- Menstrual disorders and Covid-19 vaccination: what’s going on?
- Is the link between vaccination against Covid-19 and menstrual disorders proven?
- What are the disorders involved?
- What are these menstrual disorders due to?
- How are these disorders recognized?
- Menstrual disorders linked to Covid vaccination: what to do if you think you are concerned?
Little by little, the impact of the vaccine against Covid-19 on menstruation is being confirmed by national and European health authorities. This Friday, October 28, the pharmacovigilance committee (PRAC) of the European Medicines Agency (EMA) has admitted that vaccines against Covid-19 may well be the cause of menstrual problems, including heavier bleeding. He also recommended that this symptom be added to the list of common side effects of messenger RNA vaccines.
“Heavy menstrual bleeding (heavy periods) can be defined as bleeding characterized by increased volume and/or duration that interferes with a person’s physical, social, emotional, and material quality of life. Cases of heavy menstrual bleeding have been reported after the first, second and booster dose of Comirnaty and Spikevax“, recalls the EMA. Nevertheless, the agency wants to be reassuring and indicates that there is currently no proof that these menstrual disorders have consequences on reproduction and fertility.
Menstrual disorders and Covid-19 vaccination: what’s going on?
Since the start of the vaccination campaign against Covid-19, thousands of women have complained about their menstrual cycle disorders on social networks. Between July and September 2022, 2,952 cases of menstrual disorders were reported with the Cominarty -Pfizer-BioNTech vaccine) and 515 with the Spikevax vaccine (Moderna), indicates the ANSM. The majority of these declarations were made directly by the patients.
As of 28 April 2022, the Agency had already identified 9,381 reports of cycle disorders reported with the Comirnaty vaccine, and 1,557 with the Spikevax vaccine in reports from regional pharmacovigilance centers (CRPV). By that date, 58 million people of all sexes had been vaccinated with the Comirnaty vaccine and 12 million people with the Spikevax vaccine.
>> Please note: these cases occurred both after the first injection and after the second or booster dose.
Disturbed cycles, very heavy periods, metrorrhagia (bleeding outside the rules), bleeding that can last up to three weeks, pelvic pain… At first, many women have faced these disorders without talking about it. Then the word was released, they spoke about it to their doctor and some of them found themselves within the collective “Où est ton cycle”, which was auditioned on April 4 at the European Parliament. Other women were then received in the Senate to request recognition of their side effects.
#westmycycle ? , and you, where is yours? pic.twitter.com/D6r2H3scZk
— Where is my cycle (@ouestmoncycle) August 10, 2022
“Even if it is difficult to make a causal link, it is true that, like other colleagues, I have many patients who have declared menstrual disorders in the month following vaccination.“explains Dr. Julia Maroauni, gynecologist and general secretary of the French Society of Colposcopy and Cervico-Vaginal Pathology (SFCPCV). “And this is a possible consequence from a biological point of view. But these are mostly transient disorders“.
Is the link between vaccination against Covid-19 and menstrual disorders proven?
According to the Pharmacovigilance Committee of the European Medicines Agency, heavy bleeding has occurred in some women”can be considered a potential adverse effect of vaccines“. In a press release published this Friday, October 28, the agency indicated that these effects will now be added to the summaries of product characteristics (SPC) and package inserts of the two vaccines Pfizer-BioNTech and Moderna.
These disorders were previously the subject of careful monitoring at national and European level. In July 2022, the broadcast of a “guide to reporting severe menstrual cycle disorders” had made it possible to collect new testimonies from the women concerned.
What are the disorders involved?
In a communicated published on June 23, 2022, the ANSM reported on the adverse effects most often shared in the testimonies of the women concerned, namely:
- Of the abnormally long bleeding during menstruation or outside of menstruation;
- An absence of periods for several months (amenorrhea);
- Significant pelvic or abdominal pain;
- In women with endometriosis: a reactivation of their painful symptoms when the disease was well controlled until then;
- In postmenopausal or transgender women: abnormal bleeding;
- In some cases, abnormal bleeding in quantity and duration that led to hysterectomies, i.e. surgical removal of the uterus.
The ANSM nevertheless indicates that “the majority of observed menstrual disturbances were generally non-serious, short-lived and self-limiting”. However, in some patients, possible persistence of these effects was noted after six months. “The more precise analysis of these cases by the regional pharmacovigilance centers is continuing“, indicates the ANSM.
![Menstrual disorders linked to the covid vaccine](https://file1.topsante.com/var/topsante/storage/images/1/3/5/4/1354863/les-troubles-menstruels-lies-vaccin-covid.jpg?alias=reference&size=x100&format=jpeg)
What are these menstrual disorders due to?
Today, the ANSM indicates that the available data do not make it possible to describe “the mechanism of occurrence” of these disorders. Nevertheless, several hypotheses are evoked:
- Reactogenicity (fever, headache, nausea, etc.) caused by vaccination: it could, as during an infection, influence the hormones involved in the menstrual cycle;
- THE stress or anxiety generated by the act of vaccination or the context of the pandemic: it is known that stress can disrupt the hypothalamic-pituitary-ovarian axis, which will upset the smooth running of the menstrual cycle;
- Other factors: gynecological disease, pregnancy, contraceptive treatment, etc.
How are these disorders recognized?
Initially, in December 2020, the European Medicines Agency (EMA) said that it had not established a link between changes in menstrual cycles and vaccination against Covid-19, after having learned from a Norwegian study.
But on February 11, 2022, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said it had decided to request an assessment of all available data on the subject, including patient reports. and healthcare professionals, clinical trials and published literature. A recognition for the women concerned. This inclusion in the list of side effects is therefore a new step forward in recognizing the link between the Covid-19 vaccine and menstrual disorders.
In the United States, this potential link between menstrual cycle disorders and vaccination against Covid-19 has been taken seriously since a grant of 1.67 million dollars has been awarded by the National Institutes of Health to understand the underlying mechanisms. The study, which involved more than 4,000 women, actually shows that just after receiving a vaccine against Covid-19, the menstrual cycle of women is lengthened by less than a day on average. But this effect is considered not serious and appears to be transient, the duration of the cycles returning to normal in one or two months.
Menstrual disorders linked to Covid vaccination: what to do if you think you are concerned?
Menstrual disorders reported after vaccination with an mRNA vaccine have been closely monitored at national (ANSM/CRPV) and European (EMA) levels since their detection.
If you experience unusual effects, abnormal pain, your menstrual cycle is disrupted, and these disorders persist, the ANSM invites you to:
- Consult a doctor first, in order to carry out additional examinations.
- Declare your symptoms, then on the portal of the Ministry of Health (signalement.social-sante.gouv.fr).
If you wish to declare menstrual disorders which appeared after vaccination against Covid-19, it is necessary to provide the most detailed information possible, via the declaration assistance guide published by the ANSM (link above in the article).
Sources:
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24-27 October 2022, EMAOctober 28, 2022
- Update on the monitoring of vaccines against Covid-19 – Period from 09/30/2022 to 10/20/2022, ANSM, October 28, 2022
- Menstrual disorders after vaccination against Covid-19: state of knowledge and advice for the women concerned, ANSM, June 23, 2022
- Association Between Menstrual Cycle Length and Coronavirus Disease 2019 (COVID-19) Vaccination, Obstetrics & GynecologyJanuary 2022
- Menstrual changes after covid-19 vaccination, British Medical JournalSeptember 16, 2021