tetano
Editor, Senior Moderator
Vaccine. 2019 Oct 31. pii: S0264-410X(19)31002-3. doi: 10.1016/j.vaccine.2019.07.081. [Epub ahead of print] [h=1]Why we need more collaboration in Europe to enhance post-marketing surveillance of vaccines.[/h]
Sturkenboom M[SUP]1[/SUP], Bahri P[SUP]2[/SUP], Chiucchiuini A[SUP]3[/SUP], Grove Krause T[SUP]4[/SUP], Hahn? S[SUP]5[/SUP], Khromava A[SUP]6[/SUP], Kokki M[SUP]7[/SUP], Kramarz P[SUP]8[/SUP], Kurz X[SUP]9[/SUP], Larson HJ[SUP]10[/SUP], de Lusignan S[SUP]11[/SUP], Mahy P[SUP]12[/SUP], Torcel-Pagnon L[SUP]13[/SUP], Titievsky L[SUP]14[/SUP], Bauchau V[SUP]15[/SUP]; ADVANCE consortium.
[h=3]Author information[/h] 1 Julius Global Health, University Medical Center Utrecht, Heidelberglaan 100, the Netherlands; VACCINE.GRID, Spitalstrasse 33, Basel, Switzerland; P-95, Koning Leopold III laan 1, 3001 Heverlee, Belgium. Electronic address: m.c.j.sturkenboom@umcutrecht.nl. 2 European Medicines Agency, 30 Churchill Pl, Canary Wharf, London E14 5EU, UK. Electronic address: Priya.Bahri@ema.europa.eu. 3 Takeda Pharmaceuticals International GmbH, Thurgauerstrasse 130, 8152 Glattpark, Switzerland. Electronic address: Antonella.Chiucchiuini@takeda.com. 4 Department of Infectious Disease, Epidemiology and Prevention, Statens Serum Institut, Artillerivej 3, DK-2100, Denmark. Electronic address: TGV@ssi.dk. 5 National Institute for Public Health and the Environment, PO Box 1, 3720 BA Bilthoven, the Netherlands. Electronic address: susan.hahne@rivm.nl. 6 Sanofi Pasteur, 1755 Steeles Ave W, North York, ON M2R 3T4, Canada. Electronic address: Alena.Khromava@sanofi.com. 7 European Center for Disease Prevention and Control, Gustav III:s boulevard 40, 169 73 Solna, Sweden. Electronic address: Maarit.Kokki@ecdc.europa.eu. 8 European Center for Disease Prevention and Control, Gustav III:s boulevard 40, 169 73 Solna, Sweden. Electronic address: Piotr.Kramarz@ecdc.europa.eu. 9 European Medicines Agency, 30 Churchill Pl, Canary Wharf, London E14 5EU, UK. Electronic address: Xavier.Kurz@ema.europa.eu. 10 London School of Hygiene & Tropical Medicine, Keppel St, Bloomsbury, London WC1E 7HT, UK. Electronic address: heidi.larson@lshtm.ac.uk. 11 University of Surrey, Guildford, Surrey GU2 7XH, UK; Royal College of General Practitioners, 30 Euston Square, London NW1 2FB, UK. Electronic address: s.lusignan@surrey.ac.uk. 12 Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, Belgium. Electronic address: Patrick.Mahy@sciensano.be. 13 Vaccine Epidemiology and Modelling (VEM), Sanofi Pasteur, Campus SANOFI LYON, 14 Espace Henry Vall?e, 69007 Lyon, France. Electronic address: Laurence.Pagnon@sanofi.com. 14 Pfizer, 219 East 42nd St, NY, NY 10017, USA. Electronic address: lina.titievsky@pfizer.com. 15 GSK-Vaccines, Av. Fleming 20, 1300 Wavre, Belgium. Electronic address: vincent.g.bauchau@gsk.com.
[h=3]Abstract[/h] 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 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.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Collaboration; Electronic healthcare databases; Europe; Post-marketing monitoring; Real-world evidence; Vaccine benefit-risk
PMID: 31677952 DOI: 10.1016/j.vaccine.2019.07.081
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Sturkenboom M[SUP]1[/SUP], Bahri P[SUP]2[/SUP], Chiucchiuini A[SUP]3[/SUP], Grove Krause T[SUP]4[/SUP], Hahn? S[SUP]5[/SUP], Khromava A[SUP]6[/SUP], Kokki M[SUP]7[/SUP], Kramarz P[SUP]8[/SUP], Kurz X[SUP]9[/SUP], Larson HJ[SUP]10[/SUP], de Lusignan S[SUP]11[/SUP], Mahy P[SUP]12[/SUP], Torcel-Pagnon L[SUP]13[/SUP], Titievsky L[SUP]14[/SUP], Bauchau V[SUP]15[/SUP]; ADVANCE consortium.
[h=3]Author information[/h] 1 Julius Global Health, University Medical Center Utrecht, Heidelberglaan 100, the Netherlands; VACCINE.GRID, Spitalstrasse 33, Basel, Switzerland; P-95, Koning Leopold III laan 1, 3001 Heverlee, Belgium. Electronic address: m.c.j.sturkenboom@umcutrecht.nl. 2 European Medicines Agency, 30 Churchill Pl, Canary Wharf, London E14 5EU, UK. Electronic address: Priya.Bahri@ema.europa.eu. 3 Takeda Pharmaceuticals International GmbH, Thurgauerstrasse 130, 8152 Glattpark, Switzerland. Electronic address: Antonella.Chiucchiuini@takeda.com. 4 Department of Infectious Disease, Epidemiology and Prevention, Statens Serum Institut, Artillerivej 3, DK-2100, Denmark. Electronic address: TGV@ssi.dk. 5 National Institute for Public Health and the Environment, PO Box 1, 3720 BA Bilthoven, the Netherlands. Electronic address: susan.hahne@rivm.nl. 6 Sanofi Pasteur, 1755 Steeles Ave W, North York, ON M2R 3T4, Canada. Electronic address: Alena.Khromava@sanofi.com. 7 European Center for Disease Prevention and Control, Gustav III:s boulevard 40, 169 73 Solna, Sweden. Electronic address: Maarit.Kokki@ecdc.europa.eu. 8 European Center for Disease Prevention and Control, Gustav III:s boulevard 40, 169 73 Solna, Sweden. Electronic address: Piotr.Kramarz@ecdc.europa.eu. 9 European Medicines Agency, 30 Churchill Pl, Canary Wharf, London E14 5EU, UK. Electronic address: Xavier.Kurz@ema.europa.eu. 10 London School of Hygiene & Tropical Medicine, Keppel St, Bloomsbury, London WC1E 7HT, UK. Electronic address: heidi.larson@lshtm.ac.uk. 11 University of Surrey, Guildford, Surrey GU2 7XH, UK; Royal College of General Practitioners, 30 Euston Square, London NW1 2FB, UK. Electronic address: s.lusignan@surrey.ac.uk. 12 Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, Belgium. Electronic address: Patrick.Mahy@sciensano.be. 13 Vaccine Epidemiology and Modelling (VEM), Sanofi Pasteur, Campus SANOFI LYON, 14 Espace Henry Vall?e, 69007 Lyon, France. Electronic address: Laurence.Pagnon@sanofi.com. 14 Pfizer, 219 East 42nd St, NY, NY 10017, USA. Electronic address: lina.titievsky@pfizer.com. 15 GSK-Vaccines, Av. Fleming 20, 1300 Wavre, Belgium. Electronic address: vincent.g.bauchau@gsk.com.
[h=3]Abstract[/h] 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 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.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Collaboration; Electronic healthcare databases; Europe; Post-marketing monitoring; Real-world evidence; Vaccine benefit-risk
PMID: 31677952 DOI: 10.1016/j.vaccine.2019.07.081
Free full text