FDA announces Janssen COVID-19 vaccine use revisions

Dec. 15, 2021

The U.S. Food and Drug Administration (FDA) has announced revisions to its fact sheets about the Janssen COVID-19 vaccine for providers, as well as for and vaccine recipients and caregivers. The revisions warn of a contraindication in the administration of the Janssen COVID-19 vaccine to people with a history of thrombosis with thrombocytopenia.

The change applies to the Janssen COVID-19 vaccine or any other adenovirus-vectored COVID-19 vaccine, the agency said. It also updates the information about the risk of thrombosis with thrombocytopenia syndrome (TTS) following vaccination. 

The FDA said, “cases of TTS following administration of the Janssen COVID-19 vaccine have been reported in males and females 18 years of age and older, with the highest reporting rate of approximately 1 (one) case per 100,000 doses administered in females 30-49 years of age. Overall, approximately 1 out of 7 cases has been fatal.”

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.”

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