“Where’s my cycle?” v. European Commission: Tens of Thousands of European Women Demand Answers Regarding Undesirable Menstrual Effects Following COVID-19 Vaccination.
Attorney Diane Protat is “counsel for the collective “Where is my cycle?,” which groups together tens of thousands of women in Europe who suffer from the undesirable effects of the Covid 19 vaccination on their menstrual cycle: amenorrhea, menorrhagia, adenomyosis, endometriosis, polycystic ovarian syndrome, miscarriage or even hysterectomy.”
In October 2022, “Where’s my cycle?” asked Ursula von der Leyen, President of the European Commission, “to refer the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) so that it can open a procedure for examining the safety of vaccines against COVID 19 (‘EU referral procedures for safety reasons’) and organize a public hearing with the EMA to allow the European institutions and pharmaceutical companies to answer women’s questions but also so that women can make their views known on the acceptability of the gynecological risks associated with vaccination against Covid 19.”
Despite the fact that “…the PRAC acknowledged at its October 28, 2022 meeting that the Comirnaty and Spikevax mRNA vaccines could cause menorrhagia and added this effect to the list of side effects for these two products: ‘Comirnaty and Spikevax: heavy menstrual bleeding added as a side effect’, but nevertheless considered them generally temporary and benign” [https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-october-2022], Ms. von der Leyen’s November 3, 2022, response stated, “At this point, no review of the safety of COVID 19 vaccines is underway.” The European Medicines Agency’s (EMA) response on that same date stated:
- “The PRAC…concluded in October 2021 that the evidence did not support a causal link between these vaccines and menstrual disorders.”
- “With respect to amenorrhea, which also includes early menopause and cycle interruption, the PRAC concluded in June 2022, based on evaluation of the available data, that there was insufficient evidence to suggest a causal action with mRNA vaccines.”
- “In general, menstrual disorders are very common in the general population…with COVID-19 vaccines having been used in large vaccination campaigns worldwide…the high number of reports of suspected side effects is not surprising. In addition, media attention to this issue may also have led to an increase in spontaneous reports of these events.”
- “…the high number of reported events observed after vaccination does not automatically mean that there is a causal relationship between that event and vaccination…they may have occurred due to other factors or simply by coincidence…”
- “…we would like to point out that data from safety databases such as Eudravigilance cannot be used to calculate the frequencies or incidences of potential side effects…please also note that self-reported data cannot be used to compare vaccines and their reactogenicity.”
- “…We want to reassure you that rigorous safety monitoring is in place for all COVID 19 vaccines.”
On November 10, 2022, the EMA published a safety update on COVID-19 vaccines confirming the addition of heavy menstrual bleeding as a potential adverse event and added, “There is no evidence to suggest that menstrual changes experienced by some people following vaccination have any impact on fertility…” [https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccines-safety-update-10-november-2022_en.pdf]
In contrast, the testimonies collected by “Where’s my cycle” show that “[heavy menstrual bleeding after COVID-19 vaccination] is painful, repetitive and affects the quality of life of women in Europe.” Moreover, the French demographics report by National Institute of Statistics and Economic Studies (INSEE) shows a historic decline in the birth rate in France [https://www.francetvinfo.fr/replay-radio/question-de-societe/bilan-demographique-un-pays-qui-se-depeuple-est-un-pays-qui-s-affaiblit-et-qui-a-moins-de-gens-pour-cotiser-pour-les-retraites-souligne-jean-viard_5586708.html], and “[t]he same observation is made throughout Europe.”
“Where’s My Cycle” maintains its request for a public hearing “…for an exchange between all the actors, European and national institutions, pharmaceutical laboratories and patients, and [to] make it possible to shed light in all transparency on the causes and consequences of the disorders of the cycle undergone by women in Europe since the launch of the mass vaccination against Covid 19 and to answer their questions:
- What is the database that the EMA uses to establish the frequency of side effects of mRNA vaccination if it is not Eudravigilance?
- On what basis did the PRAC conclude in June 2022 that there was insufficient evidence to suggest a causal action of mRNA vaccines on amenorrhea (which also includes early menopause and cycle interruption) reported by women as a side effect? Does the PRAC now stand by this conclusion and if so on the basis of what safety data?
- Can we exclude any risk of infertility in connection with post-vaccination menorrhagia?
- Can we exclude any link between the drop in the birth rate observed in Europe in the year 2022 and mass vaccination against COVID 19?
- Do COVID 19 treatments with fewer gynecological side effects than mRNA vaccines exist and are they available in Europe?”
Please read this important five-page letter below.23.3.10 A VLD Audition Publique en-US