Results of a study published this Wednesday by the ANSM show a 20% increased risk of heavy menstrual bleeding between 1 and 3 months after primary vaccination (two doses).
According to the National Medicines Safety Agency (ANSM) in a press release on 24th January, the risk of possible menstrual disorders appeared on notices of heavy menstrual bleeding that required hospital treatment.
A pharmaco-epidemiological study conducted by AP-FARE (ANSM-Cnam Scientific Interest Group) was conducted when cases of late periods, heavy bleeding, absence of periods were reported to health authorities as part of a surveillance system. against covid-19 Even before the results “At the European level, heavy menstrual bleeding was considered by the EMA in October 2022 as an adverse effect of the mRNA vaccines Comirnati and Spikevax after an evaluation of pharmacovigilance data, in particular those shared by the ANSM. These disorders were subsequently added. The product characteristics for these two vaccines (SmPC ) and a summary of the package insert. Refers to ANSM.
8 women are affected per 1 million women vaccinated
The study included 4,610 women between the ages of 15 and 50. All were hospitalized for heavy menstrual bleeding between May 12, 2021 and August 31, 2022. He had no history of hysterectomy or coagulation disorder. These cases were compared with a control group of 89,375 women with similar characteristics. 28.8% of women participating in the study were not vaccinated, as were 28.7% of women in the control group.
Result: “The risk of major menstrual bleeding requiring hospital care was increased by 20% for women whose last dose was a primary vaccination dose given within 1 to 3 months prior.” The risk was not observed 3 months after the primary vaccination dose or after the booster dose. 8 cases of heavy bleeding are thus attributable to vaccination per 1 million vaccinated women, or 103 cases during the period studied. As a reminder, only hospitalized women were included in the study.
“This study provides new arguments in favor of the existence of an increased risk of heavy menstrual bleeding after vaccination against COVID-19 with an mRNA vaccine,” Completes studies.
