February 12, (THEWILL) – The European Medicines Agency (EMA) has began probe into reports of heavy menstrual bleeding and absence of menstruation from women who had received COVID vaccines from Pfizer/BioNTech and Moderna.
According to EMA, it’s Pharmacovigilance Risk Assessment Committee (PRAC), said the probe became necessary 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, THEWILL learnt, 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, 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.
The agency on Friday added that there was also no evidence to suggest that COVID-19 vaccines affected fertility.