EU watchdog reviewing Janssen vaccine data after US regulator warns of rare neurological reaction

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EU watchdog reviewing Janssen vaccine data after US regulator warns of rare neurological reaction
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US experts said there had been reports of people who had the jab developing Guillain-Barre syndrome.

Image: SIPA USA/PA Images Image: SIPA USA/PA Images THE EUROPEAN MEDICINES Agency is seeking further information from Johnson & Johnson after US regulators added a warning to the firm’s Janssen Covid-19 vaccine over links to a rare neurological reaction.

EMA will continue its review of the cases and will communicate further when new information becomes available. The US Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can cause muscle weakness and occasionally paralysis. Health officials described the side effect as a “small possible risk”.

The number of cases reported in connection with J&J’s vaccine represents a tiny fraction of the nearly 13 million Americans who have received the shot. Most cases were reported in men — many aged 50 and older — and usually about two weeks after vaccination. The new warning will be included in pamphlets given to people getting the J&J vaccine. They should seek medical attention if they experience any symptoms, which include tingling sensations, trouble walking and double vision, the FDA said.

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