Celebrating 5 Years of VAC4EU
Advancing Real-World Evidence for Vaccine Monitoring towards Future Pandemic Preparedness
VAC4EU’s 5th anniversary symposium took place at the Royal Academies for Science and the Arts of Belgium in Brussels on 4 November 2025. Bringing together experts in vaccinology, vaccine development, pharmacovigilance, pharmacoepidemiology, health policy, public health and regulatory practice, the purpose of the event was to focus on future pandemic preparedness.
Background
VAC4EU was formally established in 2019 as the sustainability solution for ADVANCE, the IMI-funded public-private partnership that developed a blueprint, code of conduct and governance framework for collaborative vaccine monitoring in Europe. Building on that foundation, VAC4EU was created to maintain Europe’s readiness to generate timely, robust real-world evidence on vaccine safety, effectiveness and benefit-risk. This was a mission that became especially relevant during the COVID-19 pandemic and continues to guide the network’s work today.
Learn more about the history of VAC4EU
Discussions throughout the day explored the importance of timely evidence generation, the value of primary data collection, and the need for effective communication and citizen engagement. A recurring theme was the challenge of communicating scientific evidence with appropriate nuance while maintaining transparency and fostering public trust, which was covered both from the panellists and the keynote speech from Heidi Larson of the Vaccine Confidence Project.
The symposium also looked ahead to future priorities for vaccine monitoring and pandemic preparedness. Participants discussed real-world evidence in low- and middle-income countries, the necessity of international collaboration, and the implications of forthcoming European Health Data Space legislation. The expertise of VAC4EU’s Data Expert & Access Partners was identified as a unique strength of the network.
Recordings
The event featured reflections from the co-founders of VAC4EU, followed by a keynote lecture from Heidi Larson on vaccine confidence. The rest of the day consisted of two interactive panel discussions: one on lessons learned so far from 5 years of vaccine monitoring, with the other moving to the future and where to focus, followed by closing remarks from EMA and VAC4EU once more.
Below you can browse the recordings from all sessions of the event.
Speakers
Speakers included representatives from Data Expert & Access Partner organisations and others from our network, industry, the European Medicines Agency, the Innovative Health Initiative, the Vaccine Confidence Project, Vaccines Europe, PRAC, CEPI, and more.
Miriam Sturkenboom
President & Co-Founder, VAC4EUMiriam is professor in Real World Evidence, and head of the department of Data Science and Biostatistics at the Julius Center in the University Medical Center Utrecht in the Netherlands. She was professor in Observational Data Analysis at the department of Medical Informatics at Erasmus MC until 2017. She is past president of the International Society for Pharmacoepidemiology. Her research interests focus on knowledge discovery from data collected in routine health care to improve evidence on drug and vaccine safety in particular in vulnerable populations (children, pregnancy and elderly). She is co-founder and president of the Vaccine Monitoring Collaboration for Europe (VAC4EU), she coordinated 3 EU-FP7 funded studies (SOS, ARITMO, SAFEGUARD), 7 EMA funded studies, and the IMI funded ADVANCE and ConcePTION projects. She graduated 52 PhD students and has more than 450 peer reviewed papers in the area of pharmacovigilance, pharmacoepidemiology and medical informatics and an h-index of 97.
Heidi J. Larson
Professor of Anthropology, Risk, and Decision Science and Director of the Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine.Professor Larson holds a concurrent position as Clinical Professor of Health Metrics Sciences at the University of Washington, and Guest Professor at the University of Antwerp and KULeuven. Professor Larson previously headed Global Immunization Communication at UNICEF, chaired Gavi’s Advocacy Task Force, and served on the WHO SAGE Working Group on vaccine hesitancy. She is author of STUCK: How Vaccine Rumors Start – and Why They Don’t Go Away (Oxford University Press, 2020). In 2021, she was awarded the Edinburgh Medal and BBC named her as one of the 100 most influential women in the world.
Rosa Gini
Vice President, VAC4EUAs the Head of the Pharmacoepidemiology Unit at the ARS Toscana, Rosa has elaborate experience driving the success of VAC4EU. Rosa has largely contributed to the development and maintenance of tools during her time as Vice President of VAC4EU. Rosa was involved with the testing of infrastructure for conducting studies, as well as broader activities outside of studies such as the Journal Club and courses in the VAC4EU Academy. As the organisation matures, Rosa looks to leverage her expertise to further improve the way the scientific community generates evidence, in addition to focusing her energy on capacity building.
Peter Arlett
Head of the Data Analytics and Methods Taskforce, European Medicines Agency (EMA)Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Network Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group, and Member of the ACT EU Steering Group. Prior to taking up this role in 2020, he held leadership roles within the EMA in the areas of pharmacovigilance, epidemiology, and risk management.
Heather Rubino
Head of Safety Surveillance Research (SSR) at Pfizer, Inc.Heather Rubino is the Head of Safety Surveillance Research (SSR) at Pfizer, Inc.. Heather is responsi ble for providing strategic and innovative approaches utilizing real world data in the post-approval setting that will support and inform safety signal identification and characterisation, assess the effectiveness of additional risk minimisation measures, and quantitative benefit risk assessments for marketed products. Additionally, in her capacity she oversees Pfizer’s business processes related non-interventional studies and post approval safety studies and represents Pfizer in various external working groups, including, BeCome, COVID R&D Alliance, PhRMA, and ISPE, and IHI/IMI among others. Prior to Pfizer, Heather managed the Surveillance and Surveillance Systems program for the Bureau of Epidemiology at the Florida Department of Health.
Susana Pérez-Gutthann
Vice President and Global Head of Epidemiology at RTI Health SolutionsSusana Pérez-Gutthann is Vice President and Global Head of Epidemiology at RTI Health Solutions. Before, Susana held global epidemiology leadership positions at Pfizer/Pharmacia and Novartis/Ciba-Geigy. Past president of ISPE, past Vice-Chair of the Steering Committee of ENCePP, Susana has over 30 years of experience driving strategy and research programs for safety, pharmacovigilance, risk management, R&D, real world evidence, and regulatory activities applying public health and epidemiologic methods.
Emilie Karafillakis
Assistant Professor and the European Director of the Vaccine Confidence Project™, at the London School of Hygiene & Tropical Medicine and the University of AntwerpEmilie is a senior social scientist with more than 10 years of experience in international research and teaching in academia. With a background in public health, infectious disease control, and health systems and policies research, her work focuses on understanding individual and group beliefs, attitudes and confidence in health interventions and assess how these can influence public health control measures and health promotion strategies, including vaccination. Emilie has extensive experience on issues of vaccine confidence in Europe, including among parents, adolescents, pregnant women and healthcare professionals.
Felipe Villalobos Martínez
Senior researcher at IDIAP Jordi Gol in BarcelonaFelipe Villalobos Martínez is a senior researcher at IDIAP Jordi Gol in Barcelona, specializing in pharmacoepidemiology, pharmacovigilance, and real-world evidence (RWE) generation for patient safety. With over six years of experience, Dr. Villalobos has coordinated multiple EMA- and industry-funded projects that have strengthened RWE frameworks for vaccine safety across Europe. He currently leads the flagship CSIR Project, driving innovation in primary care health system reform in Catalonia, and directs international collaborations such as the PAHO dengue vaccine safety initiative in Latin America. As member of the advisory board of ISoP (2025–2028), he is committed to advancing global harmonisation and education in real-world evidence and pharmacovigilance.
Rebecca Chandler
Senior Vaccine Safety Lead, Coalition of Epidemic Preparedness Innovations (CEPI)Rebecca, a native of the US, was educated and trained as a physician in both internal medicine and infectious diseases. Her career took an unexpected turn into vaccine safety in 2008 when she started work as a clinical safety assessor at the Swedish Medical Products Agency. She was involved in the assessment of pre- and post-authorisation safety data of many of the vaccines used in national immunization programmes today, including two pneumococcal vaccines, the first meningococcal B vaccine, and the HPV vaccines. She was forever changed by the Pandemirix-narcolepsy vaccine safety crisis during the H1N1 pandemic when her professional aspirations in vaccine safety became solidified. Rebecca moved to the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, in 2014 and there she was involved in the evaluation of new methodologies for mining the global database of suspected adverse drug reactions and in capacity building efforts in signal detection in pharmacovigilance around the globe. She moved to CEPI in 2021 to build a concept of vaccine safety and pharmacovigilance into CEPI’s a mission for a response to public health emergencies in 100 days.
Jean-Michel Dogne
Full Professor and Dean of the Faculty of Medicine (UNamur)Jean-Michel Dogné is Full Professor in the Department of Pharmacy at the Université de Namur (Belgium) and Dean of the Faculty of Medicine. He holds a PharmD and a PhD in Pharmaceutical Sciences. His research focuses on drug safety and development, pharmacovigilance, thrombosis and haemostasis, and cardiovascular pharmacology. He is a member of research units including the Namur Thrombosis & Haemostasis Center and the Namur Medicine & Drug Innovation Center. He also serves as an expert for national and European regulatory agencies.
Eva Molero
Administrator, VAC4EUEva is the founder and CEO of Teamit Institute, a research management organisation building strong public-private partnerships and providing transversal expertise for impactful health science. Eva has a background in law and communications and initially developed her career in the field of marketing and technology transfer. She then transitioned into European project management and coordination at Fundació IMIM (the Barcelona Municipal Health Research Institute). She was the founder and CEO of Synapse Research Management Partners and founded Teamit in 2020. Eva has a strong focus on public private partnerships, project management, governance, communication, business development and sustainability. She has participated in several initiatives to commercialize results from research projects, including the creation of research alliances. She often teaches courses in European Commission funding programmes and project management and acts as an advisor for public and private institutions in project design, evaluation and assessment.
Niklas Blomberg
Executive Director, IHIDr Niklas Blomberg joined IHI as Executive Director in January 2024. He brings to the role extensive experience in both research and leadership roles in the life sciences. A Swedish national, he has a bachelor’s degree in chemistry from the University of Gothenburg, and a PhD in structural biology and bioinformatics from the European Molecular Biology Laboratory (EMBL) in Germany. Niklas worked as a research scientist for AstraZeneca in Sweden for 14 years, taking on increasingly senior roles in the company, and leading the establishment of a team for data driven drug discovery in the respiratory and inflammation fields. During this time, he was industry co-lead of Open PHACTS, a project funded by the Innovative Medicines Initiative (IMI), the forerunner to IHI. In 2013, he joined the fledgling research infrastructure ELIXIR. As its founding director, he oversaw the final negotiations between the member states to formally establish and launch ELIXIR. Under his leadership, the organisation built up its operational and project management capacity, grew to include 23 member states, and secured funding from both the member states and an extensive portfolio of EU-funded projects, including projects from IMI2, the European Open Science Cloud and the European Genomic Data Infrastructure.
Charlotte Vernhes
Director of Scientific and Medical Affairs at Vaccines EuropeCharlotte Vernhes is a bioengineer with 15 years of experience in vaccine research and development, spanning immunogenicity assessment, translational science and biomarker discovery, innovation management and public-private partnerships. Currently serving as Director of Scientific and Medical Affairs at Vaccines Europe, she leads strategic initiatives to foster collaboration between industry, scientific communities, and policymakers, to advance vaccine innovation and science-driven policy. Charlotte has played a pivotal role in European initiatives on RSV, where she focused on fostering broad stakeholder collaboration and raising RSV disease awareness.
María Dutarte
Executive Director of the European Patients’ Academy on Therapeutic Innovation (EUPATI)María Dutarte is the Executive Director of the European Patients’ Academy on Therapeutic Innovation (EUPATI) since 2020. Maria has previously worked for the European AIDS Treatment Group (EATG) coordinating patient involvement in a number of training initiatives and scientific projects. She has also worked for different scientific and international organisations, e.g. French National Research Center for Scientific Research (CNRS), International AIDS Society (IAS), The Global Fund to Fight AIDS, Tuberculosis and Malaria and The International Foundation for Science (IFS). Her educational background is in International Education and Communications.
Laura Cornelissen
Co-lead of the Belgian Risk Assessment Group and member of the Belgian NITAGDr. Laura Cornelissen is a medical doctor with a specialist degree in Obstetrics & Gynaecology and additional master in public health. Since 2019, she is working at the Belgian Public Health Institute, Sciensano, at the department of epidemiology of infectious diseases, where she now leads the team of vaccine-preventable diseases. As co-lead of the Belgian Risk Assessment Group and member of the Belgian NITAG, Dr. Cornelissen has had first-hand experience with the challenges of advising policy makers in uncertain pandemic times. She acts as Belgian National Focal Point for vaccine-preventable diseases for ECDC and as such is also a member of the recently founded European Immunisation and Vaccine Monitoring Board and the representative of Belgium in the EU-NITAG collaboration as well as a member of the WHO technical advisory group on combination vaccines.