A medical magazine reports on irregularities in a study by the corona vaccine manufacturer.
Experts are now weighing up.
Mainz - The allegations of a whistleblower have sparked a debate about test procedures.
And the Mainz-based company Biontech now wants to investigate US reports on irregularities in a study on their corona vaccine, which they manufacture together with their US partner Pfizer.
Background information are women compared to the journal
British Medical Journa
l
(The BMJ)
.
In the fall of 2020, she worked for a subcontractor in the USA that had carried out a small part of the study on the vaccine, which is now used worldwide, on behalf of Pfizer.
She accused her former employer of generating incorrect vaccination data because, among other things, laboratory samples were incorrectly labeled, the vaccine was incorrectly stored and reports about side effects were only followed up slowly.
Allegations to Biontech / Pfizer: vaccine effectiveness is still given
"Careful implementation and data collection in clinical studies has the highest priority for Biontech," said a spokeswoman for the Mainz-based company of the German press agency on Thursday. "We take statements like those made in the article seriously and check them immediately after we have seen them." All that would have been
described
to
The BMJ
, criticized the press office
when asked
by
Die
Welt
, but never had the opportunity to do so.
German experts said they did not see the effectiveness of the drug being called into question by the allegations. Oliver Cornely, scientific director of the Center for Clinical Studies in Cologne, said: “The errors described in the“ The BMJ ”article do not limit the informative value of the approval study of the vaccine.” The subcontractor’s investigation centers only have 2.3 percent of the 44,000 participants supervised the study.
The head of the Medicines Commission, Wolf-Dieter Ludwig
, made a similar statement
to
Die Welt
, and the verdict from the director of the University Hospital Tübingen, Peter Kremsner, was: "Based on the report, I do not see that anything essentially went wrong at Biontech / Pfizer." led the registration study for Biontech competitor Curevac.
"It all had to happen very quickly, so there might not always have been the perfect approach everywhere," Kremser told the newspaper.
Lack of staff at the licensing authorities?
EU Commission reacts
The report goes on to say that outsourcing studies to external service providers is generally problematic, because the necessary quality must also be checked.
"The current case shows that obviously not all CROs have the necessary expertise and the necessary staff", quoted the newspaper Ludwig.
It is up to the client to control the quality, in this case Pfizer and Biontech.
The next critical step in the process lies with the regulatory authorities: “What worries me most, however, is that the US American regulatory authority clearly does not have the necessary staff to ensure that such serious deficiencies in the conduct of a clinical trial in a timely manner be uncovered, "said Ludwig of the
world
.
According to the report, the EU Commission had given its own licensing authority the opportunity to quickly increase its staff in the event of medical emergencies.
In the case of the currently approved Covid-19 vaccines, such measures will no longer be necessary, said Philipp Henneke from the Freiburg University Hospital in the report.
"In this respect, I see these sloppinesses as deplorable, but not as decisive."
(Frs with material from dpa)