Incorrectly labeled samples, incorrectly stored vaccine, slow reactions to side effects: a whistleblower makes many allegations about a study on the Biontech / Pfizer vaccine.
New York / Mainz – Despite allegations of sloppiness in the decisive study on the corona vaccine by Biontech and Pfizer, experts do not see the effectiveness of the agent in question.
The information in the specialist magazine “The BMJ” about irregularities and errors is not sufficient “to doubt the quality of the clinical study by Biontech / Pfizer,” said Peter Kremsner, Director of the Institute for Tropical Medicine at the University of Tübingen.
The background is information from a whistleblower (whistleblower) to “The BMJ”: The woman had worked for two weeks in autumn 2020 for a subcontractor that carried out a small part of the study on the corona vaccine, which is now used worldwide, on behalf of Pfizer. She accused the subcontractor of generating incorrect vaccination data because, among other things, laboratory samples were incorrectly labeled, the vaccine was incorrectly stored and reports of side effects were only followed up slowly.
Biontech wants to investigate the allegations. “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. “We take statements such as those made in the article seriously and check them immediately after we have read them.”
“What the whistleblower has uncovered is without question unpleasant,” says expert Kremsner. But it is not enough to generally question the vaccination dates. “That’s just not enough for me. The vaccination dates have already been confirmed in numerous studies. ”However, if mistakes were made, the great pressure to succeed and time in the pandemic could have played a role. “The risk that a subcontractor may not meet the quality standards of the major clinical sponsor can increase in such a case.”
Oliver Cornely, scientific director of the Center for Clinical Studies in Cologne, has a similar opinion. “The errors described in” The BMJ “article do not limit the validity of the vaccine registration study,” he explains. The subcontractor’s investigation centers also looked after only 2.3 percent of the 44,000 participants in the study.
And last but not least, the hospitals show how well the vaccines work every day: “We hardly admit people who have been vaccinated because of Covid-19, so we recognize the effectiveness every day,” continues Cornely. Despite everything, an official inspection of all centers of the subcontractor is urgently needed. dpa
