J&J Vaccine Gets Additional Warning On Bleeding Side Effect

J&J's coronavirus vaccine has also been previously connected to rare but serious blood clots, with women aged 30 to 49 being at the highest risk.

The fact sheet for Johnson & Johnson's Covid-19 vaccine has been revised by U.S. regulators 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 following vaccination. Symptoms include bruising or excessive or unusual bleeding, according to the agency.

The changes to the fact sheet include recommendations to vaccination providers about giving the J&J shot to people with existing medical conditions, including those who have a low level 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 talk to their health-care provider regarding the risk of ITP and the potential need for platelet monitoring following vaccination."