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Pharmacoepidemiology and Drug Safety
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Pharmacoepidemiology and Drug Safety
Article . 2024
License: CC BY NC ND
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Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals

Authors: Ella van Vliet; Nanča Čebron Lipovec; Marloes van der Goot; Shahab Abtahi; Inês Ribeiro ‐Vaz; Elita Poplavska; Foteini Dermiki‐Gkana; +12 Authors

Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals

Abstract

ABSTRACTPurposeThe 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).MethodsWeb‐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.ResultsWe 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.ConclusionsAwareness 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.

Keywords

Male, Adult, regulatory actions, Health Knowledge, Attitudes, Practice, Health Personnel/statistics & numerical data, COVID-19 Vaccines, Health Personnel, COVID-19/prevention & control, COVID-19 vaccines, SARS‐CoV‐2 adenovirus vector vaccines, Thrombocytopenia/epidemiology, SARS-CoV-2 adenovirus vector vaccines, Europe/epidemiology, risk communication, SDG 3 - Good Health and Well-being, Adenovirus Vaccines, Adenovirus Vaccines/administration & dosage, Surveys and Questionnaires, Humans, COVID‐19 vaccines, COVID-19 Vaccines/administration & dosage, Practice, Thrombosis/prevention & control, Health Knowledge, Communication, COVID-19, Thrombosis, healthcare professionals, Middle Aged, Thrombocytopenia, thrombosis with thrombocytopenia syndrome, Europe, Cross-Sectional Studies, Attitudes, Original Article, Female

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    2
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
2
Top 10%
Average
Average
Green
hybrid