The European Medicines Agency (EMA) warned that the capillary leak syndrome (CLS) must be added as a new secondary effect to the labeling of the AstraZeneca coronavirus vaccine.
“The EMA safety committee has concluded that people who previously have had capillary leak syndrome should not be vaccinated with Vaxzevria (formerly COVID-19 AstraZeneca vaccine), “the entity highlighted in a statement.
In addition, he specified that the capillary leak syndrome “should be added to the product information as a new side effect of the vaccine, along with a warning to raise awareness among healthcare professionals and patients about this risk. “
“Capillary leak syndrome is a very rare serious condition that causes a loss of fluid from small blood vessels (capillaries), which causes swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low levels of albumin in the blood “, described the EMA.
The Committee conducted a review of six cases of capillary leak syndrome in people who had received the vaccine, “the majority of cases occurred in women and within 4 days of vaccination,” the EMA reported.
“Three of those affected had a history of capillary leak syndrome and one of them passed away later “, the European organization pointed out.
The EMA specified that the capillary leak syndrome “should be added to the product information as a possible side effect. FotoReuter.
East new side effect, extremely rare, added to thromboembolism. In April, the EMA concluded an investigation and stated that there is a “possible link” between the AstraZeneca vaccine and cases of unusual blood clotting detected weeks after the injection, so it decided to include this clinical picture among the side effects. very rare of this vaccine.
However, the EMA did not define any specific risk factors, such as age, gender or a specific medical history, and maintained its positive assessment between benefits and risks of vaccination with AstraZeneca, since it prevents hospitalizations and deaths among people infected with covid-19.
According to official data, as of May 27, more than 78 million doses of the AstraZeneca vaccine in the United Kingdom and the European Economic Area (EEA), which includes the 27 countries of the European Union (EU), along with Iceland, Liechtenstein and Norway.
On the other hand, the EMA urged pharmaceutical companies and health professionals to report on cases of myocarditis or pericarditis in patients who have received any of the COVID-19 vaccines authorized in the EU, to complete an ongoing evaluation on its possible relationship between the formula and these inflammations.
According to the European Medicines Agency, it continues to evaluate, since last April, “the reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane that surrounds the heart) reported in a small number of people” a which was administered one or two doses of Pfizer / BioNTech, Moderna, AstraZeneca or Janssen.