WASHINGTON, D.C. – A new report by the U.S. Food and Drug Administration (FDA) has officially linked the Pfizer COVID-19 vaccine to instances of blood clotting – including in the heart and lungs – in individuals over the age of 65.
The FDA utilized a database tracking health issues amongst the elderly in the United States and discovered that the frequency of blood clotting in the lungs – otherwise known as pulmonary embolism – had reached the point that further research was warranted into the cause.
Other rising medical issues in this age group included a lack of oxygen to the heart, immune thrombocytopenia – a blood platelet disorder – and intravascular coagulation, a rare but serious condition that causes abnormal blood clotting throughout the body’s blood vessels.
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FDA researchers examined the data of 17.4 million Americans of the age of 65 and over – including many Medicare Fee-for-Service beneficiaries – among which had received a combined total of 34.6 million vaccine doses between Dec. 10, 2020, and Jan. 16, 2022.
Probability testing was utilized by researchers to check to see if those who had received the Pfizer vaccine had an increased risk for 14 different adverse outcomes following vaccination, including pulmonary embolism, or blood clotting in the lungs. Four of those 14 outcomes displayed an increased risk, including 9,065 cases of acute myocardial infarction – a lack of oxygen to the heart – 6,346 cases of pulmonary embolism, 1,064 cases of immune thrombocytopenia, and 263 cases of coagulation.
Medical conditions that did not spike after vaccination included stroke, heart inflammation, and appendicitis.
FDA researchers allowed a degree of error in the study based on possible false signals due to several factors, including search parameters being specified incorrectly.
While the FDA said that they found correlations between individuals who had suffered from any one of the four specified disorders after having received the Pfizer COVID-19 vaccine, they noted that they would not be taking any direct action at present time as they are currently unable to prove that the vaccine was the ultimate cause.
Per FDA communication of these findings, FDA is currently not taking any regulatory actions based on these signal detection activities because these signals are still under investigation and require more robust study.