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.

As a result, EMA researchers will “evaluate all the available data to decide if a causal relationship is considered likely or not,” the bulletin reads.

It also noted there is “currently insufficient evidence” of a link between Moderna’s vaccine and cases of multisystem inflammatory syndrome.

Capillary leak syndrome, according to the Mayo Clinic, is a rare disorder involving repeated leaks of large amounts of plasma from blood vessels into nearby body cavities and muscles. The condition—known as Clarkson’s disease—can result in a sharp drop in blood pressure that can lead to organ failure or even death.- READ MORE