Archiv: BMJ (media)


19.01.2022 - 19:15 [ Gregor Amelung / Reitschuster.de ]

Brisant: Gravierende Mängel in der Zulassungsstudie von BioNTech/Pfizer

Indem man die anderen Zeugen und das Indizien-Material wie Fotos und Emails ignorierte, wurde aus den in Texas festgestellten Mängeln die lokale „Schlamperei“ (ntv, t-online, Focus, RND) eines „Subunternehmens“ (Spiegel, ntv, t-online, Tagesspiegel, RND) von Pfizer/BioNTech. Auf die Effektivität und die Sicherheit des Vikzins wirke sich die texanische Nebengeschichte nach Ansicht von „Experten“ nicht aus.

Beim kollektiven Weichspülen übersahen die großen Medien allerdings eine Quelle in Thackers Bericht – vermutlich, weil man in den Redaktionen dachte, hier ginge es eh nur um Kritik an der US-Zulassungsbehörde FDA und damit um „Ausland“. Liest man allerdings in die Quelle hinein, sieht die Sache schon deutlich anderes aus.

04.11.2021 - 07:45 [ theWire.in ]

Company That Managed Pfizer Vaccine Trial Sites ‘Falsified Data’: Whistleblower

Despite Jackson repeatedly notifying Ventavia of the problems, the company reportedly took no corrective action. This prompted Jackson to send a complaint by email to the US Food and Drug Administration (FDA) – the country’s top regulatory body – in September 2020. But less than 24 hours later, Ventavia fired her in an apparent reprisal.

In a further surprise, the FDA did not follow up on Jackson’s complaint either.

04.11.2021 - 07:35 [ BMJ.com ]

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day.