Research & Development
US FDA amends fact sheet for J&J's COVID-19 vaccine to include rare bleeding risk
12 January 2022 -

The US Food and Drug Administration on Tuesday amended the fact sheet for US pharmaceutical company Johnson & Johnson's (NYSE:JNJ) COVID-19 vaccine to include a rare risk of immune thrombocytopenia, a bleeding disorder, Reuters news agency reported on Wednesday.

In a letter to Janssen Biotech Inc, J&J's division that manufactures the vaccine, the health regulators said: "Reports of adverse events following use of the Janssen COVID-19 vaccine under emergency use authorisation suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination."

These symptoms include easy bruising or tiny blood spots under the skin, or unusual or excessive bleeding, the FDA said.