Understanding thrombosis with thrombocytopenia syndrome after COVID-19 vaccination

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  • Alessandra Buoninfante
  • Arno Andeweg
  • Alexander T. Baker
  • Mitesh Borad
  • Nigel Crawford
  • Jean Michel Dogné
  • David Garcia-Azorin
  • Andreas Greinacher
  • Rita Helfand
  • Hviid, Anders Peter
  • Stefan Kochanek
  • Marta López-Fauqued
  • Ishac Nazy
  • Anand Padmanabhan
  • Sue Pavord
  • Daniel Prieto-Alhambra
  • Huyen Tran
  • Ulla Wandel Liminga
  • Marco Cavaleri
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.
Original languageEnglish
Article number141
Journalnpj Vaccines
Volume7
Issue number1
Number of pages6
DOIs
Publication statusPublished - 2022

Bibliographical note

Funding Information:
We would like to thank all workshop participants for sharing their expertise and insights on the topic of TTS and VITT including the workshop presenters: Nicolas Praet, Kerstin Luhn, Nadia Foskett, and Taylor Cohen, who shared data on behalf of the marketing authorization holders for adenovirus vector COVID-19 vaccines.

Funding Information:
M.B. declared a research grant to institution from AstraZeneca for clinical study. A.P. reported pending/issued patents in the area of anti-PF4 antibodies, HIT, VITT and platelet storage (assigned to Mayo Clinic, Retham Technologies, and Versiti Blood Center of Wisconsin), equity ownership in and serving as an officer of Retham Technologies, and member of the advisory board of Veralox Therapeutics. D.P.A. receives funding from the UK National Institute for Health and Care Research (NIHR) in the form of a senior research fellowship and from the Oxford NIHR Biomedical Research Centre. His research group has received funding from the European Medicines Agency and Innovative Medicines Initiative. His research group has received research grant/s from Amgen, Chiesi-Taylor, GSK, Novartis, and UCB Biopharma. His department has also received advisory or consultancy fees from Amgen, Astellas, Astra Zeneca, Johnson and Johnson, and UCB Biopharma; and speaker fees from Amgen and UCB Biopharma. Janssen and Synapse Management Partners have supported training programmes organised by DPA’s department and open for external participants organized by his department outside the submitted work. AG has received funding from the European Medicines Agency and reports consulting fees from: Aspen, Bayer Vital, Chromatec, Instrumentation Laboratory, Macopharma, Sanofi-Aventis, Roche, GTH e.V., Mylan Germany, Takeda Pharma, Falk Foundation e.V., Dilaflor, outside of this work. Also, AG has a patent Screening Methods for transfusion related acute lung injury (TRALI) with royalties paid to EP2321644, 18.05.2011. All the other authors declared no competing interests.

ID: 328694087