January 3, 2022 — The U.S. Food and Drug Administration (FDA) recently revised its Janssen COVID-19 Vaccine Fact Sheets with a contraindication for any individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 vaccine or any other adenovirus-vectored COVID-19 vaccine.
The fact sheets now include updated information about the risk of thrombosis with thrombocytopenia syndrome (TTS) following vaccination. The updates Occurred December 14.
Cases of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 vaccine have been reported in males and females 18 years of age and older. The highest reporting rate of approximately one case per 100,000 doses administered in females 30-49 years of age. Overall, the FDA said approximately 1 out of 7 cases has been fatal.
The FDA and Centers for Disease Control and Prevention (CDC) said they continue to investigate the level of potential excess risk. The FDA said it continues to find that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older.
The FDA said individuals should speak to their healthcare provider to determine which COVID-19 vaccine is most appropriate for their own situation.
Access the Fact Sheet for Healthcare Providers Administering Vaccine.
Access the Fact Sheet for Recipients and Caregivers.
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October 16, 2023 
