FDA Tacks Warning About Rare Reaction To J&J COVID-19 Vaccine

US regulators on Monday (Tuesday, July 13, 2021, in Manila) added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction but said it’s not entirely clear the shot caused the problem, Matthew Perrone and Mike Stobbe reported for the Associated Press (AP).

The Food and Drug Administration (FDA) announced the new warning, flagging reports of Guillain-Barre syndrome (GBS), an immune system disorder that can causes muscle weakness and occasionally paralysis. Health officials described the side effect as a “small possible risk” for those getting the shot.

The action comes after the FDA and the Centers for Disease Control and Prevention (CDC) reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine, almost all of whom were hospitalized. One person died, the FDA said.

GBS occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that typically is temporary. An estimated 3,000 to 6,000 people develop the syndrome each year, according to the CDC.

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 one-dose shot. Most cases were reported in men — many 50 years old and up — and usually about two weeks after vaccination.

J&J said in a statement it has been discussing the reports with the FDA and other health regulators around the world. The CDC said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting.

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