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A story published in Science Advances presents the most comprehensive knowledge about the effects of COVID-19 vaccines on menstrual cycles to date.
Clinical trials are structured to explore the efficacy and protection of an investigational new drug (IMP), such as a vaccine. As a component of the assessment of the protection of an IMP, all prospective aspect effects that occur after management are evaluated. The experience of certain side effects after vaccination is identified as a common phenomenon and is not a concern. The 2020 trials of the first COVID-19 vaccines, which advanced to obtain authorization for human use, reported that some participants experience tenderness, pain, heat. , itching or bruising at the injection site, plus fatigue, chills, joint pain, and nausea.
Fast forward to the day of provision and approximately 12. 16 billion doses of a COVID-19 vaccine have been administered worldwide, with 66% of the world’s population receiving at least one dose. This large-scale management of vaccines allows the collection of information in real time. protection and efficacy data, adding the notification of effects of aspects that have been studied in clinical trials.
Clinical trials of the 2020 COVID-19 vaccine did not explore whether COVID-19 vaccines had side effects on the menstrual cycle. This is not an unusual case; Clinical studies have been criticized for their lack of inclusion, with the “complexities of the menstrual cycle” even cited as the basis for certain American studies.
In early 2021, reports of changes in the menstrual cycle after COVID-19 vaccination began to appear on official channels, including the UK Yellow Card Programme and social media. This led to researchers such as Dr. Kathryn Clancy, a professor of anthropology at the University of Illinois at Urbana-Champaign, and Dr. Kathryn Clancy. Katharine Lee, a professor of anthropology at Tulane University, begins to gather knowledge about those reports.
“Dr. Lee and I had our own reports of strange periods after the vaccine,” Clancy says. “If Dr. Lee hadn’t pointed them out to me first, I might never have made the connection myself. the reaction was overwhelming, we designed a survey tool that would allow us to capture those reports, as well as any point that might make a user more threatened by this side effect. We seek to pay attention to other people and validate their conceptions because there were so many who rushed to reject them.
Clancy and his colleagues used their survey to ask Americans about their reporting after receiving a COVID-19 vaccine. “We recruit online, basically through Twitter, but also facebook and Instagram. The survey took off in what’s known as “snowball sampling,” where other people who participated encouraged others to participate. The media attention we have attracted has also attracted many other people to our studio. Because the language of our study included gender, many other LGBT people also shared our study and encouraged others to participate. ” says Clancy.
On June 29, 2021, the study team uploaded their data and began their analysis. To avoid confusing the data, other people who had been diagnosed with COVID-19, which is known to be related to changes in the menstrual cycle, and those over forty were excluded from five to 55 years, which can be considered as perimenopause. In total, the effects of 39,129 participants were analyzed (this included another 35,572 people known as women and 3,557 people of other genders).
All respondents had won two doses of a COVID-19 vaccine at least 14 days before the end of the study, Pfizer, Moderna, AstraZeneca, Johnson
“We focused our research on those who menstruate and those who don’t have menstruation lately but have had them in the past,” Clancy said. who to bleed is surprising. “
The effects of the survey showed that 42. 1% of menstruating people experienced heavier menstruation after vaccination, with some reporting this happening within the first 7 days, while others experienced changes 8 to 14 days later. In contrast, 43. 6% of respondents reported feeling unreplaced in their menstrual womb
“Our main finding is that the accumulation of bleeding (more abundant in other people who menstruate and breakthrough bleeding in other people who do not menstruate) is real, credible and experienced by a significant number of other people,” says Clancy. “It is also now supported by several prospective studies that have also discovered the same thing. “
“A secondary location is that there are key points that increase a person’s risk of having this phenotype of accumulation and bleeding: being older (for other menstruating people, younger if menopausal), having been pregnant/having children, having a hyperproliferative reproductive state. “
The precise biological mechanism behind adjustments in the menstrual cycle after vaccination has not yet been identified, although several hypotheses are cited in the study. Vaccines induce an immune reaction, generating the production of antibodies. This induced immune reaction can lead to adjustments in hemostasis and inflammatory pathways in the body. It is conceivable that such effects have an effect on the complex chemical interactions that regulate menstrual cycles. Other vaccines, such as the human papillomavirus (HPV) vaccine, have been reported to have a transitory effect on menstrual cycles.
“The uterus is an immune organ. When the immune formula is activated through something like a vaccine, it’s going to have all sorts of after-effects, which add to the uterus,” Clancy says. “The endometrium (wall of the uterus) wants to bleed and clot while maintaining and healing. A disruption of the immune system or inflammation will disrupt those processes in at least some people.
The researchers hypothesized that the other people most vulnerable to such disorders would be those whose uterus had gone through abundant cycles of repair and healing, for example: other people who had many periods (i. e. , who were older), were pregnant or had children, or participants who would possibly have hyperproliferative disorders, such as endometriosis or fibroids. “These hypotheses were supported in our study,” Clancy says.
It is important to note that there is no evidence to suggest that COVID-19 vaccines may have a negative effect on fertility.
“The vital message is that it is very transparent that the vaccine has no adverse effects on fertility or pregnancy. Many studies have looked at the effect of the vaccine on fertility and male and female pregnancy. Evidence shows that getting vaccinated has no negative effects on any of those things and it is vital to protect pregnant women and their babies. These new findings are not a marvel and, in fact, do not explain why to delay or avoid a COVID-19 vaccine,” says Associate Professor Helen Petousis-Harris. , a vaccinologist at the University of Auckland, who was not involved in the study.
The new study followed a self-assessment method and is retrospective in nature. Causality between COVID-19 vaccination and changes in the menstrual cycle cannot be proven, a limitation that researchers acknowledge. However, the team states that the information is useful to “help shape the narrative about the nature of short-term menstrual adjustments, help doctors working with patients who are hesitant to get vaccinated, and expand knowledge of the mandatory picture about this new phenomenon. “
The study also highlights the need for clinical trials to investigate menstrual cycle experiences. “At a minimum, trials should include questions about menstruation and adverse daily reports should span at least 14 days, as many of our respondents had heavy periods. “of doors the existing 7-day window in the maximum test designs,” says Clancy. “Some participants told us they were concerned in vaccine trials and tried to report their symptoms; in one case, the user they spoke to downplayed their considerations and said ‘you just have to be in perimenopause’ than write down their symptoms. “
Drs. Clancy and Lee are excited to advance their research. “First, we need to reanalyze the entire knowledge set to see if our effects from the first few months of knowledge gathering are still compatible,” Clancy says. “Next, we need to analyze a moment survey that we sent to our participants that analyzes how many periods were interrupted, among which they experienced changes. “
The Moment survey explores stressors that can worsen symptoms, adding lifestyle points such as stress. “It examines the types of health care reports that other people have had in the past,” Clancy says. with us reports of institutional betrayal in health services (times when they were fired or mistreated when they tried to say they had menstrual adjustments or heavy bleeding with the vaccine) we wanted to explore this further and give more people the possibility to share what happened,” he concludes.
Any replacement in menstrual cycles, whether transient or prolonged, can be distressing for a user and can raise concerns about her health. For this reason, the study team recommends that people with breakthrough bleeding consult their doctor.
Dr. Kathryn Clancy speaking with Molly Campbell, Senior Science Writer at Technology Networks.
Reference: Lee K, Junkins E, Luo C et al. Survey of trends in which they experience adjustments in menstrual bleeding after vaccination against SARS-CoV-2. Sci Adv. 2022. doi: 10. 1126/sciadv. abm7201.