FDA updates J&J COVID-19 vaccine fact sheets to warn of thrombosis risk

Dec 15, 2021 - 03:59 PM
FDA-guidance

The Food and Drug Administration yesterday updated its fact sheets for providers and recipients and caregivers for the Johnson & Johnson COVID-19 vaccine, with each revised document outlining a contraindication for the vaccine’s administration to individuals with histories of thrombosis with thrombocytopenia following doses of this or any other adenovirus-vectored COVID-19 vaccine. The updated fact sheets discuss the risk of thrombosis with thrombocytopenia syndrome following vaccination, an ailment that has been observed in males and females 18 years of age and older, with females 30-49 years of age experiencing the highest reporting rate (approximately one case per 100,000 administered doses). Overall, thrombosis with thrombocytopenia syndrome is fatal in approximately one out of seven cases.

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