On April 25, 2021, CDC and the U.S. Food and Drug Administration (FDA) recommended use of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine resume in the United States, after a temporary pause. Reports of adverse events following the use of J&J/Janssen vaccine suggest an increased risk of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS). Nearly all reports of this serious condition, which involves blood clots with low platelets, have been in adult women younger than 50 years old. A review of all available data at this time shows that the J&J/Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks. However, women younger than 50 years old especially should be aware of the rare but increased risk of this adverse event and that there are other COVID-19 vaccine options available for which this risk has not been seen. CDC and FDA will continue to monitor the safety of all COVID-19 vaccines.
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