The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended adding heavy menstrual bleeding to the product information as a secondary side effect of unknown frequency of Covid-19 “Comirnaty” mRNA vaccines by Pfizer / BioNTech and “Spikevax” by Moderna.
According to data from the Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, up to 9 October 2022 in Spain, 1,220 cases were recorded after vaccination in women aged 12 to 49 years.
Specifically, 921 notifications of this type of disorder were recorded after the administration of “Comirnaty” and 299 notifications after the administration of “Spikevax”. Up to that date, more than 15.6 million doses of “Comirnaty” and 6.2 million doses of “Spikevax” had been administered to women.
Intense menstrual bleeding can be defined as bleeding characterized by an increase in volume or duration that interferes with a person’s physical, social, emotional, and material quality of life. There have been reports of heavy menstrual bleeding after the first, second and booster doses of “Comirnaty” and “Spikevax”.
The PRAC finalized the safety assessment after reviewing the available data, including cases reported during clinical trials, cases reported spontaneously in Eudravigilance and results from the medical literature. Therefore, the Committee concluded that “there is at least a reasonable possibility that the occurrence of heavy menstrual bleeding is causally associated with these vaccines and therefore recommended that the product information be updated”.
The available data initially examined show that the cases that have occurred are of a temporary and not serious nature. Furthermore, there is no evidence to suggest that the menstrual disturbances experienced by some people have an impact on reproduction and fertility. Available data provide reassurance on the use of COVID-19 mRNA vaccines before and during pregnancy.
Menstrual disorders in general are quite common and can occur for a wide variety of reasons. This includes some underlying medical conditions. Anyone who has postmenopausal bleeding or is concerned about a change in menstruation should see their doctor.
On the other hand, a review by the EMA Emergency Task Force showed that COVID-19 mRNA vaccines do not cause complications during pregnancy for pregnant women and their babies and are equally effective in reducing the risk of hospitalization and death. in pregnant people as much as they are in non-pregnant women.
The Committee reiterates that all available data confirm that the benefits of these vaccines far outweigh the risks. And healthcare professionals and patients are encouraged to continue reporting cases of heavy menstrual bleeding to national authorities. In addition, the PRAC will continue to monitor cases of this condition and will further communicate whether new recommendations are warranted.
