TY - JOUR
T1 - Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID-19 Adenovirus Vector Vaccines on European Healthcare Professionals
AU - van Vliet, Ella
AU - Lipovec, Nanča Čebron
AU - van der Goot, Marloes
AU - Abtahi, Shahab
AU - Ribeiro -Vaz, Inês
AU - Poplavska, Elita
AU - Dermiki-Gkana, Foteini
AU - Oikonomou, Chara
AU - Deligianni, Elena
AU - Kontogiorgis, Christos
AU - Silva, Ana Marta
AU - Ferreira, Paula Barão Sousa
AU - Kos, Mitja
AU - Almarsdóttir, Anna Birna
AU - Jacobsen, Ramune
AU - Buhl, Caroline
AU - de Bruijn, Adrie
AU - Hegger, Ingrid
AU - Alves, Teresa Leonardo
N1 - Funding Information:
Funding: The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network which is a public academic partnership coordinated by the Utrecht University, The Netherlands. The project has received support from the European Medicines Agency under the Framework service contract nr. EMA/2018/23/PE. The content of this paper expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.
Funding Information:
The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network which is a public academic partnership coordinated by the Utrecht University, The Netherlands. The project has received support from the European Medicines Agency under the Framework service contract nr. EMA/2018/23/PE. The content of this paper expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties. Funding:
Publisher Copyright:
© 2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
PY - 2024
Y1 - 2024
N2 - Purpose: The European Medicines Agency (EMA) issued regulatory actions and communications in 2021 on thrombosis with thrombocytopenia syndrome (TTS) associated with adenovirus vector vaccines Vaxzevria or Jcovden. This study aimed to evaluate the impact of these actions on awareness, knowledge and implementation in practises of healthcare professionals (HCP). Methods: Web-based cross-sectional surveys were conducted on HCPs engaged in the vaccination, monitoring or counselling about the vaccines. We measured awareness and knowledge of the risk of TTS and their implementation of recommendations in practise. Descriptive and qualitative analyses were conducted. This study took place in Greece, Latvia, Netherlands, Portugal and Slovenia. Results: We surveyed 1659 HCPs. From these, 914 were included in the analysis. Most were aware about the reports of TTS associated with COVID-19 adenovirus vector vaccines, with countries reporting percentages between 85% and 97%. Mainstream media, health authorities and peers were the main sources of TTS risk information. Most HCPs were able to identify key symptoms from TTS but were less familiar with minor symptoms. Guidelines from health authorities on COVID-19 vaccination impacted on professional practise of 55%–77% of HCPs. The reported use of product information across countries was moderate, with some variations. Conclusions: Awareness about and knowledge of TTS risk from COVID-19 adenoviral vector vaccines were high among HCPs. HCPs reported a clear preference for national guidelines as source of risk information and the implementation of product information remained moderate across countries.
AB - Purpose: The European Medicines Agency (EMA) issued regulatory actions and communications in 2021 on thrombosis with thrombocytopenia syndrome (TTS) associated with adenovirus vector vaccines Vaxzevria or Jcovden. This study aimed to evaluate the impact of these actions on awareness, knowledge and implementation in practises of healthcare professionals (HCP). Methods: Web-based cross-sectional surveys were conducted on HCPs engaged in the vaccination, monitoring or counselling about the vaccines. We measured awareness and knowledge of the risk of TTS and their implementation of recommendations in practise. Descriptive and qualitative analyses were conducted. This study took place in Greece, Latvia, Netherlands, Portugal and Slovenia. Results: We surveyed 1659 HCPs. From these, 914 were included in the analysis. Most were aware about the reports of TTS associated with COVID-19 adenovirus vector vaccines, with countries reporting percentages between 85% and 97%. Mainstream media, health authorities and peers were the main sources of TTS risk information. Most HCPs were able to identify key symptoms from TTS but were less familiar with minor symptoms. Guidelines from health authorities on COVID-19 vaccination impacted on professional practise of 55%–77% of HCPs. The reported use of product information across countries was moderate, with some variations. Conclusions: Awareness about and knowledge of TTS risk from COVID-19 adenoviral vector vaccines were high among HCPs. HCPs reported a clear preference for national guidelines as source of risk information and the implementation of product information remained moderate across countries.
KW - COVID-19 vaccines
KW - healthcare professionals
KW - regulatory actions
KW - risk communication
KW - SARS-CoV-2 adenovirus vector vaccines
KW - thrombosis with thrombocytopenia syndrome
U2 - 10.1002/pds.70057
DO - 10.1002/pds.70057
M3 - Journal article
C2 - 39586738
AN - SCOPUS:85210103790
VL - 33
JO - Pharmacoepidemiology and Drug Safety
JF - Pharmacoepidemiology and Drug Safety
SN - 1053-8569
IS - 12
M1 - e70057
ER -