VAC4EU - Vaccine Monitoring Collaboration for Europe

Looking back at great discussions at the @The World Vaccine Congress 2024 in Barcelona. Equity and equitable access, as well as vaccine production and research were core topics. Equity between Global North and South. We held panel discussions about #real world evidence and how vaccines for emerging diseases can be studied. Core topic, we need to think global and act global as equal partners between regions and stakeholders. No one can keep up preparedness to act alone, and infectious diseases spread rapidly. On Thursday a great discussion about public private partnerships and how trust can be ensured with Niklas Blomberg @Vincent Loh from BioNTech and myself. It was excellently moderated by Hamilton Bennett. VAC4EU - Vaccine Monitoring Collaboration for Europe was considered a perfect example of how public private collaborations can be turned in sustainable ecosystems, with many organisations working together to build a Community and share knowledge. This was resulting from #IHI funded project. We discussed that the lessons learned in building the Vac4eu community may be an example for other regional ecosystems that are building such ecosystems in a collaborative manner. Alignment and a global community is needed to be prepared to monitor and assess vaccine effects for outbreak situations

🙌 #WVCEU is a wrap! We are very happy to have contributed to making this conference a success. It was a fantastic opportunity for learning, networking, and inspiration. Hope to see you next time! In the meantime, check out some of these photos from the event! #WVCEU #pharmacoepidemiology #conferences 

📍 We have enjoyed a productive time at the #WVCEU in Barcelona so far! Will you be joining us at the Partnerships & Access track today? VAC4EU will be represented on a panel: ‘Why are public private partnerships so important for vaccine development and how do we sustain them?’ In this session we will focus on how the public and private sectors can work together with the IHI director, showcasing VAC4EU, which started from a public-private collaboration and successfully transformed into a multistakeholder international association. Hoping to see you there!    ⏰ 10:30 CET  📅 31 October  📍 Theater 2  🔗 https://lnkd.in/escXaQfp #WVCEU #pharmacoepidemiology #vaccines 

🌟 If you're at the #WVCEU in Barcelona and curious about ways the global health community can consider evaluating vaccines outside of clinical trials, check out our panel!    Join the Emerging & Infectious Diseases track for ‘Post-authorization safety and effectiveness evaluation of vaccines deployed under emergency use authorization.’ VAC4EU President Miriam Sturkenboom will be a panelist for this fascinating section.    The following topics will be explored:    ❧ Diseases (e.g. Ebola, Malaria, Dengue) that are associated with outbreaks and are not established as endemically with vaccines that have been or are being developed  ❧ How should the global health community consider evaluation of these vaccines outside of clinical trials?    Hope to see you there!    ⏰ 15:40 CET  📅 30 October  📍 Theater 2  🔗 https://lnkd.in/escXaQfp    #WVCEU #pharmacoepidemiology #vaccines

🌟 Are you attending the #WVCEU in Barcelona and interested in ways to generate regulatory grade RWE for vaccines?    The The World Vaccine Congress has kicked off, and this morning VAC4EU will lead a working group focused on this very topic. Based on COVID-19 vaccine RWE generation experience, we will discuss how regulatory grade RWE could be produced in high income settings with readiness of people, data, methods and infrastructure and what we can do to align further towards sharing of protocols, code lists, definitions, etc. At the same time, vaccines are now rolled out in settings that do not have the same level of readiness and need to generate regulatory grade RWE. What can be done to work together to achieve that?    The session, coordinated by Miriam Sturkenboom, will feature VAC4EU members Fabio Riefolo, PhD, Gianmarco Di Mauro, PhD, Felipe Villalobos, and Cristina Rebordosa as panelists, and have Walter Straus, M.D., Marion Gruber, and Marco Cavaleri as moderators for specific topics given their perspectives and expertise.    Hoping to see you there!    ⏰ 11:10 – 12:10 CET  📅 29 October  📍 Theater 4 | Fira de Barcelona Montjuïc | Barcelona    If you’re already registered for the conference, you can find out more about the working group here 👉 https://lnkd.in/eVndjufH    #WVCEU #pharmacoepidemiology #vaccines 

✈️ VAC4EU is headed to Spain for #WVCEU next week! We are very much looking forward to The World Vaccine Congress in Barcelona. As the largest and most established meeting on vaccine research and development, the #WVCEU covers all elements of vaccine R&D, from basic research to commercial manufacture, and including experts from manufacturers, academia, regulators, and more! VAC4EU is proud to contribute to this event in the following ways: ✅ Organised a working group, “How to generate regulatory grade RWE for vaccines,” moderated by VAC4EU President Miriam Sturkenboom and featuring speakers from member organisations Teamit , RTI Health Solutions, and IDIAPJGol, along with industry and regulatory speakers ✅ Miriam will also be a panelist for “Post-authorization safety and effectiveness evaluation of vaccines deployed under emergency use authorization,” a panel featuring industry speakers as well as the CEPI (Coalition for Epidemic Preparedness Innovations) ✅ She will also serve on the panel, "Why are public private partnerships so important for vaccine development and how do we sustain them?” featuring industry voices, as well as representation from the Innovative Health Initiative (IHI) Hope to see you in Barcelona! 📅 29 - 31 October 📍Barcelona, Spain 🔗 https://lnkd.in/escXaQfp hashtag #WVCEU hashtag #pharmacoepidemiology hashtag #vaccines

📃 Protocols from SAFETY-VAC accepted by the EMA! 📃 The EMA ROC18-SAFETY-VAC project, “A framework for the post-authorisation safety evaluation of vaccines in the EU,” kicked off earlier this year as a collaboration between VAC4EU and the EU PE&PV Research Network. The primary aim of this EMA-funded project is to assess “the feasibility of participating data sources to participate in vaccine safety studies using electronic healthcare databases in European countries” through two specific studies. We are very excited to share that the protocols and the first study report have now been accepted by the European Medicines Agency and are both publicly available on the HMA-EMA Catalogue of Real-World Data and Zenodo (links below). The first study aims to “provide and describe a network of nine EEA real-world data sources for the evaluation of vaccine safety signals," as well as assessing whether the data are fit for the purpose of real-time safety monitoring of vaccine safety studies. The protocol for this study was accepted, as well as the first study report. The second study aims to estimate the background and cumulative incidence of the flares of 10 pre-defined autoimmune diseases, while also analysing the contribution of different provenances of data. The protocol for this study was also accepted, and the study report is currently under development. Both studies employ a retrospective, multi-database, population-based cohort design using data from 2017 up to the most recent updates. Congratulations to the study team (partners tagged below) for this achievement! We look forward to reporting on future milestones and results. Links Fit-for-purpose Framework study protocol 👉 https://lnkd.in/epQasY-v Fit-for-purpose Framework study report 👉 https://lnkd.in/ejk_ye9e Chronic disease study 👉 https://lnkd.in/eCtbDJXm Partners Utrecht University, UMC Utrecht, Agenzia regionale di sanità della Toscana, Societa Servizi Telematici, University of Verona, Bordeaux PharmacoEpi, University of Eastern Finland, University of Oslo, IDIAPJGol, Aarhus University, Agencia Española de Medicamentos y Productos Sanitarios, Instituto Aragonés de Ciencias de la Salud (IACS), Drug Safety Research Unit (DSRU), Teamit , Fisabio foundation, Vall d’Hebron Institute of Research (VHIR) - Vall d'Hebron Institut de Recerca

We are looking forward to starting this productive collaboration!

🤝 We’re partnering with EVI and TBVI! VAC4EU is proud to announce a new partnership with the European Vaccine Initiative (EVI) and the TuBerculosis Vaccine Initiative (TBVI). EVI and TBVI are both European non-profit Product Development Partnerships that support global efforts to develop effective and affordable vaccines. While EVI is focused on the prevention of diseases of poverty and emerging infectious diseases, TBVI is focused on tuberculosis. We are very interested in exchanging research and funding opportunities, collaborative fundraising efforts, networking, joint communication, and knowledge sharing with these two initiatives. We are exploring possible opportunities to co-create and collaborate on studies and topics of mutual interest (for example, European pandemic preparedness).  We are glad to take this initial step of signing a Memorandum of Understanding and look forward to working with EVI and TBVI! Learn more about TBVI 👉 www.tbvi.eu  Learn more about EVI 👉 www.euvaccine.eu    #collaboration #partnership #infectiousdisease #vaccines 

Language is important. The titles we use to describe roles within an organisation should accurately reflect what the contribution is about. That’s why VAC4EU members have proposed a change to the way we refer to research partners who access local observational healthcare data and provide expertise that ensures the data is reliably analysed and interpreted. They were previously known as ‘Data Access Partners’ (DAPs), but we recently took this to a vote and ultimately settled on the term ‘Data Expert and Access Partners,' or DEAPs (pronounced “deeps”). This title better captures the breadth of the work performed, which requires specific expertise, skills, knowledge and experience. In fact, within the VAC4EU study network, there are 16 different contributing data sources covering over 150 million individuals across Europe. Data collected from such sources can be extremely diverse: they can differ in terms of the characteristics of the source population and country, prompt for data recording, the healthcare setting in which the recording took place, underlying healthcare policies and culture, data dictionaries and data quality. Therefore, knowledge and understanding of the structure and peculiarities of each local healthcare data source is very important when conducting studies. For these reasons, DEAPs play a central role with respect to the generation of reliable real world evidence in VAC4EU since their expertise is leveraged to actively assist with all steps of the study pipeline in VAC4EU, including review of the study protocol and statistical analysis plan, script running, review and discussion of results, and approval of the final study report. We would like to take a moment to appreciate our members who serve as Data Experts and Data Access Partners, or DEAPs, in our network. Thank you!   Universitetet i Oslo (UiO) | University of Oslo, Aarhus University, Drug Safety Research Unit (DSRU), RTI Health Solutions, PHARMO Institute, part of Lumanity, Bordeaux PharmacoEpi, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Instituto Aragonés de Ciencias de la Salud (IACS), Societa Servizi Telematici, Agencia Española de Medicamentos y Productos Sanitarios, IDIAPJGol, Fisabio foundation, Vall d’Hebron Institute of Research (VHIR) - Vall d'Hebron Institut de Recerca, Sciensano, Società Italiana di Medicina Generale, Agenzia regionale di sanità della Toscana #pharmacoepidemiology #secondaryuseofdata #collaboration