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The problem
Intervention: Nirsevimab immunization (monoclonal antibody against RSV) administered to children aged 0-24 months during RSV epidemic season
Who it was tested with: Children aged 0-24 months in European Union countries who received nirsevimab.
Experience from people who deliver programmes: stories, case studies and lessons learned. Valuable for understanding how and why, and for spotting what to test next, but not a measure of effect.
"We described suspected adverse drug reactions (ADRs) following nirsevimab administration in children aged 0-24 months, reported in the EudraVigilance system between 2023 and 2025... Our study can support the continue monitoring of the real-world safety and guide the planning of analytical observational studies on the safety profile of nirsevimab." This is a post-market surveillance analysis characterizing the safety profile of an intervention in routine practice, based on spontaneous adverse event reporting.
Spontaneous reporting data subject to underreporting bias; no denominator data provided to calculate actual adverse reaction rates; cannot determine causality from reported reactions; limited ability to compare with untreated population
Across countries and designs
1 study · 0 countries
A reviewer checked the classification against the source.
claude-haiku-4-5-20251001 · synth-v1
