European Medicines Agency To Review Period Irregularities With mRNA COVID-19 Vaccines
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The PRAC is assessing reported cases of heavy menstrual bleeding (heavy periods) and absence of menstruation (amenorrhea) with the COVID-19 vaccines Comirnaty and Spikevax.
The Committee had previously analysed 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.
Menstrual disorders are very common and can occur with a wide range of underlying medical conditions as well as from stress and tiredness. Cases of these disorders have also been reported following COVID-19 infection.
Heavy periods may be defined as bleeding characterised by a volume, which may interfere with the person’s physical, social, emotional and material quality of life. Amenorrhea may be defined as the absence of menstrual bleeding for three or more months in a row.
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.
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.
EMA will communicate further when more information becomes available.
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