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

Benzinga logo Benzinga 1/12/2022 Vandana Singh
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The FDA amended the fact sheet for Johnson & Johnson's (NYSE: 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 (NYSE: PFE) - BioNTech SE (NASDAQ: 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 sheetPrice Action: JNJ shares are down 1.02% at $169.50 during the market session on the last check Wednesday.

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