- Health Impact News - https://healthimpactnews.com -

Just Released Documents by Pfizer Show BioNTech Paid FDA $2,875,842.00 “Drug User Fee” for COVID-19 Vaccine Approval

by Brian Shilhavy
Editor, Health Impact News

As the news cycle continues to focus on the Ukraine situation, the FDA complied with a court order to begin releasing 55,000 pages of Pfizer data per month that was used to authorize their COVID-19 vaccine produced with BioNTech, with the first batch quietly released yesterday, March 1st.

There are 150 documents that the public can now download here [1].

One of the documents released was the “Prescription Drug User Fee Payment” that BioNTech paid to the FDA on 4/20/2021 for the “COMIRNATY COVID-19 mRNA Vaccine” which the FDA subsequently approved in August of 2021.

That “Prescription Drug User Fee Payment” was $2,875,842.00. (Source [2].)

Another interesting document I found was the “EXTERNAL DATA MONITORING COMMITTEE” found here [3].

Here is the stated purpose of this “External Data Monitoring Committee”:

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.

And to make sure that this Committee is doing their job properly to ensure “the safety of subjects and to maintain scientific rigor,” who at the FDA is responsible to make sure this happens?

Well, that would be no one. Pfizer is the one who was responsible, and BioNTech funded it.

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

The committee members are to be free from “conflicts of interest.”

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.

And who at the FDA is responsible for assuring that this committee who is overseeing “safety and efficacy data” is free from conflicts of interest?

Well, that would be no one. Again, Pfizer is responsible for that.

“Pfizer will determine if any potential conflict requires termination of committee membership.”

The question that then begs to be answered here is, what role did the FDA play, if any, in the “external” monitoring of the data to ensure integrity and safety of a new vaccine about to be injected into hundreds of millions people in the U.S.?

It would appear that all they did was rubber stamp the process that was completely managed by Pfizer, and funded by BioNTech.

Here are the members of the “External Data Monitoring Committee” that apparently were chosen by Pfizer, monitored by Pfizer, and investigated by Pfizer to make sure they were doing their job and that there were no “conflicts of interest.”

The other interesting thing this document reveals is that a significant number of people compiling the data for this committee to review were located in China.

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
Rong.Zhang@pfizer.com

Chen Xu*: Senior Statistical Programmer
4/F, Building 3, Lotus Business Park, Lane
60, Naxian Road,
Pudong ZhangJiang Hi-tech. Park, Shanghai,
China, 201203
Chen.Xu4@pfizer.com

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

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

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

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

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

There is a lot more data I am still reviewing, and tens of thousands of more pages of data still to be released by the FDA.

But with everyone watching what is happening in the Ukraine right now, I wonder if anyone is even noticing this?

See Also:

Funeral Embalmer: 85% of Dead Bodies Now Have Strange Blood Clots Since COVID Vaccine Roll-outs [4]

BOMBSHELL: Video Emerges Where Fauci and Others Planned for a “Universal mRNA Flu Vaccine” Which Became the “COVID-19 mRNA Vaccine” Because People were not Afraid Enough of the Flu Virus [5]

[5]

COVID-19 “Vaccine” Casualties List

32 Young Canadian Doctors “Died Suddenly” in the Past 16 Months While Fully COVID-19 Vaccinated [6]

[6]

SADS: “Sudden Adult Death Syndrome” Explodes as Young and Healthy Adults Die Following COVID Vaccine Mandates [7]

[7]

76,789 Deaths 6,089,773 Injuries Reported in U.S. and European Databases Following COVID-19 Vaccines [8]

[8]

6 Canadian Medical Doctors Died Within 2 Weeks After 4th COVID Booster Shots for Employees Started at One Hospital [9]

[9]

76,253 Dead 6,033,218 Injured Recorded in Europe and USA Following COVID Vaccines with 4,358 Fetal Deaths in U.S. [10]

[11]

Injecting Babies with COVID-19 Vaccines: Brain Damage, Seizures, Rashes are Recorded Side Effects in VAERS [12]

[12]

Official Government Data Record 74,783 Deaths and 5,830,235 Injuries Following COVID-19 Vaccines in the U.S. and Europe [13]

[13]

45,316 Dead 4,416,778 Injured Following COVID-19 Vaccines in European Database of Adverse Reactions – Sudden Adult Death Syndrome (SADS) is New Category to Deny Vaccine Deaths [14]

[14]

FDA had Data Showing 82% – 97% of Pregnant Women Injected with the Pfizer COVID-19 Vaccine Lost Their Babies Before Approving the Shots [15]

[15]

44,821 Dead 4,351,483 Injured Following COVID-19 Vaccines in European Database of Adverse Reactions [16]

[16]

Cases of Brain Damage in Children Skyrocket Following COVID-19 Vaccines [17]

[17]

Recorded Cases of Heart Disease Among Under 40 Years Old Explodes 20,000% After COVID-19 Vaccines Roll Out [18]

[18]

Killer COVID Vaccines: 4,400% Increase in Deaths Compared to All FDA-Approved Vaccines for Previous 30 Years [19]

[19]

4,113 Fetal Deaths in VAERS Following COVID-19 Vaccines Not Including Those Murdered Alive to Develop the Vaccines [20]

[20]

43,898 Dead 4,190,493 Injured Following COVID-19 Vaccines in European Database of Adverse Reactions [21]

[21]

Millions of American Lives in Danger as Airline Pilots Suffer Heart Problems from Mandatory COVID Vaccines [22]

[22]

43,000 Deaths 4 MILLION Injuries Following COVID-19 Vaccines in European European Database of Adverse Reactions [23]

[23]

1000% Increase in Vaccine Deaths and Injuries Following Pfizer COVID-19 EUA Vaccine for 5 to 11 Year Olds [24]

[24]

42,507 DEAD 3,984,978 Injured Following COVID Vaccines in European Database of Adverse Reactions [25]

[25]

17,500% Increase in Heart Disease in Children Following COVID-19 Vaccines – This is NOT Rare! [26]

[26]

22,000% Increase in Deaths following COVID Vaccines for Adults Over 50 as FDA Authorizes 2nd Booster for this Age Group [27]

[27]

COVID-19 Vaccine Massacre: 68,000% Increase in Strokes, 44,000% Increase in Heart Disease, 6,800% Increase in Deaths Over Non-COVID Vaccines [28]

[28]

Moderna Seeks Approval from FDA and European Medicines Agency (EMA) to Start Injecting Children Under 6 with mRNA COVID-19 Vaccines [29]

[29]

41,834 DEAD 3.9 Million Injured Following COVID Vaccines in European Database as U.S. Military Deaths Soar 1100% [30]

[30]

The Thousands of Fetal Deaths Recorded After COVID-19 Vaccines that Nobody Wants to Report and that Facebook is Trying Hard to Censor [31]

[31]

65,615 Deaths Now Reported in Europe and the USA Following COVID-19 Vaccines – Corporate Media Refuses to Publish this Data [32]

[32]

2000% Increase in Fetal Deaths Following COVID-19 Vaccines but CDC Still Recommends Them for Pregnant Women [33]

[33]

Official Government Data: Twice as Many Deaths Following COVID-19 Vaccines in 1 Year as Deaths Following All Vaccines for the Previous 30 Years [34]

[34]

California Nurse: “I Want People to Know What I Lost to this Vaccine – I am Living a Nightmare, It’s Not Worth it.” [35]

[35]

German Health Insurance Claims Show 31,254 Deaths Following COVID-19 Vaccines While Official Government Stats Report Only 2,255 [36]

[36]

68,000% Increase in Strokes as FDA and HIH Secretly Study Reports of Neurological Injuries After COVID-19 Vaccines [37]

[37]

40,000 Deaths Following COVID Shots in European Database as Life Insurance Death Claims Skyrocket [38]

[38]

34-Year-Old Canadian Father Drops Dead in Front of His Daughters After COVID-19 Vaccine [39]

[39]

6-Year-Old Minnesota Boy Develops Myocarditis And Becomes Severely Injured After Receiving Pfizer COVID-19 Vaccine [40]

[40]

Double-Vaccinated 20-Year-Old Florida Model Develops Myocarditis, Suffers Heart Attack And Has Both Legs Amputated [41]

[41]

Comedian Collapses on Stage During Joke: “I’m vaxxed, double vaxxed, boosted, and Jesus loves me most” [42]

[42]

GENOCIDE! Military Medical Whistleblowers Reveal Miscarriages, Birth Defects, and Infertility Rates Exploded in 2021 Following COVID Vaccines [43]

[43]

Government VAERS Data Reveal 15,600% Increase in Heart Disease Among Under 30 Year-Olds Following COVID-19 Vaccination [44]

[44]

COVID-19 Vaxxed Olympic Gold Medalist Dies at 51 but Media Calls Him “Anti-Vaxxer” [45]

[45]

Over 1 Million Deaths and Injuries Following COVID “Vaccines” Reported in VAERS as Second Year of “Experimental Use Authorization” Begins [46]

[46]

2021: COVID Deaths Increase, Flu Deaths Disappear, 400,000+ More Total Deaths than 2020 [47]

[47]

Actor Bob Saget “Dies Suddenly” 1 Month After Receiving COVID Booster Shot [48]

[48]

Crisis in America: Deaths Up 40% Among Those Aged 18-64 Based on Life Insurance Claims for 2021 After COVID-19 Vaccine Roll Outs [49]

[49]

Year 2021 was America’s Holocaust: Unprecedented Lives Destroyed by Experimental COVID-19 “Vaccines” [50]

[50]

One Year Anniversary of President Trump Forcing the FDA to give Emergency Use Authorization to the Pfizer Shot [51]

[51]

Registered Nurse Suffers Pericarditis from Pfizer Shot – Put in Hospital Section for Vaccine Injured as She was 7th Patient Admitted That Day for Heart Issues Following COVID Shots [52]

[52]

#RealNotRare New Website for COVID-19 Vaccine Injured [53]

[53]

German Study Finds ZERO COVID-19 Deaths in Healthy Children but the Children are Now Dying from the Vaccine [54]

[54]

666 Cases of Heart Disease in 12 to 17-Year-Olds After COVID Shots – Less than 2 Cases Per Year Following All Vaccines for Past 30+ Years [55]

[55]

7-Year-Old Girl Has Stroke and Brain Hemorrhage 7 Days After Pfizer COVID-19 Shot [56]

[56]

Vaccine Cult Exposed by Government’s Own Data: More than 50% of ALL Vaccine Adverse Reactions Reported for Past 30+ Years Have Occurred in Past 11 Months Following COVID-19 Shots [57]

[57]

A List Of People Who Had Their Leg Amputated Shortly After Receiving a COVID-19 Shot [58]

[58]

Fully Vaccinated Pro-Vaccine Canadian Senator Dead at the Age of 56 [59]

[59]

Bill Gates Charged with Murder for COVID-19 Vaccine Death in India’s High Court – Death Penalty Sought [60]

[60]

Pfizer’s War on Children Invades Canada and Israel as COVID Shots Begin to be Injected Into 5 to 11 Year Olds [61]

[61]

Families of South Korea’s COVID Vaccine Victims Mourn Loved Ones During Mass Memorial Service [62]

[62]

Vaccinated Doctors are Dying and Unvaccinated Doctors are Quitting or Being Fired: Who will Run the Hospitals? [63]

[63]

The Genocide of American Seniors Continues: 8 Dead in Fully-Vaccinated Connecticut Nursing Home [64]

[64]

Parents in NY Take to the Streets to Warn Ignorant Parents Injecting Their Children with Pfizer Shots as Injuries Among 5 to 11 Year Olds Now Being Reported [65]

[65]

Parents Sacrifice Hundreds of Thousands of Children Ages 5 to 11 to the COVID-19 Vaccine Gods This Weekend [66]

[66]

Cardiologist Medical Doctor who Wanted to Punch Anti-Vaxxers in the Face DEAD After COVID Booster Shot [67]

[67]

Texas Church Injects Young Children with COVID Shot in Halloween Celebration – Christian Churches Now Working with the CDC to Abuse and Murder Children [68]

[68]

Grieving Mother Who Threatened Health Impact News for Publishing Daughter’s Death following COVID-19 Shot Now Goes Public [69]

[69]

Do You Have Blood on Your Hands? Tens of Thousands of Children Age 5 to 11 Injected with Gene Therapy Shots [70]

[70]

41 Year Old Florida Man Who Cursed Anti-Vaxxers Found Dead in His Home by Neighbors After Second COVID-19 Pfizer Shot [71]

[71]

12-Year-Old In Germany Dies 2 Days After Pfizer COVID-19 Vaccine – 12-Year-Old in Thailand In ICU After Heart Problems Caused By The Pfizer Shot [72]

[72]

Whistleblower Reveals Fraud in Pfizer COVID Vaccine Trials as 5 to 11-Year-Olds Begin to be Injected – Vaccine Deaths and Injuries to Follow [73]

[73]

Doctors and COVID-19 Vaccine Injured Testify in Washington D.C. to Crimes Against Humanity – CDC, FDA, NIH, Fauci are No Shows [74]

[74]

UK Stats Show 82% of COVID-19 Deaths and 66% of Hospitalizations were Among Fully Vaccinated for Past Month [75]

[75]

Fully Vaccinated are Suffering Far Higher Rates of Infection than the Unvaccinated, and It is Getting Worse [76]

[76]

White House To “Quickly” Vaccinate 28 Million Children Age 5-11 as Deaths and Injuries Continue to Increase among 12 to 19-Year-Olds Who Received a COVID-19 Shot [77]

[77]

Evidence Clearly Shows Deaths are Increasing Worldwide After COVID-19 Shots – Major Labor Shortages Loom [78]

[78]

As Deaths and Injuries to Teens Increase After COVID-19 Shots Pfizer Asks FDA for Emergency Authorization to Inject 5 to 11-Year-Olds [79]

[79]

Post COVID-19 Injections: The Dead Don’t Speak, but Those with Crippling Injuries Issue Warnings [80]

[80]

Denver Policeman Crippled After Mandatory Pfizer Shot – Are Law Enforcement the Key to Resisting Medical Tyranny? [81]

[81]

1,969 Fetal Deaths Recorded Following COVID-19 Shots but Criminal CDC Recommends Pregnant Women Get the Shot [82]

[82]

Study: COVID-19 Vaccines INCREASE Deaths and Hospitalizations from COVID-19 Based on Analysis of Most-Vaccinated Countries [83]

[83]

Whistleblower Lawsuit! Government Medicare Data Shows 48,465 DEAD Following COVID Shots – Remdesivir Drug has 25% Death Rate! [84]

[84]

Mockers of Anti-Vaxxers Continue to Die After Taking a COVID-19 Injection [85]

[85]

STUDY: Government’s Own Data Reveals that at Least 150,000 Probably DEAD in U.S. Following COVID-19 Vaccines [86]

[86]

Local Detroit TV Asks for Stories of Unvaxxed Dying from COVID – Gets over 180K Responses of Vaccine Injured and Dead Instead [87]

[87]

Teens 50X More Likely to Have Heart Disease After COVID Shots than All Other FDA Approved Vaccines in 2021 Combined – CDC Admits True but Still Recommends It [88]

[88]

Besides Fetal Deaths, Breastfeeding Babies are Dying and becoming Sick following Mothers’ COVID Shots [89]

[89]

Military Members are Dying and Suffering Crippling Effects from COVID Vaccinations [90]

[90]

CDC: Teens Injected with COVID Shots have 7.5 X More Deaths, 15 X More Disabilities, 44 X More Hospitalizations than All FDA Approved Vaccines in 2021 [91]

[91]

COVID Shots Are Killing and Crippling Teens in Record Numbers – Young Children Are Next [92]

[92]

 

See the Full List of Tragic Deaths and Injuries Here! [93]

 

[94]

 

See Also:

Understand the Times We are Currently Living Through

What Happens When a Holy and Righteous God Gets Angry? Lessons from History and the Prophet Jeremiah [95]

[95]

The Most Important Truth about the Coming “New World Order” Almost Nobody is Discussing [96]

[96]

Are You on the Right Path in Life? There May Not be Much Time Left to Decide [97]

[97]

The American Dream was Always a Lie – The Path of Christ is a Lonely, Difficult One [98]

[98]

Insider Exposes Freemasonry as the World’s Oldest Secret Religion and the Luciferian Plans for The New World Order [99]

[99]

Identifying the Luciferian Globalists Implementing the New World Order – Who are the “Jews”? [100]

[100]

Fact Check: “Christianity” and the Christian Religion is NOT Found in the Bible – The Person Jesus Christ Is [101]

[101]

What is Life? [102]

[102]

The Seal and Mark of God is Far More Important than the “Mark of the Beast” – Are You Prepared for What’s Coming? [103]

[103]

The Satanic Roots to Modern Medicine – The Mark of the Beast? [104]

[104]

Medicine: Idolatry in the Twenty First Century – 7-Year-Old Article More Relevant Today than the Day it was Written [105]

[105]

[106]

Having problems receiving our newsletters? See:

[107]

How to Beat Internet Censorship and Create Your Own Newsfeed [107]

[108]

We Are Now on Minds.com [109], MeWe [110], and Telegram [111]. Video channels at Bitchute [112], and Odysee [113].

If our website is seized and shut down, find us on Minds.com [109], MeWe [110], and Telegram [111], as well as Bitchute [112] and Odysee [113] for further instructions about where to find us.

If you use the TOR Onion browser [114], here are the links and corresponding URLs to use in the TOR browser [114] to find us on the Dark Web: Health Impact News [115], Vaccine Impact [116], Medical Kidnap [117], Created4Health [118], CoconutOil.com [119].