Zachary Stieber December 17, 2022
Pfizer’s COVID-19 vaccine has been linked to blood clotting in the elderly, according to the US Food and Drug Administration (FDA).
FDA researchers, analyzing data from a database of elderly people in the United States, found that pulmonary embolism (blood clotting in the lungs) met the initial threshold of a statistical signal and continued to meet the criteria after further evaluation.
Three other findings 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, the researchers said. Further evaluations, such as comparisons with populations that received flu shots, showed that these three no longer met the statistical threshold for a signal.
Researchers analyzed data from 17.4 million older Americans who received a total of 34.6 million vaccine doses between December 10, 2020, and January 16, 2022.
The study was published by the journal Vaccine on December 1.
The FDA said it was taking no action on the results because they do not prove that 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 at the Truth for Health Foundation, told The Epoch Times by email that the new paper “corroborates doctors’ concerns that the large increase in blood clots, the progression of heart disease atherosclerosis and blood disorders are independent.” associated with vaccination against COVID-19″.
Pfizer did not respond to a request for comment.
How the research was done
FDA researchers, assisted by researchers from the Centers for Medicare and Medicaid Services (CMS), analyzed data from the CMS database. They include Medicare fee-for-service beneficiaries age 65 and older who received a vaccine within the time frame, were enrolled when they were vaccinated, and were enrolled during a “clear window” of time before vaccination. The window was either 183 days or 365 days, depending on the outcome.
About 25 million people receive fee-for-service Medicare, but only about 17 million were vaccinated during the time period studied.
The researchers used probability tests to detect an increased risk of one or more of the 14 outcomes after vaccination. The goal was to see if vaccination may increase the risk of adverse outcomes, such as pulmonary embolism or blood clotting in the lungs. If a result reached a certain statistical threshold, this meant that the risk could increase.
Initial safety monitoring results detected an increased risk of four events, the FDA announced on July 12, 2021. They were the same four described in the new document, which is the first update the agency has given on the subject since its announcement. .
As of January 15, 2022, 9,065 cases of lack of oxygen to the heart, known as acute myocardial infarction, were detected, researchers revealed in the new study. On the same date, 6,346 cases of pulmonary embolism, 1,064 cases of immune thrombocytopenia and 263 cases of coagulation were detected.
One of the tables of the new newspaper.
The main analysis showed a safety signal for all four outcomes. The researchers tried to adjust the numbers using different variables. For example, at a given time they were adjusted for the variation in the background rates, or the rates of each outcome in the general population before the pandemic. After some, but not all, adjustments, myocardial infarction, immune thrombocytopenia, and intravascular coagulation were no longer statistically significant.
Pulmonary embolism, however, remained statistically significant, the researchers said. Pulmonary embolism is a serious disease that can lead to death.
Limitations of the study included possible false signals and possible missed signals due to factors such as incorrectly specified parameters.
Conditions that did not trigger a signal included stroke, inflammation of the heart and appendicitis.
The signs were detected only after the Pfizer vaccination. Signal analyzes after receiving the Moderna and Johnson & Johnson vaccines showed no concern.
Moderna and Johnson & Johnson did not respond to requests for comment.
All three vaccines have been linked to a number of side effects. Heart inflammation is causally linked to Moderna and Pfizer’s injections, experts worldwide 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, although some articles have found no increased risk after vaccination.
Approximately 4,214 reports of post-vaccination pulmonary embolism, including 1,886 reports after receiving the Pfizer vaccine, have been reported to the US Vaccine Adverse Event Reporting System as of December 9.
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