The European Medicines Agency (EMA) said on Friday that it was investigating reported menstrual irregularities after the reception of COVID shots.
In a release about recent meetings held by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA said that "The PRAC is assessing reported cases of heavy menstrual bleeding (heavy periods) and absence of menstruation (amenorrhea) with the COVID-19 vaccines Comirnaty [manufactured by Pfizer] and Spikevax [manufactured by Moderna]."
"The Committee had previously analyzed reports of menstrual (period) disorders in the context of the safety summary reports for COVID-19 vaccines approved in the EU and concluded at the time that the evidence did not support a causal link between these vaccines and menstrual disorders.
"In view of spontaneous reports of menstrual disorders with both vaccines and of findings from the literature, the PRAC decided to further assess occurrences of heavy periods or amenorrhea following vaccination," the EMA explained.
"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."
The EMA added that "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."
In June, Kan News cited an increasing number of reports of menstrual irregularities among Israeli women following the COVID shot, including cases of earlier and later-than-usual periods, heavy bleeding, and periods occurring after menopause - including the case of a 92-year-old woman who experienced bleeding after receiving the shot.
The health ministry told Kan News at the time that the mechanism for the phenomenon was unknown, and that they had still not proven a causal link between the shot and menstrual irregularities.