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The link between anti-Covid vaccine and menstrual disorders confirmed
Messenger RNA vaccines against Covid-19 may cause heavy menstrual bleeding in some women after vaccination, according to the European Medicines Agency.
Muriel Kaiser with AFP
Written on 31/10/2022
A few months after inviting women to declare their menstrual disorders in connection with their vaccination against Covid-19 , the National Medicines Agency ( ANSM ) reports the conclusions of the pharmacovigilance committee of the European Medicines Agency (EMA). Disruptions to the menstrual cycle "may be considered a potential adverse effect of vaccines" from Pfizer/BioNTech and Moderna. Thus, these effects will now be added to the summaries of product characteristics and package leaflets of these two vaccines.
Menstrual disorders reported after vaccination with a messenger RNA (mRNA) vaccine, namely those from Pfizer and Moderna, had been the subject of careful monitoring at national and European level since their detection. Multiple testimonies evoked the appearance of disorders after an anti-Covid vaccination, but the health authorities had not yet established a causal link.
Nearly 3,000 cases studied
The Medicines Agency recalls having brought to European level all the data collected by the French pharmacovigilance system and the results of the analyzes carried out.
Between July and September 2022, 2,952 cases of menstrual disorders were reported with the Comirnaty vaccine (Pfizer/BioNTech), and 515 with the Spikevax vaccine (Moderna). The majority of these declarations were made directly by the patients. Some declarations relate to very earlier events, possibly dating as far back as the spring of 2021.
"Non-serious" problems
Reported menstrual disorders mainly concern changes in the duration and intensity of bleeding. These may or may not be associated with pain. They are most often "not serious" and transient, specifies the ANSM.
In some patients, however, there is a possible persistence of these effects around six months. A more precise analysis of these cases is in progress, specifies the ANSM.
https://www.allodocteurs.fr/le-lien-...rme-33558.html
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Menstrual disorders reported with Comirnaty and Spikevax vaccines
The ANSM, in collaboration with the CRPV network, continues to be mobilized on menstrual disorders declared after vaccination against Covid-19. The distribution of the guide for the declaration of severe menstrual cycle disorders in July 2022 made it possible to collect new pharmacovigilance declarations.
Based on these new declarations, the reporting CRPVs carried out a quantitative interim analysis. Between July and September 2022, 2,952 cases of menstrual disorders were reported with the Comirnaty vaccine (Pfizer/BioNTech), and 515 with the Spikevax vaccine (Moderna). The majority of these declarations were made directly by the patients. Some declarations relate to very earlier events, possibly dating as far back as the spring of 2021. The menstrual disorders declared mainly concern changes in the duration and intensity of bleeding, whether or not associated with pain. The quantitative characteristics (time to onset, average age of patients, etc.) seem similar to previous analyzes (read our press release of June 23, 2022 and ourupdate of December 21, 2021). This new quantitative interim analysis provided results with greater follow-up on the duration of these disorders in some women. Indeed, we observe a possible persistence of these effects in some patients around 6 months. The more precise analysis of these cases by the CRPVs is continuing.
The ANSM brought to European level all the data collected by the French pharmacovigilance system and the results of the analyzes carried out by the reporting CRPVs.
The EMA's European Pharmacovigilance Committee (PRAC) this week reviewed all the data available to date on heavy menstrual bleeding(menorrhagia) reported with mRNA vaccines against Covid-19. Heavy menstrual bleeding is defined as too heavy and/or too long menstrual flow.
On 28 October 2022, the PRAC concluded that heavy menstrual bleeding can be considered a potential adverse reaction to Comirnaty and Spikevax vaccines. The reported cases are most often “non-serious” and transient. Heavy menstrual bleeding will be added to the summaries of product characteristics (SPC) and package leaflets for these two vaccines.
What to do in case of menstrual disorders occurring after vaccination against Covid-19?
https://ansm.sante.fr/actualites/poi...-au-20-10-2022
The link between anti-Covid vaccine and menstrual disorders confirmed
Messenger RNA vaccines against Covid-19 may cause heavy menstrual bleeding in some women after vaccination, according to the European Medicines Agency.
Muriel Kaiser with AFP
Written on 31/10/2022
A few months after inviting women to declare their menstrual disorders in connection with their vaccination against Covid-19 , the National Medicines Agency ( ANSM ) reports the conclusions of the pharmacovigilance committee of the European Medicines Agency (EMA). Disruptions to the menstrual cycle "may be considered a potential adverse effect of vaccines" from Pfizer/BioNTech and Moderna. Thus, these effects will now be added to the summaries of product characteristics and package leaflets of these two vaccines.
Menstrual disorders reported after vaccination with a messenger RNA (mRNA) vaccine, namely those from Pfizer and Moderna, had been the subject of careful monitoring at national and European level since their detection. Multiple testimonies evoked the appearance of disorders after an anti-Covid vaccination, but the health authorities had not yet established a causal link.
Nearly 3,000 cases studied
The Medicines Agency recalls having brought to European level all the data collected by the French pharmacovigilance system and the results of the analyzes carried out.
Between July and September 2022, 2,952 cases of menstrual disorders were reported with the Comirnaty vaccine (Pfizer/BioNTech), and 515 with the Spikevax vaccine (Moderna). The majority of these declarations were made directly by the patients. Some declarations relate to very earlier events, possibly dating as far back as the spring of 2021.
"Non-serious" problems
Reported menstrual disorders mainly concern changes in the duration and intensity of bleeding. These may or may not be associated with pain. They are most often "not serious" and transient, specifies the ANSM.
In some patients, however, there is a possible persistence of these effects around six months. A more precise analysis of these cases is in progress, specifies the ANSM.
https://www.allodocteurs.fr/le-lien-...rme-33558.html
---------------------------
Menstrual disorders reported with Comirnaty and Spikevax vaccines
The ANSM, in collaboration with the CRPV network, continues to be mobilized on menstrual disorders declared after vaccination against Covid-19. The distribution of the guide for the declaration of severe menstrual cycle disorders in July 2022 made it possible to collect new pharmacovigilance declarations.
Based on these new declarations, the reporting CRPVs carried out a quantitative interim analysis. Between July and September 2022, 2,952 cases of menstrual disorders were reported with the Comirnaty vaccine (Pfizer/BioNTech), and 515 with the Spikevax vaccine (Moderna). The majority of these declarations were made directly by the patients. Some declarations relate to very earlier events, possibly dating as far back as the spring of 2021. The menstrual disorders declared mainly concern changes in the duration and intensity of bleeding, whether or not associated with pain. The quantitative characteristics (time to onset, average age of patients, etc.) seem similar to previous analyzes (read our press release of June 23, 2022 and ourupdate of December 21, 2021). This new quantitative interim analysis provided results with greater follow-up on the duration of these disorders in some women. Indeed, we observe a possible persistence of these effects in some patients around 6 months. The more precise analysis of these cases by the CRPVs is continuing.
The ANSM brought to European level all the data collected by the French pharmacovigilance system and the results of the analyzes carried out by the reporting CRPVs.
The EMA's European Pharmacovigilance Committee (PRAC) this week reviewed all the data available to date on heavy menstrual bleeding(menorrhagia) reported with mRNA vaccines against Covid-19. Heavy menstrual bleeding is defined as too heavy and/or too long menstrual flow.
On 28 October 2022, the PRAC concluded that heavy menstrual bleeding can be considered a potential adverse reaction to Comirnaty and Spikevax vaccines. The reported cases are most often “non-serious” and transient. Heavy menstrual bleeding will be added to the summaries of product characteristics (SPC) and package leaflets for these two vaccines.
What to do in case of menstrual disorders occurring after vaccination against Covid-19?
https://ansm.sante.fr/actualites/poi...-au-20-10-2022