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After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome, it was announced in a July 9, 2021 press release.
This recommendation has been based on a review of three cases where capillary leak syndrome occurred in people within two days of receiving Janssen’s COVID-19 vaccine. One of the patients had a history of capillary leak syndrome and two of the patients have subsequently died.
Capillary leak syndrome is a very rare and serious condition and as a result of PRAC’s review, it has been recommended that the condition be added to the product information as a new side effect of the vaccine. Additionally, EMA specified in its press release that awareness of the condition should be raised with healthcare professionals and patients.
Signs and symptoms of capillary leak syndrome include rapid swelling of the arms and legs or sudden weight gain, which is a result of the fluid leakage from small blood vessels. Associated symptoms include feeling faint as a result of low blood pressure.
PRAC will continue to review and monitor any further cases of capillary leak syndrome post vaccination. Furthermore, the committee has requested that Janssen provides further information about the possible mechanism for the development of capillary leak syndrome after vaccination.