The European Medicines Agency’s (EMA) safety committee concluded on Friday 11 June that people who have already experienced capillary leak syndrome should not receive the vaccine developed by AstraZeneca.
This syndrome, the EMA recalls, is a very rare and serious condition that causes fluid leakage from small blood vessels, resulting in, among other things, “low blood pressure, thickening of the blood and low blood levels of albumin (an important blood protein)”.
The EMA has investigated six cases of capillary leak syndrome in people who received this vaccine. Most of these cases occurred in women, and three of the people involved had a history of the syndrome, the agency said in a statement, adding that one of them later died.
It therefore recommends that people who have already received the vaccine should seek immediate medical attention if they experience rapid swelling of the arms and legs or sudden weight gain in the days following vaccination.
The Agency is now awaiting further information from AstraZeneca “on a possible mechanism for the development of capillary leak syndrome following vaccination”.
Johnson & Johnson. On the same day, the EMA indicated that the European authorities had been informed of the contamination of a batch of the active substance of the Janssen vaccine, the European subsidiary of the American group Johnson & Johnson.
The batch in question, which was contaminated with materials destined for another vaccine manufactured at the same site in Maryland, was not intended for Europe, the Agency said.
Although batches of the vaccine marketed in the EU are not affected, according to information available to the EMA, “the supervisory authorities have recommended not releasing vaccine batches containing the active substance manufactured at around the same time that the contamination occurred”.
The European agency assures that the EU authorities are doing their utmost to safeguard supplies and mitigate the effects of delivery delays. (Original version in French by Agathe Cherki)