With its Comirnaty® vaccine, the American laboratory Pfizer is on the rise. But that might not last: for a few days, on social networks, the hashtag #PfizerGate has fueled conversations. The Pfizer laboratory is accused (through a subcontractor) of not having respected certain rules during the clinical trials of its anti-Covid-19 vaccine.
Pfizer Gate: what exactly happened? Everything starts from a testimony published this Tuesday, November 2, 2021 in the British Medical Journal (BMJ) : that of Brook Jackson, a woman who worked for two weeks (in September 2020, before being made redundant) for the company Ventavia, a subcontractor of the Pfizer laboratory, specializing in the performance of clinical trials.
It is common (and public) that pharmaceutical companies tend to “delegate” the clinical trials of their products to subcontracting companies – we speak of “contract research company”. Thus, clinical trials of the Comirnaty® vaccine were held in 153 sites, of which 3 depended on the American company Ventavia.
Anomalies that only concern a minority of clinical trial participants
As she explains in her testimony, Brook Jackson would have observed several anomalies during his time at Ventavia. First, there would have been concerns with the “double-blind” dose allocation process – this implies, in theory, that neither patients nor caregivers know whether the product being administered is the vaccine or the placebo. However, during the clinical trial conducted by Ventavia, pouches containing the real doses of vaccine with “participant identification numbers“would have been left in plain sight of the staff. And”medication allocation forms were left in participants’ files“.
Deuzio, Ventavia would have been considerably slow to report certain adverse effects of the Comirnaty® vaccine, with dozens of reports recorded more than 3 days late – while the protocol provides for a maximum delay of 24 hours. Third, Brook Jackson evokes badly stored and badly labeled doses, poorly trained employees, and even falsification of data …
In his testimony, Brook Jackson claims to have alerted the Food and Drug Administration (FDA), that is to say the American health authorities. According to her, it is this report which would have led to her dismissal, “the same day“.
Pfizer Gate: should we be worried? While the situation is indeed unclear (for example, the FDA has inspected 9 sites involved in the production of the Comirnaty® vaccine in August 2021… but none belonged to the company Ventavia), the Pfizer Gate “scandal” does not call into question the safety or the effectiveness of the anti-Covid-19 vaccine produced by the Pfizer laboratory.
Indeed: the sites managed by the company Ventavia (and implicated, therefore) have only carried out tests with about a thousand people, which represents “only” 2.3% of the all the participants (more than 44,000) who tested the Comirnaty® vaccine all over the world. A drop of water in the ocean, then.
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