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.
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is currently investigating six reported cases of capillary leak syndrome in people who were vaccinated with Spikevax, previously known as COVID-19 vaccine Moderna.
These six cases are out of over 61.6 million doses of the Moderna vaccine administered in the European Union and the European Economic Area (Norway, Iceland and Liechtenstein) and since it received authorization in January 2021. The EMA also pointed out that currently there is no evidence of a causal link between the Moderna vaccine and capillary leak syndrome.