Understanding thrombosis with thrombocytopenia syndrome after COVID-19 vaccination
Alessandra Buoninfante,
Arno Andeweg,
Alexander T. Baker,
Mitesh Borad,
Nigel Crawford,
Jean-Michel Dogné,
David Garcia-Azorin,
Andreas Greinacher,
Rita Helfand,
Anders Hviid,
Stefan Kochanek,
Marta López-Fauqued,
Ishac Nazy,
Anand Padmanabhan,
Sue Pavord,
Daniel Prieto-Alhambra,
Huyen Tran,
Ulla Wandel Liminga,
Marco Cavaleri
Affiliations
Alessandra Buoninfante
Health Threats and Vaccines Strategy, European Medicines Agency
Arno Andeweg
Health Threats and Vaccines Strategy, European Medicines Agency
Alexander T. Baker
Division of Hematology and Medical Oncology, Mayo Clinic
Mitesh Borad
Mayo Clinic Cancer Center
Nigel Crawford
Royal Children’s Hospital, Murdoch Children’s Research Institute, Department Paediatrics, The University of Melbourne
Jean-Michel Dogné
Department of Pharmacy, Namur Research Institute for Life Sciences, University of Namur
David Garcia-Azorin
Department of Neurology, Hospital Clínico Universitario de Valladolid
Andreas Greinacher
Department of Transfusion Medicine, University Medicine Greifswald
Rita Helfand
National Center for Emerging and Zoonotic Infectious Diseases, CDC
Anders Hviid
Pharmacovigilance Research Center, Department of Drug Development and Clinical Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen
Stefan Kochanek
Department of Gene Therapy, University of Ulm
Marta López-Fauqued
Vaccines and Therapies for Infectious Diseases, European Medicines Agency
Ishac Nazy
McMaster Centre for Transfusion Research, McMaster University
Anand Padmanabhan
Department of Laboratory Medicine and Pathology, Mayo Clinic
Sue Pavord
Department Hematology, Oxford University Hospitals NHS Foundation Trust
Daniel Prieto-Alhambra
Centre for Statistics in Medicine (CSM), Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDROMS), University of Oxford
Huyen Tran
Department of Clinical Haematology, The Alfred Hospital
Ulla Wandel Liminga
EMA Pharmacovigilance Risk Assessment Committee member
Marco Cavaleri
Health Threats and Vaccines Strategy, European Medicines Agency
Safety and efficacy of vaccines against the SARS-CoV-2 coronavirus has been demonstrated in clinical trials and next by their real world use through the course of the ongoing COVID-19 pandemic. However, very rare adverse events have been detected post-authorization in certain parts of the world. This meeting report summarizes an EMA workshop’s discussion on the epidemiology, clinical presentation and biology of thrombosis with thrombocytopenia syndrome after adenovirus vector COVID-19 vaccination. General agreement was reached by international regulators, scientists and developers on the steps needed to fill the gaps in the characterization of this new syndrome. In particular, actions should be taken to improve the post-vaccination surveillance activities in low and middle income countries and investigate potential genetic predisposition factors.
