Regulators in the United States reviewed the information sheet of the Johnson & Johnson covid-19 vaccine to warn of the risk of an unusual bleeding disorder.
The Food and Drug Administration (FDA) warned the company in a letter that reports of adverse events suggested an increased risk of immune thrombocytopenia during the 42 days after vaccination. Symptoms include excessive and unusual bruising or bleeding, according to the agency.
The fact sheet changes include recommendations to vaccine providers about giving the Johnson & Johnson biologic to people with existing medical conditions, including those who have low platelets, a type of blood cell that helps stop bleeding. .
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 to clot. This condition is sometimes associated with abnormal bleeding.
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.
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Last month, the CDC recommended vaccines for mRNA manufactured by Moderna Inc. and Pfizer Inc. for use in adults, instead of the Johnson & Johnson vaccine.
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