Tuesday, March 21

Spain opens a new evaluation on menstrual disorders after the vaccine against COVID-19

The European drug agencies evaluated in the second half of 2021 whether the COVID-19 vaccine could be causing menstrual disorders. They concluded, after reviewing all the information then available for each of the vaccines, that there was insufficient data to support “the hypothesis of a possible causal relationship.” Now, the Spanish Medicines Agency (AEMPS) has reported that it is starting a new evaluation as a result of “two studies that suggest an increase in the frequency of these disorders after vaccination, with slight and transitory changes in menstrual cycles.”

A midwife collects data on menstrual alterations after receiving vaccines against COVID-19: “Don’t take us for crazy”

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well figure in the latest Pharmacovigilance report of vaccines, published on February 23 by the AEMPS. The evaluation will focus on the Pfizer (Comirnaty) and Moderna (Spikevax) vaccines to “assess and put into context” all the available evidence.

The decision is made in line with the European environment. The European Medicines Agency (EMA) announced on February 11 that it would reassess the possible effects of vaccines on menstruation in light of new findings, with special attention to cases of heavy and absent menstruation (amenorrhea) after vaccination “requesting an in-depth review of all available data, including reports from spontaneous reporting systems, clinical trials, and the published literature.”

The AEMPS cites two investigations. The first is from the Norwegian Institute of Public Health and is based on interviews with nearly 4,000 women between the ages of 18 and 30. 13.6% reported alterations in the amount of bleeding after the first dose compared to 7.6% before the administration of the injection. The percentage rose to 15% after the second dose. 12% reported changes in the duration of the rule after the first vaccine and 14% once received the full regimen.

The second study referred to by the AEMPS is published in the journal Obstetrics and Gynegocologic. The results link vaccination with a slight lengthening of the menstrual cycle in a small number of cases, although the change, the conclusions say, is transitory. The research, carried out on a cohort of almost 4,000 women (2,500 vaccinated and the rest, not vaccinated), clarifies that there are open questions about other possible alterations, such as menstrual symptoms or changes in the amount of bleeding.

In Spain, at least two universities are conducting research. The University of Granada began the study in the summer for a response based on scientific evidence to the symptoms reported by many women, as reported by elDiario.es. On the other hand, the University of Extremadura has already published the preliminary results in the absence of peer review. Of the slightly more than 17,500 women who responded to the survey launched by several researchers, half – between 45 and 50% – suffered alterations in their cycle as a result of becoming ill or being vaccinated against the coronavirus. One of the gynecologists collaborating in the study, Miriam Al Adib Mendiri, assured in this article that the prevalence of alterations is high, although in some cases they may be due to other factors, such as stress, the high number of respondents makes the conclusion that links vaccination with changes in the cycle is solid. The complicated thing to always confirm the secondary effects of the vaccine is to demonstrate that one thing is a consequence of another.