Pfizer’s COVID-19 vaccine blood clotting In the elderly, according to the U.S. Food and Drug Administration (FDA).
FDA researchers processed data from a database of older adults in the United States to find that pulmonary embolism (blood clots in the lungs) met an initial threshold for statistical signal and remained standard after more detailed evaluation. was found to satisfy
Three other intriguing results first raised the alarm, the researchers said, including a lack of oxygen to the heart, a platelet disorder called immune thrombocytopenia, and another type of clotting called intravascular coagulation. said. A more detailed evaluation, including comparison with the influenza vaccine-treated population, showed that these three no longer met the statistical threshold for signal.
Researchers looked at data from 17.4 million older Americans who received a total of 34.6 million doses of vaccine between December 10, 2020 and January 16, 2022.
This research journal vaccine December 1st.
Because the FDA has not proven that the vaccine causes any of the four outcomes, and because the findings are “still under investigation and stronger studies are needed,” no action will be taken against the results. He said he did not teach
Dr. Peter McCullough, Chief Medical Advisor for the Truth for Health Foundation, told The Epoch Times in an email. Related to COVID-19 vaccination. ”
Pfizer did not respond to a request for comment.
Survey method
FDA researchers, assisted by researchers at the Centers for Medicare and Medicaid Services (CMS), analyzed data from the CMS database. They included his 65+ Medicare service fee recipients who were vaccinated in time, registered at the time of vaccination, and registered during the pre-vaccination “clean window” period. The window was 183 or 365 days, depending on the results.
About 25 million people have paid Medicare services, but only about 17 million were vaccinated during the study period.
Researchers used probability tests to detect an increased risk of 1 or more of the 14 outcomes after vaccination. The goal was to see if vaccination might increase the risk of adverse outcomes such as pulmonary embolism and blood clots in the lungs. That meant it could be risky.
Initial results of safety monitoring detected an increased risk of four events. Announced on July 12, 2021Those are the same four people outlined in the new paper, and this is the first update the agency has provided on the matter since its publication.
As of January 15, 2022, 9,065 cases of heart oxygen deprivation, known as acute myocardial infarction, have been detected in a new study by researchers. As of the same date, 6346 cases of pulmonary embolism, 1064 cases of immune thrombocytopenia, and 263 cases of coagulation were detected.
Primary analyzes showed safety signals for all four outcomes. Researchers tried to calibrate the numbers using different variables. For example, at some point we adjusted for background rate variability, or rates for each outcome in the pre-pandemic general population. Not all but myocardial infarction, immune thrombocytopenia, and intravascular coagulation were no longer statistically significant after certain adjustments.
However, pulmonary embolism remains statistically significant, the researchers said. Pulmonary embolism is a serious condition that can lead to death.
Limitations of this study included the possibility of false signals or missing signals due to factors such as incorrect specification of parameters.
Conditions that did not trigger the signal include stroke, heart inflammation, and appendicitis.
Signal was detected only after Pfizer vaccination. Analysis of signals after receiving the Moderna and Johnson & Johnson vaccines showed no concerns.
Moderna and Johnson & Johnson did not respond to requests for comment.
side effects
All three vaccines are associated with many side effects. Experts worldwide confirm that heart inflammation is causally linked to Moderna and Pfizer injections, while Johnson & Johnson injections are associated with blood clots.
Other conditions, such as pulmonary embolism, have been reported to authorities and explained in researchbut some papers No increased risk was seen after vaccination.
As of December 9, approximately 4,214 reports of post-vaccination pulmonary embolism have been reported to the U.S. Vaccine Adverse Event Reporting System, including 1,886 post-vaccination reports from Pfizer.
As of the same date, there were 1,434 reports of post-vaccination myocardial infarction, including 736 post-vaccination for Pfizer. 469 reports of immune thrombocytopenia after vaccination. Includes 234 post-Pfizer vaccinations. Seventy-eight reports of post-vaccination intravascular coagulation have been reported, including 42 after Pfizer vaccination.
Anyone can report to the system, but research shows that most are submitted by healthcare professionals. Research shows that the number of reports is underestimated.
The new study states that the FDA “strongly believes that the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.” No evidence has been cited to support that belief.
FDA plans to meet with the Vaccine Advisory Committee on the future of COVID-19 vaccines in January 2023. This is because the vaccine has done much worse against his Omicron and its variants.
McCullough told the Epoch Times: Given the large number of vaccinated individuals, the population-attributable proportion of vaccine-induced medical problems is staggering.worried about the future Burden on the health system As a result of massive and indiscriminate COVID-19 vaccination. ”
Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers US and world news.
