According to an article in British Medical Journal, Numerous shortcomings were made during the testing of Pfizer’s coronavirus vaccine by a subcontractor of the pharmaceutical group responsible for carrying out a small part of the clinical trials. The media cites a former employee for this.
The Texan group Ventavia, specializing in conducting clinical trials and commissioned last year by Pfizer to assess the effectiveness of its anti-Covid vaccine, notably “falsified data” and “delayed in monitoring Side effects “, according to this article published on Tuesday.
Labeling issue
Ventavia played only a small role in the trials of this vaccine developed by Pfizer with the German BioNTech. The Texan group has conducted tests on a thousand people, while the vaccine has, in total, been evaluated on about 44,000 people around the world. These trials, demonstrating particularly high efficacy, have led to the authorization of the vaccine in many countries, such as the United States and the countries of the European Union.
The primary source for the BMJ article is former Ventavia employee Brook Jackson, who worked there for two weeks during the Pfizer / BioNTech vaccine trials, before being fired. Brook Jackson says he has witnessed many breaches. She accuses Ventavia in particular of having, through its inconsistencies in labeling, compromised the double-blind allocation of the vaccine.
Poor conservation
This procedure is essential for evaluating the effectiveness of a treatment compared to a placebo. She makes sure that neither patients nor caregivers know whether it is one or the other. Brook Jackson cites other shortcomings, such as the fact that the vaccines were not stored at the right temperature, and says she informed the US health authorities, the FDA, which she said took note of her report. but did not follow up.
When contacted, the FDA refrained from commenting on this file but assured “its full confidence in the data which led to support the authorization of the Pfizer / BioNTech vaccine”. According to another source cited by the BMJ, anonymous this one, Pfizer dispatched an audit of Ventavia once informed of “problems” in the conduct of the tests. Neither Pfizer nor Ventavia responded immediately to the requests.