Women affected by menstrual disorders that appeared after vaccination against Covid-19 are invited to declare them, the Medicines Agency (ANSM) asked on Tuesday July 19, in a context of uncertainty about a direct link between the vaccines and these disorders. Declarations can be made on Ministry of Health portal. Women who feel trouble are asked to bring “the most detailed information possible in the declaration form”.
The ANSM has posted a guide help with reporting as well as tutorials for patients and healthcare professionals. The elements collected must allow “the regional pharmacovigilance centers to carry out their assessment of declared cases in the most efficient way possible”she explains.
Menstrual disorders declared after vaccination with a messenger RNA vaccine, namely those of Pfizer-BioNTech and Moderna, have been the subject of careful monitoring at the national and European level since their detection, recalls the agency.
Multiple testimonies evoke the appearance of disorders after an anti-Covid vaccination, but the health authorities have not yet established a cause and effect link.
More than 10,000 declarations of cycle disorders reported
As of April 28, the regional pharmacovigilance centers have analyzed 9,381 declarations of cycle disorders reported with the Pfizer vaccine, and 1,557 with the Moderna vaccine, reports the ANSM. The majority of these declarations were made by the patients directly, specifies the agency. To date, 58 million injections had been made in women with the Pfizer vaccine, and 12 million with that of Moderna.
At this stage, adverse events most often remain “not serious” and generally manifest themselves in two ways: by abnormal bleeding (metrorrhagia, menorrhagia), and by delayed menstruation or amenorrhea, underlines the drug agency.
To date, the available data do not make it possible to describe the mechanism of occurrence of these menstrual cycle disorders, she adds.
However, she cites several hypotheses such as reactogenicity (fever, headache, nausea, etc.) caused by vaccination which could, as during an infection, influence the hormones involved in the menstrual cycle. Or even a significant stress, caused by the act of vaccination, likely to disturb the hypothalamic-pituitary-ovarian axis which regulates the smooth running of the menstrual cycle.