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The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.
The European Medicines Agency (EMA) announced on Feb. 11, 2022 that its Pharmacovigilance Risk Assessment Committee (PRAC) is assessing reports of heavy menstrual bleeding and lack of menstruation associated with COVID-19 vaccines Comirnaty and Spikevax. Previous reports of period disorders were analyzed in the safety summary reports for COVID-19 vaccines approved in the European Union. It was concluded that evidence at the time did not support a causal link between the vaccines and menstrual disorders.
PRAC has requested an in-depth evaluation of available data from spontaneous reporting systems, clinical trials, and published literature after spontaneous reports of menstrual disorders with both vaccines. “At this stage, it is not yet clear whether there is a causal link between the COVID-19 vaccines and the reports of heavy periods or amenorrhea. There is also no evidence to suggest that COVID-19 vaccines affect fertility,” the agency stated in a press release.