When Dr. Katharine Lee gets her COVID-19 vaccine, she notices that her next period is a little “different.”
Lee, a postdoctoral fellow in the Department of Public Health at Washington University in St. Louis. Louis, was curious if anyone else was experiencing an irregular period after being vaccinated. She reaches out to a few friends and colleagues, some of whom have also remarked that something is not right either.
It turns out she’s not alone: many said they had the same experience. Then why was it not reported as a side effect?
Lee is curious and subsequently contacted Dr. Kate Clancy, associate professor of anthropology at the University of Illinois. As an anthropologist studying human reproductive ecology, which includes the effects of environmental stressors on menstrual cycles, Lee asked her if Clancy had ever heard of irregular menstrual cycles after receiving the vaccine; and, if so, if she thinks about why it might happen.
Together, the two launched a survey, which gathered 22,000 responses from April 15 – a number that Clancy described as ‘bananas’, pointing to the importance of the topic for people who are menstruating. A popular Twitter thread started by Clancy-inspired answers that confirm that the topic has been studied below.
“So many people felt very alone in this experience because it was not on the list of possible side effects,” Lee said. “They thought there was something wrong with them, that something could be worse wrong, and for a number of people who did try to report it to someone who fired them.”
While Lee and Clancy have yet to analyze the results, they have noticed some trends.
“People who historically menstruate but do not menstruate now because they are trans on sex hormones, long-acting reversible contraceptives or postmenopausal, for example – we hear from all three groups that a number of them experienced bleeding when it was not very long, “Clancy added that it was not a universal experience, but that many reported it. Among ‘people who were expecting to menstruate’, Clancy said they received three different general reactions: ‘no change.’ ‘,’ absent or late ‘and’ heavy and early ‘.
The duo do not yet need to properly analyze the data to make associations, they explain.
According to U.S. Food and Drug Administration documents containing the possible side effects for both the Moderna and Pfizer BioNTech COVID-19 vaccines, a possible irregular period was not included, indicating that this data is not explicitly collected or reported during the clinical trials.
Kathryn Schubert, president and CEO of the Society for Women’s Health Research, told Salon she thinks questions about a woman’s menstrual cycle should be taken “absolutely” and be an expected standard in clinical trials involving women.
“Every time you include women in a clinical trial or a study design, it has to be part of the thinking,” Schubert said. “Standard questions are more in the line of, ‘If you are a person of reproductive age, are you birth control?’ or “Can you get pregnant?”
“I think a lot of the concern around the reproductive side of the matter is whether there is going to be a problem regarding damage to a fetus or possibly an unintended pregnancy and what it means to you if you are in a clinical trial, “Schubert added.
Schubert noted that only in the 1990s could women even be admitted to clinical trials.
“That was not so long ago, and that’s why we’re still making ground,” Schubert said. The logic at the time was that it was a ‘risk’ to include women of reproductive age, or ‘difficult’ to explain hormonal change in studies. “Well, the reality is that women have hormonal changes, and we need to incorporate them from the beginning,” she added.
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Schubert said she believes the COVID-19 vaccine trials were so “inclusive” given the time they had, and the urgent public health emergency. Nevertheless, she hopes that inclusivity will be included in future COVID-19 vaccine trials for the inevitable iterations of the vaccines containing different variants.
Indeed, it is not just the monitoring of menstrual cycles that has been missed in clinical trials – pregnant women have also been excluded from the initial clinical vaccination trials. Pregnant women are at increased risk for complications and the development of severe COVID-19.
According to experts, the vaccine is safe for pregnant people based on previous trials with the mRNA vaccine technology. Since the beginning of this year, clinical trials have been conducted on the safety and how well the COVID-19 vaccines in pregnant people take into account, or are planned. The issue as a whole, however, addresses the need for clinical trials considering categories outside gender, race, and ethnicity.
“The NIH [The National Institutes of Health] now these rules about including different types of participants revolve around gender, race, and so on, “Clancy said. However, it is not enough to include them if you do not take into account their specific community needs or their specific differences. inclusion required. “
Based on what scientists know of some vaccines and menstrual cycles, Clancy said that the reports of irregular periods may be due to a change in platelets that coincides with a normally occurring ‘bleeding’ such as menstruation. Sometimes, Clancy added, a typical immune response is inflammatory. The uterus and ovaries are a place where tissue reform takes place, which needs inflammation to work. It is a complex biological process that can be thrown away if too much happens at the same time, but the lack of research currently yields a lack of definitive answers. And its consequences affect everyday life for people who are menstruating.
“I think someone who normally suppresses their menstrual cycle has supplies on hand, and anyone who thought they were menstruating forever has supplies on hand,” Lee said. “There is this whole range of similar body management and logistics of this, ranging from irritating to dysphoric.”