Reports of Abnormal Periods After COVID-19 Vaccinations Prompt NIH to Grant Funding to Study Potential Link | Coronavirus

Months after people started sharing their stories of abnormal periods after COVID-19 vaccination online, clinical research into a potential link is about to begin.

The National Institutes of Health announced this week that they have awarded funding to five institutions to study whether coronavirus vaccines cause changes in menstruation.

The additional one-year grants, totaling $ 1.67 million, were awarded to Boston University, Harvard Medical School, Johns Hopkins University, Michigan State University and at Oregon Health and Science University, according to the NIH press release.

Medical experts say abnormal periods following a COVID-19 vaccine are not a safety concern, a reason not to get the vaccine, or a sign of infertility.

The studies plan to establish whether there is a correlation between irregular periods and Pfizer, Moderna or Johnson & Johnson vaccines, and if so, why the change is occurring, according to Dr Diana Bianchi, director of the Eunice Kennedy Shriver National Institute. of Child Health and Human Development, a branch of the NIH that funds the study.

Although no link has been made so far, Bianchi said it was “biologically feasible” due to the way the shot generates an immune response in the body. She added that the number of people who may experience abnormal periods after inoculation is not yet known.

The NIH-funded studies come after an investigation focused on collecting anecdotal reports of people’s menstruation experiences after COVID-19 vaccinations garnered a lot of attention on social media and among researchers. The survey, launched in April and led by Kathryn Clancy, associate professor at the University of Illinois at Urbana-Champaign, and Katharine Lee, postdoctoral researcher at the Washington University School of Medicine, counts to date more than 150,000 questioned person.

Clancy and Lee told the Tribune in April that they created the survey because of their own experiences with abnormal periods after their inoculations. The investigation is open to anyone over the age of 18 who has received at least one dose of a COVID-19 vaccine and who has had or is having menstrual cycles.

Clancy recently tweeted that they applied for the NIH grant but did not get funding.

Bianchi said the NIH issued a special notice to fund clinical studies after seeing online reports of people reporting irregular periods as well as seeing a “sharp gap” in the evidence.

Despite reports earlier this month that the Centers for Disease Control and Prevention had started research into abnormal menstruation after vaccination, the institution is not conducting further research into the 1,589 incidents of “menstrual irregularity. “that were recorded in its reporting system,” said Martha Sharan, public affairs officer for the CDC’s vaccine task force.

“At this time, the CDC sees no safety issues that warrant additional monitoring for irregular menstrual symptoms reported to the Vaccine Adverse Event Reporting System,” Sharan said in an email to the Tribune.

Sharan said the reports, recorded through the end of July, represent “a very small number,” given the more than 300 million doses of COVID-19 vaccines that have been administered.

Bianchi said that although the CDC’s numbers are low, the actual number of people experiencing abnormal periods after a vaccine injection may be much higher because the system relies on people responding to them voluntarily.

“I would bet most people don’t even know it,” Bianchi said.

Reports made to the CDC system are consistent with symptoms that have been more widely discussed online.

“I was due for my menstrual cycle, but when it happened I started to bleed profusely. It’s not a norm for me – my period is usually light with spotting at the start of my cycle, ”a COVID-19 vaccine recipient told the CDC system. “It was so heavy when it started on Friday that I bled through my pants.”

“I’m in menopause and haven’t had a period for 18 months. Within 72 hours of the vaccine, I had a light period which lasted 24 hours, ”said another.

The NIH-funded studies will be prospective, Bianchi said. They will include a control group and monitor for potential changes in menstruation in people who have not yet been vaccinated after receiving a COVID-19 vaccine. One problem with the existing information regarding COVID-19 vaccines and irregular periods is that everything has been retrospective, she said.

The lack of information available on potential changes in the period before vaccinations begin to be given to the general public has contributed to a fear that “didn’t need to be there,” said Nicole Woitowich, assistant professor of research at the Feinberg School at Northwestern University. of medicine, who added that this has also led to a “mistrust gap”.

“I think what really confused people was that they were totally taken by surprise because they weren’t told that they would be having the most painful time of their life, for example.” , said Bianchi.

Bianchi and Woitowich said the lack of information had also fueled fears surrounding infertility. There is no evidence that COVID-19 vaccines affect fertility, Bianchi said, and the injections have been shown to be safe for pregnant people, according to the CDC. Earlier this month, the CDC urged pregnant women to get vaccinated.

The combination of these factors likely led to increased hesitation about the vaccine, Woitowich said.

“The myth has escalated with the misinformation surrounding infertility, I think it’s a double whammy and can really prevent some people from getting vaccinated,” she said.

Bianchi said the reason there probably wasn’t a study on the vaccine’s effect on menstruation in the first trials last fall was because it was a situation of emergency in which they were only looking for major complications. But she added: “It really wouldn’t be that difficult to add a few questions specifically focused on women’s health.

For Woitowich, the lack of consideration of health issues that affect women and menstruating people in vaccine trials was probably also due to the historically male-dominated culture of biomedical research.

“Maybe people think that only women’s menstrual cycles are not a big concern,” Woitowich said. These problems are exacerbated when it comes to gender nonconforming people, she added.

In comments to the Twitter feed in February that kicked off Clancy and Lee’s investigation, some of the people who were discussing their experiences with abnormal periods were identified as transgender or non-binary.

“People belonging to gender minorities have their own social determinants of health which, again, are not taken into account when we do not consider gender as a variable in research studies,” said Woitowich. . “So we are harming these people by not taking into account precisely the influence of gender on health and disease.”

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