EU vaccine warning as regulators link rare nerve disorder to Johnson & Johnson Covid jab
AstraZeneca vaccine: EU's stance discussed by virologist
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The European Medicines Agency’s (EMA) safety committee is analysing data provided on cases of Guillain-Barre syndrome in people following vaccination. The watchdog is looking into the cases after the US Food and Drug Administration added the condition to a list of potential rare side effects. J&J has distributed some 18.6 million doses to EU countries, according to the European Centre for Disease Prevention and Control.
The EMA has recently approved a ramp-up of production of the J&J jab at a plant in Leiden, the Netherlands.
EMA bosses said its review was part of regular safety reports for the US firm’s Covid jab.
The FDA has reported 100 preliminary cases of GBS, including 95 serious cases that required hospitalisation and one reported death.
Around 12.8 million people have received J&J’s one-shot jab in the United States.
GBS is a rare neurological condition in which the body’s immune system attacks nerve fibres.
Most cases follow a bacterial or viral infection, and most people fully recovery from it.
Britain’s MHRA regulator has separately announced that it is also reviewing cases of GBS in vaccinated people.
It said: “Our review has not established that these vaccines increase the risk of GBS.”
J&J has yet to be used in the UK’s vaccination drive, but AstraZeneca shots have been widely used.
The two jabs, which use similar viral vector technology to build up an immune response to COVID-19, already include warnings about very rare, but potentially deadly, blood clotting.
The EMA has also added heart inflammation as a “very rare” side-effect of the vaccines made by Pfizer and Moderna.
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The watchdog continues to say the benefit of the jabs outweighs any risks.
But doctors and patients have been advised to be aware of the symptoms of heart inflammation.
These can include chest pain, a feeling of breathlessness and a pounding or fluttering heartbeat.
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The UK’s medicines regulator has also been investigating the link.
The MHRA reported: “A consistent pattern of cases occurring more frequently in young males and shortly after the second dose of the vaccines.
“These reports are extremely rare, and the events are typically mild with individuals usually recovering within a short time with standard treatment and rest,” it added.
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