The European Medicines Agency (EMA) recommended that heavy menstrual bleeding should be added to the product information as a side effect of unknown frequency of the mRNA COVID vaccines Comirnaty (Pfizer/BioNtech) and Spikevax (Moderna).
Heavy menstrual bleeding may be defined as bleeding characterised by an increased volume and/or duration which interferes with the person’s physical, social, emotional and material quality of life. Cases of heavy menstrual bleeding have been reported after the first, second and booster doses of Comirnaty and Spikevax.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) assessed this safety signal after reviewing the available data, including cases reported during clinical trials, cases spontaneously reported in Eudravigilance and findings from the medical literature.
After a review of the available data, the PRAC concluded that there is at least a reasonable possibility that the occurrence of heavy menstrual bleeding is causally associated with these vaccines and therefore recommended the update of the product information.
The available data reviewed involved mostly cases which appeared to be non-serious and temporary in nature.
There is no evidence to suggest the menstrual disorders experienced by some people have any impact on reproduction and fertility. Available data provides reassurance about the use of mRNA COVID vaccines before and during pregnancy. A review carried out by EMA’s Emergency Task Force showed that mRNA COVID vaccines do not cause pregnancy complications for expectant mothers and their babies, and they are as effective at reducing the risk of hospitalisation and deaths in pregnant people as they are in non-pregnant people.
Source: European Medicines Agency
