Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals
ABSTRACT 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, knowled...
Gespeichert in:
Veröffentlicht in: | Pharmacoepidemiology and drug safety 2024-12, Vol.33 (12), p.e70057-n/a |
---|---|
Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | n/a |
---|---|
container_issue | 12 |
container_start_page | e70057 |
container_title | Pharmacoepidemiology and drug safety |
container_volume | 33 |
creator | van Vliet, Ella Lipovec, Nanča Čebron van der Goot, Marloes Abtahi, Shahab Ribeiro ‐Vaz, Inês Poplavska, Elita Dermiki‐Gkana, Foteini Oikonomou, Chara Deligianni, Elena Kontogiorgis, Christos Silva, Ana Marta Ferreira, Paula Barão Sousa Kos, Mitja Almarsdóttir, Anna Birna Jacobsen, Ramune Buhl, Caroline Bruijn, Adrie Hegger, Ingrid Alves, Teresa Leonardo |
description | ABSTRACT
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. |
doi_str_mv | 10.1002/pds.70057 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11589195</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3147192331</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3347-a4bb0382eb86b3b031f836ba3ae6a1923ba87de297821253428f3f773ac0aac13</originalsourceid><addsrcrecordid>eNp1kdFO1TAYxxejEUQvfAHTxBu9GLTrtrZXhhxATkICATxeNt-6jlPc2tFumN3xCL6Db-aT2HGAqIlJk6_t9-v_-zf_JHlL8C7BONvr67DLMC7Ys2SbYCFSUhTs-bwvaMqLUmwlr0K4xjj2RP4y2aKi4CWjfDv5uex6UANyDTrXV2MLg_MTOjfhG1q4rhutUTAYZ1Fcl2vvusoFE9BXM6wfz2oaXK-tAXQx2TpeadQ4jxanq-XBr7sfRKD9Wlt3a_wY0EqrOAGtQCljdZhlD0cf34NFxxraYa3Aa3TmXaNDiIOhDa-TF00s-s1D3Um-HB1eLo7Tk9PPy8X-SaoozVkKeVVhyjNd8bKicUsaTssKKOgSiMhoBZzVOhOMZyQraJ7xhjaMUVAYQBG6k3za6PZj1elaaTt4aGXvTQd-kg6M_LtjzVpeuVtJSMEFEUVU-PCg4N3NqMMgOxOUbluw2o1BUkIzHufeo-__Qa_d6OfvRipns186W_q4oZR3IXjdPLkhWM7Zy5i9vM8-su_-tP9EPoYdgb0N8N20evq_kjw7uNhI_gYlGL0a</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3147192331</pqid></control><display><type>article</type><title>Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals</title><source>MEDLINE</source><source>Wiley Online Library</source><creator>van Vliet, Ella ; Lipovec, Nanča Čebron ; van der Goot, Marloes ; Abtahi, Shahab ; Ribeiro ‐Vaz, Inês ; Poplavska, Elita ; Dermiki‐Gkana, Foteini ; Oikonomou, Chara ; Deligianni, Elena ; Kontogiorgis, Christos ; Silva, Ana Marta ; Ferreira, Paula Barão Sousa ; Kos, Mitja ; Almarsdóttir, Anna Birna ; Jacobsen, Ramune ; Buhl, Caroline ; Bruijn, Adrie ; Hegger, Ingrid ; Alves, Teresa Leonardo</creator><creatorcontrib>van Vliet, Ella ; Lipovec, Nanča Čebron ; van der Goot, Marloes ; Abtahi, Shahab ; Ribeiro ‐Vaz, Inês ; Poplavska, Elita ; Dermiki‐Gkana, Foteini ; Oikonomou, Chara ; Deligianni, Elena ; Kontogiorgis, Christos ; Silva, Ana Marta ; Ferreira, Paula Barão Sousa ; Kos, Mitja ; Almarsdóttir, Anna Birna ; Jacobsen, Ramune ; Buhl, Caroline ; Bruijn, Adrie ; Hegger, Ingrid ; Alves, Teresa Leonardo</creatorcontrib><description>ABSTRACT
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.</description><identifier>ISSN: 1053-8569</identifier><identifier>ISSN: 1099-1557</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.70057</identifier><identifier>PMID: 39586738</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Inc</publisher><subject>Adenovirus Vaccines - administration & dosage ; Adenoviruses ; Adult ; Communication ; COVID-19 ; COVID-19 - epidemiology ; COVID-19 - prevention & control ; COVID-19 vaccines ; COVID-19 Vaccines - administration & dosage ; Cross-Sectional Studies ; Europe - epidemiology ; Female ; Health care ; Health Knowledge, Attitudes, Practice ; Health Personnel - statistics & numerical data ; healthcare professionals ; Humans ; Immunization ; Male ; Medical personnel ; Middle Aged ; Original ; Professionals ; regulatory actions ; risk communication ; SARS‐CoV‐2 adenovirus vector vaccines ; Surveys and Questionnaires ; Thrombocytopenia ; Thrombocytopenia - epidemiology ; Thrombosis ; Thrombosis - epidemiology ; Thrombosis - etiology ; Thrombosis - prevention & control ; thrombosis with thrombocytopenia syndrome ; Vaccines</subject><ispartof>Pharmacoepidemiology and drug safety, 2024-12, Vol.33 (12), p.e70057-n/a</ispartof><rights>2024 The Author(s). published by John Wiley & Sons Ltd.</rights><rights>2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.</rights><rights>2024. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3347-a4bb0382eb86b3b031f836ba3ae6a1923ba87de297821253428f3f773ac0aac13</cites><orcidid>0000-0002-8142-9807 ; 0000-0001-6226-5491 ; 0000-0003-0482-5563 ; 0000-0001-7835-8246 ; 0000-0002-3442-8158 ; 0000-0001-5712-1338</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fpds.70057$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fpds.70057$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,777,781,882,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39586738$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van Vliet, Ella</creatorcontrib><creatorcontrib>Lipovec, Nanča Čebron</creatorcontrib><creatorcontrib>van der Goot, Marloes</creatorcontrib><creatorcontrib>Abtahi, Shahab</creatorcontrib><creatorcontrib>Ribeiro ‐Vaz, Inês</creatorcontrib><creatorcontrib>Poplavska, Elita</creatorcontrib><creatorcontrib>Dermiki‐Gkana, Foteini</creatorcontrib><creatorcontrib>Oikonomou, Chara</creatorcontrib><creatorcontrib>Deligianni, Elena</creatorcontrib><creatorcontrib>Kontogiorgis, Christos</creatorcontrib><creatorcontrib>Silva, Ana Marta</creatorcontrib><creatorcontrib>Ferreira, Paula Barão Sousa</creatorcontrib><creatorcontrib>Kos, Mitja</creatorcontrib><creatorcontrib>Almarsdóttir, Anna Birna</creatorcontrib><creatorcontrib>Jacobsen, Ramune</creatorcontrib><creatorcontrib>Buhl, Caroline</creatorcontrib><creatorcontrib>Bruijn, Adrie</creatorcontrib><creatorcontrib>Hegger, Ingrid</creatorcontrib><creatorcontrib>Alves, Teresa Leonardo</creatorcontrib><title>Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals</title><title>Pharmacoepidemiology and drug safety</title><addtitle>Pharmacoepidemiol Drug Saf</addtitle><description>ABSTRACT
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.</description><subject>Adenovirus Vaccines - administration & dosage</subject><subject>Adenoviruses</subject><subject>Adult</subject><subject>Communication</subject><subject>COVID-19</subject><subject>COVID-19 - epidemiology</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - administration & dosage</subject><subject>Cross-Sectional Studies</subject><subject>Europe - epidemiology</subject><subject>Female</subject><subject>Health care</subject><subject>Health Knowledge, Attitudes, Practice</subject><subject>Health Personnel - statistics & numerical data</subject><subject>healthcare professionals</subject><subject>Humans</subject><subject>Immunization</subject><subject>Male</subject><subject>Medical personnel</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Professionals</subject><subject>regulatory actions</subject><subject>risk communication</subject><subject>SARS‐CoV‐2 adenovirus vector vaccines</subject><subject>Surveys and Questionnaires</subject><subject>Thrombocytopenia</subject><subject>Thrombocytopenia - epidemiology</subject><subject>Thrombosis</subject><subject>Thrombosis - epidemiology</subject><subject>Thrombosis - etiology</subject><subject>Thrombosis - prevention & control</subject><subject>thrombosis with thrombocytopenia syndrome</subject><subject>Vaccines</subject><issn>1053-8569</issn><issn>1099-1557</issn><issn>1099-1557</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kdFO1TAYxxejEUQvfAHTxBu9GLTrtrZXhhxATkICATxeNt-6jlPc2tFumN3xCL6Db-aT2HGAqIlJk6_t9-v_-zf_JHlL8C7BONvr67DLMC7Ys2SbYCFSUhTs-bwvaMqLUmwlr0K4xjj2RP4y2aKi4CWjfDv5uex6UANyDTrXV2MLg_MTOjfhG1q4rhutUTAYZ1Fcl2vvusoFE9BXM6wfz2oaXK-tAXQx2TpeadQ4jxanq-XBr7sfRKD9Wlt3a_wY0EqrOAGtQCljdZhlD0cf34NFxxraYa3Aa3TmXaNDiIOhDa-TF00s-s1D3Um-HB1eLo7Tk9PPy8X-SaoozVkKeVVhyjNd8bKicUsaTssKKOgSiMhoBZzVOhOMZyQraJ7xhjaMUVAYQBG6k3za6PZj1elaaTt4aGXvTQd-kg6M_LtjzVpeuVtJSMEFEUVU-PCg4N3NqMMgOxOUbluw2o1BUkIzHufeo-__Qa_d6OfvRipns186W_q4oZR3IXjdPLkhWM7Zy5i9vM8-su_-tP9EPoYdgb0N8N20evq_kjw7uNhI_gYlGL0a</recordid><startdate>202412</startdate><enddate>202412</enddate><creator>van Vliet, Ella</creator><creator>Lipovec, Nanča Čebron</creator><creator>van der Goot, Marloes</creator><creator>Abtahi, Shahab</creator><creator>Ribeiro ‐Vaz, Inês</creator><creator>Poplavska, Elita</creator><creator>Dermiki‐Gkana, Foteini</creator><creator>Oikonomou, Chara</creator><creator>Deligianni, Elena</creator><creator>Kontogiorgis, Christos</creator><creator>Silva, Ana Marta</creator><creator>Ferreira, Paula Barão Sousa</creator><creator>Kos, Mitja</creator><creator>Almarsdóttir, Anna Birna</creator><creator>Jacobsen, Ramune</creator><creator>Buhl, Caroline</creator><creator>Bruijn, Adrie</creator><creator>Hegger, Ingrid</creator><creator>Alves, Teresa Leonardo</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-8142-9807</orcidid><orcidid>https://orcid.org/0000-0001-6226-5491</orcidid><orcidid>https://orcid.org/0000-0003-0482-5563</orcidid><orcidid>https://orcid.org/0000-0001-7835-8246</orcidid><orcidid>https://orcid.org/0000-0002-3442-8158</orcidid><orcidid>https://orcid.org/0000-0001-5712-1338</orcidid></search><sort><creationdate>202412</creationdate><title>Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals</title><author>van Vliet, Ella ; Lipovec, Nanča Čebron ; van der Goot, Marloes ; Abtahi, Shahab ; Ribeiro ‐Vaz, Inês ; Poplavska, Elita ; Dermiki‐Gkana, Foteini ; Oikonomou, Chara ; Deligianni, Elena ; Kontogiorgis, Christos ; Silva, Ana Marta ; Ferreira, Paula Barão Sousa ; Kos, Mitja ; Almarsdóttir, Anna Birna ; Jacobsen, Ramune ; Buhl, Caroline ; Bruijn, Adrie ; Hegger, Ingrid ; Alves, Teresa Leonardo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3347-a4bb0382eb86b3b031f836ba3ae6a1923ba87de297821253428f3f773ac0aac13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adenovirus Vaccines - administration & dosage</topic><topic>Adenoviruses</topic><topic>Adult</topic><topic>Communication</topic><topic>COVID-19</topic><topic>COVID-19 - epidemiology</topic><topic>COVID-19 - prevention & control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - administration & dosage</topic><topic>Cross-Sectional Studies</topic><topic>Europe - epidemiology</topic><topic>Female</topic><topic>Health care</topic><topic>Health Knowledge, Attitudes, Practice</topic><topic>Health Personnel - statistics & numerical data</topic><topic>healthcare professionals</topic><topic>Humans</topic><topic>Immunization</topic><topic>Male</topic><topic>Medical personnel</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Professionals</topic><topic>regulatory actions</topic><topic>risk communication</topic><topic>SARS‐CoV‐2 adenovirus vector vaccines</topic><topic>Surveys and Questionnaires</topic><topic>Thrombocytopenia</topic><topic>Thrombocytopenia - epidemiology</topic><topic>Thrombosis</topic><topic>Thrombosis - epidemiology</topic><topic>Thrombosis - etiology</topic><topic>Thrombosis - prevention & control</topic><topic>thrombosis with thrombocytopenia syndrome</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van Vliet, Ella</creatorcontrib><creatorcontrib>Lipovec, Nanča Čebron</creatorcontrib><creatorcontrib>van der Goot, Marloes</creatorcontrib><creatorcontrib>Abtahi, Shahab</creatorcontrib><creatorcontrib>Ribeiro ‐Vaz, Inês</creatorcontrib><creatorcontrib>Poplavska, Elita</creatorcontrib><creatorcontrib>Dermiki‐Gkana, Foteini</creatorcontrib><creatorcontrib>Oikonomou, Chara</creatorcontrib><creatorcontrib>Deligianni, Elena</creatorcontrib><creatorcontrib>Kontogiorgis, Christos</creatorcontrib><creatorcontrib>Silva, Ana Marta</creatorcontrib><creatorcontrib>Ferreira, Paula Barão Sousa</creatorcontrib><creatorcontrib>Kos, Mitja</creatorcontrib><creatorcontrib>Almarsdóttir, Anna Birna</creatorcontrib><creatorcontrib>Jacobsen, Ramune</creatorcontrib><creatorcontrib>Buhl, Caroline</creatorcontrib><creatorcontrib>Bruijn, Adrie</creatorcontrib><creatorcontrib>Hegger, Ingrid</creatorcontrib><creatorcontrib>Alves, Teresa Leonardo</creatorcontrib><collection>Wiley-Blackwell Open Access Collection</collection><collection>Wiley Free Archive</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pharmacoepidemiology and drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van Vliet, Ella</au><au>Lipovec, Nanča Čebron</au><au>van der Goot, Marloes</au><au>Abtahi, Shahab</au><au>Ribeiro ‐Vaz, Inês</au><au>Poplavska, Elita</au><au>Dermiki‐Gkana, Foteini</au><au>Oikonomou, Chara</au><au>Deligianni, Elena</au><au>Kontogiorgis, Christos</au><au>Silva, Ana Marta</au><au>Ferreira, Paula Barão Sousa</au><au>Kos, Mitja</au><au>Almarsdóttir, Anna Birna</au><au>Jacobsen, Ramune</au><au>Buhl, Caroline</au><au>Bruijn, Adrie</au><au>Hegger, Ingrid</au><au>Alves, Teresa Leonardo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals</atitle><jtitle>Pharmacoepidemiology and drug safety</jtitle><addtitle>Pharmacoepidemiol Drug Saf</addtitle><date>2024-12</date><risdate>2024</risdate><volume>33</volume><issue>12</issue><spage>e70057</spage><epage>n/a</epage><pages>e70057-n/a</pages><issn>1053-8569</issn><issn>1099-1557</issn><eissn>1099-1557</eissn><abstract>ABSTRACT
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.</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Inc</pub><pmid>39586738</pmid><doi>10.1002/pds.70057</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0002-8142-9807</orcidid><orcidid>https://orcid.org/0000-0001-6226-5491</orcidid><orcidid>https://orcid.org/0000-0003-0482-5563</orcidid><orcidid>https://orcid.org/0000-0001-7835-8246</orcidid><orcidid>https://orcid.org/0000-0002-3442-8158</orcidid><orcidid>https://orcid.org/0000-0001-5712-1338</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 1053-8569 |
ispartof | Pharmacoepidemiology and drug safety, 2024-12, Vol.33 (12), p.e70057-n/a |
issn | 1053-8569 1099-1557 1099-1557 |
language | eng |
recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11589195 |
source | MEDLINE; Wiley Online Library |
subjects | Adenovirus Vaccines - administration & dosage Adenoviruses Adult Communication COVID-19 COVID-19 - epidemiology COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - administration & dosage Cross-Sectional Studies Europe - epidemiology Female Health care Health Knowledge, Attitudes, Practice Health Personnel - statistics & numerical data healthcare professionals Humans Immunization Male Medical personnel Middle Aged Original Professionals regulatory actions risk communication SARS‐CoV‐2 adenovirus vector vaccines Surveys and Questionnaires Thrombocytopenia Thrombocytopenia - epidemiology Thrombosis Thrombosis - epidemiology Thrombosis - etiology Thrombosis - prevention & control thrombosis with thrombocytopenia syndrome Vaccines |
title | Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-17T17%3A31%3A57IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Impact%20of%20Regulatory%20Risk%20Communication%20on%20Thrombosis%20With%20Thrombocytopenia%20Syndrome%20for%20COVID%E2%80%9019%20Adenovirus%20Vector%20Vaccines%20on%20European%20Healthcare%20Professionals&rft.jtitle=Pharmacoepidemiology%20and%20drug%20safety&rft.au=van%20Vliet,%20Ella&rft.date=2024-12&rft.volume=33&rft.issue=12&rft.spage=e70057&rft.epage=n/a&rft.pages=e70057-n/a&rft.issn=1053-8569&rft.eissn=1099-1557&rft_id=info:doi/10.1002/pds.70057&rft_dat=%3Cproquest_pubme%3E3147192331%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3147192331&rft_id=info:pmid/39586738&rfr_iscdi=true |