ZURICH (Reuters) – The European Medicines Agency (EMA) on Tuesday said it is analysing Johnson & Johnson 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.
(Reporting by John Miller, editing by Louise Heavens)
