Our Vision
Evidence-based decision making on vaccines
Our Mission
Delivering timely and robust real-world evidence on vaccines and cutting-edge methodology through a European community of expert organisations
Key Objectives
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Create and implement a European partnership that can respond rapidly and reliably to relevant questions around post licensure vaccine coverage, benefits and risks by generating robust and trustworthy evidence.
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Stimulate scientific discussions and implement continuous methodological developments to support reliable and rapid generation of evidence on vaccines in Europe.
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Train and provide rapid access to a unique vaccine expert community and study network.
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Build synergy and consensus between stakeholders (regulators, public health, researchers, patient/citizen organizations, healthcare providers, vaccine manufacturers).
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Define and support the adoption of best practices in study conduct governance, including ethics, privacy protection, relating to the capture, sharing and trustworthy generation of evidence of health data Ensuring sustainability of VAC4EU
Our History
Ongoing Activities
VAC4EU has implemented a shared research infrastructure including the VAC4EU Molgenis Catalogue, CodeMapper, a SharePoint, digital research environment, a phenotype library of more than 100 variables with definitions.
Discover more toolsVAC4EU has adopted the ConcePTION common data model as a basis for the syntactic harmonisation of electronic health data, but it also allows for primary data collection.
Learn more about syntactic harmonisationVAC4EU has consolidated its governance structure for implementation of pharmacovigilance studies on vaccines and successfully participated in four public tenders regarding vaccine safety and effectiveness launched by the European Medicines Agency (EMA), as well as four required post-authorization safety studies on COVID-19 vaccines sponsored by vaccine manufacturers, and other studies promoted by the Global Vaccine Data Network.
How we work Projects & studiesWe register all protocols developed within VAC4EU in the HMA-EMA RWD Catalogue. We also publish results on either the HMA-EMA RWD Catalogue, or the VAC4EU Zenodo Community. When contracts allow, we publish results as open access peer-reviewed articles in impactful journals and we publish the study scripts to our GitHub repository
Outputs & results Zenodo communityFirst VAC4EU Annual Report published
With VAC4EU maturing as an organisation, expanding capacity, consolidating outputs, and increasing outreach, they produced the first Annual Report, covering achievements from 2023.
View all Annual ReportsA new vaccine for RSV
A vaccine for respiratory syncytial virus (RSV) was approved in the European Union (Pfizer ABRYSVO®). ABRYSVO is indicated for older adults as well as pregnant individuals to protect infants after birth. VAC4EU has been contacted for risk management, with PASS on special populations not included in clinical trials now ongoing.
Learn more about RSV vaccine monitoring in VAC4EU
First live General Assembly Meeting
Two years of collaborative work between different principal investigators, programmers, statisticians, DEAPs and LOCs in the VAC4EU network proved fruitful. With social distancing restrictions easing, VAC4EU held its first live General Assembly Meeting, hosted by Teamit at Sant Pau in Barcelona. This was after additional strengthening of outreach with the first live appearance at ISPE and WVC.
Commitment to open science and availability of results
VAC4EU created a community on Zenodo and published all EMA-funded work there, including background incidence rates for 27 AESI and all deliverable reports.
Explore the VAC4EU Zenodo communityCOVID vaccine monitoring in VAC4EU
VAC4EU, now at 23 member organisations, began PASS for Pfizer Comirnaty®, Moderna Spikevax®, AstraZeneca Vaxzevria and Janssen Jcovden. Reports were delivered to market authorisation holders and VAC4EU participated in multiple EMA-funded studies.
Learn more about COVID vaccine monitoring in VAC4EUVaccine rollout begins in Europe
Several COVID-19 vaccines were developed and VAC4EU was contacted by market authorisation holders to conduct PRAC-recommended post-marketing evaluation studies.
Preparing for vaccine rollout
As VAC4EU was growing and establishing in its first year, EMA began preparing for vaccine rollout with a call for feasibility analysis. UMC Utrecht, the European Pharmacoepidemiology & Pharmacovigilance Research Network and VAC4EU formed the ACCESS consortium.
Learn more about the ACCESS projectCOVID-19 declared a pandemic
WHO declared COVID-19 a pandemic. Masking and distancing measures were implemented, and vaccine manufacturers began developing mRNA vaccines.
VAC4EU officially established
King Philippe of Belgium signed the VAC4EU Articles of Association. VAC4EU was envisioned as a network of experts and DEAPs for collaborative vaccine studies, starting now with 11 founding members.
View the VAC4EU Articles of AssociationPlans for VAC4EU publicly unveiled
At the ADVANCE Closing Event, plans for VAC4EU were announced as a non-profit international association to continue vaccine monitoring work.
A blueprint for vaccine monitoring in Europe
ADVANCE’s final deliverable was a document with step-by-step instructions for using the platform, written by ECDC. This was a pioneering blueprint for vaccine monitoring in Europe.
View the ADVANCE BlueprintA Code of Conduct for collaborative vaccine studies
ADVANCE published a Code of Conduct with 45 recommendations covering protocols, conflict of interest, privacy, data sharing, and scientific integrity.
Read the ADVANCE Code of ConductIMI-funded project ADVANCE established
The ADVANCE project was launched to build an ecosystem for rapid and robust vaccine monitoring in Europe, co-led by Miriam Sturkenboom (then P95, now UMCU) and Vincent Bauchau (GSK).
Towards a multistakeholder partnership for vaccine knowledge exchange
EFPIA, IMI, EMA, ECDC, and Erasmus MC scientists began working on a multistakeholder partnership involving public health institutions, universities, regulators, and vaccine manufacturers.
Scientists call for an ecosystem for vaccine monitoring in Europe
The H1N1 pandemic highlighted challenges in post-authorisation vaccine evaluation and the need for better integration of electronic health records and surveillance databases. Scientists call for an ecosystem for vaccine monitoring in Europe.
Timing is everything
On the 26th of October, 2021, VAC4EU President Miriam Sturkenboom was invited to feature on the Vital Health Podcast series hosted by Vital Transformation. Listen to the podcast here, titled "Miriam Sturkenboom & VAC4EU: Timing is everything."