PRAC concludes review of signal of capillary leak syndrome with COVID-19 vaccine Vaxzevria
EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk.
Capillary leak syndrome is a very rare, serious condition that causes fluid leakage from small blood vessels (capillaries), resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low blood levels of albumin (an important blood protein).
The committee carried out an in-depth review of six cases of capillary leak syndrome in people who had received Vaxzevria. Most of the cases occurred in women and within four days of vaccination. Three of those affected had a history of capillary leak syndrome and one of them subsequently died. As of 27 May 2021, more than 78 million doses of Vaxzevria had been administered in the EU/EEA and the UK.
The PRAC also discussed a direct communication to healthcare professionals to raise awareness of the signs and symptoms of capillary leak syndrome and of its risk of recurrence in people who have previously been diagnosed with the condition (see more information in the dedicated section “New safety information for healthcare professionals”).
The PRAC will continue to monitor for cases of the condition and will take any further actions necessary. For more information see EMA’s public health communication.