Covid vaccine and menstrual disorders. The Prac Pharmacovigilance Committee of the European Medicines Agency EMA is examining “cases of irregular menstruation” reported after vaccination with anti-Covid mRna vaccines. Under the lens of the experts – explains the EU regulatory body – the alerts arrived on two issues in particular: heavy menstrual bleeding (heavy menstruation) and absence of menstruation (amenorrhea), conditions observed after the administration of Comirnaty * by Pfizer / BioNTech and Spikevax * by Moderna. “After reviewing the available evidence, the PRAC decided to request a thorough evaluation of all available data, including episodes reported in spontaneous reporting systems, clinical trials and published literature.”
The committee had previously reviewed reports of menstrual disorders in the context of safety summary reports for EU-approved Covid vaccines and concluded at the time that the evidence did not support a causal link between these vaccines and menstrual disorders. In light of spontaneous reports of menstrual disorders with both mRna products and the results of the literature, the Prac has decided to further evaluate the incidence of these problems of heavy cycles or post vaccine amenorrhea.
“Menstrual disorders – the experts point out – are very common and can occur for a wide range of underlying medical conditions, as well as for stress and fatigue. Cases of these disorders have also been reported following Covid infection”. Heavy cycles, it is specified in the Ema note, can be defined as “bleeding of such a volume that it can interfere with the quality of life on a physical, social, emotional and material level of the person. Amenorrhea can be defined as absence of menstrual bleeding for 3 or more consecutive months “. At this stage, the agency specifies, “it is not yet clear whether there is a causal link between Covid vaccines and reports. Furthermore, there is no evidence to suggest that these vaccines affect fertility. The EMA will communicate further when they become available. further information”.
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