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F.D.A to attach warning of rare nerve syndrome to Johnson & Johnson vaccine: What you need to know

  • The J&J coronavirus vaccine has been linked to an extremely rare neurological disorder, according to the Centers for Disease Control and Prevention. Of the more than 12 million vaccine doses administered in the U.S., there have been around 100 reports of people developing Guillain-Barré Syndrome.

  • Guillain-Barré is a neurological disorder that can cause numbness in the extremities and lead to full-body paralysis in the most severe cases, but most people recover.

  • In light of the newly discovered risk, the Food and Drug Administration has updated the label of the vaccine to include a new warning: "Guillain-Barré Syndrome Reports of adverse events following use of the JanssenCOVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination."

  • The Centers for Disease Control describes Guillain-Barré syndrome as a “rare, autoimmune disorder in which a person’s own immune system damages the nerves, causing muscle weakness and sometimes paralysis.” The agency said in a statement on Monday that the reported cases of the syndrome among J&J vaccine recipients were mostly among men 50 and older.

  • This is not the first setback for the Johnson & Johnson vaccine. 15 million doses of the vaccine had to be thrown out back in March due to contamination concerns at the Baltimore plant where they were manufactured. Emergent BioSolutions, the company that runs the plant, was told by the FDA in June that 60 million doses had to be disposed of for similar reasons.

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