Regulators U.S, reviewed the vaccine fact sheet for the COVID-19 from Johnson & Johnson to warn of the risk of an unusual bleeding disorder.
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The Food and Drug Administration (FDA), warned the company in a letter, that reports of adverse events suggested an increased risk of immune thrombocytopenia for 42 days after vaccination. Symptoms include unusual and excessive bleeding or bruising, according to the agency.
The factsheet changes include recommendations to vaccine providers about administering Johnson & Johnson biologic to people with existing medical conditions, including those with low platelets, a type of blood cell that helps stop bleeding. .
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The Johnson & Johnson vaccine has also previously been linked to atypical but serious blood clots. The biological, in addition, is associated with a condition called thrombosis syndrome with thrombocytopenia or TTS.
Thrombocytopenia is any disorder in which there is an abnormally low number of platelets, which are parts of the blood that help it clot. This condition is sometimes associated with abnormal bleeding
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Women ages 30 to 49 are at the highest risk, according to the Centers for Disease Control and Prevention (CDC). So far, about 17 million Americans have received the single-dose vaccine.
Last month, the CDC recommended mRNA vaccines made by Moderna Inc. and Pfizer Inc. for use in adults, instead of the Johnson & Johnson vaccine.
El Tiempo, Colombia / GDA
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