Posted on 12/19/2022 5:01:04 AM PST by george76
Pfizer’s COVID-19 vaccine has been linked to blood clotting in older individuals, according to the U.S. Food and Drug Administration (FDA).
FDA researchers, crunching data from a database of elderly persons in the United States, found that pulmonary embolism—blood clotting in the lungs—met the initial threshold for a statistical signal and continued meeting the criteria after a more in-depth evaluation.
Three other outcomes of interest—a lack of oxygen to the heart, a blood platelet disorder called immune thrombocytopenia, and another type of clotting called intravascular coagulation—initially raised red flags, researchers said. More in-depth evaluations, such as comparisons with populations who received influenza vaccines, showed those three as no longer meeting the statistical threshold for a signal.
Researchers looked at data covering 17.4 million elderly Americans who received a total of 34.6 million vaccine doses between Dec. 10, 2020, and Jan. 16, 2022.
The study was published by the journal Vaccine on Dec. 1.
The FDA said it was not taking any action on the results because they do not prove the vaccines cause any of the four outcomes, and because the findings “are still under investigation and require more robust study.”
Dr. Peter McCullough, chief medical adviser for the Truth for Health Foundation, told The Epoch Times via email that the new paper “corroborates the concerns of doctors that the large uptick in blood clots, progression of atherosclerotic heart disease, and blood disorders is independently associated with COVID-19 vaccination.”
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How the Research Was Done..
FDA researchers, with assistance from researchers with the Centers for Medicare & Medicaid Services (CMS), analyzed data from the CMS database. They included Medicare Fee-for-Service beneficiaries aged 65 or older who received a vaccine within the timeframe, were enrolled when they were vaccinated, and were enrolled for a “clean window” of time prior to vaccination. The window was 183 days or 365 days, depending on the outcome.
About 25 million people receive the Medicare Fee-for-Service, but only about 17 million were vaccinated during the period of time studied.
Researchers used probability testing to detect an increased risk of one or more of 14 outcomes following vaccination. The goal was to see whether vaccination may increase the risk of adverse outcomes, such as pulmonary embolism, or blood clotting in the lungs. If an outcome met a certain statistical threshold, that meant it could increase the risk.
The initial results of the safety monitoring detected an increased risk of four events, the FDA announced on July 12, 2021. They were the same four outlined in the new paper, which is the first update the agency has given on the matter since its announcement.
As of Jan. 15, 2022, 9,065 cases of a lack of oxygen to the heart—known as acute myocardial infarction—were detected, researchers revealed in the new study. As of the same date, 6,346 cases of pulmonary embolism, 1,064 cases of immune thrombocytopenia, and 263 cases of the coagulation were detected.
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The primary analysis showed a safety signal for all four outcomes. Researchers tried adjusting the numbers by using different variables. For instance, at one point they adjusted for the variation of background rates, or the rates of each outcome in the general population prior to the pandemic. After certain adjustments—not all—the myocardial infarction, immune thrombocytopenia, and intravascular coagulation ceased being statistically significant.
Pulmonary embolism, though, continued to be statistically significant, the researchers said. Pulmonary embolism is a serious condition that can lead to death.
Limitations of the study included possible false signals and possible missed signals due to factors such as parameters being specified wrongly.
The conditions that didn’t trigger a signal included stroke, heart inflammation, and appendicitis.
The signals were detected only after Pfizer vaccination. Analyses for signals after receipt of the Moderna and Johnson & Johnson vaccines did not show any concerns.
Moderna and Johnson & Johnson did not respond to requests for comment.
Side Effects..
All three vaccines have been linked to a number of side effects. Heart inflammation is causally linked to the Moderna and Pfizer shots, experts around the world have confirmed, while Johnson & Johnson’s has been associated with blood clots.
Other conditions, such as pulmonary embolism, have been reported to authorities and described in studies, though some papers have found no increase in risk following vaccination.
Approximately 4,214 reports of post-vaccination pulmonary embolism, including 1,886 reports following receipt of Pfizer’s vaccine, have been reported to the U.S. Vaccine Adverse Event Reporting System as of Dec. 9.
As of the same date, 1,434 reports of post-vaccination myocardial infarction, including 736 following receipt of Pfizer’s vaccine; 469 reports of post-vaccination immune thrombocytopenia, including 234 following receipt of Pfizer’s vaccine; and 78 reports of post-vaccination intravascular coagulation, including 42 after receipt of Pfizer’s vaccine, have been reported.
Reports to the system can be made by anybody, but most are lodged by health care workers, studies show. The number of reports are an undercount, according to studies.
The new study states that the FDA “strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.” No evidence was cited in support of the belief.
The FDA is set to meet with its vaccine advisory panel in January 2023 about the future of COVID-19 vaccines, as the vaccines have been performing much worse against Omicron and its subvariants.
McCullough told The Epoch Times: “A shortcoming of the CMS surveillance system is that it did not capture prior and subsequent SARS-CoV-2 infection which accentuate the cumulative risk of COVID-19 vaccination. Given the large number of individuals who have been vaccinated, the population attributable fraction of medical problems ascribed to the vaccines is enormous. I have concerns over the future burden to the healthcare system as a consequence of mass indiscriminate COVID-19 vaccination.”
I’m sorry for your loss.
####The FDA finally gets a clue!#####
Reading the article it doesn’t appear that the FDA is clearly admitting there’s a problem....They’re using vague terms of “there could be a connection”.
When is NPR going to broadcast this news?
Right after they announced that Donald j Trump was the true winner of the 2020 election.
Everyone knows that, that’s why they’ve had the side effects listed at the end of all the Covidjection commercials . . . . /sarc
I’ll put this in the NFS file
The cartoon at the link says it all.
BTW, if the truth offends, do NOT click.
DIC and ITP are not small things. Break out the lawyers! It’s past time.
Is The Donald still keeping quiet about his leadership on this? Complicit crimes are a little problem.
If you have never looked up the federal statute on EUAs…. You should. It’s an abuse of power and a crime to use them in the way they were used… with one exception.
So why isn’t anyone asking about the exception? Because they would rather be complicit in deaths of others than to be wrong.
And btw…. If these clots are not comprised of traditional components we cannot measure them in the lab or treat them well with traditional clot busters that are based on those components.
Another problem… iirc, Moderna had a higher dose. I know people who took both and te Moderna crowd had more tea yin’s.
Another problem…. We look for clots in the older group, but by the time you are symptomatic… your clots are big.
What about the people with small clots.. or clots in vital areas. Tie is my biggest concern with healthy people who can compensate. I wonder about the damage that is done.
And this will essentially halt all vaccine injections until the FDA can properly perform clinical trials and follow protocols to safely release the vaccine that doesn’t KILL. How convenient the government gave big pharma unconditional release of liability from injury.
Is it OK now for one to brag on FR that they didn’t get the clot shots, or will such a comment bring name calling like being a conspiracy theorist Qtard?
BTTT.
Everyone and anyone connected in the FDA who approved that ‘vaxxine’ should be prosecuted for corruption and murder, IMO.
“The Donald still keeping quiet about his leadership on this?”
There you go again...
19 months and still have clots. It’s a delicate dance with aspirin between preventing an ischemic clot stroke or a hemorrhagic thin blood stroke.
I clicked.
One of the comments said PEOPLE ARE STUPID ENOUGH TO RUB HUMAN FECES ON THEI FACE IF THE GOV’T SAID IT WOULD STOP COVID
I personally prefer dog feces. Or maybe IVM and/or HCQ+Zn instead.
Are there any double blind peer reviewed papers out there for these tactics?
Great and truthful meme. BUMP!
“Is it OK now for one to brag on FR that they didn’t get the clot shots...”
You’re a bit late to that party.
“””Is it OK now for one to brag on FR that they didn’t get the clot shots, or will such a comment bring name calling like being a conspiracy theorist Qtard?”””
I would be careful. FR may be infiltrated with FBI plants just like Twitter.
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