The EU drug regulator is recommending that people who have had a rare blood vessel syndrome are not immunised with AstraZeneca’s Covid-19 vaccine.
In a statement on Friday, the European Medicines Agency said it reviewed cases of six people who had capillary leak syndrome after they had received 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 being immunised with vaccines made by Pfizer-BioNTech and Moderna.
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, although 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 finalise its review of such cases next month.
Meanwhile, a new manufacturing facility for the production of the Moderna Covid vaccine has been approved in France.
The EMA has given the green light for the facility, in addition to several other sites for batch control/testing.
The health regulator says the changes are expected to allow the production of an additional one to two million vials of ready to use vaccine for the EU every month.