EU advises adding condition to AstraZeneca label

The European Medicines Agency says it's recommending that people who have had a rare blood vessel syndrome not be immunised with AstraZeneca's COVID-19 vaccine. In a statement on Friday, the EU drug regulator said it reviewed cases of six people who had capillary leak syndrome after they had received a shot of the AstraZeneca vaccine.

The vaccine has previously been linked to rare blood clots, but health officials say its benefits still outweigh the small risks.

EMA experts also concluded that the capillary leak condition should be added to the product information as a new side effect of the vaccine.


The agency said it is continuing its review of heart inflammation in a small number of people who developed conditions after getting immunized with the vaccines made by Pfizer-BioNTech or Moderna Inc.

The EMA said it is studying cases of myocarditis, inflammation of the heart, and pericarditis, inflammation of the membrane surrounding the heart. Symptoms include shortness of breath and chest pain; the problems are usually temporary.

"Further analysis is needed to determine whether there is a causal link with the vaccines," the EU agency said.

The EMA said it expects to finalize its review of such cases next month.