Pfizer's COVID-19 Vaccine Linked to Blood Clotting: FDA - The Epoch Times

Pfizer’s COVID-19 vaccine has been linked to blood clotting successful older individuals, according to the U.S. Food and Drug Administration (FDA).

FDA researchers, crunching information from a database of aged persons successful the United States, recovered that pulmonary embolism—blood clotting successful the lungs—met the archetypal threshold for a statistical awesome and continued gathering the criteria aft a much in-depth evaluation.

Three different outcomes of interest—a deficiency of oxygen to the heart, a humor platelet upset called immune thrombocytopenia, and different benignant of clotting called intravascular coagulation—initially raised reddish flags, researchers said. More in-depth evaluations, specified arsenic comparisons with populations who received influenza vaccines, showed those 3 arsenic nary longer gathering the statistical threshold for a signal.

Researchers looked astatine information covering 17.4 cardinal aged Americans who received a full of 34.6 cardinal vaccine doses betwixt Dec. 10, 2020, and Jan. 16, 2022.

The survey was published by the diary Vaccine connected Dec. 1.

The FDA said it was not taking immoderate enactment connected the results due to the fact that they bash not beryllium the vaccines origin immoderate of the 4 outcomes, and due to the fact that the findings “are inactive nether probe and necessitate much robust study.”

Dr. Peter McCullough, main aesculapian advisor for the Truth for Health Foundation, told The Epoch Times via email that the caller insubstantial “corroborates the concerns of doctors that the ample uptick successful humor clots, progression of atherosclerotic bosom disease, and humor disorders is independently associated with COVID-19 vaccination.”

Pfizer did not respond to a petition for comment.

A pedestrian walks by Pfizer’s New York City office successful a record photograph. (Jeenah Moon/Getty Images)

How the Research Was Done

FDA researchers, with assistance from researchers with the Centers for Medicare & Medicaid Services (CMS), analyzed information from the CMS database. They included Medicare Fee-for-Service beneficiaries aged 65 oregon older who received a vaccine wrong the timeframe, were enrolled erstwhile they were vaccinated, and were enrolled for a “clean window” of clip anterior to vaccination. The model was 183 days oregon 365 days, depending connected the outcome.

About 25 cardinal radical person the Medicare Fee-for-Service, but lone astir 17 cardinal were vaccinated during the play of clip studied.

Researchers utilized probability investigating to observe an accrued hazard of 1 oregon much of 14 outcomes pursuing vaccination. The extremity was to spot whether vaccination whitethorn summation the hazard of adverse outcomes, specified arsenic pulmonary embolism, oregon humor clotting successful the lungs. If an result met a definite statistical threshold, that meant it could summation the risk.

The archetypal results of the information monitoring detected an accrued hazard of 4 events, the FDA announced connected July 12, 2021. They were the aforesaid 4 outlined successful the caller paper, which is the archetypal update the bureau has fixed connected the substance since its announcement.

As of Jan. 15, 2022, 9,065 cases of a lack of oxygen to the heart—known arsenic acute myocardial infarction—were detected, researchers revealed successful the caller study. As of the aforesaid date, 6,346 cases of pulmonary embolism, 1,064 cases of immune thrombocytopenia, and 263 cases of the coagulation were detected.

One of the tables from the new paper.

The superior investigation showed a information awesome for each 4 outcomes. Researchers tried adjusting the numbers by utilizing antithetic variables. For instance, astatine 1 constituent they adjusted for the saltation of inheritance rates, oregon the rates of each result successful the wide colonisation anterior to the pandemic. After definite adjustments—not all—the myocardial infarction, immune thrombocytopenia, and intravascular coagulation ceased being statistically significant.

Pulmonary embolism, though, continued to beryllium statistically significant, the researchers said. Pulmonary embolism is simply a superior information that tin pb to death.

Limitations of the survey included imaginable mendacious signals and imaginable missed signals owed to factors specified arsenic parameters being specified wrongly.

The conditions that didn’t trigger a awesome included stroke, bosom inflammation, and appendicitis.

The signals were detected lone aft Pfizer vaccination. Analyses for signals aft receipt of the Moderna and Johnson & Johnson vaccines did not amusement immoderate concerns.

Moderna and Johnson & Johnson did not respond to requests for comment.

Side Effects

All 3 vaccines person been linked to a fig of broadside effects. Heart inflammation is causally linked to the Moderna and Pfizer shots, experts astir the satellite person confirmed, portion Johnson & Johnson’s has been associated with humor clots.

Other conditions, specified arsenic pulmonary embolism, person been reported to authorities and described successful studies, though some papers person recovered nary summation successful hazard pursuing vaccination.

Approximately 4,214 reports of post-vaccination pulmonary embolism, including 1,886 reports pursuing receipt of Pfizer’s vaccine, have been reported to the U.S. Vaccine Adverse Event Reporting System arsenic of Dec. 9.

As of the aforesaid date, 1,434 reports of post-vaccination myocardial infarction, including 736 pursuing receipt of Pfizer’s vaccine; 469 reports of post-vaccination immune thrombocytopenia, including 234 pursuing receipt of Pfizer’s vaccine; and 78 reports of post-vaccination intravascular coagulation, including 42 aft receipt of Pfizer’s vaccine, person been reported.

Reports to the strategy tin beryllium made by anybody, but astir are lodged by wellness attraction workers, studies show. The fig of reports are an undercount, according to studies.

The caller survey states that the FDA “strongly believes the imaginable benefits of COVID-19 vaccination outweigh the imaginable risks of COVID-19 infection.” No grounds was cited successful enactment of the belief.

The FDA is acceptable to conscionable with its vaccine advisory sheet successful January 2023 astir the aboriginal of COVID-19 vaccines, arsenic the vaccines person been performing overmuch worse against Omicron and its subvariants.

McCullough told The Epoch Times: “A shortcoming of the CMS surveillance strategy is that it did not seizure anterior and consequent SARS-CoV-2 corruption which accentuate the cumulative hazard of COVID-19 vaccination. Given the ample fig of individuals who person been vaccinated, the colonisation attributable fraction of aesculapian problems ascribed to the vaccines is enormous. I person concerns implicit the aboriginal burden to the healthcare system arsenic a effect of wide indiscriminate COVID-19 vaccination.”