Enlarge image
The vaccine Comirnaty from Biontech / Pfizer: inoculated billions of times
Photo: GEORGI LICOVSKI / EPA
The registration study of the Comirnaty vaccine from Biontech / Pfizer could have been irregular.
As the British trade magazine "British Medical Journal" (BMJ) reports, a subcontractor of the US pharmaceutical company Pfizer apparently collected the study data in some places.
The "BMJ", one of the most important specialist magazines in medicine, refers to the statements of the whistleblower Brook Jackson. She had been employed as a regional director for the Ventavia Research Group. The private research organization carries out clinical studies on drug and vaccine development, recruits participants, looks after them at their locations, collects scientific data and passes them on to the respective client.
Last year, Ventavia was involved in the phase III clinical trial of the Comirnaty vaccine from Biontech / Pfizer. According to the report, around 1000 test persons were looked after by the organization at three research locations in Texas. According to the “BMJ” report, the company apparently failed to comply with certain standards, or only inadequately.
Former Ventavia regional director Jackson claims to have observed how data were falsified during the study, insufficiently trained vaccination doctors were employed and side effects were only very slowly followed up.
Patient data were also unblinded, which means that it was sometimes known which test subjects were given a placebo and who received the vaccine.
However, the expectations and behavior of the staff could affect and falsify the ratings.
The problems were noticed when employees carried out quality controls, Jackson told the BMJ.
After repeatedly reporting the irregularities to Ventavia, Jackson emailed the FDA with the incidents.
In the letter, Jackson raised a number of concerns about the Ventavia clinical investigation that was being fed into the entire Biontech / Pfizer Phase III pivotal study.
The points criticized by her should therefore be:
Participants were housed in a hallway after the injection and were not monitored by clinical staff
Protocol deviations were not reported
Vaccines were not stored at the correct temperatures
Incorrectly labeled laboratory samples
Lack of timely follow-up care for patients who have experienced adverse events
Harassment from Ventavia employees reporting these types of issues.
Jackson was immediately released, the report said. She received feedback from the FDA a few hours later, thanking her for reporting the problems and advising her not to comment on ongoing studies. A few days later, Jackson received a call from an FDA official who took their concerns seriously, but apparently did not commission any further investigation. A short time later, the vaccine received emergency approval from Biontech / Pfizer in the USA.
The companies Biontech / Pfizer recruited around 44,000 test subjects for their phase III study and tested the vaccine at a total of 153 locations.
It is unclear what the consequences would be if the allegations were confirmed.
In phase III of a clinical study, the effectiveness of a drug is tested.
Sufficient real-world data now
In the meantime, billions of people around the world have been vaccinated against the coronavirus using Biontech / Pfizer. So-called real-world data, i.e. observations from the use in people outside of clinical studies, show that the vaccine protects very well against severe Covid courses and deaths. The irregularities that have become known therefore have no influence on the real-world data that has now been sufficiently collected, even if it turns out that they are scientifically unusable due to the possible sloppiness.
At the federal press conference, the head of the Robert Koch Institute (RKI), Lothar Wieler, was asked about the BMJ report. "I know it, but we can't check it," he replied. It is about a manageable number of participants. The allegation must be investigated, "but we also have to state that the vaccine has now been inoculated billions of times".
When asked by the Science Media Center, Peter Kremsner, Director of the Institute for Tropical Medicine at the Eberhard Karls University in Tübingen, commented: "What the whistleblower has uncovered is without question unattractive." Biontech / Pfizer clinical trial. “That's just not enough for me,” says Kremser, “the vaccination dates have already been confirmed in numerous studies. So I see no reason to question them now. "
Kremser explains that there are two important units in clinical studies: the study director and the clinical sponsor. The latter is here Pfizer. The clinical sponsor is responsible, among other things, for quality assurance of the data. Smaller pharmaceutical companies, but also increasingly larger ones, have now often outsourced certain areas of responsibility to subcontractors who take on certain tasks for them. "This is how Pfizer did it, too, although the company would definitely have been able to take on all the tasks of a clinical sponsor itself." In the event of a pandemic, everything has to be done quickly. The risk that a subcontractor might not meet the quality standards of the major clinical sponsor could increase in such a case. "As a study doctor, I always preferCommunicate directly with the clinical sponsor. The involvement of subcontractors makes many areas of a clinical trial more complicated and sometimes worse. "
The senior physician and internist Oliver Cornely, scientific director of the Center for Clinical Studies in Cologne, said: "The errors described in" The BMJ "article do not limit the validity of the approval study of the vaccine." The data from the subjects of these centers should be removed the analysis and thus check whether the study statement has changed. It is good that these centers only accounted for around 2.3 percent of the approximately 44,000 participants. "In addition, the effectiveness has now been proven from data from Israel and other countries," says Cornely. "We hardly admit vaccinated people because of Covid-19, so we recognize the effectiveness every day."
Ventavia describes itself on its website as the largest private clinical research company in Texas and lists many awards it has won for its commissioned work.
Jackson reported to the BMJ that during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors about poor laboratory management, patient safety concerns and data integrity issues.
Jackson is a clinical trial auditor, an independent scientist who checks quality before or during the clinical trial.
According to her own statements, she has around 15 years of experience in coordinating and managing clinical research projects.
When Ventavia did not take care of solving the problems in response to her reports, she took the initiative herself and took photos on her cell phone, according to the "BMJ" report.
The corresponding cell phone photos are available to the "BMJ" according to its own information.
Sloppy waste disposal, unprotected personal data
They are supposed to document that needles in a plastic bag for biological hazardous substances were thrown away instead of in a container for sharp objects.
Another is to show packaging for vaccines, on which the identification numbers of the study participants are written, which stood around openly and thus possibly unblind the participants.
Jackson also passed on internal Ventavia documents to the "BMJ", which are supposed to prove that the executives had known since August 2020 at the latest that there were problems in quality assurance.
In August of this year, following the full US approval of Pfizer's vaccine, the FDA released a summary of its inspections of the company's registration study.
Nine of the 153 sites in the study were examined.
Ventavia's locations were not one of them.
The "BMJ" also spoke to other Ventavia employees who reported incidents similar to those of Jackson.
"I don't think it was good, clean data," the associate said of the data Ventavia generated for the Pfizer study.
"It's a crazy mess."
