Autoimmune Cytopenias

The US Food and Drug Administration (FDA) announced in mid January revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers, in response to new safety information regarding the serious risk of immune thrombocytopenia (ITP) following administration of the Janssen COVID-19 Vaccine. The Fact Sheet for Health Care Providers includes information about reports of adverse events following receipt of this vaccine, noting an increased risk of ITP during the 42 days following vaccination and advising people with a history of ITP to discuss this risk with their healthcare providers, as well as the potential need for platelet monitoring following vaccination. The Fact Sheet for Recipients and Caregivers includes new information about ITP under the questions, "What should you mention to your vaccination provider before you get the Janssen COVID-19 Vaccine?" and "What are the risks of the Janssen COVID-19 Vaccine?" It also outlines postvaccination symptoms to look for and when to seek medical attention. The news release states that the FDA and the Centers for Disease Control and Prevention "continue to monitor the level of potential excess risk," advising that "[i]ndividuals should speak to their health care provider to determine which COVID-19 vaccine is most appropriate for their own situation."