Why we need more collaboration in Europe to enhance post-marketing surveillance of vaccines
ADVANCE consortium
(2020) Vaccine, volume 38, issue 2, pp. B1 - B7
(Article)
Abstract
The influenza A/H1N1 pandemic in 2009 taught us that the monitoring of vaccine benefits and risks in Europe had potential for improvement if different public and private stakeholders would collaborate better (public health institutes (PHIs), regulatory authorities, research institutes, vaccine manufacturers). The Innovative Medicines Initiative (IMI) subsequently issued a competitive
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call to establish a public-private partnership to build and test a novel system for monitoring vaccine benefits and risks in Europe. The ADVANCE project (Accelerated Development of Vaccine benefit-risk Collaboration in Europe) was created as a result. The objective of this paper is to describe the perspectives of key stakeholder groups of the ADVANCE consortium for vaccine benefit-risk monitoring and their views on how to build a European system addressing the needs and challenges of such monitoring. These perspectives and needs were assessed at the start of the ADVANCE project by the European Medicines Agency together with representatives of the main stakeholders in the field of vaccines within and outside the ADVANCE consortium (i.e. research institutes, public health institutes, medicines regulatory authorities, vaccine manufacturers, patient associations). Although all stakeholder representatives stated they conduct vaccine benefit-risk monitoring according to their own remit, needs and obligations, they are faced with similar challenges and needs for improved collaboration. A robust, rapid system yielding high-quality information on the benefits and risks of vaccines would therefore support their decision making. ADVANCE has developed such a system and has tested its performance in a series of proof of concept (POC) studies. The system, how it was used and the results from the POC studies are described in the papers in this supplementary issue.
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Keywords: Collaboration, Electronic healthcare databases, Europe, Post-marketing monitoring, Real-world evidence, Vaccine benefit-risk, General Veterinary, Public Health, Environmental and Occupational Health, Infectious Diseases, Molecular Medicine, General Immunology and Microbiology, Journal Article
ISSN: 0264-410X
Publisher: Elsevier BV
Note: Funding Information: The Innovative Medicines Initiative Joint Undertaking funded this project under ADVANCE grant agreement n° 115557 , resources of which were composed of a financial contribution from the European Union's Seventh Framework Programme ( FP7/2007-2013 ) and in kind contributions from EFPIA member companies. Funding Information: The authors acknowledge editorial assistance from Margaret Haugh, MediCom Consult, Villeurbanne, France and the persons who provided input and steering during the initial phases of the ADVANCE project that are not co-authors: Jan Bonhoeffer (University Basel, Switzerland), Marianne van der Sande (RIVM, The Netherlands), Michael Greenberg (Sanofi Pasteur, France), Francois Simondon (IRD, France), Thomas Verstraeten, (P-95, Belgium), Mendel Haag (Seqirus, The Netherlands), John Weil (Takeda, Switzerland), Germano Ferreira, (Independent consultant, Portugal). Priya Bahri, Tyra Grove Krause, Susan Hahn?, Maarit Kokki, Piotr Kramarz, Xavier Kurz and Patrick Mahy declared no conflict of interests. Miriam Sturkenboom declared that she has received grants from Novartis, CDC and Bill & Melinda Gates Foundation for work unrelated to the work presented here. Antonella Chiucchiuini declared that she received personal fees from Takeda Pharmaceuticals International AG during the study. Alena Khromava and Laurence Torcel-Pagnon declared that they are employed by Sanofi Pasteur and hold company shares/stock options. Heidi J Larson declared that her research group has received funding from Merck to convene a research symposium, and research funding from GSK for a global study on maternal vaccine acceptance. Simon de Lusignan declared he has university-based research (enhanced surveillance of influneza vaccines) funded by GSK, he is also a member of Seqirus and Sanofi Pasteur Advisory Boards for influenza. Lina Titievsky declared that she is employed by Pfizer and holds company stocks/shares. Vincent Bauchau declared that he is employed by GSK Vaccines and holds restricted company shares. The Innovative Medicines Initiative Joint Undertaking funded this project under ADVANCE grant agreement n? 115557, resources of which were composed of a financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and in kind contributions from EFPIA member companies. Funding Information: Simon de Lusignan declared he has university-based research (enhanced surveillance of influneza vaccines) funded by GSK, he is also a member of Seqirus and Sanofi Pasteur Advisory Boards for influenza. Publisher Copyright: © 2019 Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
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