Study identification

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 institutions and networks

Institutions

Institute of Public Health, Riga Stradins University Riga, Latvia

Networks

Contact details

Olaf Klungel

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable