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Peer reviewed "SCIENCE", my gullible friends... It's all SCIENCEY! lol... I mentioned this back when it happened, but Pfizer vaxxed it's control group to utterly destroy the "SCIENCE" because they knew what was going to happen. Here is the abstract that indicates they hid vaxxed deaths in order to gain the EUA.
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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.
The very first study indicated cardiovascular issues... and Pfizer lied about it.
According to an analysis, published this month in the International Journal of Vaccine Theory, Practice, and Research, of Pfizer-BioNTech COVID-19 vaccine clinical trial data, the vaccine makers hid fatality data from regulators in order to qualify for Emergency Use Authorization
Pfizer-BioNTech delayed reporting vaccine-associated deaths among BNT162b2 clinical trial participants until after the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the product.
The vaccine makers also failed to account for a large number of subjects who dropped out of the trial.
Together, these strategies kept regulators and the public ignorant of a 3.7-fold increase in cardiac deaths among subjects who received the vaccine, according to analysis in the International Journal of Vaccine Theory, Practice, and Research.
The authors of the paper described it as a “forensic analysis,” defined by the U.S. National Institute for Standards and Technology as “the use of scientific methods or expertise to investigate crimes or examine evidence that might be presented in a court of law.”
What the analysis shows
Corinne Michels, Ph.D., retired distinguished professor of biology at Queens College, New York, led the DailyClout Pfizer/BioNTech Documents Investigations Team on what the authors claim was the first independent examination of original data from the Pfizer-BioNTech COVID-19 mRNA vaccine (BNT162b2) clinical trial.
Investigators looked at each of the 38 deaths occurring between July 27, 2020, the start of phase 2/3 of the Pfizer-BioNTech vaccine trial, and March 13, 2020, the end date culminating in Pfizer-BioNTech’s 6-month interim report.
This trial phase involved 44,060 subjects. Half received a dose of BNT162b2, half got a placebo consisting of an inactive sterile salt solution.
The trial was unusual because at week 20 after the FDA issued the EUA for the vaccine, trial subjects in the placebo group were allowed to switch to the vaccinated group and receive their first BNT162b2 shot.
Switching from the placebo to the vaccinated group — or “unblinding” — normally occurs when the benefit of the drug is so great that not treating subjects becomes unethical. For example, investigators might consider unblinding a cancer trial if at some point all untreated patients deteriorated or died but all treated patients improved.
Unblinding conditions may be specified in the study design, but they usually involve input or review from medical ethicists.
Of 20,794 unblinded placebo subjects in the Pfizer trial, 19,685 received at least one dose of BNT162b2.
Normally the decision to unblind a vaccine trial would be based on the product’s safety and effectiveness in reaching certain endpoints or objectives. Endpoints for a drug to prevent viral infections might be a positive test or self-reported COVID-19 illness (the “case” numbers that drove much of COVID-19 policy), illness requiring hospitalization or death.
But, perhaps unexpectedly, after 33 weeks the data revealed no significant difference between deaths in the vaccinated and placebo groups for the initial 20-week placebo-controlled portion of the trial.
After week 20, after most former placebo subjects had received the vaccine, deaths among those in the vaccine group continued unabated.
The authors revealed “inconsistencies” between data presented in Pfizer-BioNTech’s 6-month interim report and subsequent publications by Pfizer-BioNTech trial site administrators:
“Most importantly, we found evidence of an over 3.7-fold increase in the number of deaths due to cardiac events in the BNT162b2 vaccinated individuals compared to those who received only the placebo.”
This means that 79% of relevant deaths were not recorded in time to be included in Pfizer’s regulatory paperwork.
By not including relevant subject deaths in the case report, Pfizer obscured cardiac adverse event signals, allowing the EUA to proceed unchallenged.
How did Pfizer get around legal, ethical obligations?
The Pfizer-BioNTech data, obtained through a Freedom of Information Act lawsuit, uncovered four additional deaths in the vaccine group and one more in the placebo group — but Pfizer failed to include these data in their FDA submission despite an explicit study design requirement to do so.
These data, and how they differ from what Pfizer-BioNTech reported in their applications, are summarized in Table 3 of Michels’ study.
One case involved a 63-year-old woman who died 41 days after receiving the shot, but whose death only entered the data pool 37 days later. Another was a 58-year-old woman whose death 72 days after vaccination went unreported for 26 days.
Had Pfizer-BioNTech met their legal and ethical obligation to report all serious adverse events their data would have shown equal deaths in placebo and vaccine groups — which would have shown no clear benefit for the vaccine.
How were they able to skirt those obligations?
For one, they were able to hide behind the the 2005 Public Readiness and Emergency Preparedness (PREP) Act, which provided an almost impenetrable liability shield for vaccine manufacturers for “medical countermeasures” in response to any “public health emergency.”
Second, because COVID-19 was viewed as a national health emergency, regulators abandoned the established, patient-centered, safety-based approval process requiring years of preclinical animal testing — and Pfizer-BioNTech unsurprisingly went along.
Timing of death reports raises questions
Michels also raised issues regarding total death reports and their timing.
Since the death total from both study groups, 38, appeared “surprisingly low” to study authors — particularly during a pandemic — they undertook their own analysis based on population mortality expectations at the time.
Assuming that age-adjusted death rates for the study subjects were similar to those of the general population, they estimated that 222 subjects should have died from July 27, 2020, to March 13, 2021. The reported number, 38, is just 18% of the expected number.
Michels explained this by the large number, 4.2% of “discontinued subjects.” The most concerning of these were subjects “lost to follow-up,” which means missing scheduled visits or other required activities.
Pfizer-BioNTech tried to reach these subjects via phone, certified mail or through their emergency contact but despite their efforts could not account for 395 subjects who had dropped out.
The authors wrote:
“These are not insignificant numbers and could easily account for the low number of deaths reported in this safety period of the trial. Given the importance of knowing the status of each trial subject, there should have been greater effort to locate these individuals.
“Additionally, Pfizer/BioNTech was responsible for oversight of the trial sites. Sites with excessive numbers of lost to follow-up should have been evaluated for performance.”
Michels was also concerned over how certain trial centers had many dropped-out subjects while others had none or just a few.
Ninety-six of 153 trial sites (63%) reported 0 or 1 subjects lost to follow-up and 34 (22%) reported 2-5 dropouts. But four sites reported more than 20 subjects lost to follow-up, amounting to about 5% of all trial subjects.
Since the vaccine makers were responsible for trial site oversight, the authors wrote, “Sites with excessive numbers of lost to follow-up should have been evaluated for performance.”
Finally, based on the data, it appears Pfizer-BioNTech was in no hurry to enter death reports before the EUA submission deadline, particularly for the BNT162b2 group.
Of the 38 reported deaths only one case was added on the day the subject died. Delays of 20+ and 30+ days were common.
One death took 72 days to find its way into the database, and all were entered as occurring on the reporting day, not on the actual date of death.
Of the eight subjects in the vaccine group that should have been reported by Dec. 10, 2020, the EUA application cutoff, the average reporting delay was 17.5 days for subjects in the vaccine group, but just 5.9 days for deaths among subjects in the placebo group.
I was part of the Pfizer study group and received the placebo. I believe that this was around August 2020. Due to the increasing death rates from Covid for people in my age group, Pfizer gave me the option of becoming "unblinded" and I took that opportunity. When I was told I received the placebo, I was given the option of getting the real Pfizer Covid vaccine, which I immediately took.
People are going to believe what they want to believe. I can find nothing to either support nor discredit the statements made in the reports you cited. What I do know is that the various Covid vaccines work and ended the Covid pandemic. The vaccines are safe and there have been no long-term negative problems with the vaccines to date.
The pandemic was declared over four years ago. I am still not convinced that we were told where it originated, or how bad it was. Many people died to be sure, but how many were sick and recovered, or how many were infected but asymptomatic. . . .what was the real death rate. I am thinking it was less than 1%. For a sense of scale in this, the historic death rate for the plague was around 30%
Issues of natural immunity, heard immunity and the efficacy of the so-called "vaccines" in the context of the pandemic are also open and unanswered questions for me.
Most troubling for me are the enduring societal dislocations stemming from lock-downs, forced business and school closures, and mandatory shots. While somehow legalized by various courts, I believe that most clauses of the First Amendment were egregiously violated. The refusal of the health care authorities to formally explore existing theraptic drugs and treatment modalities while focusing exclusively on the big pharma vaccines is staggering.
What is telling was the way "they" tried to make a big deal out of Monkey Pox and the current attempts to resurrect some varient of Covid as another public menace.
The pandemic was declared over four years ago. I am still not convinced that we were told where it originated, or how bad it was. Many people died to be sure, but how many were sick and recovered, or how many were infected but asymptomatic. . . .what was the real death rate. I am thinking it was less than 1%. For a sense of scale in this, the historic death rate for the plague was around 30%
Issues of natural immunity, heard immunity and the efficacy of the so-called "vaccines" in the context of the pandemic are also open and unanswered questions for me.
Most troubling for me are the enduring societal dislocations stemming from lock-downs, forced business and school closures, and mandatory shots. While somehow legalized by various courts, I believe that most clauses of the First Amendment were egregiously violated. The refusal of the health care authorities to formally explore existing theraptic drugs and treatment modalities while focusing exclusively on the big pharma vaccines is staggering.
What is telling was the way "they" tried to make a big deal out of Monkey Pox and the current attempts to resurrect some varient of Covid as another public menace.
The pandemic had not started 4 years ago. Most would say it started in March 2020. Yes, the lock-downs definitely had negative repercussions, especially on school children, but it is debatable whether or not they were in the best interests of all.
What "existing therapeutic drugs and treatment modalities" do you believe should have been looked at as alternatives to the vaccines?
The pandemic had not started 4 years ago. Most would say it started in March 2020. Yes, the lock-downs definitely had negative repercussions, especially on school children, but it is debatable whether or not they were in the best interests of all.
No, there is no debate. the lockdowns were a mistake, as I said at the time. They neither slowed the spread of COVID or kept anyone alive that wasn't already going to die from COVID since we know that the vaxx jabs didn't stop or prevent death either.
The detrimental effects of the lockdowns was entirely preventable and it didn't save anyone life.
It did make a lot of democratic donors wealthy so there is that....
No, there is no debate. the lockdowns were a mistake, as I said at the time. They neither slowed the spread of COVID or kept anyone alive that wasn't already going to die from COVID since we know that the vaxx jabs didn't stop or prevent death either.
The detrimental effects of the lockdowns was entirely preventable and it didn't save anyone life.
It did make a lot of democratic donors wealthy so there is that....
Oh I gotcha. So essentially the vax that Trump fast tracked via warp speed, is a bogus sham, and he should be held totally and completely accountable for its implementation and the lockdowns during the pandemic?
What would you recommend we do to Donald Trump since he was the one who encouraged people to stay home and take students out of schools, while operation Warp speed developed a poison for people - all the time it was built to line the pockets of politicians but only politicians that were Democrats?
Hopefully I got your facts you stated 100% correct.
Or are you complaining only about the lockdowns that happened under a Democrat leader?
Just want to make sure I understand the hypocrisy of your statement.
Oh I gotcha. So essentially the vax that Trump fast tracked via warp speed, is a bogus sham, and he should be held totally and completely accountable for its implementation and the lockdowns during the pandemic?
Did he develop teh vaccine personally or was it contracted at the behest of Fauci? you know the guy that funded the development of COVID gain of function in bats?
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Originally Posted by eyecu2
What would you recommend we do to Donald Trump since he was the one who encouraged people to stay home and take students out of schools, while operation Warp speed developed a poison for people - all the time it was built to line the pockets of politicians but only politicians that were Democrats?
LOL... I don't blame Biden for the vax jabs either... just for attempting to MANDATE the shot to all Federal employees and contractors which put the bullseye on me as well. I was about 2 weeks away from losing my job when SCOTUS shot his stupid plan down.
Quote:
Originally Posted by eyecu2
Just want to make sure I understand the hypocrisy of your statement.
I just want to make sure you know that Pfizer, the CDC, the FDA, and the WHO lied to you. lol... I never took the experimental drugs because well I'm not stupid.
Peer reviewed "SCIENCE", my gullible friends... It's all SCIENCEY! lol... I mentioned this back when it happened, but Pfizer vaxxed it's control group to utterly destroy the "SCIENCE" because they knew what was going to happen. Here is the abstract that indicates they hid vaxxed deaths in order to gain the EUA.
The very first study indicated cardiovascular issues... and Pfizer lied about it.
I'm not sure this is as inciteful as the authors believe. Forty four thousand people were divided equally into vaccinated and placebo groups. The duration of the study was 33 weeks. Twenty weeks into the study, the placebo group was allowed to get vaccinated, and almost all of them did.
Kicking out two accidents, one suicide and one overdose, eighteen people in the vaccinated group died and sixteen in the placebo group died. That's not much of a difference.
Several of the deaths appeared to be due to combined pulmonary and cardiac failure, so I'm not sure whether to count those as cardiovascular events. If you do, 11 people died of cardiovascular events in the vaccinated group and 5 people died in the control group. If not, the number of cardiac related deaths is 9 and 4 respectively. In the vaccinated group, only one of the deaths was attributable to myocarditis/pericarditis, which is supposed to be the main heart-related risk factor associated with the COVID vaccine. Two in the placebo group died from myocardial infarction, before they were able to receive the vaccine. Was the myocarditis associated with COVID the disease? If so is this evidence myocarditis associated with the disease was a bigger risk than myocarditis associated with the vaccine?
The vaccine did appear to work, based on cause of death. One person died of "COVID pneumonia" in the vaccinated group, and four died of COVID related diseases in the placebo group.
Interestingly, the average age at death of the vaccinated group was 68 years old, and the average of the placebo group was 60 years. You would expect more cardiac related deaths in an older group of people, vaccinated or not vaccinated. But you'd expect fewer COVID deaths in a younger group of people. More evidence perhaps that the vaccine worked.
Given there were only 34 total deaths (not counting suicide, traffic accidents and an overdose) and only 13 to 16 total cardiac related deaths, I don't think this study was large enough or long enough for the results to be considered earth shattering.
Given there were only 34 total deaths (not counting suicide, traffic accidents and an overdose) and only 13 to 16 total cardiac related deaths, I don't think this study was large enough or long enough for the results to be considered earth shattering.
The math says you're wrong... but that's not the part that should bother you. It's the hiding of the deaths. Where I come from that's called fraud because altering the data was used to call the experimental drugs "Safe".
But you know, Science, it's what YOU THINK... not what the math says.
The math says you're wrong... but that's not the part that should bother you. It's the hiding of the deaths. Where I come from that's called fraud because altering the data was used to call the experimental drugs "Safe".
But you know, Science, it's what YOU THINK... not what the math says.
Not counting two traffic accidents, a suicide and an overdose, there were 18 deaths in the vaccinated group and 16 in the placebo group. Out of 44,000 people. It doesn’t appear that the vaccinated were keeling over dead from the vaccine.
Not counting two traffic accidents, a suicide and an overdose, there were 18 deaths in the vaccinated group and 16 in the placebo group. Out of 44,000 people. It doesn’t appear that the vaccinated were keeling over dead from the vaccine.
LOL.. then why were Pfizer obscuring the deaths in the vaccinated group?
And since you pointed it out... what does the fact there were 18 deaths in the jabbed group and 16 in the placebo group indicate?
C'on, you're not stupid... what does it tell you about the efficacy of the jab?
And since you pointed it out... what does the fact there were 18 deaths in the jabbed group and 16 in the placebo group indicate?
C'on, you're not stupid... what does it tell you about the efficacy of the jab?
That doesn't mean much. COVID deaths during the period in question accounted for about 12% of total deaths from natural causes. If the "jab" were 100% effective at preventing death from COVID, and if the placebo group hadn't gotten vaccinated (most did after 20 months), you might expect to see about two less deaths from natural causes in the vaccinated group -- 18 x 0.12 = 2. The theoretical difference would actually be less since most of the placebo group ended up getting vaccinated during the study period. Instead you saw two more deaths in the vaccinated group. Out of 44,000 subjects. I've limped through life without a good background in statistics, but even I know that's not very significant.
The question you should be asking is why are the cardiac related deaths in the vaccinated group over twice the number of deaths in the placebo group. Well, the difference is only 5 or 6 deaths for the control vs. vaccinated groups, out of 44,000 subjects. That may provide a LITTLE evidence in favor of what you believe, but again it's not earth shattering.
About 20% of deaths in 2020 were related to heart disease, so you might expect about 4 cardiac related deaths in either the placebo or vaccinated group. And that's what you actually see in the control group. In the vaccinated group, the deaths are a bit over double that. I don't believe that's extremely significant, again, given there were 44,000 subjects.
The strongest evidence of what we're discussing is that the vaccine provided good protection from Death by COVID. One person died of COVID in the vaccinated group, and four died in the control group. And that's even though most of the control group got vaccinated after week 20 of the 33 week study.
pfizer lied, but so did the govt. lol
