Report 89: BOMBSHELL – War Room/DailyClout Researchers Find Pfizer Delayed Recording Vaccinated Deaths at Critical Juncture of EUA Process. Improper Delays in Reporting Deaths in the Vaccinated Led FDA to Misstate Vaccine’s Effectiveness, Influenced EUA Grant Decision.
On September 5, 2023, DailyClout reported that a War Room/DailyClout Research Team – Corinne Michels, PhD; Daniel Perrier; Jeyanthi Kunadhasan, MD; Ed Clark, MSE; Joseph Gehrett, MD; Barbara Gehrett, MD; Kim Kwiatek, MD; Sarah Adams; Robert Chandler, MD; Leah Stagno; Tony Damian; Erika Delph; and Chris Flowers, MD – broke a huge story about there being more cardiovascular deaths in the vaccinated than in the unvaccinated in Pfizer’s clinical trial, as well as that Pfizer did not report the 3.7-fold cardiovascular adverse events signal and also delayed reporting deaths so that it favored the vaccinated arm of the trial. (https://dailyclout.io/report-84-warroom-dailyclout-research-team-breaks-huge-story/)
Now, as a follow up to that report, DailyClout reveals that Jeyanthi Kunadhasan, MD, part of that same Research Team, found even more damning evidence showing that Pfizer delayed recording deaths in Case Report Forms (CRFs), which allowed the company to not report those deaths as part of its emergency use authorization (EUA) data filing with the Food and Drug Administration (FDA). Daniel Perrier from the Research Team and Dr. Kunadhasan found, analyzed, and verified the data supporting this discovery. It is very likely that had the deaths been recorded when Pfizer became aware of them and then accurately filed as part of the EUA dataset, the public would not have accepted the FDA granting an EUA for Pfizer’s mRNA COVID-19 product.
On December 10, 2020, one day before the FDA granted Pfizer’s EUA, Susan Wollersheim, M.D. of the FDA/Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review, Division of Vaccines and Related Products Applications, presented, “FDA Review of Efficacy and Safety of Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Request” at the CBER Vaccines and Related Biological Products Advisory Committee 162nd Meeting. On page 42 of the slide deck, Dr. Wollersheim presented:
The data showing two vaccine deaths and four placebo deaths as of December 10, 2020, was incorrect at the time of the EUA request presentation, and the correct data was available in Pfizer’s own documentation and, thus, also available to the FDA.
As of November 14, 2020, the data cutoff for the EUA dataset, Pfizer possessed data showing that the vaccine arm of the COVID-19 mRNA vaccine clinical trial had the same number of deaths as the placebo arm. In other words, there was no evidence of Pfizer’s COVID vaccine having a positive impact on death outcomes.
The Pfizer narrative descriptions of the deaths show that, though that the clinical trial sites had been informed by the deceased patients’ loved ones on the days of their deaths [October 19, 2020, and November 7, 2020 (pp. 71 and 75), well before the EUA data cutoff date in both cases], those two deaths from the vaccinated arm that were not included in the FDA presentation are listed below:
Case Report Forms (CRFs) capture patient data during a clinical trial. The CRFs for these two patients, Subjects 11141050 and 11201050, do not mention that Pfizer knew of their deaths on their dates of death. Rather, Subject 1141050’s death was first entered into the CRF on November 25, 2020, at 18:51:46 Central Time, 37 days after the patient’s death.
And, Subject 11201050’s death was first entered into the CRF on December 3, 2020, at 12:48:29 Eastern Time, 26 days after the patient died:
It appears that Pfizer not entering the death dates of the above two Subjects into their CRFs when Pfizer first learned of them – i.e., on the dates of death – allowed the company to hide the deaths until the EUA data cutoff date had passed. To summarize what was known and important dates:
According to Pfizer’s own protocol, reporting of deaths should have occurred within 24 hours:
- Section 8.3.1.1. “Reporting SAEs to Pfizer Safety” states, “All SAEs occurring in a participant during the active collection period as described in Section 8.3.1 are reported to Pfizer Safety on the Vaccine SAE Report Form immediately upon awareness and under no circumstance should this exceed 24 hours, as indicated in Appendix 3 [pp. 1271-1277]. The investigator will submit any updated SAE data to the sponsor within 24 hours of it being available.” [Emphasis added.] [p. 74]
- Additionally, Section 8.3.1.2. “All nonserious AEs and SAEs occurring in a participant during the active collection period, which begins after obtaining informed consent as described in Section 8.3.1, will be recorded on the AE section of the CRF. The investigator is to record on the CRF all directly observed and all spontaneously reported AEs and SAEs reported by the participant.” [Emphasis added.] [p. 74]
This graphic below shows the accurate and available serious adverse events data which should have been presented at the December 10, 2020, EUA Authorization Request meeting:
It shows an equal chance of death in vaccine and placebo arms of the trial and, thus, no benefit from Pfizer’s mRNA COVID vaccine. Moreover, it also clearly shows Pfizer knew and, therefore, the FDA should have known that there were twice as many cardiovascular adverse events in the vaccinated arm of the clinical trial versus the placebo arm.
The charts below show the delays in recording deaths in the vaccinated (“BNT”) arm trial subjects. The chart on the left is based on CRF data, which is the data that was used to request EUA approval. The chart on the right shows marked improvement in the speed of reporting deaths when the newly discovered date in the report narrative, outlined above, is included.
The NEJM article mentioned in the chart is available at https://www.nejm.org/doi/10.1056/NEJMc2036242.
Had the death data that was available to Pfizer before November 14, 2020, and which showed no positive impact on death outcomes, been presented at the December 10, 2020, Vaccines and Related Biologics Products Advisory Committee (VRBPAC) Meeting for Pfizer’s COVID vaccine emergency use authorization request, it would have been very difficult, if not impossible, for the VRBPAC members to vote to authorize Pfizer’s EUA. Instead, Pfizer seemingly buried two “inconvenient” deaths from the vaccinated arm until after the data cutoff date, thus inaccurately showing twice as many deaths in the placebo arm of its trial on December 10, 2020. On December 11, 2020, the FDA granted the EUA for Pfizer’s vaccine based on inaccurate data, and that data-related negligence has negatively impacted the health of countless people worldwide.
###
Dr. Kunadhasan will be presenting about this finding, as well as on the Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial preprint, both in the Australian Parliament in Canberra, Australia, and at the Australian Medical Professionals’ Society’s “Inquiry into Australia’s Excess Mortality” in Kambah, Australia, on October 18, 2023. Please read more about the inquiry here. Tickets are available for the public event here. Additionally, the results of the inquiry will be published as a book, and book-related information is available here.
Subscribe to DailyClout so you never miss an update!
Every action during this false Scamdemic was meticulously planned. including, the modification of a virus, and the useless and incredibly speedy invention of a ‘pretend ‘vaccine’ that just increases your susceptibility to illnesses or can kill recipients! Pfizer were in cahoots with their ‘friends’ at FDA – so every part of this scam was rehearsed, coordinated and pre-determined by all concerned.
The UN joins WHO and many other international agencies have become illegitimate, CORRUPT and are now obsolete!
As far as I’m concerned the British nation is now out of the United Nations and the World Health Organisation. These agencies now cease to exist!
Being the biggest contributor (INFLUENCER) Bill Gates now pulls the strings of the WHO for his own financial gain! Gates publicly stated, “The most profitable investment I ever made was VACCINES”. Join the dots!
Have you heard? Pfizer is now pretending to have ‘financial difficulties’. Are you kidding me?
I then suddenly realised the reason Pfizer is suggesting (or pretending) that they’re having ‘financial difficulties’. It’s all about ‘LIABILITY’ which they’ve dodged throughout this bonanza ‘Vax’ gold rush they’re enjoying.
It suddenly came to me (I must be getting a bit slower in my old age?) – Pfizer needs to go BANKRUPT, thereby disappearing and avoiding genuine imminent litigation that will contest their ‘ridiculous ZERO LIABILITY’ from responsibility of Pfizer’s VAX INDUCED INJURIES AND Pfizer’s VAX RELATED DEATHS, caused by their useless and dangerous products.
It can’t be anything to do with PROFITS, because they’ve been loading their vials with any crap they like. After all, there’s ‘NO LIABILITY’, so = No CONSEQUENCES, particularly when their business mysteriously collapses. Clever criminals!
Bankruptcy might enable Pfizer Directors to hide behind this loophole, to avoid Claims against them for Mass and Premeditated Murder.
Was this planned ‘BANKRUPTCY’ a pre-planned Business Strategy?
Mick from Hooe (UK) Unjabbed to live longer.
Everything ‘VAX’ is manipulated, modified, altered, delayed (etc) in order to pump as much of their sh*t into the population, thereby maximising the CULL with its Covid mRNA ‘Vax’. No Safety, No Efficacy, NO LIABILITY, No responsibility, no guilt – just pure PROFIT and DEPOPULATION.
mRNA is Genetic Modification – so it;’s too late to turn back the clock!” Those who dodged the ‘Vax bullet’ are all Genetically Modified!
Let’s tell them we know their dirty little secrets and we’re not playing ball from now on!
Also, from today, the WHO and UN cease to exist so stick your scam TREATY where it hurts!
It’s widely accepted that the US (and many other countries) experimented with diseases as possible weapons of WAR. The US conducted these experiments as part of their military options.
After it became known to US citizens that this dangerous technology was taking place in US Universities and other specific locations, it was determined the projects must cease on US soil! Hence Wuhan was one of the centres the US government sponsored with Fauci heading the project. Fauci called the maximising the impact of diseases on humans – ‘Gain of Function’.
It matters not as to whether Covid was leaked or deliberately released – it was predetermined by Fauci & friends, to occur in order to create a need for an incredibly ‘PROFITABLE CURE’, which they could enjoy ongoing wealth sharing from enormous profits, while injection recipients were treated as guinea pigs – many dying or suffering lifelong injuries.
All the while, Big Pharma enjoy ZERO LIABILITY for this ongoing DEPOPULATION project! ‘ZERO LIABILITY’ (culpability) for the increasing number of injuries and DEATHS by injection – enjoyed by all those profiting from the Depopulating Cull of humanity.
Now Pfizer is now pretending to be having financial difficulties so they can declare bankruptcy, thereby avoiding legal action for Pre-meditated MASS-MURDER.
Mick from Hooe (UK) Unjabbed and ready to fight for FREEDOM!
Thanks for your hard work, this is very interesting. But I’m puzzled: according to you, “November 14, 2020,” was “the data cutoff for the EUA dataset”.
They do mention that “Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened”.
But in their paper they talk of “2 months of follow-up as of October 9, 2020” and they say that “At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. ” Are you sure that the data cut-off date was November 14?
To make matters even more confusing, the deaths that they included occurred after October 9 so that the casually mentioned November 14 may well be correct. However, it would be great if the correct data cut-off date can be found in a protocol that they had to follow.
Harry,
This October 9 statement is an example of how the Pfizer authors insert total confusion into their documents. You picked up on a very important point. November 14 was the data cutoff for the EUA application. This is clearly stated in the EUA application and probably elsewhere as well.
The FDA had told Pfizer that the “safety” determination had to be based on data on subjects that were at least 2-months post-dose 2. Subjects STARTED to enter the trial on July 27 but some didn’t get Dose 1 until October, and a few even later. As a result, not that many subjects met the 2-month post-dose 2 requirement. Pfizer was receiving reports on AE/SAEs on at least a weekly basis, possibly twice per week. One of these “data cut-off dates” must have been October 9. The quoted statement is reporting that, “At the data cut-off date of October 9, a total of 37,706 participants had a MEDIAN of at least 2 months of safety data available after the second dose and contributed to the main safety data set.” The use of the word MEDIAN introduces confusion. It means that as of October 9 only HALF of the 37,706 subjects (ie. 18,853 subjects) had met the FDA’s requirement of 2-months post dose 2 safety data. They want you to assume its all of the subjects, all 44,060, but clearly it is not on October 9 and not at November 14th either.
Thanks cmichels24. So then, if I understand correctly, according to the 24hour protocol not 4 but 6 vaccine group deaths should have been included with the approval papers, and certainly in the publication.
But the confusing matters don’t stop there. For it looks as if an earlier data release shows that according to Pfizer itself, subject C4591001 1152 11521497 fell within the data cut-off.
See https://infocheckers.org/wiki/Blog:Pfizer_omitted_at_least_one_vaccine_trial_death
His hospitalization had been wrongly recorded as “subject withdrawal” before the data cut-off and so he was kind of dumped preemptively. In that same report appear also the 4 placebo group deaths and no more (with some reason for doubt about one of those 4 placebo deaths).
So, if I’m not mistaken then depending on one’s interpretation, we should probably count – based on the Pfizer data – with not 2 but 4 or even 5 vaccine group deaths (of which at least 4 were of cardiovascular nature), vs. 4 placebo deaths before the true data cut-off. Arguably even 6 vaccine groups deaths, but then the true number of placebo group deaths needs checking as well. And of course, that’s without accounting for the possibility that one vaccine death may have been relabeled as placebo death.