Capillary Leak Syndrome Risk from COVID-19 Vaccine Identified in Europe

The European Medicine Agency (EMA) announced on July 9, 2021, the safety committee (PRAC) has recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 Vaccine Janssen.

The PRAC reviewed three cases of capillary leak syndrome in people who had received COVID-19 Vaccine Janssen, which occurred within 2 days of vaccination. One of those affected had a history of capillary leak syndrome, and two of them subsequently died.

The PRAC also recommended that capillary leak syndrome 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, resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood, and low blood levels of albumin.

Healthcare professionals should be aware 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, says the EMA.

As of June 21, 2021, more than 18 million doses of COVID-19 Vaccine Janssen had been administered worldwide. People vaccinated with COVID-19 Vaccine Janssen should seek immediate medical assistance if they experience rapid swelling of the arms and legs or sudden weight gain in the days following vaccination. These symptoms are often associated with feeling faint, says the EMA.

This review was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for evaluating safety issues for human medicines in the context of a procedure known as a 'type II variation.' The PRAC’s recommendations will be submitted to EMA’s human medicine committee, CHMP, for endorsement.