The European Medicines Agency’s safety committee announced on Friday that it was evaluating reports of severe menstrual bleeding and period absence in women who had received COVID vaccinations from Pfizer/BioNTech and Moderna.
The assessment was made in light of reports of menstruation abnormalities following administration of either of the two vaccines, both based on messenger RNA technology, and it was not yet known whether there was a link between the reports .
The agency stated that it was unclear whether there was a significant connection between the immunizations and the reports about the changes in menstrual cycles.
Menstrual abnormalities can arise as a result of a variety of underlying medical issues, as well as stress and fatigue, according to the EMA, who added that cases of such disorders had also been documented following COVID-19 infection.
According to a recent study funded by the National Institutes of Health, vaccination against COVID-19 was associated with a small, temporary change in menstrual cycle length, which collected data from nearly 4,000 users of a smartphone app that tracks menstrual cycles.
However, the EMA stated in December that it had not established a relationship between changes in menstrual cycles and COVID-19 vaccines, following a Norwegian study that found some women had heavier periods after being injected.
Following an assessment of the evidence, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decided to request an evaluation of all available data, including patient and healthcare professional reports, clinical trials, and published literature.
The agency noted on Friday that there was no indication that COVID-19 vaccinations impaired fertility.
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