Covid-19: EMA rejects link between Covid-19 vaccine and absence of menstruation


In Spain, Amps has recorded 4,712 reports of gynecological changes. They are the sixth group after general disorders in the nervous system, musculoskeletal, digestive problems and skin.

a student received
Last year, a student at a vaccination center at Hunter Street Health Center in London received a dose of the Pfizer-BioNtech vaccine.Danielle Leal-OlivasoAFP

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that “There is insufficient evidence to establish a causal relationship between Pfizer and Moderna’s COVID-19 vaccines and missed periods.” (amenorrhea). The absence of menstruation can be defined as the absence of bleeding for a period of 90 days or more, as explained through a statement by the EMA.

The Committee has evaluated all available data, including results from the scientific literature and cases of amenorrhea reported to the European Database of Adverse Effects. eudra vigilance After vaccination with Moderna or Pfizer. Therefore, PRAC has determined that “Available data do not support a causal relationship and update of product information For either of the two vaccines.

In any case, the EMA has announced that PRAC “Continue to monitor this issue carefully“and requested Moderna and Pfizer to include this issue in their next periodic updated reports on the safety of their vaccines. PRAC, on the other hand, has further added that “Cases of heavy menstrual bleeding continue to be evaluated (heavy period) with Moderna and Pfizer vaccines.

Heavy menstruation can be defined as bleeding characterized by an increase in volume and/or duration that interferes with a person’s physical, social, emotional and physical quality of life. Menstrual disorders are very common and can occur with a wide range of underlying medical conditions.As well as from stress and fatigue.

In Spain, the Spanish Agency for Medicines and Health Products (Aemps) has Lodged 4,712 notifications of gynecological changes (referring to the breast and reproductive system) according to data from 15 Pharmacovigilance Reports on Kovid Vaccines, 101,369,478 doses of vaccines post-administration in our country, They are the sixth group after general disorders in the nervous system, musculoskeletal, digestive problems and skin.

For now, the committee has agreed to continue evaluating this safety signal and request an updated cumulative review of the heavy-duty cases from Moderna and Pfizer.

Studies that support changes in menstruation due to anti-Covid vaccine

Earlier this year, the journal ‘Obstetrics and Gynecology’ echoed a study by the US National Institutes of Health (NIH). The conclusion of the investigation is that vaccination From COVID-19 have an impact on Menstrualalthough it is very limited,

In work, he showed that a dose of covid-19 vaccine can reach enlarge into one Menstrual cycle (the time between bleeding) during a cycle, something they consider within themselves Normal Variability Range, It does not affect the number of bleeding days. They observed this when comparing vaccinated women with others who were not.

From the moment the female population of childbearing age was largely vaccinated, changes in menstruation began to appear. Last year, around the same time, the journal ‘British Medical Journal’ was composed of a letter written by Professor of Pharmacy at the University of Huddersfield (United Kingdom), Hamid Merchant, in which he mentioned a thousand cases of affected women: ” As of April 5, 2021, 958 cases of post-vaccination menstrual irregularities have been reported.”

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