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Researchers report the reliability of Pfizer's new crown vaccine trial data, and the effectiveness of FDA clinical supervision is questioned

 Last Update: 2021-11-14
 Source: Internet
 Author: User

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An investigative article published in the British Medical Journal (BMJ) on November 2, 2021 [1] received much attention.

The information in the article comes from a disclosure by a regional director of the research organization Ventavia Research Group

Poor laboratory management

Ventavia states on its website that it is the largest private clinical research company in Texas

Fear of FDA inspections

During the meeting in late September, Jackson and Ventavia executives discussed the possibility of FDA inspections several times

Complaint letter to FDA

Jackson wrote in an email to the FDA on September 25 that Ventavia has recruited more than 1,000 participants in three venues

Participant was left in the corridor after receiving the injection, without clinical staff monitoring

Lack of timely follow-up of patients with adverse events

Scheme deviation not reported

The vaccine is not stored at the proper temperature

The laboratory samples are mislabeled, and

These types of issues have been reported to Ventavia employees

A few hours later, Jackson received an e-mail from the FDA, thanking her for her concern, and notifying her that the FDA was unable to comment on the possible investigation

Evidence from other employees

In recent months, Jackson has reconnected with several former Ventavia employees

[1] Thacker P D.

[1] Thacker P D.
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial BMJ 2021; 375 :n2635 doi:10.
1136/bmj.
n2635

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