This week VAC4EU joined colleagues from across the pharmacoepidemiology community at the 42nd Annual Meeting of the International Society for Pharmacoepidemiology (ISPE) in Milan, Italy. The meeting offered an important opportunity to share scientific work, connect with the community, and explore opportunities.
With our network of 29 institutions across 8 European countries, having the opportunity to spend time together in person is extremely valuable. Over 50 people in the network attended this year, representing more than half our member organisations. Members used the VAC4EU booth to meet, exchange ideas, network, and support one another between sessions. Additionally, VAC4EU organised a networking session for members, which was a wonderful opportunity to get to know colleagues.
The VAC4EU booth served as an important connection point throughout the conference. Representatives from the Secretariat (Taylor Brown and Ashton Babcock) and Business Development (Fabio Riefolo and Alba Ortega Flores) greeted dozens of visitors throughout the conference, engaging in conversations about the network, its data sources, ongoing studies, and opportunities for collaboration.
Aside from ad hoc traffic, the booth also provided a practical base for planned activity. For the Business Development team, it served as a space to hold discussions with potential collaborators, sponsors and data partners, allowing exploration of promising study opportunities. The booth also functioned as a studio to record interviews with presenters and members of the VAC4EU Journal Club Organising Committee. These conversations will help bring the scientific work presented at ISPE to a wider audience through future website and social media content. Watch this space for these videos as they roll out!
VAC4EU members contributed extensively to ISPE’s scientific programme through a course, two symposia, three presentations across two lightning sessions and 12 poster presentations. Across these sessions, members shared study results, methodological developments, and reported on tools from our pipeline that support multi-database research and reliable evidence generation.
Course: Intermediate/Advanced Topics in Vaccine Safety and Effectiveness
Sunday, 30 August
On Sunday afternoon, VAC4EU President Miriam Sturkenboom contributed to the intermediate/advanced course on vaccine safety and effectiveness. Her session focused on emerging topics and methods in vaccine safety assessment, including rare adverse events of special interest, self-controlled designs and target trial emulation, with an emphasis on moving beyond temporal associations towards causal, absolute and contextual risk assessment.
Lightning: Validation of Algorithms for the Identification of Myocarditis and Pericarditis in Real-World Data to Evaluate the Safety of the Pfizer-BioNTech COVID-19 Vaccine (COMIRNATY): A Post-authorisation Safety Study in the VAC4EU Network
Monday, 31 August
The lightning sessions kicked off on Monday, starting with three panels focused on methods. Amirreza Dehghan Tarazjani (VAC4EU and UMCU) participated in the third session, ‘Know Your Data & Validate.’ The session covered results from a VAC4EU validation study assessing how accurately real-world data algorithms identified myocarditis and pericarditis in a retrospective post-authorisation safety study of the Pfizer-BioNTech COVID-19 vaccine.
Poster Session
Monday, 31 August
In this first poster presentation session, attendees saw three VAC4EU posters covering case validation, semantic harmonisation, diagnostic code lists and more.
- How good is a Large Language Model in a validation study? Application to a screening phenotype for myocarditis using hospital discharge records validated with medical charts in the VAC4EU SeValid project (Giulia Hyeraci, et al)
- A Semantic Harmonisation Workflow for Multinational Vaccine Studies: The VAC4EU CodeMapper Approach (Sima Mohammadi, et al)
- Developing Sensitive Diagnostic Codelists Using Clinician Interviews: A Methodological Framework Illustrated by Myocarditis within the VAC4EU Sevalid study (Sima Mohammadi, et al)
Symposium: Data Are Not Enough – Communication Practices for Pharmacoepidemiologists in a Complex Information Ecosystem
Monday, 31 August
Monday, 31 August
On Monday evening, Debabrata Roy (DSRU) contributed to a symposium dedicated to communication practices. The symposium sought practical guidance and best practices for communicating real-world evidence, bringing a behavioural science perspective to the issue alongside pharmacoepidemiological and other expertise.
Debs’ talk, entitled “Beyond the Study Report: The Pharmacoepidemiologist’s Role in Evidence Stewardship,” explored how pharmacoepidemiologists can help maintain the integrity and interpretability of real-world evidence, and support its appropriate communication, as findings move beyond the study report.
Symposium: Identify, Quantify and Act: Advancing Methods for Reducing Bias from Measurement Error
Monday, 31 August
Meanwhile, Rosa Gini (ARS) was contributing to another parallel symposium detailing findings from a 2025 workshop which brought together a diverse group of researchers to address measurement error. The purpose of the symposium was to identify key challenges and explore recent innovation in the field, contributing to the future of RWD validation.
Rosa’s session, entitled “Quantify Measurement Error,” highlighted opportunities emerging from AI tools to improve study variable validations. She introduced the component strategy that leverages RWD diversity in multidatabase studies to quantify the share of true positives missed by phenotypes.
Lightning: Results from the Vaccine Monitoring Collaboration for Europe (VAC4EU) post-authorisation safety study for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) in Europe
Tuesday, 1 September
Tuesday’s programme featured three mini sessions dedicated to safety and effectiveness, including a panel for the final verdict on the COVID-19 vaccines. Alejandro Arana (RTI-HS) presented results from the VAC4EU network in this panel, covering Pfizer-BioNTech COVID-19 vaccine safety.
Lightning: Interim results from Post-Authorisation Safety Study (PASS) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) Bivalent/Omicron BA.1 and BA.4-5 in Europe: A study in the VAC4EU network
Tuesday, 1 September
Constanza Andaur Navarro (UMCU) also contributed to the panel on the COVID-19 vaccines, presenting interim results from the Pfizer-BioNTech Bivalent/Omicron COVID-19 vaccine.
Poster Session
Tuesday, 1 September
In the second poster presentation session, attendees saw eight posters covering results, tools or workflows from the VAC4EU network or studies in which VAC4EU was a contributing partner:
- RWD-FIT: A Tool for Standardised Data Source Evaluation (Christina Read, et al)
- Identifying Flares of 10 Autoimmune Diseases in Electronic Healthcare Data: Operational Algorithms and Background Incidence Rates from 10 Pan-European data sources (Fabio Riefolo, et al)
- Immunocompromised Status Definition in Observational Studies using Electronic Health Records: A Scoping Review and a Proposal for a Phenotype Identification Algorithm (Judit Riera, et al)
- Estimating sensitivity of a highly specific algorithm for myocarditis using a sensitive screening algorithm: results from the VAC4EU SeValid project (Rosa Gini, et al)
- Interpreting measurement error in multi-database studies using the Component Algorithm Strategy: analysis of three clinical outcomes across four diverse data sources from the VAC4EU network (Paolo Pricoco, et al)
- Assessing the Impact of different data prompts on the identification of ulcerative colitis patients, time to cohort entry and occurrence of flares in four European healthcare data sources: the Component Algorithm Strategy (Giuseppe Roberto, et al)
- Maternal ABRYSVO vaccination in the VAC4EU European network: National recommendations and early uptake patterns (Vjola Hoxhaj, et al)
- The utilisation of antiseizure medications in pregnant women, and women and men of childbearing potential (ADEPT): a multi-database study from 6 European countries (Shahab Abtahi, et al)
Poster Session
Wednesday, 2 September
The final poster session also included VAC4EU results, with a poster detailing myocarditis outcomes following vaccination with the Pfizer-BioNTech COVID-19 vaccine:
- Natural History and Clinical Outcomes of Myocarditis and Pericarditis Following Pfizer-BioNTech COVID-19 Vaccine (Comirnaty): A Multi-Database European Post-Authorisation Safety Study (PASS) in the VAC4EU network (Sima Mohammadi, et al)
A warm thank you to all presenters, chairs, discussants, collaborators, booth visitors and colleagues who contributed to such an energising week. VAC4EU leaves Milan grateful for the conversations, inspired by the work being done across the field, and motivated to continue building strong, transparent and collaborative vaccine monitoring in Europe.