About VAC4EU

Overview

VAC4EU (Vaccine monitoring Collaboration for Europe) is the sustainability solution of the ADVANCE project which was funded by the Innovative Medicines Initiative from October 2013- March 2019. VAC4EU implements the ADVANCE vision, system and blueprint and enables robust and timely evidence-generation on the effects of vaccines in a collaborative manner in Europe for use by citizens, health care professionals, public health organisations and regulatory agencies. VAC4EU is a multi-stakeholder international association with a study network to run studies and an open community for scientific debate. Research and public health organizations can join VAC4EU as member.

VAC4EU

  • 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.

  • has an independent scientific and audit committee, and strategic advisory board for advise.

  • will maintain a community which is an open forum for scientific discussions and methods development

For more details, see our VAC4EU overview poster. The Poster provides an overview of VAC4EU history, introducing our members, explaining our data sources and how VAC4EU is governed, and detailing which studies we are working on.

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Our Vision

The Vision of VAC4EU is best real world evidence on vaccine coverage, benefits and risks in Europe to support public health and decision making. The overall mission of VAC4EU is to enable, coordinate and accelerate the generation of best actionable evidence and expertise on vaccine coverage, benefits and risks.

Objectives to

  • 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.
  • Stimulate scientific discussions and implement continuous methodological developments to support reliable and rapid generation of evidence on vaccines in Europe
  • Train and provide rapid access to a unique vaccine expert community and study network
  • Build synergy and consensus between stakeholders (regulators, public health, researchers, patient/citizen organizations, healthcare providers, vaccine manufacturers)
  • 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

Background on ADVANCE and the need for collaboration in Europe

Lessons learnt from the 2009 (H1N1) flu pandemic highlighted factors limiting the capacity to collect European data on vaccine exposure, safety and effectiveness, including lack of rapid access to available data sources or expertise, difficulties to establish efficient interactions between multiple parties, lack of confidence between private and public sectors, concerns about possible or actual conflicts of interest (or perceptions thereof) and inadequate funding mechanisms. The Innovative Medicines Initiative’s Accelerated Development of VAccine benefit-risk Collaboration in Europe (ADVANCE) consortium was established to create an efficient and sustainable infrastructure for rapid and integrated monitoring of post-approval benefit-risk of vaccines, including a code of conduct and governance principles for collab- orative studies.

A description of the need for a Collaboration in Europe to study Vaccines can be found in the following papers:

 Sturkenboom MCJM, Bahri P, Chiucchiuini A, Grove Krause T, Hahné S, Khromava A, Kokki M, Kramarz P, Kurz X, Larson HJ, de Lusignan S, Mahy P, Torcel-Pagnon L, Titievsky L, Bauchau V. Why we need more collaboration in Europe to enhance post-marketing surveillance of vaccines. In press Vaccine.
Sturkenboom M. Advancing collaborative vaccine benefits and safety research in Europe via the ADVANCE code of conduct.