Pfizer’s COVID-19 vaccine has been linked to blood clotting in the elderly, according to the U.S. Food and Drug Administration (FDA).
FDA researchers, analyzing data from a database of elderly people in the United States, found that pulmonary embolism – the clotting of blood in the lungs – reached the initial threshold of a statistical signal and continued to meet the criteria after further assessment.
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 people no longer met the statistical threshold for a signal.
The researchers looked at data covering 17.4 million older Americans who received a total of 34.6 million doses of the vaccine between Dec. 1 and Dec. 1. Jan. 10, 2020 and Jan. 16, 2022.
The study was published by the magazine Vaccine the dec. 1.
The FDA said it was taking no action on the findings because they do not prove the vaccines caused any of the four outcomes, and because the findings “are still under investigation and require further study.” .
Dr. Peter McCullough, chief medical adviser for the Truth for Health Foundation, told The Epoch Times via email that the new article “supports doctors’ concerns that the sharp increase in blood clots, progression of heart disease atherosclerosis and blood disorders are independently associated with COVID-19 vaccination.
Pfizer did not respond to a request for comment.
How the research was carried out
FDA researchers, with the help of researchers from the Centers for Medicare & Medicaid Services (CMS), analyzed data from the CMS database. They included Medicare Fee-for-Service beneficiaries age 65 or older who received a vaccine on time, were enrolled when they were vaccinated, and were enrolled for a “clean window” before 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 study period.
The researchers used probability tests to detect an increased risk of one or more of the 14 outcomes after vaccination. The aim was to see if vaccination could increase the risk of side effects, such as pulmonary embolism or blood clotting in the lungs. If a result reached a certain statistical threshold, it meant that it could increase the risk.
Early safety monitoring results detected increased risk of four events, 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 matter since its announcement.
As of Jan. 15, 2022, 9,065 cases of lack of oxygen to the heart – known as acute myocardial infarction – have been detected, the 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.
The primary analysis showed a safety signal for all four outcomes. The researchers tried to adjust the numbers using different variables. For example, at one point they adjusted to change in base rates or rates of each outcome in the general population before the pandemic. After some adjustments – not all – myocardial infarction, immune thrombocytopenia and intravascular coagulation ceased to be statistically significant.
The pulmonary embolism, however, continued to be statistically significant, the researchers said. Pulmonary embolism is a serious illness that can lead to death.
Limitations of the study included possible false signals and possible missed signals due to factors such as misspecified parameters.
Conditions that did not trigger a signal included stroke, heart inflammation and appendicitis.
The signals were detected only after the Pfizer vaccination. Signal analyzes after receipt of Moderna and Johnson & Johnson vaccines showed no concern.
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 commonly linked to Moderna and Pfizer injections, experts around the world have confirmed, while Johnson & Johnson injections have been linked to blood clots.
Other conditions, such as pulmonary embolism, have been reported to authorities and described in studiesalthough some papers found no increased risk after vaccination.
About 4,214 reports of post-vaccination pulmonary embolism, including 1,886 reports following receipt of Pfizer’s vaccine, have been reported to the US Vaccine Adverse Event Reporting System as of December 1. 9.
On the same date, 1,434 declarations of post-vaccination myocardial infarction, including 736 following receipt of the Pfizer vaccine; 469 reports of post-vaccination immune thrombocytopenia, including 234 following receipt of the Pfizer vaccine; and 78 reports of post-vaccination intravascular coagulation, including 42 after receiving the vaccine from Pfizer, have been reported.
Reports to the system can be made by anyone, but most are filed by healthcare workers, studies show. The number of reports is an undercount, according to studies.
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 was cited to support this belief.
The FDA is scheduled to meet with its Vaccine Advisory Group in January 2023 regarding the future of COVID-19 vaccines, as the vaccines performed significantly 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 compounds the cumulative risk of vaccination against SARS-CoV-2. COVID-19. Given the large number of individuals who have been vaccinated, the population-attributable fraction of medical problems attributed to vaccines is enormous. I have concerns about the future burden on the health system following mass vaccination against COVID-19. »
Zachary Stieber is a Maryland-based senior reporter for The Epoch Times. He covers US and world news.
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