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European Medicines Agency (EMA) Studies Menstrual Disorders Potentially Linked to COVID-19 Vaccine

The agency decided to deepen its study on the links between COVID vaccines and menstrual disorders after reports of more similar cases

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The European Medicines Agency (EMA) announced Friday that its safety committee is studying heavy menstrual bleeding and absence of menstruation in women who have received Pfizer and Moderna’s COVID-19 vaccines.

The EMA clarified that the investigation is being conducted after receiving reports of certain menstrual disorders that have started in some women after being vaccinated with one of the formulations based on messenger RNA technology.

It is not clear whether this is a casual link between these reports and the effects of the vaccines, given that this type of disorders is usual in conditions of high fatigue and stress.

The agency adds that cases of similar disorders have also been reported following infection with COVID-19, so they will also seek to rule out a direct link with the presence of the virus.

Other studies on menstrual disorders after vaccination

In mid-January, Reuters reported that a study funded by the National Institutes of Health (NIH) found links between COVID-19 vaccination and slight temporary changes in the menstrual cycle, after evaluating data collected from nearly 4,000 women enrolled in an app.

In addition, a Norwegian Institute of Public Health (NIPH) study, first published in December, noted some menstrual changes in women following vaccination.

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“Menstrual changes are very common, and even before vaccination, almost four out of ten young women reported that they had experienced such changes. However, in this study we see that more women experienced changes after the first or second vaccine dose,” said Lill Trogstad, project leader at NIPH.

The EMA decided to further its study on the links between vaccination and menstrual disorders after reports of more similar cases. “After reviewing the available evidence, the PRAC decided to request an in-depth evaluation of all available data, including reports from spontaneous reporting systems, clinical trials and the published literature,” its report reads.

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