Regulator Reviewing Reports of ‘Rare’ and Serious Condition Linked to Moderna Vaccine

Europe’s drug regulator on Thursday confirmed it is investigating reports of a blood condition in recipients of Moderna’s mRNA COVID-19 vaccine.

According to a bulletin posted by the European Medicines Agency (EMA), it is reviewing six cases of capillary leak syndrome, considered a “very rare disorder,” after they were reported in the EMA’s EudraVigilance database.

“At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of capillary leak syndrome,” the EMA wrote on Thursday, adding that “these reports point to a safety signal … information on new, or changes in, adverse events that may potentially be associated with a medicine or vaccine and that warrant further investigation.”

The review also will address the risk of capillary leak syndrome in groups who have a medical history of the disorder.