Pfizer subcontractors
Whistleblower reports irregularities in vaccine registration study – experts give the all-clear
The vaccine from Biontech / Pfizer is one of the most effective and most widely used vaccines against the coronavirus worldwide
© Sebastian Gollnow / DPA
According to an ex-employee, there were apparently irregularities in a US subcontractor during the approval study for the corona vaccine from Biontech / Pfizer. However, this does not affect the safety and effectiveness of the vaccine.
Serious allegations have been made against a subcontractor commissioned by Pfizer to conduct clinical studies on the corona vaccine. As the renowned specialist journal British Medical Journal (BMJ) reported on Wednesday, citing an ex-employee of the company, the company from the US state of Texas is said to have apparently worked improperly in studies on the vaccine by Biontech / Pfizer. However, this does not affect the effectiveness and safety of the vaccine.
The BMJ report based largely on testimony from a former employee who spent two weeks in the company’s clinical trials of the corona vaccine before being fired.
According to the woman, the company did not follow the so-called double-blind procedure. This procedure ensures that neither the patient nor the medical staff know whether an effective drug or a placebo is being given. This is intended to enable the study results to be assessed as objectively as possible. She also accuses her former employer 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. She told the BMJ that she had informed the US Food and Drug Administration of the violations.
Biontech wants to examine allegations
Biontech wants to investigate the reports of irregularities. “Careful implementation and data collection in clinical studies is a top priority for Biontech,” said a spokeswoman for the Mainz-based company on Thursday. “We take statements such as those made in the article seriously and check them as soon as we become aware of them.”
The FDA initially did not want to comment on the process when asked by the AFP news agency. However, the agency said it had “full confidence” in the data that led to the approval of Biontech / Pfizer’s corona vaccine. Neither Pfizer nor the subcontractor initially responded to inquiries.
Allegations affect only a small percentage of the subjects
It should be noted that the company only played a minor role in the clinical testing of Biontech / Pfizer’s corona vaccine. According to the former employee, the company recruited a total of 1,000 test subjects for the study, which comprised around 44,000 test subjects. This corresponds to around 2.3 percent of all study participants.
What the whistleblower uncovered was “without question unpleasant”, commented Peter Kremsner on the report at the request of the “Science Media Center”. But it is not enough to doubt the quality of the clinical study by Biontech / Pfizer, according to the director of the Institute for Tropical Medicine at the Eberhard Karls University of Tübingen. “That’s just not enough for me. The vaccination dates have already been confirmed in numerous studies.”
“We recognize the effectiveness every day”
Oliver A. Cornely, senior physician at the Cologne University Hospital and scientific director of the Center for Clinical Studies in Cologne, sees it similarly: “The errors described in ‘The BMJ’ article do not limit the validity of the approval study of the vaccine.” It is good that the company only accounts for a small percentage of the study participants. The effectiveness of the vaccine is also proven with data from Israel and other countries. “We hardly admit vaccinated people because of COVID-19, so we recognize the effectiveness every day.”
There has certainly never been such a pressure to succeed and speed as in the vaccine development of the current pandemic, said Cornely. “Errors should become visible more quickly.” The decisive factor is recognizing errors, open communication and consistent improvement of processes. He strongly advised an administrative inspection of all the subcontractor’s centers.
According to studies, the preparation from Biontech / Pfizer is one of the most effective vaccines against the coronavirus and forms the backbone of the vaccination campaign in Germany with more than 80 million doses. Hundreds of millions of cans have already been inoculated worldwide.