Skip to main content

Home  »  Spotlight   »   U.S. FDA amends J&J vaccine fact sheet to include rare bleeding risk

U.S. FDA amends J&J vaccine fact sheet to include rare bleeding risk


The FDA Jobs updated the fact sheet for Johnson & Johnson's (JNJ.N) COVID-19 vaccine on Tuesday to include a rare risk of immune thrombocytopenia, a bleeding disorder.

"Reports of adverse events following use of the Janssen COVID-19 vaccine jobs under emergency use authorization suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination," the regulator said in a letter to J&J's arm, Janssen Biotech Inc.

According to the FDA, the symptoms include easy bruising or tiny blood spots under the skin, as well as unusual or excessive bleeding. The fact sheet amendment follows similar moves by other regulators for the vaccine, including one by the European Medicines Agency in October.

Both the J&J jobsand AstraZeneca (AZN.L) vaccines, which are based on the same platform, have previously been linked to thrombosis with thrombocytopenia syndrome, a very rare combination of blood clotting and low platelet counts.

Due to the rare but sometimes fatal risk, the Centers for Disease Control and Prevention (CDC) recommended last month that Americans choose one of two other authorized COVID-19 vaccines from Pfizer-BioNTech (PFE.N) over J&J's single-dose shot.


Follow WhatNews on YouTubeTwitterLinkedin, and Facebook