BioNTech Gave FDA $2,8 Million ‘’Drug User Fee’’ For C-19 Vaccine Approval!

While the entire world is obsessed with the Russia-Ukraine war, the Pfizer document release is unnoticed!

Does the C-19 virus disappear with the war?

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We can now tell you how corrupt Pfizer, BioNTech, and FDA are! Among the most incriminating discoveries is the document called ‘’Prescription Drug User Fee Payment.’’

BioNTech paid $2.8 million on 4/20/21 for the Comirnaty C-19 mRNA Vaccine.

Check this out:

Health Impact News reported:

This External Data Monitoring Committee (E-DMC) (hereafter referred to as “the committee”) is a single, external,  independent, expert advisory group established to oversee safety and efficacy data from the BNT162 Vaccine Program. The  primary rationale for establishing the committee is to make certain that appropriate external safeguards are in place to help ensure the safety of subjects and to maintain scientific rigor and study integrity while the trial is on-going.

The committee will review accumulating safety data across all studies, as well as efficacy data in the Phase 2/3 portion of the C4591001 study. The committee will advise Pfizer regarding the safety of current participants and those yet to be recruited, as well as the continuing scientific validity of the trial. In addition to safety review by the committee, qualified Pfizer personnel will review safety data as specified in the safety surveillance review plan and will inform the committee of  significant findings. Efficacy data from the C4591001 study will be available to the committee when there is a planned  interim analysis of efficacy or if this is considered necessary to conduct a risk-benefit assessment.

The FDA didn’t have this task. Pfizer was in charge of conducting the study, and BioNTech was the regulatory sponsor of the study.

Section 1 Introduction says:

Pfizer is responsible for conducting this study. BioNTech is the regulatory sponsor of this study.

Section 2.1 Conflicts of Interest reads:

The committee members will complete a CT22-GSOP-RF01 Independent Oversight Committee Member Conflict of Interest Form. Committee members should be free of apparent significant conflicts of interest. Any potential conflict of interest that develops during a member’s tenure on the committee must be disclosed by the committee member. Pfizer will determine if any potential conflict requires termination of committee membership.

Each time the committee meets, the study team will ask the committee members to consider whether or not any changes in their conflict of interest status have emerged. Status must be recorded in the committee open meeting minutes and any potential conflicts must be reported using CT22-GSOP-RF01.

Below you can see the members of the ‘’External Data Monitoring Committee’’, according to the document, chosen monitored, and investigated by Pfizer to conclude that there were no conflicts of interest.

Health Impact News reported:

Rong Zhang: Senior Statistical Programming Lead
4/F, Building 3, Lotus Business Park, Lane
60, Naxian Road,
Pudong ZhangJiang Hi-tech. Park, Shanghai,
China, 201203
[email protected]

Chen Xu*: Senior Statistical Programmer
4/F, Building 3, Lotus Business Park, Lane
60, Naxian Road,
Pudong ZhangJiang Hi-tech. Park, Shanghai,
China, 201203
[email protected]

Huan Liu* Senior Statistical Programmer
4/F, Building 3, Lotus Business Park, Lane
60, Naxian Road,
Pudong ZhangJiang Hi-tech. Park, Shanghai,
China, 201203
[email protected]

Jiyang Chen*: Senior Statistical Programmer
4/F, Building 3, Lotus Business Park, Lane
60, Naxian Road,
Pudong ZhangJiang Hi-tech. Park, Shanghai,
China, 201203
[email protected]

Bochen Zhu*: Senior Statistical Programmer
4/F, Building 3, Lotus Business Park, Lane
60, Naxian Road,
Pudong ZhangJiang Hi-tech. Park, Shanghai,
China, 201203
[email protected]

Ran Xiong*: Senior Statistical Programmer
4/F, Building 3, Lotus Business Park, Lane
60, Naxian Road,
Pudong ZhangJiang Hi-tech. Park, Shanghai,
China, 201203
[email protected]

I wonder if the raw data is also located in China?

Source

Health Impact News Phmpt

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