PRAC has started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated with Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Five cases of this very rare disorder, characterised by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure, were reported in the 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. These reports point to a ‘safety signal’ – information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation.
PRAC will evaluate all the available data to decide if a causal relationship is confirmed or not. In cases where a causal relationship is confirmed or considered likely, regulatory action is necessary in order to minimise the risk. This usually takes the form of an update of the summary of product characteristics and the package leaflet. EMA will further communicate on the outcome of the PRAC’s review.