Italian Medicines Agency Agenzia Italiana del Farmaco

COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome - COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome

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COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome

COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome.

Summary

Capillary leak syndrome (CLS):

  • Very rare cases of capillary leak syndrome (CLS) have been reported in the first days after vaccination with COVID-19 Vaccine Janssen, in some cases with a fatal outcome. A history of CLS has been reported in at least one case.
  • COVID-19 Vaccine Janssen is now contraindicated in individuals who have previously experienced episodes of CLS.
  • CLS is characterised by acute episodes of oedema mainly affecting the limbs, hypotension, haemoconcentration and hypoalbuminaemia. Patients with an acute episode of CLS following vaccination require prompt recognition and treatment. Intensive supportive therapy is usually warranted.

Thrombosis with thrombocytopenia syndrome (TTS)

  • Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with COVID-19 Vaccine Janssen should be actively investigated for signs of thrombosis. Similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia.
  • TTS requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.


Published on: 19 July 2021

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