The Pfizer Clinical Trial Documents:

Following protracted legal challenges from the Public Health and Medical Professionals for Transparency group, the Food and Drug Administration has released a further 125 Pfizer Covid vaccine clinical trial and related authorization documents at the beginning of March. You can read the documents released by the FDA for yourself on the PHMPT web site , including the smaller number of documents already released in December and January.

The Court required the FDA to publish all the documents connected to the approval of the Pfizer Covid vaccine in-line with the following schedule:

– 10,000 pages in March and April
– 80,000 pages in May 2, June and July
– 70,000 pages in August
– 55,000 pages per month thereafter until all documents are released.

The FDA have been seeking to delay the release of the documents claiming they do not have sufficient resources to meet the publication schedule. Fortunately for us the Court dismissed the FDA’s request. Meanwhile, Pfizer seem to have been been surprised by the large number of adverse event reports and admit to delays in reporting information to the FDA:

“Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritized 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.”

The majority of the documents relate to the set up of the clinical trial or contain large amounts of non-summarized individual patient data. Unfortunately the court did not stipulate the type of documents that should be released as a priority, so we have been left to sort through masses of irrelevant content in order to find the important information.

Having reviewed all the documents in the latest release, my conclusion is that the FDA seem to be doing a great job of meeting their Court obligations without revealing anything that will bring the house down – at least for now. I expect that over the coming months there will be some significant documents released within a much larger number of mostly irrelevant documents.

The key document released so far is titled “5.3.6-Postmarketing-Experience” and summarizes the adverse event reports received by Pfizer to the end of February 2021 . This document reports “there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events.” As with all adverse event reporting systems, it can be assumed that the actual number of adverse events greatly exceeds the numbers reported to Pfizer as typically around 10% or less of actual events are reported.

The 5.3.6 document details what happened to the 42,056 individuals reported to have experienced an adverse event associated with the Pfizer vaccine. In three short months, 1,223 individuals had died and a further 11,881 either had not recovered or had recovered with significant lasting effects from a vaccine injury. Almost half of the individuals had recovered with the outcome of the remaining 22% not being known at the time of the report.

 

The 5.3.6 document states that 75% of events were experienced by women and then breaks down the age of the individuals experiencing adverse events as shown in figure 2. Bear in mind that the reporting period here is from December 2020 to February 2021, when the main emphasis of the vaccination program was on the elderly, specific patient groups at risk from Covid disease and also frontline healthcare workers. It is therefore surprising to learn that the majority of adverse events occurred in the 31-50 age group as they were not the focus of the vaccination program at that time.

The 5.3.6 document highlights safety concerns in the following areas:

1. Anaphylaxis, which is identified as an “important risk”
2. Vaccine-Associated Enhanced Disease (VAED), which is identified as an “important potential risk”
3. Use in pregnant and breastfeeding women
4. Vaccine effectiveness or vaccine failure

Pfizer confirm they had received 2,958 reports of anaphylaxis, involving 1,002 individuals, with almost 90% of these being female and resulting in 9 deaths. This section of the document includes the recommendation to the FDA that the evaluation “did not reveal any significant new safety information. Anaphylaxis is appropriately described in the product labeling as are non-anaphylactic hypersensitivity events. Surveillance will continue.” Pfizer readily admits that no new safety information was revealed to them by the reporting, but sidestep the scale of the actual number of adverse events to ensure the FDA does not intervene to protect populations from unsafe pharmaceuticals.

Vaccine-Associated Enhanced Disease (VAED) was reported in 138 individuals with 38 having died and another 65 not recovering by the end of February 2021. This section of the report concludes with the following statement and recommendation to the FDA:

“VAED may present as severe or unusual clinical manifestations of COVID-19.
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 hospitalization, 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.”

How can Pfizer propose and the FDA accept that VAED is only a “theoretical risk” when they have reports of this number of individuals experiencing severe Covid disease and death following vaccination?

In my last blog I highlighted the section of the 5.3.6 document that reports the adverse events where the vaccine was given to pregnant women. To me, this is the most alarming section of the document in that it confirms the vaccine is not safe for pregnant women and contains the following outcomes for the 270 pregnant women reported to have experience adverse events:

– 23 spontaneous abortions
– 5 “outcome pending”
– 2 premature birth with neonatal death
– 2 spontaneous abortion with intrauterine death
– 1 spontaneous abortion with neonatal death
– 1 normal outcome
– 238 no outcome data reported

Once again this section of the document concludes with an astonishing comment for the FDA:

“Conclusion: There were no safety signals that emerged from the review
of these cases of use in pregnancy and whilst breast feeding”

The final section in the document that I believe deserves a mention here concerns Pfizer’s assessment of the effectiveness of their vaccine, and is quite revealing. The following table from the document shows how Pfizer have been assessing ‘lack of effectiveness’ (LOE) of their vaccine:

This confirms that only Covid infections that occurred more than 7 days after the 2nd vaccination dose are being recorded as a failure of the vaccine. From day 1 to 13 following the first vaccination the individual is essentially regarded as unvaccinated and from day 14 after the 1st dose to day 6 after the 2nd dose any Covid infection is regarded as “drug ineffective” rather than “vaccination failure”. It is therefore not surprising to read that cases of “drug ineffective” are recorded as 1,646 and “vaccination failure” cases number only 19.

The classification of recently vaccinated individuals as essentially unvaccinated is something we have also seen in the hospital activity and death statistics. When we know from the VERS database that approximately 50% of all reported deaths following a Covid vaccination occurred within the first 48 hours, it is fraudulent to intentionally unlink adverse events from the vaccine for the first 14 days.

Whilst the March document drop can be regarded as a little disappointing, I sense that we are being given large quantities of irrelevant information in the hope that we will not notice when some very revealing documents are released in the coming months.

You can rest assured that the Red Pill Revolution team will maintain close scrutiny of the remaining Pfizer document drops. We sense that Globalists are busy creating another distraction to mask the inevitable increase in adverse events and deaths related to Covid vaccinations. The Globalists methods are now being revealed in plain sight and WE SEE YOU!