At the beginning of August, one of the periodic safety updates of covid-19 vaccines from the European Medicines Agency (EMA), echoed the communication of Menstrual disorders after vaccination and requested more information to the marketing agencies, committing to review the available evidence and monitor this possible effect.
In turn, the Spanish Agency for Medicines and Health Products (AEMPS) also included this aspect in its seventh pharmacovigilance report, on July 20, informing that so far no causal relationship has been found between these changes in the rule and the covid-19 vaccines, although it clarifies that it is under study .
In this sense, from the Biosanitary Research Institute of Granada University of Granada and Hospital Universitario San Cecilio de Granada , a scientific study is being carried out, the EVA Project , led by professor Laura Baena , in which it is about evaluating whether vaccination is associated with this increasingly frequent consultation of menstrual disorders.
The study has three branches. The first is an online questionnaire that already has about 14,000 responses and which they expect to close in September. Although the data is not definitive and not yet published, more than 70% of the women who have participated report having presented changes in their rule after vaccination , including increased bleeding, more frequent bleeding and delays in menstruation, among others.
A second branch focuses on the follow-up over a year of just over 100 women, from before vaccination, and if these disorders occur, they can be characterized; Among them, and without having completed the study, about 30% report having some type of alteration. In a third branch, blood tests are being carried out on a subgroup of these volunteers (before, between doses and after the last dose of vaccine) to try to study the biological mechanism that could be involved.
Lack of comprehension
The menstrual cycle and a self-perception of a normal menstrual pattern is one of the most important physiological processes for women's health , since its alteration is sometimes an early sign of other pathologies, although it can also be modified by external factors, such as habits life, psychological aspects, physical activity and drug use, among others. However, there is still today a lack of understanding about menstrual physiology, visible in the lack of studies that exist in this area.
The Covid-19 has affected until August to more than 200 million people worldwide. The disease is associated with serious effects, reflected in a high death rate and serious health consequences. In addition, some studies have associated this viral infection with changes in the levels of sex hormones in women and with significant alterations in certain parameters of coagulation.
However, the studies carried out in this regard continue to be scarce to infer a clear knowledge about the mechanism and the consequences in menstrual cycle disorders, even more so if the lack of incorporation of the gender perspective in scientific research is taken into account , that is, research differentiated by sex and subsequent analysis with a gender perspective to understand the reasons for the differences, if any.
The first vaccines
One of the most important objectives in the search for strategies to stop this pandemic has been the development of effective vaccines against the spread of the SARS-CoV-2 virus and a massive worldwide vaccination campaign .
The European Medicines Agency (EMA) approved four vaccines based on randomized clinical trials: Pfizer / BioNTech, Moderna, AstraZeneca, and Janssen. To date, in Spain 73.3% of the population has at least one dose of one of these vaccines. However, none of these vaccines includes the risk of menstrual alterations as a possible side effect of their administration in their leaflets . The scientific literature is very scarce in relation to the secondary effects of vaccination on the reproductive health of the woman .
This may be due to the fact that these types of possible alterations are not usually included in studies on adverse effects of vaccines. We return to the lack of a scientific methodology with a gender perspective , even more so knowing that 77% of side effects of the SARS-CoV-2 vaccines reported to the EMA have occurred in women.
We hope in the coming months to be able to give more answers about the effect of these vaccines on menstrual health , so that it can be reported and included in the technical data sheet of the commercialized vaccines as well as the rest of already known side effects, which could avoid unnecessary consultations and tests in women who present them.
It is also necessary to apply a gender perspective in health research, without simplifying and attributing to stress or neuroticism the health effects observed in women, both due to the disease of covid-19 and with other diseases or in clinical trials such as those carried out with vaccination against SARS-CoV-2.