Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024

15 mars 2024 – EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of postmenopausal bleeding. Postmenopausal bleeding is commonly defined as vaginal bleeding occurring one year or more after the last menstrual period. Postmenopausal bleeding is always considered abnormal and can be a symptom of serious medical conditions.

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