The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA, for its acronym in English) has concluded that “there is not enough evidence” to establish a causal relationship between Pfizer and Moderna covid vaccines and cases of missed menstruation (amenorrhea).
The absence of menstruation It can be defined as the absence of bleeding for a period of 90 days or more, as explained by the EMA through a statement. The PRAC has evaluated all available data, including results from the scientific literature and cases of amenorrhea reported to the EudraVigilance European Database of Adverse Effects following administration of the vaccines from Moderna or Pfizer.
The committee has determined that “the available data do not support a causal association and an update to the product information for either vaccine.
In any case, the EMA has announced that the PRAC “will continue to monitor this issue carefully.” and has asked Moderna and Pfizer to include this issue in their next periodic safety update reports for their vaccines.
Doubts about heavy bleeding
On the other hand, the PRAC has advanced that “still evaluating” cases of heavy menstrual bleeding (heavy periods) with Moderna and Pfizer vaccines.
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Heavy menses can be defined as bleeding characterized by an increase in volume and/or duration that interferes with the person’s physical, social, emotional and material quality of life. The menstrual disorders are very common and can occur with a wide range of underlying medical conditions, as well as from stress and exhaustion.
The committee has agreed continue with the evaluation of this signal de Safety and ask Moderna and Pfizer for an updated cumulative review of heavy periods.