Update on review of cases of heavy menstrual bleeding with mRNA COVID-19 vaccines
The PRAC is continuing its assessment of cases of heavy menstrual bleeding (heavy periods) with the COVID-19 mRNA vaccines Comirnaty and Spikevax.
Heavy periods may be defined as bleeding characterised by an increased volume and/or duration which interferes with the person’s physical, social, emotional and material quality of life. Menstrual disorders are very common and can occur with a wide range of underlying medical conditions as well as from stress and tiredness. The PRAC has reviewed all the available data, including cases reported during clinical trials, cases spontaneously reported in Eudravigilance and data from the literature.
The committee agreed to continue the assessment of this safety signal and to request from the marketing authorisation holders an updated cumulative review of the cases of heavy periods…
