On April 23, 2021, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) issued a statement recommending that the use of the Janssen COVID-19 Vaccine should be resumed in the United States. After a thorough safety review, the FDA and CDC have determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years and older.
At this time, the data available suggests that the chance of developing thrombosis-thrombocytopenia syndrome is very low. However, the FDA and CDC will continue to investigate the risk. Additionally, the FDA has revised its fact sheet for healthcare providers administering the Janssen COVID-19 vaccine and fact sheet for recipients and caregivers to include updated risk information.
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