VAC4EU - Vaccine Monitoring Collaboration for Europe

What VAC4EU - Vaccine Monitoring Collaboration for Europe does

VAC4EU (Vaccine Monitoring Collaboration for Europe) is a not-for-profit international association founded in December 2019 in Utrecht, Netherlands, as the sustainability vehicle of the IMI ADVANCE project. It operates a collaborative research network of 28 European research centres and public health institutions providing access to 14 pre-characterised real-world data sources covering millions of individuals across hospital records, GP databases, and registries. VAC4EU conducts post-licensure vaccine benefit, risk, and coverage studies on request from market authorisation holders, regulators, and European organisations, using the ConcePTION Common Data Model to enable federated multi-database analyses.

The organisation's core offering is the VAC4EU Toolbox, a suite of shared methodological resources including the VaccO vaccine ontology, a Background Rates Dashboard for adverse events of special interest, template protocols, a Brighton Collaboration-based validation pipeline with REDCap forms, and utility tools for IR interrelations and vaccine effectiveness estimation. Its go-to-market is largely requester-driven: studies are triggered by vaccine manufacturers, EMA, ECDC, or European Commission grants, with the secretariat coordinating team assembly across member institutions. Revenue is generated through individually negotiated study fees, membership contributions, and grant funding; no public pricing exists.

VAC4EU serves three primary customer segments: regulatory agencies (EMA, ECDC), vaccine manufacturers (Pfizer, Moderna, AstraZeneca, Janssen) requiring post-authorisation safety studies, and public health institutes needing evidence for vaccination policy. The network is governed by its members through General Assembly and Executive Board (including President and Co-Founder Miriam Sturkenboom) and operates with a lean secretariat of approximately 9 employees hosted at UMC Utrecht.

Name

VAC4EU - Vaccine Monitoring Collaboration for Europe

Legal name

Vaccine Monitoring Collaboration for Europe

Website

https://vac4eu.org

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

VAC4EU is a not-for-profit European research association of 28 institutions that runs collaborative post-licensure vaccine safety and effectiveness studies across 14 real-world data sources for regulators, manufacturers, and public health bodies.

Ownership category

akta.pro rank

Headquarters

HQ city

Utrecht

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Revenue model

1. Study Conduct Fees: VAC4EU primarily conducts studies upon request from market authorisation holders (vaccine manufacturers) or in response to grant applications from European organisations. Studies are funded by the requesters through contractual arrangements.
2. Membership Contributions: As a not-for-profit international association with institutional memberships, members provide access to data and expertise. VAC4EU also funds methodological research through annual calls for bottom-up funding through working groups and offers competitive fellowships.
3. European Commission/Regulatory Grants: VAC4EU receives funding through grants from European organisations including the EMA-funded ACCESS project and participates in collaborative European research initiatives.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels7 records

Core offering

VAC4EU is a not-for-profit international research association that conducts collaborative post-licensure studies on vaccine benefits, risks, and coverage using primary and secondary health data across Europe. It provides a network of 28 member organisations with access to 14 real-world data sources, harmonised workflows through the ConcePTION Common Data Model, and a suite of methodological tools (VaccO, Background Rates Dashboard, Template Protocols, Validation Pipeline) to support multi-database vaccine safety and effectiveness studies.

Product overview

VAC4EU is a not-for-profit international collaborative research network for vaccine benefit and risk monitoring across Europe. Its offering is built around the VAC4EU Toolbox — a suite of shared tools and resources enabling multi-database vaccine safety and effectiveness studies. Key products include the VaccO (Vaccine Ontology Tool) for standardising vaccine data, a Background Rates Dashboard for querying adverse event background rates, Template Protocols for standardised study designs, a Brighton Collaboration-based Validation Pipeline for outcome case validation, and utility tools for IR interrelations and vaccine effectiveness estimation. The network provides access to 14 real-world data sources across Europe, uses the ConcePTION Common Data Model for data harmonisation, and operates through federated analytics without a central data repository.

Differentiator

Problem solved

Functional benefit

Products and services

• VAC4EU Collaborative Study Network A not-for-profit international research network of 28 member organisations providing access to a well-characterised study network for conducting collaborative post-licensure vaccine benefit and risk monitoring studies across Europe using primary and secondary health data, including hospital records, GP databases, and national registries.
• VAC4EU Toolbox A suite of shared tools and workflows used by VAC4EU members to conduct multi-database vaccine safety and effectiveness studies, including harmonised workflows, template protocols, data dashboards, and methodological resources.
• VaccO (Vaccine Ontology Tool) A specialised ontology tool to harmonise and standardise vaccine-related data across diverse sources and studies, providing a common vocabulary for vaccine products, components, and administration details.
• Background Rates Dashboard An interactive dashboard providing background rates of adverse events of special interest (AESI) for COVID-19 vaccines, allowing users to query and explore rates stratified by data source, age, sex, and calendar year.
• Template Protocols Template protocols for vaccine safety, effectiveness, and coverage studies providing standardised study templates including cohort event monitoring, rapid safety assessment, and vaccine effectiveness protocols.
• Validation Pipeline (Brighton Collaboration) A scalable, harmonised pipeline for outcome case validation using Brighton Collaboration case definitions adapted for real-world data, involving REDCap electronic data collection forms, abstractor training programmes, and a reproducible framework.
• IR Interrelations Tool A tool for calculating validity indices (sensitivity, specificity, positive predictive values) of event definitions when not all are observed in a study, based on observed prevalence and other parameters.
• Vaccine Effectiveness Tool A tool allowing users to explore the impact of differential and non-differential exposure and outcome misclassification on estimates of vaccine effectiveness across different study designs.
• SAFETY-VAC Framework and Reports SAFETY-VAC project framework supporting the European Vaccine Monitoring Platform by assessing fitness-for-purpose of RWD sources for post-authorisation vaccine safety evaluation across Europe.

Quantifiable outcome

• Multi-database studies spanning up to 10+ European countries and 53+ million individuals covered
• +2 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability4 records

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and major.

• ADVANCE Project (IMI-funded)coreStrategic or Co-development Partner · 1 December 2019VAC4EU was established as the sustainability solution of the ADVANCE project which was funded by the Innovative Medicines Initiative from October 2013 - March 2019. ADVANCE created an ecosystem for rapid and robust monitoring of vaccine coverage, benefits, and risks. VAC4EU continues this valuable work as a not-for-profit international association.
• Global Vaccine Data Network (GVDN)coreStrategic or Co-development PartnerGVDN is an international partnership of research institutions committed to improving global vaccine safety monitoring through harmonised methods. VAC4EU participated as European coordinator in the Global COVID Vaccine Safety (GCoVS) project coordinated by GVDN.
• European Medicines Agency (EMA)coreStrategic or Co-development PartnerVAC4EU serves as a complementary resource to the EMA's DARWIN EU network for answering complex research questions on vaccine safety. The network contributes to the European Vaccine Monitoring Platform established by EMA and ECDC.
• ConcePTION ProjectcoreTechnology or IntegrationVAC4EU uses the ConcePTION Common Data Model (CDM) for harmonising data across multiple European real-world data sources. The ConcePTION project developed the CDM as part of IMI funding for medicines safety research.
• Brighton CollaborationcoreStrategic or Co-development PartnerVAC4EU has adapted Brighton Collaboration case definitions for application to real-world data, developing a scalable validation pipeline. The partnership enables standardised outcome validation across the network.
• EU PE&PV Research NetworkmajorStrategic or Co-development PartnerVAC4EU collaborated with the EU Pharmacoepidemiology & Pharmacovigilance Research Network on COVID-19 vaccine monitoring projects, conducting collaborative studies on vaccine safety and effectiveness.
• ACCESS Project (EMA-funded)majorStrategic or Co-development PartnerVAC4EU is a consortium member of the ACCESS project funded by EMA to assess feasibility of European data sources for vaccine safety signal evaluation. The project produced template protocols for vaccine studies.
• SAFETY-VAC ProjectmajorStrategic or Co-development PartnerSAFETY-VAC project supports the European Vaccine Monitoring Platform by assessing fitness-for-purpose of RWD sources for post-authorisation vaccine safety evaluation across Europe.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Customer concentration

• YouTubeyoutube.com/channel/UC...
• LinkedInlinkedin.com/company/vac4eu

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about VAC4EU - Vaccine Monitoring Collaboration for Europe