this file but assured of “his full confidence in the data which led to support the authorization of the Pfizer / BioNTech vaccine”.
The EMA (European Medicines Agency), for its part, ensures “take all allegations involving the security and integrity of data very seriously”, while specifying that “these claims do not call into question the conclusions on the safety, efficacy and quality of the vaccine itself”, as reported Le Parisien (subscribers article).