Study of Pfizer Phase 2/3 Clinical Trial of mRNA injections by Daily Clout published in the International Journal of Vaccine Theory, Practice and Research

Titled “Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial

https://doi.org/10.56098/ijvtpr.v3i1.85 Received 5 Sep 2023 published 17 Oct 2023

Link here:

Forensic-analysis-of-the-38-subject-deaths-in-the-6-Month-Interim-Report-of-the-Pfizer-BioNTech-BNT162b2-mRNA-Vaccine-Clinical-Trial.pdf (researchgate.net)

It’s a 38 page report – I have scanned the first dozen pages but thought it worth while posting it.

The dates are significant as are the lack of details such as autopsies, follows ups of those that dropped out = amongst other issues.

Here are some important dates to keep in mind when analysing the 38 deaths that occurred across the combined injected and placebo arms, and assessed in the Daily Clout report.

Original Clinical trial period – 33 weeks from July 27, 2020 to March 13, 2021.

Almost all randomized subjects had received dose 2 by November 14, 2020 (week 16) which was the data cut-off date for Pfizer/BioNTech’s application.

(Ed: Curious minds want to know how many received first and second doses at each month end of August, September and October (10%, 20%, 30% by end August, for example?) – compared to adverse events, not just deaths!

As it is, the scheduled 33 week trial was ended after only 16 weeks – presumably, injection dates are accurate and  subjects were considered injected AFTER EACH of first and the second dose – be interesting to check whether doses one and two were given one, two or three weeks apart at the different sites or whether they were administered whenever the subjects chose to “dew drop inn”! Bear this in mind when looking at the deaths and dates of death reported in the chart below).

The application was submitted to the FDA on November 20, 2020 and included all data submitted to Pfizer/BioNTech from the 153 clinical trial sites through November 14, 2020.

Polack et al. (2020) published a journal article on December 10, 2020, covering 153 clinical trial sites in over 6 different countries. entitled, “Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine.”

December 10, 2020 (end of week 20) Pfizer/BioNTech reported its results to the  FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)

(Ed: note that the journal article and Pfizer report are the same day, 10 December 2020 – 20 days after Pfizer’s application to the FDA for EUA. VRBPAC immediately approved – without looking?!?).

Pfizer injection given EUA on 11 December 2020. The FDA also approved Pfizer’s request to unblind all subjects in the clinical trial.

(Ed: The FDA approved – without looking!?!).

The period from December 11, 2020 to January 24, 2021 is referred to as the “Open-Label Follow Up Period”.

All subjects of all vaccine status continued to be followed for 24 months regarding their general health and COVID-19 infection status, thus the term “follow up”.

(Ed: notice the affirmatory statement relating to an event that has nor happened “continued to be followed up"! The clinical trial was terminated on 14 November 2020 – we are now at the end of October 2023  - almost 36 months later – WHERE IS THE REPORT ON THOSE “FOLLOWED FOR 24 MONTHS?!?)

January 25, 2021 begins what Pfizer refers to as the “Open-Label Observational Period”, which ended at the March 13, 2021 data cut-off date of the 6-Month Interim Report.

The original clinical trial was scheduled to end on March 13, 2021 – presumably this means that, beyond the detailed analysis of the 38 deaths analysed in the Daily Clout report, there is a table detailing infections, all adverse events broken down with details of severe (life altering) and serious (life threatening) events amongst those injected in the clinical trail – which is what 43,000 eventually injected out of the original 44,000 in the trial, but with only 1,000 left not injected after the trail was (criminally) unblinded (with the permission of the corrupt FDA).

Okay, here’s the killer chart.

Figure 1: Weekly subject deaths during the initial 33 weeks of Pfizer/BioNTech Clinical Trial C4591001.

• The 38 subjects who died are accounted for in the order of their date of death during the 33 weeks starting Monday, July 27, 2020, and ending Saturday, March 13, 2021.

• Each bar between the horizontal lines on the graph represents a single death (no more than 3 ever occurred on the same day).

• Solid black bars represent BNT162b2 vaccinated subjects who died; solid grey bars represent placebo subjects; hatched bars are unblinded placebo subjects who accepted a BNT162b2 injection after December 11, 2020.

• The cumulative number of deaths for BNT162b2 recipients is shown in the solid line rising from left to right whereas the dotted line shows cumulative deaths of the placebo only recipients.

• The placebo recipients who opted to accept a BNT162b2 injection and died are counted as BNT162b2 recipients.

The three trial periods from left to right are:

1.      Blinded placebo-controlled period, July 27 – December 10, 2020;

2.      Open-label Follow-up period, December 11, 2020 – January 24, 2021;

3.      Open-label Observation period, January 25 – March 13, 2021.

The Daily Clout report goes into detail of each of the 38 deaths in the injected (21 deaths) and placebo (17 deaths) streams and laments the lack of autopsies, whilst highlighting the high incidence of heart related causes.

Out of interest, I am trying to get my head round the estimated number of people that should have died during the clinical trials v the number of those that actually died during the clinical trial.

The Daily Clout team estimates that 222 people could be estimated to have died amongst the 44,000 trial participants over the 33 weeks of the trial period. The Daily Clout wonders “One possible explanation for the low number of subject deaths lies in the large number of “Discontinued Subjects” in C4591001, 4.2% of the randomized subjects.”

That 4.2% of 44,000 = around 1,850 people, one in 25 of one of the most important clinical trails ever conducted!

It reminds me of this table from the post authorization marketing report (not to be confused with any of the reports mentioned before in this post!) that covers the period from 11 December 2020 to 28 February 2021 – just 3 months (note no-one has even attempted to calculate an under-reporting factor for this table!)

reissue_5.3.6-postmarketing-experience.pdf (phmpt.org)

9,400 “Unknown” out of 42,000 reports. The cynic in me says that this is the preferred outcome for fraudsters. Let’s leave aside the 11,361 unrecovered and the URF that might be 100, given the total lack of time and/or awareness of the need to report to adverse event reporting systems during a peak period of psychological crisis!

Ok, here’s how the Daily Clout describes its methodology for calculating the 222 deaths that should have happened over the clinical trial period,

“Given the large number of participants in the clinical trial, 44,060 subjects receiving dose 1, the 38 deaths reported in the 6-Month Interim Report (6-Month Interim Report of Adverse Events C4591001) seemed unexpectedly low, particularly in the midst of the COVID-19 pandemic.

To test this, we estimated the number of deaths based on the age-adjusted US rates of death in 2020 (Murphy et al., 2021) as described in the Methods section. Our estimate assumes that age-adjusted mortality is similar to US mortality rates at sites in the other countries participating in clinical trial C4591001.

Of the 153 trial sites, 132 were in the US with about 80% of the trial subjects. With this caveat in mind, we estimated that 222 subjects deaths should have occurred during the trial period from July 27, 2020 to March 13, 2021. The actual number of trial deaths (38) is about 18% of the expected number. With the exception of the smaller sites, every site had fewer deaths than expected.”

Here’s the methodology:

“Expected number of deaths were estimated as follows. Pfizer/BioNTech 6-Month Interim Report (6-Month Interim Report of Adverse Events C4591001, n.d.) and the Randomization scheme (Listing of Randomization Scheme and Actual Vaccine Received, n.d.) were used to determine the number of subjects in each age group enrolled at each of the 153 trial sites: 15-24 years, 25-34 years, 35-44 years, 45-54 years, 55-64 years, 65-74 years, 75-84 years, and 85+ years.

Age-adjusted mortality rates per 100,000 persons for 2020 were obtained from National Center for Health Statistics Data Brief 427 (Murphy et al., 2021). The number of subjects in each category was multiplied by the mortality rate to estimate the number of deaths expected at each trial site within each age-group. These estimates were summed and multiplied by 33/52.2 to adjust for the 33-week trial period.”

“CONCLUSIONS

1. The C4591001 placebo-controlled randomized clinical trial of 22,030 vaccinated and 22,030 placebo subjects was the world’s only opportunity for an unbiased evaluation of the Pfizer/BioNTech BNT162b2 vaccine.

2. Unblinding of placebo subjects starting in Week 20 terminated the placebo-controlled clinical trial, thereby ending all unbiased evaluation of possible adverse event signals.

3. The mRNA-LNP platform is novel, not previously phase 2/3 tested in humans, and the toxicity of PP-Spike protein was unknown. Taken together, a 20-weeks placebo-controlled clinical trial is NOT sufficient to identify any except for the most common safety concerns.

4. The number of all-cause deaths is NOT decreased by BNT162b2 vaccination.

5. Of the 38 deaths reported in the 6-Month Interim Report of Adverse Events, 21 BNT162b2 vaccinated subjects died compared to 17 placebo subjects.

6. Delayed reporting of the subject deaths into the Case Report Form, which was in violation of the trial protocol, allowed the EUA to proceed unchallenged.

7. The number of subject deaths was 17% of the expected number, based on age-adjusted US mortality. One possible explanation could lie in the 395 subjects that were “Lost to Follow[1]up”.

8. There was a 3.7-fold increase in cardiac events in subjects who received the BNT162b2 vaccine versus the placebo.

9. Of the 15 subjects who were Sudden Adult Deaths (SAD) or Found Dead (FD), 12 died of a cardiac event, 9 of whom were vaccinated.

10. The cardiac adverse event signal was obscured by delays in reporting the accurate date of subject death that was known to Pfizer/BioNTech in the subject’s Narrative Report.”

Onwards!

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