EMA guidelines for the management of vaccine thromboembolic events

The special team COVID-19 The EMA (COVID-ETF) advises health professionals in the EU to consider recommendations from trained medical companies when evaluating people with signs and symptoms of thrombocytopenic syndrome (TTS) after vaccination with Vaxzevria and the Janssen vaccine. In this context, he points out instructions from the International Society for Thrombosis and Hemostasis (ISTH).

TTS requires rapid identification and urgent clinical management. National and international recommendations have been updated with evolving experience in the management of TTS and heparin-induced thrombocytopenia and thrombosis (HITT), a situation with some similarities to TTS.

The panel acknowledged that there were differences between the available guidelines (mainly regarding the tests and imaging used to diagnose and guide treatment, as well as treatment options with heparin-free anticoagulants, intravenous immunoglobulins and glucocorticoids). To manage suspected TTS, especially if there is no local guideline, the panel advises health professionals to consider ISTH's mid-term guidance on vaccine-induced immune thrombocytopenia (VITT), based on ongoing international collaboration of health professionals. . As TTS management evolves, instructions may be further updated in the future.

Examples of learned societies with treatment recommendations

International Society for Thrombosis and Hemostasis (ISTH): https://www.isth.org/page/covid19 Belgian Society for Thrombosis and Hemostasis (BSTH): https://bsth.be/covid19-resources Czech Society for Thrombosis and Hemostasis (CSTH): https://csth.cz/ German Society of Hematology and Medical Oncology (DGHO): https://www.dgho.de/covid-19 Federation of Spanish Scientific Medical Associations (FACME): https://facme.es/covid-19/covid-19-documentos/ Hemostasis and Thrombosis Study Group (GETH): https://site.geht.org/docutheque/ Thrombosis and Hemostasis Research Company (GTH): https://gth-online.org/covid-19-info/ Italian Society for the Study of Hemostasis and Thrombosis (SISET): https://www.siset.org/linee-guida/linee-guida-siset Swedish Society for Thrombosis and Hemostasis (SSTH): https://www.ssth.se/lankar British Society of Hematology (BSH): https://b-s-h.org.uk/about-us/news/covid-19-updates/ American Society of Hematology (ASH): https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia

The advice from the panel follows the evaluation of TTS by the EMA, a very rare event after vaccination with Vaxzevria and Janssen. The findings are based on EMA security label assessments, which have led to product information updates for both Vaxzevria and Janssen. Health professionals are informed through Direct Contact with Health Professionals (DHPCs) about the signs and symptoms of TTS with either vaccine, so that those affected can be diagnosed and treated as soon as possible using the available instructions. .

The Agency recognizes and supports the extensive work of health professionals and trained medical companies, which is necessary to optimize the management of people with suspected TTS after vaccination with Vaxzevria or the vaccine. COVID-19 janssen.