Pfizer/BioNTech Comirnaty® bivalent Post-Authorisation Safety Study - VAC4EU

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Is a not-for profit international association, with institutional memberships (study network)

Provides access to a well characterised public study network, which can provide data access and perform studies for different internal and external requesters such as vaccine manufacturers, European Commission, regulators, public health institutes.

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COVID-19 MAH-funded study Safety Comirnaty® (bivalent)

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Ongoing study

The aim of this study is to assess whether there is an increased risk of AESI after receiving the bivalent Pfizer/BioNTech COVID-19 vaccine.

Lead Scientific Center

University Medical Center Utrecht

Lead Operating Centre

Fondazione Penta

Programming Expertise

RTI Health Solutions

University Medical Center Utrecht

Statistical Expertise

RTI Health Solutions

University Medical Center Utrecht

Data Expert & Access Partners

Aragon Health Sciences Institute (IACS)

Drug Safety Research Unit (DSRU)

Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)

PHARMO Data Network

Societa Servizi Telematici (SoSeTe)

University of Oslo

Other Expertise

MediCom Consult

Teamit Institute

Norwegian Registries