Impact of regulatory risk communication on thrombosis with thrombocytopenia syndrome for COVID-19 adenovirus vector vaccines on European Healthcare Professionals

Vliet, Ella van (author), Čebron Lipovec, Nanča (author), van der Goot, Marloes (author), Abtahi, Shahab (author), Ribeiro-Vaz, Inês (author), Poplavska, Elita (author), Dermiki-Gkana, Foteini (author), Oikonomou, Chara (author), Deligianni, Elena (author), Kos, Mitja (author)

Purpose: The European Medicines Agency (EMA) issued regulatory actions and communications in 2021 on thrombosis withthrombocytopenia syndrome (TTS) associated with adenovirus vector vaccines Vaxzevria or Jcovden. This study aimed to eval-uate 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 counsellingabout the vaccines. We measured awareness and knowledge of the risk of TTS and their implementation of recommendationsin practise. Descriptive and qualitative analyses were conducted. This study took place in Greece, Latvia, Netherlands, Portugaland Slovenia. Results: We surveyed 1659 HCPs. From these, 914 were included in the analysis. Most were aware about the reports of TTSassociated with COVID-19 adenovirus vector vaccines, with countries reporting percentages between 85% and 97%. Mainstreammedia, 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 vaccinationimpacted 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 infor-mation remained moderate across countries.

• Language: English
• Keywords: COVID-19 vaccines, healthcare professionals, regulatory actions, risk communication, SARS- CoV-2 adenovirus vector vaccines, thrombosis with thrombocytopenia syndrome
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2024
• Number of pages: 14 str.
• Numbering: Vol. 33, iss. 12, [article e70057]
• PID: 20.500.12556/RUL-165843
• UDC: 615.371:616-005.6
• ISSN on article: 1053-8569
• DOI: 10.1002/pds.70057
• COBISS.SI-ID: 216692483
• Publication date in RUL: 12.12.2024

Record is a part of a journal

• Title: Pharmacoepidemiology and drug safety
• Shortened title: Pharmacoepidemiol. drug saf.
• Publisher: Wiley
• ISSN: 1053-8569
• COBISS.SI-ID: 1515540

Licences

• License: CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
• Link: http://creativecommons.org/licenses/by-nc-nd/4.0/
• Description: The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.

Secondary language

• Language: Slovenian
• Keywords: regulativni ukrepi, zdravstveni delavci, tromboza s trombocitopeničnim sindromom, tromboza, cepiva, SARS-CoV-2, COVID-19

Projects

• Funder: Other - Other funder or multiple funders
• Project number: EMA/2018/23/PE
• Name: European Medicines Agency
• Acronym: EMA