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.”
Apparently somebody (who is the 64K question) said to the FDA, “The bioweapon has been used on sufficient people to spread it’s deadly effect on people far and wide for many generations to come. Therefore, you can SLOWLY begin publicizing a peek behind the curtain. But this must be done carefully and methodically. We certainly wouldn’t be accused of creating a public scare.”
Note there is nothing in this report that was not generally available to the public if they dug hard enough.
I pray on a daily basis that those responsible for this receive their just deserts.
Woman of 55 a friend Pfizer shots now has blood clots in her lungs, was relatively healthy until now
There were at least 9 billionaires created from the chinese virus and the deadly vaccines.
“Is The Donald still keeping quiet about his leadership on this? Complicit crimes are a little problem.”
Facts, questions, comments, links, draw your own conclusions. On March 23, 2020, Dr. Zelenko sent ccs of his letter to physicians to Pres. Trump and Mark Meadows. The letter stated a 3 part Protocol was helpful in treating EARLY Covid at home. It had HCQ to help virus stopper ZINC (the ionophore effect), and antibiotic Azithromycin to protect lungs from bacterial infection. I Googled the meds and price appeared to be $20 per course of treatment.
For about a week afterwards Trump and Fauci mentioned all 3 parts. Then they stopped mentioning virus killer ZINC. On May 11, Fauci announced an NIH study on HCQ and Azithromycin on hospitalized Covid patients, to prove if a known, inexpensive drug like HCQ could help heal Covid cases. No ZINC, no EARLY treatment. Designed to fail. Soon after Fauci started promoting Remdesivir (cost to govt. and taxpayers about $3000.00 per treatment course. At least 100 similar studies were run nationwide. About 5% included ZINC. There was much publicity about how deadly HCQ could be. It had many successful years treating malaria in semi-literate Africans with little danger. That fall on Stephen Colbert, Gov. Cuomo mentioned Mark Meadows had been bugging him for months to test HCQ in New York hospitals. I would love to know if ZINC was to be included with the HCQ or not?
Dr. Brix left her White House job and complained she felt something had been going on that she was excluded from. What was it, a plot to torpedo ZINC and help Pfizer and Moderna get rich? How much of our taxes did the govt. give them to buy our “free” Covid shots. I think Trump caught on at some point. His return from Covid treatment at Walter Reed Army Hosp. was televised as he walked from helicopter to WH door. He was speaking about his treatment, monoclonal antibodies, Remdesivir, etc. Then he muttered in an angry way, “And I took ZINC.”
Below are 2 sources of fascinating information on the early treatment protocol. The first link is a study performed in Turkey using the Zelenko 3 part protocol, same days and doses, plus 5000 IU Vitamin D3, and half the group of around 240 subjects receiving 24 grams of IV Vitamin C for a few days. Read the DISCUSSION and CONCLUSIONS for a quick summary of this very successful treatment. The IV treatment with Vitamin C saved significant numbers of days needing hospitalization. The second link is a very, very long list of References usable for studying how people have fought for real Covid treatments, and the blindness of our government. A number of this links have been rescued from Censorship and moved to a site like Bitchute.
www.cureus.com/articles/76496-therapies-to-prevent-progression-of-covid-19-including-hydroxychloroquine-azithromycin-zinc-and-vitamin-d3-with-or-without-intravenous-vitamin-c-an-international-multicenter-randomized-trial
http://drelef.org/zelenko/index.html [This is a monster trove of information for a serious student or a lawyer taking Covid cases., or someone trying to decide how to treat themselves or loved ones.]
Lets see if I can print this as a clickable link?
We take the Zelenko protocol everyday. Also Trump got Regeneron when he had covid which works very well.
Here is a very good Vitamin D book from a German doctor. He likes to load his patients with 100,000 units D3 for 7 days. Then go on to a more normal 10000 daily D3 units. FREE>>>> https://drive.google.com/file/d/1upUNZq4-eH9DFMVVxgd1aY5i7RIr1q1M/view?usp=sharing
"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."
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