FDA Adds Rare Bleeding Risk To Johnson & Johnson's COVID-19 Vaccine Fact Sheet

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The FDA amended the fact sheet for Johnson & Johnson's JNJ COVID-19 vaccine to include a rare risk of immune thrombocytopenia. This condition can lead to easy or excessive bruising and bleeding.

  • "Reports of adverse events following use of the Janssen COVID-19 vaccine 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.
  • The U.S. Centers for Disease Control and Prevention also recommended that Americans choose to receive one of two other authorized COVID-19 vaccines from Pfizer Inc PFEBioNTech SE BNTX over J&J's single-dose shot due to the rare but sometimes fatal risk.
  • While the chance of experiencing immune thrombocytopenia after vaccination is low, the FDA noted, individuals who have a history of ITP should consult their vaccine providers before receiving the shot, according to the updated fact sheet
  • Price Action: JNJ shares are down 1.02% at $169.50 during the market session on the last check Wednesday.
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