The European Medicines Agency’s safety committee said on Friday it was reviewing reports of heavy menstrual bleeding and absence of menstruation from women who had received COVID vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE)and Moderna (MRNA.O).
The assessment was in view of reports of menstrual disorders after receiving either of the two vaccines, both based on messenger RNA technology, and it was not yet clear whether there was a causal link, the agency said.
It was not yet clear whether there was a causal link between the vaccines and the reports, the agency said.
Menstrual disorders can occur due to a range of underlying medical conditions as well as from stress and tiredness, the EMA said, adding that cases of such disorders had also been reported following COVID-19 infection.
Vaccination against COVID-19 was linked with a small, temporary change in menstrual cycle length, according to a recent study funded by the National Institutes of Health, which collected data from nearly 4,000 users of a smartphone app that tracks menstrual cycles.
But the EMA said in December it had not established a link between changes in menstrual cycles and COVID-19 vaccines, after a study in Norway suggested some women had heavier periods after being inoculated.
After reviewing the available evidence, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said it decided to request an evaluation of all available data, including reports from patients and healthcare professionals, clinical trials and the published literature.