{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T03:10:30Z","timestamp":1773285030929,"version":"3.50.1"},"reference-count":19,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,11,25]],"date-time":"2024-11-25T00:00:00Z","timestamp":1732492800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013120","name":"European Medicines Agency","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013120","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,12]]},"abstract":"ABSTRACT<\/jats:title>Purpose<\/jats:title>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).<\/jats:p><\/jats:sec>Methods<\/jats:title>Web\u2010based cross\u2010sectional 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.<\/jats:p><\/jats:sec>Results<\/jats:title>We surveyed 1659 HCPs. From these, 914 were included in the analysis. Most were aware about the reports of TTS associated with COVID\u201019 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\u201019 vaccination impacted on professional practise of 55%\u201377% of HCPs. The reported use of product information across countries was moderate, with some variations.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Awareness about and knowledge of TTS risk from COVID\u201019 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.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.70057","type":"journal-article","created":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T02:23:25Z","timestamp":1732587805000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID\u201019 Adenovirus Vector Vaccines on European Healthcare Professionals"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6226-5491","authenticated-orcid":false,"given":"Ella","family":"van Vliet","sequence":"first","affiliation":[{"name":"Medical Technology Department, Centre for Health Protection National Institute for Public Health and the Environment (RIVM) Bilthoven The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nan\u010da \u010cebron","family":"Lipovec","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy, Department of Social Pharmacy University of Ljubljana Ljubljana Slovenia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marloes","family":"van der Goot","sequence":"additional","affiliation":[{"name":"Medical Technology Department, Centre for Health Protection National Institute for Public Health and the Environment (RIVM) Bilthoven The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0482-5563","authenticated-orcid":false,"given":"Shahab","family":"Abtahi","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3442-8158","authenticated-orcid":false,"given":"In\u00eas","family":"Ribeiro \u2010Vaz","sequence":"additional","affiliation":[{"name":"MEDCIDS \u2010 Department of Community Medicine, Health Information and Decision Faculty of Medicine of University of Porto Porto Portugal"},{"name":"CINTESIS \u2010 Centre for Health Technology and Services Research Faculty of Medicine of University of Porto Porto Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elita","family":"Poplavska","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy & Institute of Public Health Riga Stradins University Riga Latvia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Foteini","family":"Dermiki\u2010Gkana","sequence":"additional","affiliation":[{"name":"Laboratory of Hygiene and Environmental Protection, Faculty of Medicine, School of Health Sciences Democritus University of Thrace Alexandroupolis Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chara","family":"Oikonomou","sequence":"additional","affiliation":[{"name":"Laboratory of Hygiene and Environmental Protection, Faculty of Medicine, School of Health Sciences Democritus University of Thrace Alexandroupolis Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Deligianni","sequence":"additional","affiliation":[{"name":"Laboratory of Hygiene and Environmental Protection, Faculty of Medicine, School of Health Sciences Democritus University of Thrace Alexandroupolis Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7835-8246","authenticated-orcid":false,"given":"Christos","family":"Kontogiorgis","sequence":"additional","affiliation":[{"name":"Laboratory of Hygiene and Environmental Protection, Faculty of Medicine, School of Health Sciences Democritus University of Thrace Alexandroupolis Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana Marta","family":"Silva","sequence":"additional","affiliation":[{"name":"MEDCIDS \u2010 Department of Community Medicine, Health Information and Decision Faculty of Medicine of University of Porto Porto Portugal"},{"name":"CINTESIS \u2010 Centre for Health Technology and Services Research Faculty of Medicine of University of Porto Porto Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5712-1338","authenticated-orcid":false,"given":"Paula Bar\u00e3o Sousa","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Pharmacological Sciences and Health Technologies Faculty of Pharmacy of University of Lisbon Lisbon Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitja","family":"Kos","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy, Department of Social Pharmacy University of Ljubljana Ljubljana Slovenia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna Birna","family":"Almarsd\u00f3ttir","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8142-9807","authenticated-orcid":false,"given":"Ramune","family":"Jacobsen","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Buhl","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrie","family":"de Bruijn","sequence":"additional","affiliation":[{"name":"Medical Technology Department, Centre for Health Protection National Institute for Public Health and the Environment (RIVM) Bilthoven The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingrid","family":"Hegger","sequence":"additional","affiliation":[{"name":"Medicines Department, Centre for Health Protection National Institute for Public Health and the Environment (RIVM) Bilthoven The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa Leonardo","family":"Alves","sequence":"additional","affiliation":[{"name":"Medicines Department, Centre for Health Protection National Institute for Public Health and the Environment (RIVM) Bilthoven The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,11,25]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"European Medicines Agency \u201cEMA Raises Awareness of Clinical Care Recommendations to Manage Suspected Thrombosis With Thrombocytopenia Syndrome \u201dhttps:\/\/www.ema.europa.eu\/en\/news\/ema\u2010raises\u2010awareness\u2010clinical\u2010care\u2010recommendations\u2010manage\u2010suspected\u2010thrombosis\u2010thrombocytopenia."},{"key":"e_1_2_10_3_1","unstructured":"European Medicines Agency \u201cEPAR \u2010 Vaxzevria (Previously COVID\u201019 Vaccine AstraZeneca) \u201dhttps:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/vaxzevria."},{"key":"e_1_2_10_4_1","unstructured":"European Medicines Agency \u201cEPAR \u2010 Jcovden (Previously COVID\u201019 Vaccine Janssen) \u201dhttps:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/jcovden\u2010previously\u2010covid\u201019\u2010vaccine\u2010janssen."},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2104840"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n1114"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.7517"},{"key":"e_1_2_10_8_1","unstructured":"World Health Organization \u201cGuidance for clinical case management of thrombosis with thrombocytopenia syndrome (TTS) following vaccination to prevent coronavirus disease (COVID\u201019) (1\u201342) \u201d(2023) https:\/\/www.who.int\/publications\/i\/item\/9789240061989."},{"key":"e_1_2_10_9_1","unstructured":"European Medicines Agency \u201cJCOVDEN \u2010 Procedural Steps Taken and Scientific Information After the Authorisation \u201dhttps:\/\/www.ema.europa.eu\/en\/documents\/procedural\u2010steps\u2010after\/covid\u201019\u2010vaccine\u2010janssen\u2010epar\u2010procedural\u2010steps\u2010taken\u2010scientific\u2010information\u2010after\u2010authorisation_en.pdf."},{"key":"e_1_2_10_10_1","unstructured":"European Medicines Agency \u201cVaxzevria \u2010 Procedural Steps Taken and Scientific Information After the Authorisation \u201dhttps:\/\/www.ema.europa.eu\/en\/documents\/procedural\u2010steps\u2010after\/vaxzevria\u2010previously\u2010covid\u201019\u2010vaccine\u2010astrazeneca\u2010epar\u2010procedural\u2010steps\u2010taken\u2010scientific\u2010information_en.pdf."},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pbio.3000959"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(20)30461\u2010X"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2020.12.025"},{"key":"e_1_2_10_14_1","article-title":"Impact of EU Label Changes and Regulatory Communication on SARS\u2010CoV\u20102 Adenovirus Vector Vaccines in Context of Thrombosis With Thrombocytopenia Syndrome (TTS): Risk Awareness and Adherence (RiskAwareTTS)","author":"Real\u2010World Data Catalogues","year":"2024","journal-title":"European Medicines Agency"},{"key":"e_1_2_10_15_1","unstructured":"ENCePP \u201cENCePP Seal. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance \u201d(2024) https:\/\/encepp.europa.eu\/encepp\u2010toolkit\/encepp\u2010seal_en."},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines11101616"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sapharm.2018.06.015"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/2168479013501311"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2023.12.065"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1442\u20102018.2010.00541.x"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.70057","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,2]],"date-time":"2025-01-02T08:32:17Z","timestamp":1735806737000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.70057"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,25]]},"references-count":19,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1002\/pds.70057"],"URL":"https:\/\/doi.org\/10.1002\/pds.70057","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,25]]},"assertion":[{"value":"2024-01-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-11-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70057"}}