One of the biggest problems, she claims, was the trial’s “blind lifting” – critical to avoiding bias from staff and patients in knowing who got the vaccine and who got the vaccine. placebo. However, documents identifying who was part of which group were printed and put “in the cards of each participant”.
She also recounts several other issues. For example, “the temperature of the vaccine was not being properly monitored,” a problem she said should have led to the trial being suspended.
The participants themselves were at risk, she says, with “several serious adverse events reported that were never followed up.”
“We could potentially have needed to send this participant to the emergency room. But when you don’t follow up and even call to find out about the patient’s condition… that’s a patient safety concern for me. Does this affect data integrity? Certainly. And the most important [thing] is data integrity, right? Is this changing or could it change [our understanding of the vaccine]? The answer is yes.”
Pfizer strongly disputes this, saying that after a report last year on the Texas site “we have carried out a thorough investigation [and] steps have been taken to correct and correct where appropriate. He adds that the investigation, critically, “did not identify any issues or concerns that would invalidate the data or compromise the integrity of the study.” The vaccine remained, in other words, safe and effective. The company also claims to have independently alerted the US regulator, the Food and Drug Administration (FDA).
Nonetheless, Jackson said, the repeated irregularities amounted to a catalog of chaos she had not experienced before in her decades-long career: “Never in all of my clinical trial experience have I seen such a practice. blatant. “
All of this led to his intervention on September 16. The next morning, she recommended a stay of the trial and, to her surprise, Ventavia agreed. On the morning of September 25, still worried, Jackson contacted the FDA herself. That afternoon she was fired: “I was told I was not a good person.” Patient recruitment has started again, she says, “right away”.
Four days later, an investigator called the FDA. “I felt these issues were going to be resolved. There would potentially be a Ventavia shutdown, which I thought was appropriate from what I saw. But the site remained open. For her part, Ventavia says Jackson’s allegations “have been investigated and found to be unsubstantiated” and that she takes “research compliance, data integrity and privacy very seriously. participant safety and we support our work to support the development of life-saving vaccines ”.