After analyzing around 300 cases of post-injection menstrual disorders, the French drug agency says there is no established link “to date” between vaccines and period disorders.
“To date, we cannot establish a link between vaccination against Covid-19 and menstrual disorders“, indicated, Friday August 6, National Medicines Safety Agency (ANSM), after analyzing some 300 cases of menstrual disorders reported after injections of Pfizer / BioNtech and Moderna vaccines.
The ANSM looked into “261 cases of menstrual disturbances, including 30 severe (most often associated with other side effects such as flu-like illness)”In women with a median age of 36.5 years, after an injection of the Pfizer / BioNTech vaccine.
For the Moderna vaccine, these are “49 cases of menstrual disorders, including 6 severe“, which have been analyzed”in women with a median age of 38“, adds the National Medicines Safety Agency in its update on the adverse effects linked to vaccines against Covid-19.
Read also: Covid: do vaccines disrupt the menstrual cycle?
“The causes of these disorders can be multiple”
“The evolution is spontaneously favorable within a few days for the vast majority of cases. We cannot, to date, establish a link between vaccination and menstrual disorders, the causes of these disorders can be multiple.“, explains the ANSM.”If these menstrual disorders persist, we invite vaccinated people to consult their doctor.“, adds the Agency.
The ANSM had classified last week as “potential signal“menstrual disorders (heavier periods, shifted from the usual cycle, postmenopausal bleeding …) after vaccination with Pfizer or Moderna, and reported to the European Medicines Agency (EMA).
For its part, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency also indicated on Friday that “no cause and effect link had been established at this stage between the vaccines against Covid-19 and menstrual disorders“. These troubles”are very common and can occur unrelated to a medical problem“, underlines the PRAC, citing”stress and fatigue“among the possible causes.
The European Medicines Agency “continues to monitor the subject”
The European medicines gendarme adds to have asked “additional data“to laboratories and”keep monitoring the subject“by analyzing the reports of adverse reactions and the available scientific literature.
Some specialists suggest the hypothesis of a reaction of immune cells present in the uterine lining as a possible mechanism of action.
“Any immune activity can cause a slight or transient disruption of the menstrual cycle without consequences in the medium and long term.“, the infectious disease specialist Karine Lacombe said Thursday on France Inter.