A preprint paper published Monday criticized Pfizer’s shady practices and procedures from its COVID-19 jab clinical trials.

The paper, titled “Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial,” is a “forensic analysis of the 38 trial subjects who died between July 27, 2020, the start of Phase 2/3 of the clinical trial, and March 13, 2021, the data end date of their 6-Month Interim Report.”

The researchers stated, “the analysis reported here is unique in that it is the first study of the original data from the Pfizer/BioNTech BNT162b2 mRNA vaccine clinical trial (CA4591001) to be carried out by a group unaffiliated with the trial sponsor.”

Read the preprint’s full abstract:

The analysis reported here is unique in that it is the first study of the original data from the Pfizer/BioNTech BNT162b2 mRNA vaccine clinical trial (CA4591001) to be carried out by a group unaffiliated with the trial sponsor. Our study is a forensic analysis of the 38 trial subjects who died between July 27, 2020, the start of Phase 2/3 of the clinical trial, and March 13, 2021, the data end date of their 6-Month Interim Report. Phase 2/3 of the trial involved 44,060 subjects who were equally distributed into two groups and received Dose 1 of either the BNT162b2 mRNA vaccinated or the Placebo control (0.9% normal saline). At Week 20, when the BNT162b2 mRNA vaccine received Emergency Use Authorization from the U.S. FDA, subjects in the placebo arm were given the option to be BNT162b2 vaccinated. All but a few accepted. Surprisingly, a comparison of the number of subject deaths per week during the 33 Weeks of this study found no significant difference between the number of deaths in the vaccinated versus placebo arms for the first 20 weeks of the trial, the placebo-controlled portion of the trial. After Week 20, as subjects in the Placebo were unblinded and vaccinated, deaths among this still unvaccinated cohort of this group slowed and eventually plateaued. Deaths in the BNT162b2 vaccinated subjects continued at the same rate. Our analysis revealed inconsistencies between the subject data listed in the 6-Month Interim Report and publications authored by Pfizer/BioNTech trial site administrators. Most importantly, we found evidence of an over 3.7-fold increase in number of deaths due to cardiovascular events in BNT162b2 vaccinated subjects compared to Placebo controls. This significant adverse event signal was not reported by Pfizer/BioNTech. Potential sources of these data inconsistencies are identified.

Aussie17 noted an “unvaccinated death” from the trial received a dose of the Moderna mRNA COVID-19 shot.

The researchers provided additional details in the preprint:

Subject # 10841470 is an obese 65-year-old Hispanic male with a medical history including pulmonary fibrosis and hypertension. He was in the Placebo arm of the trial and received Doses 1 and 2 on September 30 and October 21, 2020, respectively. On December 23, 2020, the subject received Dose 1 of the Moderna mRNA vaccine. This Protocol Deviation was reported in his CRF after the subject reported symptoms of COVID-19 on December 28, 2020 and was admitted to the hospital on December 31, 2020. While hospitalized, he became hypoxic and was intubated on January 2, 2021. He received monoclonal antibodies as part of his treatment in the hospital. Despite these efforts, the subject continued to deteriorate, lapsed into multisystem organ failure, and ultimately died on January 11, 2021. Subject #10841470 was in the List of Discontinued Subjects [10] as a “Death” and in the 6-Month Interim Report [8] as a Placebo death with COVID-19 as the secondary cause of death. This is a misrepresentation of the subject’s clinical information. The subject should have been discontinued from the Pfizer/BioNTech clinical trial because the “subject received non-study COVID19 vaccine”.

Cont. from the preprint:

Summary of subject deaths. The last section of Table 2 provides a full accounting of the deaths that occurred over the first 33 weeks of the Pfizer/BioNTech CA4591001 clinical trial. Pfizer/BioNTech account for a total of 34 subjects who died during the 6-month follow-up period, 20 subjects who received BNT162b2 vaccine and 14 who were in the placebo control group. As discussed above, four of the 38 deaths listed in the 6-Month Interim Report are not included in their calculations: possibly the 2 HIV positive subjects, #12291083 and 11561160, and 2 Placebo subjects who died after January 24, 2021. Our results account for all 38 subject deaths: 21 deaths in the BNT162b2 vaccinated subjects and 17 in the Placebo. Three of the 38 should not have been listed in the 6-Month Interim Report, which would have brought that number to 35 subject deaths. Subjects #12291083 (Placebo) and #10971023 (BNT162b2) did not meet eligibility requirements and should have been excluded before randomization. Subject #10841470 (Placebo) received a received non-study COVID-19 vaccine. Interestingly, COVID-19 is given as the cause of death of both of these Placebo subjects. Of the 38 deaths reported in the 6-Month Interim Report [8], the foundational document of our forensic analysis, we revealed that 14 subjects died from a cardiovascular event, over one-third of all deaths (36.8%). Of these 14, 11 were from the BNT162b2 vaccinated trial arm and 3 from the Placebo only trial arm. This represents a 3.7-fold increase in cardiovascular events in subjects who received the BNT162b2 vaccine. Thomas et al. [7] and Pfizer/BioNTech’s Summary Clinical Safety [11] do not identify or remark on this clear serious adverse event signal.

 

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