ANÁLISIS DE LOS 38 FALLECIMIENTOS ACAECIDOS EN EL ENSAYO CLINICO DE LA VACUNA DE PFIZER/BIONTECH

ANÁLISIS DE LOS 38 FALLECIMIENTOS ACAECIDOS EN EL INFORME INTERINO SEMESTRAL DEL ENSAYO CLINICO  DE LA VACUNA mRNA DE PFIZER/BIONTECH

 

 International Journal of Vaccine Theory, Practice, and Research 

 

 Abstract 

The analysis reported here is unique: it is the first study of the original data from the Pfizer/BioNTech BNT162b2 mRNA vaccine clinical trial (C4591001) 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 end date of theofficial6-Month Interim Report. Phase 2/3 of the trial involved 44,060subjects who were equally distributed into two groups and received dose1 of either the BNT162b2 mRNA vaccine or a placebo consisting of a 0.9% normal salinesolution. At week 20, when the BNT162b2 mRNA vaccine received Emergency Use Authorization from the US FDA, subjects in the placebo arm were given the option to receive the BNT162b2 vaccine and switch to the vaccinatedgroup. Of the reported 20,794 unblinded placebo subjects, 19,685 received at least one dose of BNT162b2 vaccine. 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 placebogroupwere unblinded,and after the majority of them received a BNT162b2 injection, deaths among those sticking with the placebo slowed and eventually plateaued. Deaths in the BNT162b2 vaccinated subjects continued at the same rate. Our analysis revealsinconsistencies between the subject data listed in the 6-Month Interim Report and in 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 cardiacevents in the BNT162b2 vaccinated individualscompared to those who received only the placebo.Delayed reporting of the subject deaths into the Case Report Formobscured the cardiac adverse event signaland allowed the Pfizer/BioNTech Emergency Use Authorizationto proceed unchallenged.

 International Journal of Vaccine Theory, Practice, and Research3(1) Page 973https://doi.org/10.56098/ijvtpr.v3i1.85Received 5 Sep 2023published 17 Oct 2023

 Keywords:BNT162b2 vaccine, cardiacevents, placebo-controlled clinical trial, COVID-19, Pfizer/BioNTech

 

 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 20terminatedthe 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, andthe toxicity of PP-Spike proteinwas unknown. Taken together,a 20-weeks placebo-controlled clinical trial is NOT sufficient to identify any exceptfor 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, 21BNT162b2 vaccinated subjects died compared to 17 placebo subjects.  

6.Delayed reporting of the subject deathsinto the Case Report Form, whichwasin 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 liein the 395 subjects that were“Lost to Follow-up”. 

8.There was a 3.7-fold increase in cardiac events in subjects who received the BNT162b2 vaccine versusthe 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.Thecardiac adverse event signal was obscured by delays in reporting the accurate date of subject deaththat was known to Pfizer/BioNTech in the subject’s Narrative Report.