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January 11, 2022 – The U.S. FDA has announced revisions to the Johnson & Johnson (Janssen) COVID-19 vaccine fact sheets regarding the risk of immune thrombocytopenia (ITP). ITP is a blood disorder in which a very low level of blood platelets can lead to easy or excessive bruising and bleeding.
- The fact sheet for vaccination providers now includes information on potential increased risk of ITP during the 42 days following administration of Janssen's COVID-19 vaccine. According to the fact sheet, individuals with a history of ITP should speak to their healthcare provider about the risk and the potential need for platelet monitoring following vaccination.
- In the fact sheet for vaccine recipients and caregivers, there is now additional information regarding ITP, what to look for, and when to seek medical attention.
- The FDA recommends individuals speak with their healthcare provider to determine which COVID- 19 vaccine is most appropriate for their needs.