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Vaccines

5C-01 - Monitoring the Safety of mRNA-1273 COVID-19 Vaccine in the General Population: Results of a Regulator-mandated Post-authorisation Safety Study in Denmark, Norway, Spain, and the United Kingdom (EUPAS44273).

Tuesday, August 26, 2025
8:30 AM - 8:45 AM ET

    Presenting Author(s)

  • Signe Sørup, PhD

    Department of Clinical Epidemiology, Aarhus University & Aarhus University Hospital
    Aarhus N, Denmark

    • Co-Author(s)

  • TR

    Thomas B. Rasmussen

    DCE, Denmark

  • CF

    Catherine Fry

    Drug Safety Research Unit, Southampton, UK, United Kingdom

  • Felipe Villalobos

    Primary care researcher
    Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain, Spain

  • MZ

    Mahmoud Zidan

    Researcher
    Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo
    Oslo, Norway

  • Marcel van Willigen, PhD

    Data Scientist
    Julius Clinical, Netherlands

  • DM

    Denise Morris

    Drug Safety Research Unit, Southampton, UK, United Kingdom

  • AL

    Angela Lupattelli

    Professor
    Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway

  • CB

    Carlo Alberto Bissacco

    Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain, Spain

  • LW

    Lei Wang

    Biostatistician
    Department of Clinical Epidemiology, Aarhus University Hospital, Denmark, Denmark

  • AA

    Astrid Alsema, PhD

    Data Scientist
    Julius Clinical, Zuid-Holland, Netherlands

  • SL

    Samantha Lane

    Drug Safety Research Unit, Southampton, UK, United Kingdom

  • AD

    Anteneh Desalegn

    Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway

  • DR

    Debabrata Roy

    Drug Safety Research Unit (DSRU), Southampton, UK, United Kingdom

  • MF

    Marc Far

    Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain, Catalonia, Spain

  • Daina B. Esposito, MPH, PhD

    Executive Director, Global Safety Epidemiology
    Moderna
    Cambridge, Massachusetts, United States

  • SS

    Samantha St Laurent

    Moderna
    Cambridge, Massachusetts, United States

  • Lei Zhu

    Moderna, United States

  • VU

    Veronica Urdaneta

    Moderna, United States

  • ME

    Magalie Emilebacker, PharmD, CCRP

    Director, Pharmacovigilance Sciences
    Moderna
    Alexandria, Virginia, United States

  • HS

    Henrik Toft Sørensen

    Professor
    Department of Clinical Epidemiology and Center for Population Medicine, Aarhus University, Aarhus, Denmark
    AARHUS N, Denmark

  • Vera Ehrenstein, MPH, DSc

    Professor
    Department of Clinical Epidemiology and Center for Population Medicine, Aarhus University, Aarhus, Denmark
    Aarhus, Midtjylland, Denmark

Background: The Moderna mRNA-1273 vaccine was developed in response to the coronavirus disease 2019 (COVID-19) pandemic and included in vaccination programmes in Europe. This post-authorisation safety study aimed to evaluate the safety profile of the mRNA-1273 vaccine.

Objectives: To examine whether the mRNA-1273 vaccine was associated with increased rates of 39 pre-specified adverse events of special interest (AESI).

Methods: This multi-database, VAC4EU study utilized data from population-based health registries in Denmark and Norway, and primary-care databases in Spain (SIDIAP –Catalonia region) and the United Kingdom (CPRD Aurum). Data were harmonised using the ConcePTION common data model and analysed with a federated approach. The exposure was the mRNA-1273 vaccine (any dose, by dose, or within designated risk windows after vaccination). Signal detection observed/expected analyses compared AESI rates among mRNA-1273 vaccinees with historical rates using a threshold of standardized morbidity ratio ≥2 with a minimum of 5 exposed cases. When the threshold was reached, signal evaluation was conducted using self-controlled or cohort designs. Country-specific estimates were combined using random-effects meta-analysis.

Results: For signal detection, the number of eligible individuals with at least one dose of mRNA-1273 vaccine was 564,080 in Denmark, 531,172 in Norway, 621,871 in Spain, and 273,254 in the United Kingdom.
Self-controlled case series analyses were used for signal evaluation of anaphylaxis, myocarditis, and pericarditis. For anaphylaxis 0-2 days post mRNA-1273 vaccination, the combined incidence rate ratios (IRRs) (95% confidence interval [CI]) were 4.74 (2.06-10.9) after the first dose and 2.66 (1.09-6.49) after the second dose in individuals ≥12 years. For myocarditis, the combined IRRs (95% CI) were 16.8 (6.86-41.3) 0-7 days after the second dose and 9.24 (3.77-22.6) 0-14 days after the second dose in males 12-39 years. The corresponding IRRs (95% CI) for pericarditis were 8.56 (3.01-24.4) and 4.55 (1.80-11.5).
Our findings did not indicate an association between the mRNA-1273 vaccine and the remaining 36 AESIs. Among AESIs with country-specific results available for all countries, the combined association measures ranged from an adjusted IRR (95% CI) for deep vein thrombosis of 0.87 (0.70-1.09) for the risk window 1-42 days after any dose of mRNA-1273 vaccine to an adjusted hazard ratio (95% CI) for single organ cutaneous vasculitis of 1.28 (0.73-2.25) comparing mRNA-1273 recipients with age and sex matched historical comparators.

Conclusions: We confirmed previously identified associations between the mRNA-1273 COVID-19 vaccine and anaphylaxis, myocarditis, and pericarditis. However, no additional safety concerns were observed.