U.S. regulators have revised the COVID-19 vaccine fact sheet from Johnson & Johnson to warn of the risk of a rare bleeding disorder.
The Food and Drug Administration said in a letter to the company on Tuesday that adverse event reports suggested an increased risk of immune thrombocytopenia, or ITP, during the 42 days after vaccination. Symptoms include excessive or unusual bruising or bleeding, according to the agency.
Changes to the fact sheet include recommendations to vaccine providers about giving the J&J vaccine to people with existing medical conditions, including those 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 been previously diagnosed with ITP should discuss the risk of ITP and the possible need for post-vaccination platelet monitoring with their health care provider.”
The J&J vaccine has also previously been linked to rare but serious blood clots, a condition called thrombosis with thrombocytopenia syndrome, or TTS. Women ages 30 to 49 were at highest risk, according to the Centers for Disease Control and Prevention.
So far, about 17 million Americans have received the single-dose vaccine. Last month, the CDC recommended messenger RNA vaccines made by Moderna Inc. and Pfizer Inc. for use in adults instead of the J&J shot.
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