Package inserts should be balanced: A call to equally mention risks and benefits

Using an innovative study design, Fröbert et al. report that influenza vaccination within 72 hours of hospital admission for myocardial infarction significantly reduced all-cause and cardiovascular mortality over 12 months compared to placebo. The IAMI trial, in harnessing the logistical power of cardiovascular registries, elevates pragmatic research design to a new level—turning healthcare databases into engines for clinical discovery and promising a renaissance in evidence integration for secondary prevention. It stands as an example of clinical trial methodology that seeks not only statistical clarity but also real-world applicability, potentially establishing a new “golden standard” for timely immunization in post-AMI care. Yet, amid its robust design and ambitious recruitment targets, the study finds itself recapitulating well-worn territory: the beneficial impact of influenza vaccination on cardiovascular outcomes has already been substantiated in a variety of observational cohorts and meta-analyses, with effect sizes and confidence intervals that are more déjà vu than revelation (see...