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EMA Warns of New AZ Vaccine Side Effect

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Following a safety review, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has advised against use of the AstraZeneca’s Vaxzevria COVID-19 vaccine in people with a history of capillary leak syndrome. Capillary leak syndrome will be added…

Editor’s note: Find the most recent COVID-19 information and advice in Medscape’s Coronavirus Resource Center.

Following a safety review, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has advised against use of this AstraZeneca’s Vaxzevria COVID-19 vaccine in people who have a history of capillary leak syndrome.

Capillary leak syndrome will be added into this product data as a new side effect of the vaccine using”an unknown frequency,” that the EMA said.

Capillary leak syndrome is a really rare but serious condition that causes fluid leakage from capillaries, resulting in swelling in the arms and thighs, low blood pressure, thickening of the blood, and very low blood levels of albumin.

At its April meeting, the PRAC announced it had been starting a review of a safety signal to assess reports of capillary leak syndrome in people receiving Vaxzevria, as reported by Medscape Medical News.

The agency reviewed a total of 14 reports of capillary leak syndrome. They had adequate information to perform an in-depth review of six cases of capillary leak syndrome in people who had received the vaccine.

Most of these cases occurred in women and over 4 days of vaccination. Three of these affected had a history of capillary leak syndrome, and one of them subsequently died.

As of May 27, 2021, over 78 million doses of the vaccine are administered in the European Union, Liechtenstein, Iceland, Norw

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