The Food and Drug Administration (FDA) is reportedly planning to issue a warning for the Johnson & Johnson vaccine linked to a rare but serious side effect with the Guillain-Barré syndrome (Pictures: AP/Reuters/REX)

Johnson & Johnson’s coronavirus vaccine is reportedly about to suffer another setback – a potential warning from the Food and Drug Administration (FDA) that it could lead to increased risk of a rare autoimmune disorder.

The one-dose vaccine has been linked to a side effect that is rare yet serious, the Guillain-Barré syndrome, which involves the immune system attacking the nerves, four sources told the Washington Post on Monday.

There have been about 100 preliminary reports of Guillain-Barré with 12.8million doses of the Johnson & Johnson jab administered in the US, the Centers for Disease Control and Prevention (CDC) stated on Monday. The majority of the cases have been detected in men 50 years and older and about two weeks after inoculation.

The CDC’s Advisory Committee on Immunization Practices is planning to discuss the Guillain-Barré cases at an upcoming meeting.

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