Impact of EU label changes and regulatory communication on SARS-CoV-2 adenovirus vector vaccines in context of thrombosis with thrombocytopenia syndrome (TTS): risk awareness and adherence (RiskAwareTTS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49546
• EU PAS number:
  EUPAS44970
• Study ID:
  49546
• Official title and acronym:
  Impact of EU label changes and regulatory communication on SARS-CoV-2 adenovirus vector vaccines in context of thrombosis with thrombocytopenia syndrome (TTS): risk awareness and adherence (RiskAwareTTS)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Greece

  Latvia

  Netherlands

  Portugal

  Slovenia
• Study description:
  The European Medicines Agency (EMA) has provided recommendations to learned societies and healthcare professionals (HCPs) when assessing people with signs and symptoms of thrombosis with thrombocytopenia syndrome (TTS) after being vaccinated with Vaxzevria or COVID-19 Vaccine Janssen. In addition, the EMA also published safety updates on these vaccines, highlights from expert meetings and news items on its website. This study aims to evaluate the impact of the regulatory actions for Vaxzevria and for COVID-19 Vaccine Janssen following the 2021 review. In this context, the impact of regulatory actions means looking into: Whether HCPs are aware and know about the risk of TTS when administering these vaccines, Whether attitudes of HCPs and general public have changed towards national COVID-19 vaccination programmes, Whether national COVID-19 vaccination policies were altered following the regulatory actions.
• Study status:
  Finalised

Research institution and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Department of Social Pharmacy, Faculty of pharmacy, University of Ljubljana

Slovenia

Pharmacoepidemiology Research Collaboration (PRC), University of Copenhagen

Denmark

Porto Pharmacovigilance Centre, Faculty of Medicine, University of Porto (UFPorto)

Portugal

Centre for Health Protection (RIVM-GZB), National Institute for Public Health & Environment

Netherlands

Department of Medicine/Laboratory of Hygiene and Environmental Protection, Democritus University of Thrace

Greece

Institute of Public Health, Riga Stradins University Riga, Latvia

Networks

EU Pharmacoepidemiology and Pharmacovigilance (PE&PV) Research Network

Netherlands

Study timelines

Date when funding contract was signed

Planned: 04/11/2021

Actual: 04/11/2021

Study start date

Planned: 18/04/2022

Actual: 23/05/2022

Data analysis start date

Planned: 16/05/2022

Actual: 16/05/2022

Date of final study report

Planned: 30/03/2023

Actual: 26/05/2023

Sources of funding

EMA

Study protocol

Initial protocol

Protocol ROC24_COVID-19_vaccines_TTS 4

Updated protocol

080422 Protocol RiskAware TTS version 3.0 final2

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable