Here is why Pfizer asked for 50+ years to release vaccine study data...

yerrag

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Actually, it turns out the number of vaccinated globally by end of February 2021 was not that big. As of February 16, 2021 there were 172mil vaccinated globally, with roughly 2/3 of the vaccinations going to the Pfizer camp. So, by Febuary 28, 2021 it is reasonable to estimate 200mil total vaccinated worldwide, which means about 120mil Pfizer shots. A total of ~150K serious adverse events out of 120mil, would produce 0.1% rate of serious adverse events, which is pretty high compared to natural COVID-19 mortality rate for unvaxxed of about 0.02%-0.04%. However, the fact that Pfizer censored/redacted the number of distributed vaccines (and does not publish anywhere number of vaccinated with its product), makes me think that the denominator is much smaller, and thus the percentage or deaths and other SAE becoming much higher. Now, if the Pfizer report on death and SAE is only from fully vaccinated (i.e. 2+ doses) then the denominator drops even more, probably by as much as half, which doubles the deaths/SAE. Somebody should sue the FDA/Pfizer to disclose only the number of officially reported fully vaxxed with Pfizer globally by end of February 2021. That would quickly reveal the actual picture, and Pfizer/FDA have no reasonable claim to secrecy on this number as it is required to ascertain true vaccine safety and does not reveal any trade secrets or proprietary info that may harm Pfizer. Of course, Pfizer would argue otherwise in court if it knows revealing such numbers would expose its concoction as poison, and would probably ask that it must not be compelled to release it unless every other vaccine vendor is also compelled so that Pfizer is not the only one that gets burned.
"...Just over 172 million people have received their first dose of Covid-19 vaccine as of February 16, 2021 - 2.2 for every 100 people. Eight vaccines are currently in use around the world, all of which require two shots. That is expected to change over the coming weeks when Johnson & Johnson's one shot vaccine gets approval for use within the United States. As it stands, the first vaccine authorized for use in the U.S. is also the most widely used shot worldwide according to information from website Our World in Data which was reported by The New York Times. The Pfizer/BioNTech jab is one of two mRNA vaccines along with Moderna's and it was found to be 95 percent effective in Phase III trials. Israel's real world experience with the shot has closely replicated those results after the government obtained large quantities of the vaccine in exchange for sharing information on its effectiveness. Clalit Health Services, the country's largest healthcare provider, has released the results of a study of more than half a million fully vaccinated Israelis which indicates the Pfizer/BioNTech shot provides 94 percent protection. Israel and the United States are among 61 countries using the Pfizer/BioNTech vaccine with the list also including the EU and Saudi Arabia. The other mRNA vaccine produced by Moderna was found to be 94 percent effective in Stage III trials and it is being used in 27 countries. High hopes have been pinned on the Oxford/AstraZeneca shot due to its low cost and ease of storage, though it has proven controversial in some countries with Germany and Poland among those limiting its use to under-65s, citing a lack of data on its effectiveness in seniors. Currently, that jab is being distributed in 41 countries.
Thanks.

The level of malice and mendacity by Pfizer and by the FDA and their ability to control collection of data and to modify it with the collusion of many parties in a worldwide institutional scale is just unbelievable. They have been getting away with hoaxes as the system protects them each and every they do it.

They did the same kind of hoaxing with HIV and AIDS and got away with it. And they aren't still done on that hoax. Now, here come mRNA vaccine for HIV:


mRNA technology may be uniquely positioned to tackle a major hurdle for HIV vaccines: the elicitation of broadly cross-reactive neutralizing antibodies. A preclinical study takes the first step toward this goal.

The medical hoaxing business can just make the world go round by feeding on itself.
 

Rafe

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Worldwide hoaxing: I’m thinking it works by very few people & very little discussion at the top of the public health & epidemiological modeling centers worldwide really knowing how manipulated this is.

Then the narrative writes itself on the existing one-symptom-one-medication model. The narrative doesn’t have to make any sense. It just has to have experts saying it.

Bureaucratically all the way down in public health & laterally in the propaganda media is petit-authorities just being convinced that the experts are right & carrying out their directives. Once there is buy-in, then there is a tsunami of personal & institutional ridicule in store if they question.

I don’t think any state or local public health people, docs, scientists think they are perpetrating this. If they did they are either deeply authoritarian & sadistic, or they come to a crisis in participating against their conscience (we aren’t seeing much of that so it must be the former).

They aren’t blameless.

It goes to show how authoritarian our systems have been all along, public education, expert culture, medicine, law, scientific & academic publishing norms, political & economic paternalism.

It was just sitting there waiting for a pandemic narrative to be opportunistic for totalitarianism that isn’t hidden by advertising.

Now I know why anarchists have such strong objections to things like making children line up silently in school to go from room to room or making them sit in rows in dreary rooms.
 

Ben.

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It goes to show how authoritarian our systems have been all along, public education, expert culture, medicine, law, scientific & academic publishing norms, political & economic paternalism.

It was just sitting there waiting for a pandemic narrative to be opportunistic for totalitarianism that isn’t hidden by advertising.

Exactly. But it actually happening infront of our very eyes is deeply scary. I woudn't have thought it would be "that" easy. I thought that the burden of proof to cascade these events must be magnitutes higher. That the admittion of atrocieites and research from thoose involved in the scam would've needed to be more hidden. Not in plain sight available on youtube from interviews in 2014, 2015, 2002 etc.

But i have learned something valuable from this. Even more so it is important to rely on yourself. Learning and becoming more independend. It also showed me how many people in my social circle are, maybe not even to their own fault, silent "going along with it" type of people, lead by thoose yelling unscientific nonsense because the tv screen said so. People actually take pride in being a fan of a certain brand of manufacterers that develope experimental drugs with tyrannical goverments enforcing them against the will of the population.
 

yerrag

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People actually take pride in being a fan of a certain brand of manufacterers that develope experimental drugs with tyrannical goverments enforcing them against the will of the population.
Maybe their positive association with joyous erections has deeply embedded in them a loyalty to that brand. They were 'primed' long before the COVID hoax began.

One good thing leads to another. Same with bad.
 

yerrag

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The legal framework is being shed of its moral moorings and being replaced by technical procedures and meaningless legalese in order for judges to make the law impotent in meting out justice.

Go by the law but you won't get far if the judges on the top of the totem pole serve a system that favors the Zionists and their water boys.

The pretensions of law serving the people in some rulings (such as right to life) do not represent the overall sense of injustice with lady justice unblinded. The black cloak and the white and gray wig merely mask the decay in the mind and the soul underneath.They are mere symbols to assuage the masses, to give them a sense of hope they are making progress and someday their efforts will pay off.

It is just like being little boys and girls getting an A for effort while still getting a decent B in the report card even as in the game of reality they are grade A automatons following a program.

Ever hopeful, ever smiling, praying to saints as their supreme leader drinks the blood of the unborn.

Waiting for a messiah to swoop down soon and punish the evildoers by consigning to a place forever where there is gnashing of teeth.

Handel's Messiah is as good as it gets.

And thus a happy ending is as ordained as fairy tales of Snow White and Cinderella are made to be, for the little ones who have to be spared from reality.
 
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haidut

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Black Ops

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@haidut

Any response to this article against the report?


Thanks
 

Jam

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Kram

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Some helpful analysis on rates of adverse events. Keep in mind...these numbers are based on Pfizer data, are definitely underreported and therefore extremely conservative.


In August, Public Health and Medical Professionals for Transparency (PHMPT) submitted a Freedom of Information Act (FOIA) request to the U.S. Food and Drug Administration (FDA) for all of the data within Pfizer’s COVID-19 vaccine biological product file — a body of information comprising some 329,000 pages.

The FDA, arguing its poorly staffed Center for Biologics Evaluation and Research did not have the capacity to quickly redact legally exempt material, such as Pfizer proprietary information and personal private information of trial participants, the agency asked to be allowed to release only 500 pages of this data per month, thus necessitating 55 years for full disclosure.

The agency later requested up to 75 years to complete the task. As of Nov. 17, only a fraction of the data in question had been released.

Here I will discuss one of these released documents, the “Cumulative Analysis of Post-authorization Adverse Event Reports.” This document constitutes one part of Pfizer’s responsibility for pharmacovigilance with respect to their Biological License Agreement with the FDA.

Pharmacovigilance refers to the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Before we examine the quantity, seriousness and nature of the adverse events included in this document it is worthwhile to pause and consider just how significant this report should have been to the public.


Pfizer’s vaccine had yet to complete full safety and efficacy testing, yet its product was being rapidly deployed on a healthy population that dwarfed the size of the vaccine’s clinical trial.

The FDA and Pfizer were well aware that very real risks, if they existed, could not have been identified from the trials alone. There weren’t enough participants, and the participants had not been observed for very long.

Everything may seem okay if you experiment on 20,000 people, but what happens when you experiment on a million people?

The “Cumulative Analysis of Post-authorization Adverse Event Reports” should have been the “everything looks good so far” reassurance the FDA was seeking. Why was it necessary to impel the FDA to make this information public through a court order?

In the discussion section of the document (section 4), Pfizer assures the FDA it “… performs frequent and rigorous signal detection on BNT162b2 cases.”

What does “rigorous” signal detection mean? Did Pfizer survey a large number of vaccine recipients for adverse events and investigate them? No, it didn’t.

This report is merely a compilation of unsolicited, in other words, passive, reports of adverse events directly brought to Pfizer’s attention by recipients, cases reported by the health authorities, cases published in the medical literature, cases from Pfizer-sponsored marketing programs, non-interventional studies and cases of serious adverse events reported from clinical studies regardless of causality assessment.

In the report, Pfizer admitted the “magnitude of underreporting is unknown.”

It is well accepted that passive reporting will inescapably lead to underreporting. Nevertheless, according to Pfizer’s report:

“Due to the large numbers of spontaneous adverse event reports received for the product, the MAH (Marketing Authorisation Holder) has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity.”

The authors continued:

“Pfizer also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, [sic] and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.”

In other words, the number of adverse events reported overwhelmed Pfizer’s expectations, yet the vaccine maker concluded, “The findings of these signal detection analyses are consistent with the known safety profile of the vaccine.”

This paradoxical statement will prove to be an important clue as we dissect the data below.

What does the document reveal?

Through Feb. 28, a total of 42,086 recipients (cases) reported 158,893 events, or adverse reactions to the Pfizer vaccine. Approximately 50% of these events were deemed serious.

Total numbers
Figure 1: Total Numbers of BNT162b2 AEs by system organ classes and event seriousness
An overview of the characteristics of the recipients is given here:

Table 1: General overview


Of note, 1,223 recipients of the vaccine had a fatal outcome. More than 11,000 had not recovered. The outcome of 9,400 was unknown. Nearly three-quarters were female.

These numbers are concerning, but do they represent a significant safety concern? The answer to that question depends entirely upon the number of people who had been vaccinated up to that point.

Pfizer provided this number to the FDA in the general overview section of the document, section 3.1.1. — but in the document released under the FOIA request, that number was redacted:

“It is estimated that approximately (b) (4) doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021.”

In the above, “(b)(4)“ indicates that this number has been redacted.

The cumulative number of doses distributed worldwide as of Feb. 28 is not proprietary information, nor does it constitute personal, private data of individuals.

Yet without this key number there is no way to calculate the incidence of serious events, i.e., a safety signal.

The FDA chose, without explanation or any legal justification, to withhold this crucial piece of data.

Despite the FDA’s obvious intention to obfuscate, Pfizer provided a means of estimating this number when it unequivocally concluded: “… these signal detection analyses are consistent with the known safety profile of the vaccine.”

What was the known safety profile of the vaccine?

As of Feb. 28, the only known safety profile of the vaccine was determined by the initial results from the phase 3 trials from the autumn of 2020.

Of 21,621 Pfizer vaccine recipients, 126 [Polack FP, Thomas SJ, Kitchin N, et al., NEJM, Table S3] suffered a serious adverse event in the trials. This is roughly one severe adverse event in 171.6 recipients.

Thus, if these data are consistent with its known safety profile, and roughly 79,000 serious adverse events had occurred up to that time, we can estimate that approximately 13,550,000 (79,000 x 171.6) doses had been distributed.

Admittedly there is uncertainty in this calculation. Perhaps a different interpretation of the safety profile was implied.

However, Pfizer reported the number of doses that had been distributed, not administered.

Fewer doses would have been administered than delivered. Moreover, serious adverse events in the trials were distributed across participants who were fully vaccinated (having received two doses).

Here we are using the number of doses as the denominator. This estimation will result in the lower limit of the true incidence of adverse events.

In other words, by using these assumptions we are giving Pfizer’s vaccine the maximum benefit of the doubt.

Using this estimate of total doses given, the incidence of a fatal outcome is 1223/13.55 million or 1 in 11,079.

Permanent sequelae (conditions that result as a consequence of vaccination) = 520/13.55 million, or 1 in 26,057. Furthermore, 11,361 out of 13.55 million, or 1 in 1,193, had not yet recovered from an adverse event.


Pfizer inexplicably chose to group recipients who “recovered” with those who were “recovering.” How many in this large group (19,582) were still suffering from harm at the time of the report? On what basis did Pfizer determine a recipient still had a chance of full recovery?

With no clarification from the vaccine manufacturer, we are forced to lump them in with another large group of 9,400 whose ultimate outcome was “unknown” — leaving us with a high limit of 1 in 466 recipients having had an undetermined outcome.

Although none of these adverse events and fatalities were shown to be directly or indirectly caused by vaccination, Pfizer offered more data of concern around adverse events of “special Interest” (AESI).

According to Pfizer, 1,403 cardiovascular AESIs, 932 hematologic, 3,600 musculoskeletal, 501 neurologic and 3,674 “other” serious AESIs all occurred with a median time of onset of 24 hours or less from vaccination.

The 275 strokes and 449 cases of facial paralysis reported occurred with a median time of onset of two days from vaccination.

Though it is impossible to establish an unassailable causative link between vaccination and injury at this time, the temporal relationship between them is correlative and highly suggestive of causation.

Nevertheless, the authors of the Pfizer report concluded at the end of each AESI category that “This cumulative case review does not raise new safety issues.”

The report also included 24 serious cases in children younger than 12. Of those, 13 cases had not yet been resolved at the time of reporting. The mean age of these recipients was 3.7 years.

We must assume that very few children of that age were inoculated at that time given that Pfizer had authorization for use on adults only. With no number of inoculated children reported, we cannot know what the risk of injury is in children under 12.

Conclusions

Pfizer’s repeated assurances that no new safety issues exist are disingenuous at best.

The FDA was overtly obstructive by withholding crucial information required to make an accurate assessment of harm. However, by using reasonable estimations based on Pfizer’s own claims and published trial data, it is likely a safety signal does exist — and that safety signal was ignored by the very organization that is supposed to be listening for it, the FDA.

Pfizer’s estimated incidence of potential vaccine fatality, 1 in 11,079, is approximately twice that reported in VAERS. Given that the potential vaccine fatalities in this document have been passively reported, we can assume the actual incidence is higher.

More comprehensive analyses have demonstrated a VAERS underreporting factor of vaccine fatality approaching 41 or greater.

Underreported or not, the real and growing tragedy is that until an injury associated with vaccination is proven to be caused by it, it remains, for all intents and purposes, a non-existent signal to the very institutions responsible for public health and safety.

On what grounds can we as physicians and healthcare providers assure our patients this vaccine is safe if adverse events are not investigated or even acknowledged?

Is a nod from the FDA really good enough?

Or should we demand transparency, discussion or at the very least, unredacted data? What does the public expect of us?
 
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haidut

haidut

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@haidut

Any response to this article against the report?


Thanks

Did you read the article you are asking me to comment on? Also, did you read the thread and its posts so far? If you do both, you will see that the "response" in that article is bunk. Btw, there is a response right above mine that has pretty good analysis on the released data and the risks that data implies in regards to the vaccines.
 

Rafe

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On fact-checking articles data analyzing FDA redacted Pfizer adverse event signal early report:

“There’s no proof the vaccine caused those adverse events.”

Also: “Covid caused 800,000 deaths in 2 years.”
 

Black Ops

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To be frank, im looking for a solid list of resources to convince my family about the adverse affects of the vaccine and the manipulation of data.

@haidut - Yes i have read the thread and posts. Seems like i wasnt properly evaluating the statements in the fact check article. The response above is solid

I hope the people who put in the FOIA push the courts about the redaction
 
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Sergey

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Pfizer accounts for 58% of vaccines administered in the US.
By 1st of June of 2021 44% of US population has received two doses of vaccine, it gives about 25% of US population fully vaccinated with Pfizer by that date.
If there was 5% mortality within 90 days of Pfizer vaccine administration it would mean 1.25% of total US population dying during summer months from Pfizer vaccine only.
This should have given excess mortality of at least 4 million people after 1st of June.
US average mortality rates are around 0.85% annually, or around 230000 per months from all cause.

According to the above we should have seen 6.5 fold increase in mortality during summer months (1,500,000 vs 230,000), or 3.8 fold increase if those 5% deaths happen during 6 months following vaccination, not 3.

CDC reports, on average, 266000 deaths per month for summer 2021 and 275000 deaths, on average, for June-November 2021, which is lower than 2020, bit higher than average of 230000, but nothing comparable to what we should have seen if the numbers reported in the papers were true.

Am I missing something or my math is just wrong?

I am not provax btw, just trying to make sense out of all this.
 
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haidut

haidut

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To be frank, im looking for a solid list of resources to convince my family about the adverse affects of the vaccine and the manipulation of data.

They are probably not going to believe them. For example, the VAERS and openVAERS systems have been the gold-standard for decades for assessing (albeit informally) vaccine risks. Yet, when it comes to the COVID-19 vaccines the official narrative is that those reporting systems cannot be trusted because they are not definitive and cause-effect cannot be established for sure. Technically, the statement is true but there is no convincing people to look at VAERS data for prior vaccines and comparing the data to the data for COVID-19 vaccines. I tried with a few people, some of who were even doctors. The response was "well, if the public health authorities say VAERS can't be used to ascertain vaccine safety, then that's the way it is". Yet, some of those doctors use VAERS on almost daily basis to look up info on risks for other vaccines. Makes no sense, but when pressed about this absurdity they comes back with "The govt decides when VAERS is reliable and then it is not and we just follow official guidelines. Who are you to challenge that?!".
Anyways, feel free to try but I would not get my hopes too high.
 
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haidut

haidut

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Pfizer accounts for 58% of vaccines administered in the US.
By 1st of June of 2021 44% of US population has received two doses of vaccine, it gives about 25% of US population fully vaccinated with Pfizer by that date.
If there was 5% mortality within 90 days of Pfizer vaccine administration it would mean 1.25% of total US population dying during summer months from Pfizer vaccine only.
This should have given excess mortality of at least 4 million people after 1st of June.
US average mortality rates are around 0.85% annually, or around 230000 per months from all cause.

According to the above we should have seen 6.5 fold increase in mortality during summer months (1,500,000 vs 230,000), or 3.8 fold increase if those 5% deaths happen during 6 months following vaccination, not 3.

CDC reports, on average, 266000 deaths per month for summer 2021 and 275000 deaths, on average, for June-November 2021, which is lower than 2020, bit higher than average of 230000, but nothing comparable to what we should have seen if the numbers reported in the papers were true.

Am I missing something or my math is just wrong?

I am not provax btw, just trying to make sense out of all this.

Yes, the 5% mortality is a mistake. If you go through the 2ng and 3rd page of the thread you will see the discussion on that. The problem is that FDA/Pfizer have redacted the data on how many vaccines have been administered in the period covered by the report so it is impossible to get a clear picture of vaccine mortality rate or rate of SAE. There is no reasonable argument why FDA/Pfizer would not release the numbers of vaccine administered in that 90 day period, yet they refuse and so far the court has not compelled them to release it. As such, we can only guesstimate based on other sources. If you read through the entire thread there are posts deriving some more or less reliable ranges of mortality and SAE.
 
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