No proven link between anti-Covid mRNA vaccines and post-menopausal losses. The Pharmacovigilance Committee (PRAC) of the European Medicines Agency EMA, in its last meeting on 4-7 March, concluded that “there is insufficient evidence to establish a causal association between the Covid-19 Comirnaty* and Spikevax* vaccines “, those of Pfizer-BioNTech and Moderna, “and cases of postmenopausal bleeding”.
Postmenopausal bleeding, recalls the EMA, means “vaginal bleeding that occurs a year or more after the last menstruation”. A phenomenon that is “always considered anomalous” and which “can be a symptom of serious medical conditions. Recently, from the medical literature and from the post-authorization data” to marketing, “new information has emerged which has encouraged” the EU regulatory body “to investigate postmenopausal bleeding with the two anti-Covid mRNA vaccines”.
“The PRAC has evaluated all available data – informs the EMA – including the results of the literature and spontaneous post-marketing reports on suspected adverse reactions” to vaccination. And “after careful consideration”, the Safety Committee considered that “the available data do not support a causal association and an update of the product information is not justified for any of the vaccines” considered.
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