The European Union’s drug regulator on Friday said it is recommending adding “heavy menstrual bleeding” as a side effect to both Pfizer’s and Moderna’s COVID-19 vaccines, according to an advisory panel meeting.
The European Medicines Agency’s (EMA) safety committee said that “heavy menstrual bleeding should be added to the product information as a side effect of unknown frequency of the mRNA COVID-19 vaccines Comirnaty and Spikevax,” referring to the Pfizer and Moderna shots.
It defines heavy menstrual bleeding, or heavy periods, as bleeding characterized by more volume or duration that “interferes with the person’s physical, social, emotional, and material quality of life,” noting that “cases of heavy menstrual bleeding have been reported after the first, second, and booster doses of Comirnaty and Spikevax.”…