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European Medicines Agency reviews Janssen vaccine for rare nerve disorder

DUBLIN: The European Union’s drug regulator said it was examining into a possible link between the Johnson & Johnson COVID-19 vaccine and a rare nerve disorder.

The European Medicines Agency’s (EMA) analysis of data on rare cases of Guillain-Barre syndrome (GBS) followed the US Food and Drug Administration’s (FDA) warning labelling of the Janssen (J&J) vaccine.

The EU watchdog said in a statement that its safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), is analysing data provided by J&J on GBS cases reported following vaccination. The vaccine manufacturer has also been asked to provide more detailed data by the safety committee.

Guillain-Barre syndrome is a rare neurological condition in which the body’s immune system attacks the protective covering of nerve fibres. The majority of cases are caused by a bacterial or viral infection, and most people recover from this disorder.

The FDA’s decision to add a warning label to the J&J shot came after it found that 95 of GBS’s 100 preliminary reports had to be hospitalised due to serious cases and one death had been reported.

The one-dose J&J vaccine has been administered to about 12.8 million people in the United States. According to the European Centre for Disease Prevention and Control, J&J has delivered 18.6 million doses across the EU.

The EMA said its analysis was part of the regular summary safety reports for J&J vaccine. The drug regulator provided no details about potential GBS cases in Europe.

Meanwhile, the UK’s MHRA medicines regulator said it was looking into cases of GBS in patients who had been vaccinated. However, it said that their review found no evidence that these vaccines increase the risk of a rare nerve disorder.  The AstraZeneca vaccine is widely used in the UK.

AstraZeneca and Johnson & Johnson vaccines already carry warnings regarding very rare but potentially fatal blood clotting.

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