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EMA analyses J&J COVID-19 vaccine data for cases of rare nerve disorder

Reuters
Reuters
 2021-07-13
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The exterior of the European Medicines Agency is seen in Amsterdam, Netherlands, December 18, 2020. REUTERS/Piroschka van de Wouw

ZURICH, July 13 (Reuters) - The European Medicines Agency (EMA) on Tuesday said it is analysing Johnson & Johnson (JNJ.N) data on rare cases of a nerve disorder reported in patients who got the company's COVID-19 vaccine after the United States placed a warning on the vaccine.

"As part of the review...EMA’s safety committee (PRAC) is analysing data provided by the marketing authorisation holder on cases of Guillain-Barre syndrome (GBS) reported following vaccination," the regulator said in a statement to Reuters. "PRAC has requested (Johnson & Johnson) to provide further detailed data."

The scrutiny comes as the U.S. Food and Drug Administration on Monday added a warning for Guillain-Barre to the fact sheet for J&J's shot and as the EMA four days ago included a warning for AstraZeneca's COVID-19 shot, to raise awareness among healthcare professionals and people getting the vaccine to be on alert for potential side effects.

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