[Epoch Times November 05, 2021](Reported by the English Epoch Times reporter Frank Fang / compiled by Gao Shan) A company involved in the COVID-19 (Chinese Communist virus) vaccine trial confirmed that the whistleblower disclosed that Pfizer is in the process of vaccine development There is a violation of the rules and is under investigation.
In the fall of 2020, the “Ventavia Research Group” (Ventavia Research Group) operated several Pfizer COVID-19 (Chinese Communist virus) vaccine test sites. Brook Jackson worked for the company during this period. She told the British Medical Journal (BMJ) that the vaccine trial process was full of irregularities and various problems, including falsified data.
Jackson revealed that she reported the problems she witnessed to the Food and Drug Administration (FDA) and was fired a few hours later.
“Ventavia Research Group” confirmed to The Epoch Times that it had hired Jackson for two weeks last year.
Lauren Foreman, head of business development and communications at Ventavia Research Group, said in an email that Ventavia is investigating the allegations against Jackson.
She said: “Ventavia attaches great importance to research compliance, data integrity and participant safety, supports the important work of life-saving vaccine development, and is conducting corresponding investigations.”
The US Food and Drug Administration also seems to have confirmed that they understand the matter. A spokeswoman told The Epoch Times in an email: “Although the Food and Drug Administration cannot comment further on this matter at this time, the Food and Drug Administration has been The data on the 19 (Chinese Communist virus) vaccine is full of confidence.”
Ventavia participated in the trial that ultimately led to the emergency use authorization (EUA) of Pfizer’s vaccine. Later, the US Food and Drug Administration officially approved the full use of this vaccine. Although many or all of the vaccines used in the United States are still emergency licensed versions.
Pfizer did not immediately respond to a request for comment.
Jackson has been engaged in clinical trials for more than 15 years. She told the British Medical Journal that she had repeatedly raised concerns about what she had witnessed to her superiors, including concerns about patient safety. After feeling that her report had been ignored, she started taking pictures with her mobile phone. One photo shows that vaccine injection needles are discarded in a plastic bag, not a box; while another photo shows the vaccine packaging material, which shows the ID number of the trial participants, indicating that their experiment may have been unblind. Measurement.
According to the internal documents she provided, shortly after the Pfizer vaccine experiment started in August 2020, she discovered that experimenters “modified the file log” and “filled in experimental data as needed.”
In a message sent to the US Food and Drug Administration on September 25, Jackson listed 12 issues that she was concerned about. These include: experiment participants were not monitored after receiving the vaccine, and the vaccine was not stored at the proper temperature.
She also claimed that Ventavia’s staff were targeted by superiors for reporting related issues. She herself was fired on the same day she reported the problems she saw to the U.S. Food and Drug Administration.
Jackson said that the U.S. Food and Drug Administration sent her an email confirming receipt of the list. She also received a call from an inspector from the U.S. Food and Drug Administration. But since then, it has never received any news from the agency.
The Epoch Times has submitted an application to the U.S. Food and Drug Administration under the Freedom of Information Act concerning Jackson’s e-mail and the agency’s internal communications regarding the information.
The US Food and Drug Administration said that in August, they inspected 9 of the 153 test sites. However, it does not include any test sites in Ventavia.
A U.S. Food and Drug Administration official wrote in an inspection summary that the inspection work done was limited, “because the research is in progress, it is not yet possible to provide the verification and comparison of the investigational new drug (IND). The data”.
In December 2020, Philip Crooker, vice president of technology at Parexel International, the world’s top clinical research commission, said at a forum that inspections of some pharmaceutical companies have been abandoned. Or the US Food and Drug Administration officials decided to only conduct remote inspections. According to data from the U.S. Food and Drug Administration, inspections of domestic premises dropped from 13,001 in 2019 to 6,574 in 2020.
Editor in charge: Li Yuan
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