Messenger RNA vaccines against Covid-19 may be the cause of heavy menstrual bleeding in some women after their vaccination, the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA) said on Friday.
This bleeding “can be considered a potential adverse effect of the vaccines” of Pfizer and Moderna, according to this conclusion reported by the National Medicines Agency (ANSM). These effects will now be added to the summaries of product characteristics (SPCs) and package inserts for these two vaccines.
Menstrual disorders reported after vaccination with an mRNA vaccine, namely those from Pfizer/BioNTech and Moderna, have been closely monitored at the national and European level since their detection.
Multiple testimonies evoked the appearance of disorders after an anti-Covid vaccination, but the health authorities had not yet established a causal link. In July, the women in question were invited in particular by the ANSM to testify.
Almost 3,500 cases of menstrual disorders reported
The Medicines Agency recalls having brought to the European level all the data collected by the French pharmacovigilance system and the results of the analyzes carried out.
Between July and September 2022, 2,952 cases of menstrual disorders were reported with the Comirnaty (Pfizer/BioNTech) vaccine and 515 with the Spikevax (Moderna) vaccine.
Most of these statements were made directly by patients. Some statements relate to much earlier events, possibly dating back to the spring of 2021.
Reported menstrual disorders refer mainly to changes in the duration and intensity of bleeding, whether or not associated with pain. Most of the time they are “non-serious” and transitory, specifies the ANSM. In some patients, however, there is a possible persistence of these effects for around 6 months. A more precise analysis of these cases continues, specifies the ANSM.
Source: BFM TV
