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Johnson & Johnson COVID Vaccine Gets Additional Warning Over Bleeding Side Effects

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So far, about 17 million Americans have been given the single-dose J&J vaccine. (file)

The fact sheet for Johnson & Johnson’s COVID-19 vaccine has been revised by US regulators to warn about the risk of a rare bleeding disorder.

The Food and Drug Administration said in a letter to the company Tuesday that adverse event reports suggested an increased risk of immune thrombocytopenia, or ITP, during 42 days after vaccination. Symptoms include bruising or excessive or unusual bleeding, according to the agency.

Changes in the fact sheet include recommendations for vaccination providers about giving the J&J shot to people with existing medical conditions who have low levels of platelets, a type of blood cell that helps stop bleeding.

J&J said in a statement that “individuals who have previously been diagnosed with ITP should speak to their health care provider about the risk of ITP and the potential need for platelet monitoring after vaccination.”

The J&J vaccine has previously been linked to rare but serious blood clots, a condition called thrombocytopenia syndrome, or thrombosis with TTS. According to the Centers for Disease Control and Prevention, women ages 30 to 49 were at highest risk.

To date, about 17 million Americans have been given a single-dose vaccine. Last month, the CDC recommended the messenger RNA vaccines made by Moderna Inc. and Pfizer Inc. for use in adults over the J&J shot.

(Except for the title, this story has not been edited by NDTV staff and is published from a syndicated feed.)

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