Jul. 31, 2022

Court Ordered FDA/Pfizer Document Release

Part 1 of 3


Documents relating the results of COVID-19 vaccine testing by Pfizer, Moderna, et al have been released under the Freedom Of Information Act in a number of countries around the world including the United States, Canada and Japan.

This post highlights only 37 pages of approximately 500 pages released by the FDA/Pfizer in the United States thus far, and by court order the FDA and Pfizer must release fully half a million pages.

Wording is also included from a May 2021 Pfizer 'Request For Priority Review' which is a Safety and Efficacy study done for the FDA during the run up to mass vaccine roll-out. This is offered for comparison with data in their court ordered release of the 'Post-marketing Experience' document.

In the end it all comes down to demographics.

A Wonderful Product

Do you remember when the United States Food & Drug Administration (FDA) said they were NOT going to release results of COVID-19 vaccine studies for at least 55 years? Then, when they were sued through the Freedom Of Information Act (FOIA) for the release of that information in November of 2021, the FDA proceeded to ask the courts for a delay of 75 years?  

Why would the agency responsible for the safety of food and drugs in the United States NOT want transparency for a drug that they, and the manufacturers (MODERNA, Pfizer, Johnson & Johnson) promote as 'safe and effective'? Especially when in May of 2021, while the drug makers were pressuring the FDA for full approval of their vaccines, Pfizer submitted a summary of their 'clinical studies' telling of a wonderful product with 90% (or better) efficacy and no undue side effects.

Their summary, linked HERE, includes the following glowing review:

“The available clinical evidence for BNT162b2 (30 µg) effectiveness includes induction of strong immune responses and overwhelmingly high vaccine efficacy, suggesting the vaccine confers protection against COVID-19 in individuals ≥16 years of age.

The potential risks are based on the observed safety profile to date, which shows mostly mild reactogenicity, low incidence of severe or serious events, and no clinically concerning safety observations or safety concerns.

The vaccine appears to be safe and well-tolerated across the safety population comprising approximately 44,000 study participants ≥16 years of age, among whom approximately 12,000 have been followed for at least 6 months after completing the twodose regimen. Safety analyses have also included demographic subgroups based on age, sex, race, ethnicity, and baseline SARS-CoV-2 status and the subset with stable HIV.

The confinement of severe cases of COVID-19 predominantly to the placebo group versus the BNT162b2 group suggests no evidence of vaccine-associated enhanced disease (VAED). Post-authorization safety review reinforces that BNT162b2 is safe and tolerable.

Vaccine efficacy was remarkably high, ≥95% for participants without prior evidence of SARS-CoV-2 infection and >94% for those with or without prior infection, in the prespecified interim and/or final analyses. Updated analyses with all confirmed cases accrued up to approximately 6 months after Dose 2 showed persistence of protection with estimated VE of ≥91.1%.

Overall, observed VE was >90% across subgroups identified by age, sex, race, ethnicity, country, and risk factors and remained high in the updated analysis. Severe cases have been confined overwhelmingly to the placebo group in all efficacy analyses.

Efficacy data suggest highly effective protection against COVID-19 in a broad population of individuals across demographic characteristics, with durable immune responses and protection from COVID-19 disease observed up to approximately 6 months after completing the vaccination regimen...”

That sounds fantastic, doesn't it?

Why then would the FDA be sued for the release of information if the product(s) were truly that wonderful, safe and effective?

Repeat Offender

Because the deaths, not seen during the pandemic of 2020 began to increase subsequent to the release of the mRNA shots through the winter of 2020/2021 (See Top Image - Results from Israel). Doctors, lawyers and industry employees who could clearly see the correlation decided to uncover the truth and launched multiple law suits against the FDA and the drug manufacturers.

In January of 2022 and after only a few weeks of deliberation, U.S. District Judge Mark Pittman in Fort Worth, Texas ruled to have the FDA documents released immediately, saying that the court “...concludes that this FOIA request is of paramount public importance,

Why would the judge rule against the FDA when everyone else in a position of influence think the vaccine science is settled and would rather not talk about it? Was there precedence set by Pfizer before this?

Yes there was. Although not the first time they've been charged with out-right lying, in 2009 Pfizer had to pay a criminal fine of $1.195 billion and its subsidiary Pharmacia & Upjohn Company Inc. had to forfeit $105 million, for a total of $1.3 billion.

In December of 2021, while the judge was ruling on the FDA's lack of transparency, 'The Market Realist' published an article recalling that Pfizer, “...pled guilty to felony charges for violating the Food, Drug and Cosmetic Act by misbranding the anti-inflammatory drug Bextra and promoting it for uses that the FDA “specifically declined to approved due to safety concerns,” the Department of Justice stated.

Pfizer also paid $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs—Bextra, anti-psychotic drug Geodon, antibiotic Zyvox, and anti-epileptic drug Lyrica. The settlement claims that Pfizer paid kickbacks to healthcare providers to entice them to prescribe the drugs.”

What 55 Years Was Supposed To Hide

At this writing the FDA is slowly releasing documentation detailing the drug manufacturer(s) testing methods and results for their COVID-19 vaccines. Now that they have released Pfizer's trial data it should be apparent to EVERYONE who reads them just why the FDA were so opaque; they were covering up some very horrendous results.

Below is a summary of one document (37 pages out of what the FDA says are tens of thousands of pages in their files) released by Pfizer which summarizes the results of their observations on the testing of their vaccination on control groups and on the public in general. Entitled “Post-marketing Experience”, this study covers a very small window of approximately 2-1/2 months and all outcomes refute their May 2021 claim that the injections are safe and effective.

I've linked the entire .pdf file HERE. Below are a few excerpts from these 37 pages but you really should read the entire report;

5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Pg. 6

Section 2 - Methodology

Due to the large numbers of spontaneous adverse event reports received for the product, the MAH has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity....

.... Pfizer has also taken a multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately (600) additional fulltime employees (FTEs). More are joining each month with an expected total of more than (1,200) additional resources by the end of June 2021...

They have so many cases where the vaccinated suffered adverse effects that in order to conduct a timely study, all 'non-serious' injuries have been omitted. Even with that paring down of criteria they have still had to hire twelve-hundred people in order to process and summarize all of the adverse effects.

5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Pg. 11

Table 5. Important Potential Risk

...Overall, there were 37 subjects with suspected COVID-19 and 101 subjects with confirmed COVID-19 following one or both doses of the vaccine; 75 of the 101 cases were severe, resulting in hospitalisation, disability, life-threatening consequences or death. None of the 75 cases could be definitively considered as VAED/VAERD. In this review of subjects with COVID-19 following vaccination, based on the current evidence, VAED/VAERD remains a theoretical risk for the vaccine. Surveillance will continue.

Conclusion: VAED (Vaccine Associated Enhanced Disease) may present as severe or unusual clinical manifestations of COVID-19...

This explains why the majority of 'COVID-19' hospitalization and death today are vaccinated. The report goes on to describe some very troubling results from tests on pregnant mothers and their infants...

5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports Pg. 12

Table 6. Description of Missing Information

Pregnancy cases:

274 cases including:

• 270 mother cases and 4 foetus/baby cases representing 270 unique pregnancies (the 4 foetus/baby cases were linked to 3 mother cases; 1 mother case involved twins).

• Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23), outcome pending (5), premature birth with neonatal death, spontaneous abortion with intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome (1 each). No outcome was provided for 238 pregnancies (note that 2 different outcomes were reported for each twin, and both were counted). .....

In this first lot of data, 28 of the 274 pregnancies were ended spontaneously or prematurely subsequent to the mother receiving the vaccine. Apparently the outcome of the other 238 pregnancies were so bad that no follow-up was done for this portion of their safety review. Review Page 12 continues......

• 4 serious foetus/baby cases reported the PTs Exposure during pregnancy, Foetal growth restriction, Maternal exposure during pregnancy, Premature baby (2 each), and Death neonatal (1). Trimester of exposure was reported for 2 cases (twins) as occurring during the 1st trimester.

• 124 mother cases, 49 non-serious and 75 serious, reported clinical events, which occurred in the vaccinated mothers. Pregnancy related events reported in these cases coded to the Pts; Abortion spontaneous (25), Uterine contraction during pregnancy, Premature rupture of membranes, Abortion, Abortion missed, and Foetal death (1 each). Other clinical events which occurred in more than 5 cases coded to the PTs Headache (33), Vaccination site pain (24), Pain in extremity and Fatigue (22 each), Myalgia and Pyrexia (16 each), Chills (13) Nausea (12), Pain (11), Arthralgia (9), Lymphadenopathy and Drug ineffective (7 each), Chest pain, Dizziness and Asthenia (6 each), Malaise and COVID-19 (5 each). Trimester of exposure was reported in 22 of these cases: 1st trimester (19 cases), 2nd trimester (1 case), 3rd trimester (2 cases).

Not withstanding all of the deaths and injuries reported in this limited review, each of the report sections ends with a similar conclusion;

Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue

Notice that the word 'new' is used in every instance to clarify that this information was available previously.

Continued Part 2....